[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Rules and Regulations]
[Pages 77008-77831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25240]



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Vol. 81

Friday,

No. 214

November 4, 2016

Part II





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; Final Rule

  Federal Register / Vol. 81 , No. 214 / Friday, November 4, 2016 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 414 and 495

[CMS-5517-FC]
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: Final rule with comment period.

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SUMMARY: The 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 approach to payment called the Quality Payment Program that rewards 
the delivery of high-quality patient care through two avenues: Advanced 
Alternative Payment Models (Advanced APMs) and the Merit-based 
Incentive Payment System (MIPS) for eligible clinicians or groups under 
the PFS. This final rule with comment period establishes incentives for 
participation in certain alternative payment models (APMs) and includes 
the criteria for use by the Physician-Focused Payment Model Technical 
Advisory Committee (PTAC) in making comments and recommendations on 
physician-focused payment models (PFPMs). Alternative Payment Models 
are payment approaches, developed in partnership with the clinician 
community, that provide added incentives to deliver high-quality and 
cost-efficient care. APMs can apply to a specific clinical condition, a 
care episode, or a population. This final rule with comment period also 
establishes the MIPS, a new program for certain Medicare-enrolled 
practitioners. MIPS will 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 
will continue the focus on quality, cost, and use of certified EHR 
technology (CEHRT) in a cohesive program that avoids redundancies. In 
this final rule with comment period we have rebranded key terminology 
based on feedback from stakeholders, with the goal of selecting terms 
that will be more easily identified and understood by our stakeholders.

DATES: Effective date: The provisions of this final rule with comment 
period are effective on January 1, 2017.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on December 19, 2016.

ADDRESSES: In commenting, please refer to file code CMS-5517-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. You may submit comments in one of four 
ways (please choose only one of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to 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-FC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-5517-FC, 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: 

Table of Contents

I. Executive Summary
II. Provisions of the Proposed Regulations and Analysis of and 
Responses to Comments
    A. Establishing MIPS and the Advanced APM Incentive
    B. Program Principles and Goals
    C. Changes to Existing Programs
    D. Definitions
    E. MIPS Program Details
    F. Overview of Incentives for Participation in Advanced 
Alternative Payment Models
III. Collection of Information Requirements
IV. 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

Acronyms

Because of the many terms to which we refer by acronym in this rule, we 
are listing the acronyms used and their corresponding meanings in 
alphabetical order below:

ABCTM Achievable Benchmark of Care
ACO Accountable Care Organization
APM Alternative Payment Model
APRN Advanced Practice Registered Nurse
ASPE HHS' Office of the Assistant Secretary for Planning and 
Evaluation
BPCI Bundled Payments for Care Improvement
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CBSA Non-Core Based Statistical Area
CDS Clinical Decision Support
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 (CMS Innovation 
Center)
COI Collection of Information

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CPIA Clinical Practice Improvement Activity
CPOE Computerized Provider Order Entry
CPR Customary, Prevailing, and Reasonable
CPS Composite Performance Score
CPT Current Procedural Terminology
CQM Clinical Quality Measure
CY Calendar Year
eCQM electronic Clinician Quality Measure
ED Emergency Department
EHR Electronic Health Record
EP Eligible Professional
ESRD End-Stage Renal Disease
FFS Fee-for-Service
FR Federal Register
FQHC Federally Qualified Health Center
GAO Government Accountability Office
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
IHS Indian Health Service
IT Information Technology
LDO Large Dialysis Organization
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
PTAC Physician-Focused Payment Model Technical Advisory Committee
QCDR Qualified Clinical Data Registry
QP Qualifying APM Participant
QRDA Quality Reporting Document Architecture
QRUR Quality and Cost Reports
RBRVS Resource-Based Relative Value Scale
RFI Request for Information
RHC Rural Health Clinic
RIA Regulatory Impact Analysis
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

I. Executive Summary

1. Overview
    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, to reauthorize the Children's Health Insurance Program, and to 
strengthen Medicare access by improving physician and other clinician 
payments and making other improvements. This rule finalizes policies to 
improve physician and other clinician 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 (APMs). These unified policies to promote 
greater value within the healthcare system are referred to as the 
Quality Payment Program.
    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:
     Advanced Alternative Payment Models (Advanced APMs).
     Merit-based Incentive Payment System (MIPS).
    The MACRA marks a milestone in efforts to improve and reform the 
health care system. Building off of the successful coverage expansions 
and improvements to access under the Patient Protection and Affordable 
Care Act (Affordable Care Act), the MACRA puts an increased focus on 
the quality and value of care delivered. By implementing MACRA to 
promote participation in certain APMs, such as the Shared Saving 
Program, Medical Home Models, and innovative episode payment models for 
cardiac and joint care, and by paying eligible clinicians for quality 
and value under 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. By driving 
significant changes in how care is delivered to make the health care 
system more responsive to patients and families, we believe the Quality 
Payment Program supports eligible clinicians in improving the health of 
their patients, including encouraging interested eligible clinicians in 
their successful transition into APMs. To implement this vision, we are 
finalizing a program that emphasizes high-quality care and patient 
outcomes while minimizing burden on eligible clinicians and that is 
flexible, highly transparent, and improves over time with input from 
clinical practices. To aid in this process, we have sought feedback 
from the health care community through various public avenues and 
solicited comment through the proposed rule. As we establish policies 
for effective implementation of the MACRA, we do so with the explicit 
understanding that technology, infrastructure, physician support 
systems, and clinical practices will change over the next few years. In 
addition, we are aware of the diversity of clinician practices in their 
experience with quality-based payments. As a result of these factors, 
we expect the Quality Payment Program to evolve over multiple years in 
order to achieve our national goals. In the early years of the program, 
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 policies that 
are operationally feasible and made in consideration of system 
capabilities and our core strategies to drive progress and reform 
efforts. Thus, due to this staged approach, we are finalizing the rule 
with a comment period. We commit to continue iterating on these 
policies.
    The Quality Payment Program aims to do the following: (1) Support 
care improvement by focusing on better outcomes for patients, decreased 
provider burden, and preservation of independent clinical practice; (2) 
promote adoption of alternative payment models that align incentives 
across healthcare stakeholders; and (3) advance existing efforts of 
Delivery System Reform, including ensuring a smooth transition to a new 
system that promotes high-quality, efficient care through unification 
of CMS legacy programs.
    This final rule with comment period establishes the Quality Payment 
Program and its two interrelated pathways: Advanced APMs and the MIPS. 
This final rule with comment period establishes incentives for 
participation in Advanced APMs, supporting the Administration's goals 
of transitioning from fee-for-service (FFS) payments to payments for 
quality and value, including approaches that focus on better care, 
smarter spending, and healthier people. This final rule with comment 
period also includes definitions of Qualifying APM Participants (QPs) 
in Advanced APMs and outlines the 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).
    MIPS is a new program for certain Medicare-participating eligible

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clinicians that will make payment adjustments based on performance on 
quality, cost and other measures, and will 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). As prescribed by Congress, MIPS will focus on: 
Quality--both a set of evidence-based, specialty-specific standards as 
well as practice-based improvement activities; cost; and use of 
certified electronic health record (EHR) technology (CEHRT) to support 
interoperability and advanced quality objectives in a single, cohesive 
program that avoids redundancies. Many features of MIPS are intended to 
simplify and integrate further during the second and third years.
2. Quality Payment Program Strategic Objectives
    We solicited and reviewed over 4000 comments and had over 100,000 
physicians and other stakeholders attend our outreach sessions. Through 
this outreach, we created six strategic objectives to drive continued 
progress and improvement.
    These objectives guided our final policies and will guide our 
future rulemaking in order to design, implement and evolve a Quality 
Payment Program that aims to improve health outcomes, promote smarter 
spending, minimize burden of participation, and provide fairness and 
transparency in operations. These strategic objectives are as follows: 
(1) To improve beneficiary outcomes and engage patients through 
patient-centered Advanced APM and MIPS policies; (2) to enhance 
clinician experience through flexible and transparent program design 
and interactions with easy-to-use program tools; (3) to increase the 
availability and adoption of robust Advanced APMs; (4) to promote 
program understanding and maximize participation through customized 
communication, education, outreach and support that meet the needs of 
the diversity of physician practices and patients, especially the 
unique needs of small practices; (5) to improve data and information 
sharing to provide accurate, timely, and actionable feedback to 
clinicians and other stakeholders; and (6) to ensure operational 
excellence in program implementation and ongoing development. More 
information on these objectives and the Quality Payment Program can be 
found at QualityPaymentProgram.cms.gov.
    With these objectives we recognize that the Quality Payment Program 
provides new opportunities to improve care delivery by supporting and 
rewarding clinicians as they find new ways to engage patients, families 
and caregivers and to improve care coordination and population health 
management. In addition, we recognize that by developing a program that 
is flexible instead of one-size-fits-all, clinicians will be able to 
choose to participate in a way that is best for them, their practice, 
and their patients. For clinicians interested in APMs, we believe that 
by setting ambitious yet achievable goals, eligible clinicians will 
move with greater certainty toward these new approaches of delivering 
care. To these ends, and to ensure this program works for all 
stakeholders, we further recognize that we must provide ongoing 
education, support, and technical assistance so that clinicians can 
understand program requirements, use available tools to enhance their 
practices, and improve quality and progress toward participation in 
alternative payment models if that is the best choice for their 
practice. Finally, we understand that we must achieve excellence in 
program management, focusing on customer needs, promoting problem-
solving, teamwork, and leadership to provide continuous improvements in 
the Quality Payment Program.
3. One Quality Payment Program
    Clinicians have told us that they do not separate their patient 
care into domains, and that the Quality Payment Program needs to 
reflect typical clinical workflows in order to achieve its goals of 
better patient care. Advanced APMs, the focus of one pathway of the 
Quality Payment Program, contribute to better care and smarter spending 
by allowing physicians and other clinicians to deliver coordinated, 
customized, high-quality care to their patients within a streamlined 
payment system. Within MIPS, the second pathway of the Quality Payment 
Program, we believe that the unification into one Quality Payment 
Program can best be accomplished by making connections across the four 
pillars of the MIPS payment structure identified in the MACRA 
legislation--quality, clinical practice improvement activities 
(referred to as ``improvement activities''), meaningful use of CEHRT 
(referred to as ``advancing care information''), and resource use 
(referred to as ``cost'')--and by emphasizing that the Quality Payment 
Program is at its core about improving the quality of patient care. 
Indeed, the bedrock of the Quality Payment Program is high-quality, 
patient-centered care followed by useful feedback, in a continuous 
cycle of improvement. The principal way MIPS measures quality of care 
is through evidence-based clinical quality measures (CQMs) which MIPS 
eligible clinicians can select, the vast majority of which are created 
by or supported by clinical leaders and endorsed by a consensus-based 
process. Over time, the portfolio of quality measures will grow and 
develop, driving towards outcomes that are of the greatest importance 
to patients and clinicians. Through MIPS, we have the opportunity to 
measure quality not only through clinician-proposed measures, but to 
take it a step further by also accounting for activities that 
physicians themselves identify: Namely, practice-driven quality 
improvement. The MACRA requires us to measure whether technology is 
used meaningfully. Based on significant feedback, this area is 
simplified into supporting the exchange of patient information and how 
technology specifically supports the quality goals selected by the 
practice. The cost performance category has also been simplified and 
weighted at zero percent of the final score for the transition year of 
CY 2017. Given the primary focus on quality, we have accordingly 
indicated our intention to align these measures fully to the quality 
measures over time in the scoring system (see section II.E.6.a. for 
further details). That is, we are establishing special policies for the 
first year of the Quality Payment Program, which we refer to as the 
``transition year'' throughout this final rule with comment period; 
this transition year corresponds to the first performance period of the 
program, calendar year (CY) 2017, and the first payment year, CY 2019. 
We envision that it will take a few years to reach a steady state in 
the program, and we therefore anticipate a ramp-up process and gradual 
transition with less financial risk for clinicians in at least the 
first 2 years. In the transition year in 2017, we will test this 
performance category alignment, for example by allowing certain 
improvement activities that are completed using CEHRT to achieve a 
bonus score in the advancing care information performance category with 
the intent of analyzing adoption, and in future years, potentially 
adding activities that reinforce integration of the program. Our hope 
is for the program to evolve to the point where all the clinical 
activities captured in MIPS across the four performance categories 
reflect the single, unified goal of quality improvement.

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4. Summary of the Major Provisions
a. Transition Year and Iterative Learning and Development Period
    We recognize, as described through many insightful comments, that 
many eligible clinicians face challenges in understanding the 
requirements and being prepared to participate in the Quality Payment 
Program in 2017. As a result, we have decided to finalize transitional 
policies throughout this final rule with comment period, which will 
focus the program in its initial years on encouraging participation and 
educating clinicians, all with the primary goal of placing the patient 
at the center of the healthcare system. At the same time, we will also 
increase opportunities to join Advanced APMs, allowing eligible 
clinicians who chose to do so an opportunity to participate.
    Given the wide diversity of clinical practices, the initial 
development period of the Quality Payment Program implementation would 
allow physicians to pick their pace of participation for the first 
performance period that begins January 1, 2017. Eligible clinicians 
will have three flexible options to submit data to MIPS and a fourth 
option to join Advanced APMs in order to become QPs, which would ensure 
they do not receive a negative payment adjustment in 2019.
    In the transition year CY 2017 of the program, this rule finalizes 
a period during which clinicians and CMS will build capabilities to 
report and gain experience with the program. Clinicians can choose 
their course of participation in this year with four options.
    (1) Clinicians can choose to report to MIPS for a full 90-day 
period or, ideally, the full year, and maximize the MIPS eligible 
clinician's chances to qualify for a positive adjustment. In addition, 
MIPS eligible clinicians who are exceptional performers in MIPS, as 
shown by the practice information that they submit, are eligible for an 
additional positive adjustment for each year of the first 6 years of 
the program.
    (2) Clinicians can choose to report to MIPS for a period of time 
less than the full year performance period 2017 but for a full 90-day 
period at a minimum and report more than one quality measure, more than 
one improvement activity, or more than the required measures in the 
advancing care information performance category in order to avoid a 
negative MIPS payment adjustment and to possibly receive a positive 
MIPS payment adjustment.
    (3) Clinicians can choose to report one measure in the quality 
performance category; one activity in the improvement activities 
performance category; or report the required measures of the advancing 
care information performance category and avoid a negative MIPS payment 
adjustment. Alternatively, if MIPS eligible clinicians choose to not 
report even one measure or activity, they will receive the full 
negative 4 percent adjustment.
    (4) MIPS eligible clinicians can participate in Advanced APMs, and 
if they receive a sufficient portion of their Medicare payments or see 
a sufficient portion of their Medicare patients through the Advanced 
APM, they will qualify for a 5 percent bonus incentive payment in 2019.
    We are finalizing the 2017 performance period for the 2019 MIPS 
payment year to be a transition year as part of the development period 
in the program. For this transition year, for MIPS the performance 
threshold will be lowered to a threshold of 3 points. Clinicians who 
achieve a final score of 70 or higher will be eligible for the 
exceptional performance adjustment, funded from a pool of $500 million.
    For full participation in MIPS and in order to achieve the highest 
possible final scores, MIPS eligible clinicians are encouraged to 
submit measures and activities in all three integrated performance 
categories: Quality, improvement activities, and advancing care 
information. To address public comments on the cost performance 
category, the weighting of the cost performance category has been 
lowered to 0 percent for the transition year. For full participation in 
the quality performance category, clinicians will report on six quality 
measures, or one specialty-specific or subspecialty-specific measure 
set. For full participation in the advancing care information 
performance category, MIPS eligible clinicians will report on five 
required measures. For full participation in the improvement activities 
performance category, clinicians can engage in up to four activities, 
rather than the proposed six activities, to earn the highest possible 
score of 40.
    For the transition year CY 2017, for quality, clinicians who submit 
one out of at least six quality measures will meet the MIPS performance 
threshold of 3; however, more measures are required for groups who 
submit measures using the CMS Web Interface. For the transition year CY 
2017, for quality, higher measure points may be awarded based on 
achieving higher performance in the measure. For improvement 
activities, attesting to at least one improvement activity will also be 
sufficient to meet the MIPS performance threshold in the transition 
year CY 2017. For advancing care information, clinicians reporting on 
the required measures in that category will meet the performance 
threshold in the transition year. These transition year policies for CY 
2017 will encourage participation by clinicians and will provide a ramp 
up period for clinicians to prepare for higher performance thresholds 
in the second year of the program.
    Historical evidence has shown that clinical practices of all sizes 
can successfully submit data, including over 110,000 solo and small 
practices with 15 or fewer clinicians who participated in PQRS in 2015. 
The transition year and development period approach gives clinicians 
structured, practical choices that can best suit their practices. 
Resources will be made available to assist clinicians and practices 
through this transition. The hope is that by lowering the barriers to 
participation at the outset, we can set the foundation for a program 
that supports long-term, high-quality patient care through feedback and 
open communication between CMS and other stakeholders.
    We anticipate that the iterative learning and development period 
will last longer than the first year, CY 2017, of the program as we 
move towards a steady state; therefore, we envision CY 2018 to also be 
transitional in nature to provide a ramp-up of the program and of the 
performance thresholds. We anticipate making proposals on the 
parameters of this second transition year through rule-making in 2017.
b. Legacy Quality Reporting Programs
    This final rule with comment period will sunset payment adjustments 
under the current Medicare EHR Incentive Program for EPs (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) programs after CY2018. Components 
of these three programs will be carried forward into MIPS. This final 
rule with comment period establishes new subpart O of our regulations 
at 42 CFR part 414 to implement the new MIPS program as required by the 
MACRA.
c. Significant Changes From Proposed Rule
    In developing this final rule with comment period, we sought 
feedback from stakeholders throughout the process, including through 
Requests for Information in October 2015 and through the comment 
process for the proposed rule from April to June 2016. We received 
thousands of comments from a broad range of sources including 
professional associations and societies, physician practices, 
hospitals, patient

[[Page 77012]]

groups, and health IT vendors, and we thank our many commenters and 
acknowledge their valued input throughout the proposed rule process. In 
response to comments to the proposed rule, we have made significant 
changes in this final rule with comment period, including (1) 
bolstering support for small and independent practices; (2) 
strengthening the movement towards Advanced Alternative Payment Models 
by offering potential new opportunities such as the Medicare ACO Track 
1+ (3) securing a strong start to the program with a flexible, pick-
your-own-pace approach to the initial years of the program; and (4) 
connecting the statutory domains into one unified program that supports 
clinician-driven quality improvement. These themes are illustrated in 
the following specific policy changes: (1) The creation of a transition 
year and iterative learning and development period in the beginning of 
the program; (2) the adjustment of the MIPS low-volume threshold; (3) 
the establishment of an Advanced APM financial risk standard that 
promotes participation in robust, high-quality models; (4) the 
simplification of prior ``all-or-nothing'' requirements in the use of 
certified EHR technology; and (5) the establishment of Medical Home 
Model standards that promote care coordination.
    We intend to continue open communication with stakeholders, 
including consultation with tribes and tribal officials, on an ongoing 
basis as we develop the Quality Payment Program in future years.
d. Small Practices
    As outlined above, protection of small, independent practices is an 
important thematic objective for this final rule with comment. For 
2017, many small practices will be excluded from new requirements due 
to the low-volume threshold, which has been set at less than or equal 
to $30,000 in Medicare Part B allowed charges or less than or equal to 
100 Medicare patients, representing 32.5 percent of pre-exclusion 
Medicare clinicians but only 5 percent of Medicare Part B spending. 
Stakeholder comments suggested setting a higher low-volume threshold 
for exclusion from MIPS but allowing clinicians that would be excluded 
by the threshold to opt in to the program if they wished to report to 
MIPS and receive a MIPS payment adjustment for the year. We considered 
this option but determined that it was inconsistent with the statutory 
MIPS exclusion based on the low-volume threshold. We anticipate that 
more clinicians will be determined to be eligible to participate in the 
program in future years.
    MACRA also provides that solo and small practices may join 
``virtual groups'' and combine their MIPS reporting. Many commenters 
suggested that we allow groups with more than 10 clinicians to 
participate as virtual groups. As noted, the statute limits the virtual 
group option to individuals and groups of not more than 10 clinicians. 
We are not implementing virtual groups in the transition year CY 2017 
of the program; however, through the policies of the transition year 
and development period, we believe we have addressed some of the 
concerns expressed by clinicians hesitant to participate in the Quality 
Payment Program. CMS wants to make sure the virtual group technology is 
meaningful and simple to use for clinicians, and we look forward to 
stakeholder engagement on how to structure and implement virtual groups 
in future years of the program.
    In keeping with the objectives of providing education about the 
program and maximizing participation, and as mandated by the MACRA, 
$100 million in technical assistance will be available to MIPS eligible 
clinicians in small practices, rural areas, and practices located in 
geographic health professional shortage areas (HPSAs), including IHS, 
tribal, and urban Indian clinics, through contracts with quality 
improvement organizations, regional health collaboratives, and others 
to offer guidance and assistance to MIPS eligible clinicians in 
practices of 15 or fewer MIPS eligible clinicians. Priority will be 
given to practices located in rural areas, defined as clinicians in zip 
codes designated as rural, using the most recent Health Resources and 
Services Administration (HRSA) Area Health Resource File data set 
available; medically underserved areas (MUAs); and practices with low 
MIPS final scores or in transition to APM participation. The MACRA also 
includes provisions requiring an examination of the pooling of 
financial risk for physician practices, in particular for small 
practices. Specifically, section 101(c)(2)(C) of MACRA requires the 
Government Accountability Office (GAO) to submit a report to Congress, 
not later than January 1, 2017, examining whether entities that pool 
financial risk for physician practices, such as independent risk 
managers, can play a role in supporting physician practices, 
particularly small physician practices, in assuming financial risk for 
the treatment of patients. We have been closely engaged with the GAO 
throughout their study to better understand the unique needs and 
challenges faced by clinicians in small practices and practices in 
rural or health professional shortage areas. We have provided 
information to the GAO, and the GAO has shared some of their initial 
findings regarding these challenges. We look forward to further 
engagement with the GAO on this topic and to the release of GAO's final 
report. Using the knowledge obtained from small practices, other 
stakeholders, and the public, as well as from GAO, we continue to work 
to improve the flexibility and support available to small, underserved, 
and rural practices. Throughout the evolution of the Quality Payment 
Program that will unfold over the years to come, CMS is committed to 
working together with stakeholders to address the unique challenges 
these practices encounter.
    Using updated policies for the transition year and development 
period, we performed an updated regulatory impact analysis, including 
for small and solo practices. With the extensive changes to policy and 
increased flexibility, we believe that estimating impacts of this final 
rule with comment period using only historic 2015 quality submission 
data significantly overestimates the impact on small and solo 
practices. Although small and solo practices have historically been 
less likely to engage in PQRS and quality reporting, we believe that 
small and solo practices will respond to MIPS by participating at a 
rate close to that of other practice sizes. In order to quantify the 
impact of the rule on MIPS eligible clinicians, including small and 
solo practices, we have prepared two sets of analyses that assume the 
participation rates for some categories of small practices will be 
similar to those of other practice size categories. Specifically, our 
primary analysis assumes that each practice size grouping will achieve 
at least 90 percent participation rate and our alternative assumption 
is that each practice size grouping will achieve at least an 80 percent 
participation rate. In both sets of analyses, we estimate that over 90 
percent of MIPS eligible clinicians will receive a positive or neutral 
MIPS payment adjustment in the transition year, and that at least 80 
percent of clinicians in small and solo practices with 1-9 clinicians 
will receive a positive or neutral MIPS payment adjustment.
e. Advanced Alternative Payment Models (Advanced APMs)
    In this rule, we finalize requirements we will use for the purposes 
of the incentives for participation in Advanced

[[Page 77013]]

APMs, and the following is a summary of our finalized policies. The 
MACRA defines APM for the purposes of the incentive as a model under 
section 1115A of 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.
    APMs represent an important step forward in the Administration's 
efforts to move our healthcare system from volume-based to value-based 
care. APMs that meet the criteria to be Advanced APMs provide the 
pathway through which eligible clinicians, who would otherwise 
participate in MIPS, can become Qualifying APM Participants (QPs), and 
therefore, earn incentive payments for their Advanced APM 
participation. In the proposed rule, we estimated that 30,000 to 90,000 
clinicians would be QPs in 2017. With new Advanced APMs expected to 
become available for participation in 2017 and 2018, including the 
Medicare ACO Track 1 Plus (1+), and anticipated amendments to reopen 
applications for or modify current APMs, such as the Maryland All-Payer 
Model and Comprehensive Care for Joint Replacement (CJR) model, we 
anticipate higher numbers of QPs--approximately 70,000 to 120,000 in 
2017 and 125,000 to 250,000 in 2018.
    As discussed in section II.F.4.b. of this final rule with comment 
period, we are exploring development of the Medicare ACO Track 1+ Model 
to begin in 2018. The model would be voluntary for ACOs currently 
participating in Track 1 of the Shared Savings Program or ACOs seeking 
to participate in the Shared Savings Program for the first time. It 
would test a payment model that incorporates more limited downside risk 
than is currently present in Tracks 2 or 3 of the Shared Savings 
Program but sufficient financial risk in order to be an Advanced APM. 
We will announce additional information about the model in the future.
    This rule finalizes two types of Advanced APMs: Advanced APMs and 
Other Payer Advanced APMs. To be considered an Advanced APM, an APM 
must meet all three of the following criteria, as required under 
section 1833(z)(3)(D) of the Act: (1) The APM must require participants 
to use CEHRT; (2) The APM must provide for payment for covered 
professional services based on quality measures comparable to those in 
the quality performance category under MIPS and; (3) The APM must 
either require that participating APM Entities bear risk for monetary 
losses of a more than nominal amount under the APM, or be a Medical 
Home Model expanded under section 1115A(c) of the Act. In this rule, we 
finalize proposals pertaining to all of these criteria.
    To be an Other Payer Advanced APM, as set forth in section 
1833(z)(2) of the Act, a payment arrangement with a payer (for example, 
Medicaid or a commercial payer) must meet all three of the following 
criteria: (1) The payment arrangement must require participants to use 
CEHRT; (2) The payment arrangement must provide for payment for covered 
professional services based on quality measures comparable to those in 
the quality performance category under MIPS and; (3) The payment 
arrangement must require participants to either bear more than nominal 
financial risk if actual aggregate expenditures exceed expected 
aggregate expenditures; or be a Medicaid Medical Home Model that meets 
criteria comparable to Medical Home Models expanded under section 
1115A(c) of the Act.
    We are completing an initial set of Advanced APM determinations 
that we will release as soon as possible but no later than January 1, 
2017. For new APMs that are announced after the initial determination, 
we will include Advanced APM determinations in conjunction with the 
first public notice of the APM, such as the Request for Applications 
(RFA) or final rule. All determinations of Advanced APMs will be posted 
on our Web site and updated on an ad hoc basis, but no less frequently 
than annually, as new APMs become available and others end or change.
    An important avenue for the creation of innovative payment models 
is the PTAC, created by the MACRA. The PTAC is an 11-member independent 
federal advisory committee to the HHS Secretary. The PTAC will review 
stakeholders' proposed PFPMs, and make comments and recommendations to 
the Secretary regarding whether the PFPMs meet criteria established by 
the Secretary. PTAC comments and recommendations will be reviewed by 
the CMS Innovation Center and the Secretary, and we will post a 
detailed response to them on the CMS Web site.
(i) QP Determination
    QPs are eligible clinicians in an Advanced APM who have a certain 
percentage of their patients or payments through an Advanced APM. QPs 
are excluded from MIPS and receive a 5 percent incentive payment for a 
year beginning in 2019 through 2024. We finalize our proposal 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 using the patient count method.
    We finalize definitions of Medical Home Model and Medicaid Medical 
Home Model and the unique standards by which Medical Home Models may 
meet the financial risk criterion to be an Advanced APM.
    The statute sets thresholds 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 in the 
payment year 2019. The All-Payer Combination Option, which utilizes the 
Medicare Option as well as an eligible clinician's participation in 
Other Payer Advanced APMs, is applicable beginning in the payment year 
2021. For eligible clinicians to become QPs through the All-Payer 
Combination Option, an Advanced APM Entity or eligible clinician must 
participate in an Advanced APM under Medicare and also submit 
information to CMS so that we can determine whether payment 
arrangements with non-Medicare payers are an Other Payer Advanced APMs 
and whether an eligible clinician meets the requisite QP threshold of 
participation. We are finalizing our methodologies to evaluate eligible 
clinicians using the Medicare and All-Payer Combination Options.
    We are finalizing the two methods by which we will calculate 
Threshold Scores to compare to the QP thresholds and make QP 
determinations for eligible clinicians. The payment amount method 
assesses the amount of payments for Part B covered professional 
services that are furnished through an Advanced APM. The patient count 
method assesses the amount of patients furnished Part B covered 
professional services through an Advanced APM.
    We are finalizing our proposal to identify individual eligible 
clinicians by a unique APM participant identifier using the 
individuals' APM, APM Entity, and 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 their QP status 
for a year. We are finalizing 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 will assess 
the eligible

[[Page 77014]]

clinician individually to determine QP status based on combined 
participation in Advanced APMs.
    We are finalizing the method to calculate and disburse the lump-sum 
APM Incentive Payments to QPs, and we are finalizing a specific 
approach for calculating the APM Incentive Payment when a QP also 
receives non-FFS payments or has received payment adjustments through 
the Medicare EHR Incentive Program, PQRS, VM, or MIPS during the prior 
period used for determining the APM Incentive Payment.
    We are finalizing a modified policy such that, following a final 
determination that an Advanced APM Entity group or eligible clinician 
is determined to be a Partial Qualifying APM Participant (Partial QP), 
the Advanced APM Entity--or eligible clinician in the case of an 
individual determination--will make an election on behalf of all of its 
eligible clinicians in the group of whether to report to MIPS, thus 
making all eligible clinicians in the Advanced APM Entity group subject 
to MIPS payment adjustments; or not report to MIPS, thus excluding all 
eligible clinicians in the APM Entity group from MIPS adjustments. We 
finalize our proposals to vet and monitor APM Entities, Advanced APM 
Entities, and eligible clinicians participating in those entities. We 
are finalizing a definition for PFPMs and criteria for use by the PTAC 
in fulfilling its responsibility to evaluate proposals for PFPMs.
    We are finalizing an accelerated timeline for making QP 
determinations, and will notify eligible clinicians of their QP status 
as soon as possible, in advance of the end of the MIPS performance 
period so that QPs will know whether they are excluded from MIPS prior 
to having to submit information to CMS for purposes of MIPS.
    We are finalizing the requirement that MIPS eligible clinicians, as 
well as EPs, eligible hospitals, and CAHs under the existing Medicare 
and Medicaid EHR Incentive Programs demonstrate cooperation with 
certain provisions concerning blocking the sharing of information under 
section 106(b)(2) of the MACRA and, separately, to demonstrate 
engagement with activities that support health care providers with the 
performance of their CEHRT such as cooperation with ONC direct review 
of certified health information technologies.
f. Merit-Based Incentive Payment System (MIPS)
    In establishing MIPS, this final rule with comment period will 
define MIPS 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 who bill under Medicare Part B. The rule 
finalizes definitions and requirements for groups. In addition to 
finalizing definitions for MIPS eligible clinicians, the rule also 
finalizes rules for the specific Medicare-enrolled clinicians that will 
be excluded from MIPS, including newly Medicare-enrolled MIPS eligible 
clinicians, QPs, certain Partial QPs, and clinicians that fall under 
the finalized low-volume threshold.
    For the 2017 performance period, we estimate that more than half of 
clinicians--approximately 738,000 to 780,000--billing under the 
Medicare PFS will be excluded from MIPS due to several factors, 
including the MACRA itself. We estimate that nearly 200,000 clinicians, 
or approximately 14.4 percent, are not one of the eligible types of 
clinicians for the transition year CY 2017 of MIPS under section 
1848(q)(1)(C) of the Act. The largest cohort of clinicians excluded 
from MIPS is low-volume clinicians, defined as those clinicians with 
less than or equal to $30,000 in allowed charges or less than or equal 
to 100 Medicare patients, representing approximately 32.5 percent of 
all clinicians billing Medicare Part B services or over 380,000 
clinicians. Additionally, between 70,000 and 120,000 clinicians 
(approximately 5-8 percent of all clinicians billing under the Medicare 
Part B) will be excluded from MIPS due to being QPs based on 
participation in Advanced APMs. In aggregate, the eligible clinicians 
excluded from MIPS represent only 22 to 27 percent of total Part B 
allowed charges.
    This rule finalizes MIPS performance standards and a minimum MIPS 
performance period of any 90 continuous days during CY 2017 (January 1 
through December 31) for all measures and activities applicable to the 
integrated performance categories. After consideration of public 
comments, this rule finalizes a shorter than annual performance period 
in 2017 to allow flexible participation options for MIPS eligible 
clinicians as the program begins and evolves over time. For performance 
periods occurring in 2017, MIPS eligible clinicians will be able to 
pick a pace of participation that best suits their practices, including 
submitting data, in special circumstances as discussed in section 
II.E.5. of this rule, for a period of less than 90 days, to avoid a 
negative MIPS payment adjustment. Further, we are finalizing our 
proposal to use performance in 2017 as the performance period for the 
2019 payment adjustment. Therefore, the first performance period will 
start in 2017 and consist of a minimum period of any 90 continuous days 
during the calendar year in order for clinicians to be eligible for 
payment adjustment above neutral. Performance in that period of 2017 
will be used to determine the 2019 payment adjustment. This timeframe 
is needed to allow data and claims to be submitted and data analysis to 
occur in the initial years. In subsequent years, we intend to explore 
ways to shorten the period between the performance period and the 
payment year, and ongoing performance feedback will be provided more 
frequently. The final policies for CY 2017 provide flexibilities to 
ensure clinicians have ample participation opportunities.
    As directed by the MACRA, this rule finalizes measures, activities, 
reporting, and data submission standards across four integrated 
performance categories: Quality, cost, improvement activities, and 
advancing care information, each linked by the same overriding mission 
of supporting care improvement under the vision of one Quality Payment 
Program. Consideration will be given to the application of measures and 
activities to non-patient facing MIPS eligible clinicians.
    Under the requirements finalized in this rule, there will be 
options for reporting as an individual MIPS eligible clinician or as 
part of a group. Some data may be submitted via relevant third party 
intermediaries, such as qualified clinical data registries (QCDRs), 
health IT vendors,\1\ qualified registries, and CMS-approved survey 
vendors.
---------------------------------------------------------------------------

    \1\ We also note that throughout this final rule, as in the 
proposed rule, we use the terms ``EHR Vendor'' and ``Health IT 
Vendor.'' First, the use of the term ``health IT'' and ``EHR'' are 
based on the common terminology within the specified program (see 80 
FR 62604; and the advancing care information performance category in 
this rule). Second, we recognize that a ``health IT vendor'' may or 
may not also be a ``health IT developer'' and, in some cases, the 
developer and the vendor of a single product may be different 
entities. 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. Therefore, for purposes of this final 
rule, we clarify that the term ``vendor'' shall also include 
developers who create or develop health IT. Throughout this final 
rule, we use the term ``health IT vendor'' or ``EHR vendor'' to 
refer to entities that support the health IT requirements of a MIPS 
eligible clinician participating in the proposed Quality Payment 
Program. This use is consistent with prior CMS rules, see for 
example the 2014 CEHRT Flexibility final rule (79 FR 52915).

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

[[Page 77015]]

    Within each performance category, we are finalizing specific 
requirements for full participation in MIPS which involves submitting 
data on quality measures, improvement activities, and use of certified 
EHR technology on a minimum of any continuous 90 days up to the full 
calendar year in 2017 in order to be eligible for a positive MIPS 
payment adjustment. It is at the MIPS eligible clinician's discretion 
whether to submit data for the same 90-day period for the various 
measures and activities or for different time periods for different 
measures and activities. Note that during the 2017 transition year, 
MIPS eligible clinicians may choose to report a minimum of a single 
measure in the quality performance category, a single activity in the 
improvement activities performance category or the required measures in 
the advancing care information performance category, in order to avoid 
a negative payment adjustment. For full participation in MIPS, the 
specific requirements are as follows:
(i) Quality
    Quality measures will be selected annually through a call for 
quality measures process, and a final list of quality measures will be 
published in the Federal Register by November 1 of each year. For MIPS 
eligible clinicians choosing full participation in MIPS and the 
potential for a higher payment adjustment, we note that for a minimum 
of a continuous 90-day performance period, the MIPS eligible clinician 
or group will report at least six measures including at least one 
outcome measure if available. If fewer than six measures apply to the 
individual MIPS eligible clinician or group, then the MIPS eligible 
clinician or group will only be required to report on each measure that 
is applicable.
    Alternatively, for a minimum of a continuous 90-day period, the 
MIPS eligible clinician or group can report one specialty-specific 
measure set, or the measure set defined at the subspecialty level, if 
applicable. If the measure set contains fewer than six measures, MIPS 
eligible clinicians will be required to report all available measures 
within the set. If the measure set contains six or more measures, MIPS 
eligible clinicians can choose six or more measures to report within 
the set. Regardless of the number of measures that are contained in the 
measure set, MIPS eligible clinicians reporting on a measure set will 
be required to report at least one outcome measure or, if no outcome 
measures are available in the measure set, report another high priority 
measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures) within the measure set in 
lieu of an outcome measure.
(ii) Improvement Activities
    Improvement activities are those that support broad aims within 
healthcare delivery, including care coordination, beneficiary 
engagement, population management, and health equity. In response to 
comments from experts and stakeholders across the healthcare system, 
improvement activities were given relative weights of high and medium. 
We are reducing the number of activities required to achieve full 
credit from six medium-weighted or three high-weighted activities to 
four medium-weighted or two high-weighted activities to receive full 
credit in this performance category in CY 2017. For small practices, 
rural practices, or practices located in geographic health professional 
shortage areas (HPSAs), and non-patient facing MIPS eligible 
clinicians, we will reduce the requirement to only one high-weighted or 
two medium-weighted activities. We also expand our definition of how 
CMS will recognize a MIPS eligible clinician or group as being a 
certified patient-centered medical home or comparable specialty 
practice to include certification from a national program, regional or 
state program, private payer or other body that administers patient-
centered medical home accreditation. As previously mentioned, in 
recognition of improvement activities as supporting the central mission 
of a unified Quality Payment Program, we will include a designation in 
the inventory of improvement activities of which activities also 
qualify for the advancing care information bonus score, consistent with 
our desire to recognize that EHR technology is often deployed to 
improve care in ways that our programs should recognize.
(iii) Advancing Care Information Performance Category
    Measures and objectives in the advancing care information 
performance category focus on the secure exchange of health information 
and the use of certified electronic health record technology (CEHRT) to 
support patient engagement and improved healthcare quality. We are 
maintaining alignment of the advancing care information performance 
category with the other integrated performance categories for MIPS. We 
are reducing the total number of required measures from eleven in the 
proposed rule to only five in our final policy. All other measures 
would be optional for reporting. Reporting on all five of the required 
measures would earn the MIPS eligible clinician 50 percent. Reporting 
on the optional measures would allow a clinician to earn a higher 
score. For the transition year, we will award a bonus score for 
improvement activities that utilize CEHRT and for reporting to public 
health or clinical data registries.
    Public commenters requested that the advancing care information 
performance category allow for reporting on ``use cases'' such as the 
use of CEHRT to manage referrals and consultations (``closing the 
referral loop'') and other practice-based activities for which CEHRT is 
used as part of the typical workflow. This is an area we intend to 
explore in future rulemaking but did not finalize any such policies in 
this rule. However, for the 2017 transition year, we will award bonus 
points for improvement activities that utilize CEHRT and for reporting 
to a public health or clinical data registry, reflecting the belief 
that the advancing care information performance category should align 
with the other performance categories to achieve the unified goal of 
quality improvement.
(iv) Cost
    For the transition year, we are finalizing a weight of zero percent 
for the cost performance category in the final score, and MIPS scoring 
in 2017 will be determined based on the other three integrated MIPS 
performance categories. Cost measures do not require reporting of any 
data by MIPS eligible clinicians to CMS. Although cost measures will 
not be used to determine the final score in the transition year, we 
intend to calculate performance on certain cost measures and give this 
information in performance feedback to clinicians. We intend to 
calculate measures of total per capita costs for all attributed 
beneficiaries and a Medicare Spending per Beneficiary (MSPB) measure. 
In addition, we are finalizing 10 episode-based measures that were 
previously made available to clinicians in feedback reports and met 
standards for reliability. Starting in performance year 2018, as 
performance feedback is available on at least an annual basis, the cost 
performance category contribution to the final score will gradually 
increase from 0 to the 30 percent level required

[[Page 77016]]

by MACRA by the third MIPS payment year of 2021.
(v) Clinicians in MIPS APMs
    We are finalizing standards for measures, scoring, and reporting 
for MIPS eligible clinicians across all four performance categories 
outlined in this section II.E.5.h of this final rule with comment 
period. Beginning in 2017, some APMs, by virtue of their structure, 
will not meet statutory requirements to be categorized as Advanced 
APMs. Eligible clinicians in these APMs, hereafter referred to as MIPS 
APMs, will be subject to MIPS reporting requirements and the MIPS 
payment adjustment. In addition, eligible clinicians who are in 
Advanced APMs but do not meet participation thresholds to be excluded 
from MIPS for a year will be subject to the scoring standards for MIPS 
reporting requirements and the MIPS payment adjustment. In response to 
comments, in an effort to recognize these eligible clinicians' 
participation in delivery system reform and to avoid potential 
duplication or conflicts between these APMs and MIPS, we finalize an 
APM scoring standard that is different from the generally applicable 
standard. We finalize our proposal that MIPS eligible clinicians who 
participate in MIPS APMs will be scored using the APM scoring standard 
instead of the generally applicable MIPS scoring standard.
(vi) Scoring Under MIPS
    We are finalizing that MIPS eligible clinicians have the 
flexibility to submit information individually or via a group or an APM 
Entity group; however, the MIPS eligible clinician will use the same 
identifier for all performance categories. The finalized scoring 
methodology has a unified approach across all performance categories, 
which will help MIPS eligible clinicians understand in advance what 
they need to do in order to perform well in MIPS. The three performance 
category scores (quality, improvement activities, and advancing care 
information) will be aggregated into a final score. The final score 
will be compared against a MIPS performance threshold of 3 points. The 
final score will be used to determine whether a MIPS eligible clinician 
receives an upward MIPS payment adjustment, no MIPS payment adjustment, 
or a downward MIPS payment adjustment as appropriate. Upward MIPS 
payment adjustments may be scaled for budget neutrality, as required by 
MACRA. The final score will also be used to determine whether a MIPS 
eligible clinician qualifies for an additional positive adjustment 
factor for exceptional performance. The performance threshold will be 
set at 3 points for the transition year, such that clinicians engaged 
in the program who successfully report one quality measure can avoid a 
downward adjustment. MIPS eligible clinicians submitting additional 
data for one or more of the three performance categories for at least a 
full 90-day period may quality for varying levels of positive 
adjustments.
    In future years of the program, we will require longer performance 
periods and higher performance in order to avoid a negative MIPS 
payment adjustment.
(vii) Performance Feedback
    We are finalizing a process for providing performance feedback to 
MIPS eligible clinicians. Initially, we will provide performance 
feedback on an annual basis. In future years, we aim to provide 
performance feedback on a more frequent basis, as well as providing 
feedback on the performance categories of improvement activities and 
advancing care information in line with clinician requests for timely, 
actionable feedback that they can use to improve care. We are 
finalizing our proposal to make performance feedback available using a 
web-based application. Further, we are finalizing our proposal to 
leverage additional mechanisms such as health IT vendors and registries 
to help disseminate data contained in the performance feedback to MIPS 
eligible clinicians where applicable.
(viii) Targeted Review Processes
    We are finalizing a targeted review process under MIPS wherein a 
MIPS eligible clinician may request that we review the calculation of 
the MIPS payment adjustment factor and, as applicable, the calculation 
of the additional MIPS payment adjustment factor applicable to such 
MIPS eligible clinician for a year.
(ix) Third Party Intermediaries
    We are finalizing requirements for third party data submission to 
MIPS that are intended to decrease burden to individual clinicians. 
Specifically, qualified registries, QCDRs, health IT vendors, and CMS-
approved survey vendors will have the ability to act as intermediaries 
on behalf of MIPS eligible clinicians and groups for submission of data 
to CMS across the quality, improvement activities, and advancing care 
information performance categories.
(x) Public Reporting
    We are finalizing a process for public reporting of MIPS 
information through the Physician Compare Web site, with the intention 
of promoting fairness and transparency. We are finalizing public 
reporting of a MIPS eligible clinician's data; for each program year, 
we will post on a public Web site, in an easily understandable format, 
information regarding the performance of MIPS eligible clinicians or 
groups under MIPS.
5. Payment Adjustments
    We estimate that approximately 70,000 to 120,000 clinicians will 
become QPs in 2017 and approximately 125,000 to 250,000 clinicians will 
become QPs in 2018 through participation in Advanced APMs; they are 
estimated to receive between $333 million and $571 million in APM 
Incentive Payments for CY 2019. As with MIPS, we expect that APM 
participation will drive quality improvement for clinical care provided 
to Medicare beneficiaries and to all patients in the health care 
system.
    Under the policies finalized in this rule, we estimate that, 
between approximately 592,000 and 642,000 eligible clinicians will be 
required to participate in MIPS in its transition year. In 2019, MIPS 
payment adjustments will be applied based on MIPS eligible clinicians' 
performance on specified measures and activities within three 
integrated performance categories; the fourth category of cost, as 
previously outlined, will be weighted to zero in the transition year. 
Assuming that 90 percent of eligible clinicians of all practice sizes 
participate in the program, we estimate that MIPS payment adjustments 
will be approximately equally distributed between negative MIPS payment 
adjustments ($199 million) and positive MIPS payment adjustments ($199 
million) to MIPS eligible clinicians, to ensure budget neutrality. 
Positive MIPS payment adjustments will also include an additional $500 
million for exceptional performance payments to MIPS eligible 
clinicians whose performance meets or exceeds a threshold final score 
of 70. These MIPS 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 believe that starting with these modest initial 
MIPS payment adjustments, representing less than 0.2 percent of 
Medicare expenditures for physician and clinical services, is in the 
long-term best interest of maximizing

[[Page 77017]]

participation and starting the Quality Payment Program off on the right 
foot, even if it limits the upside during the transition year. The 
increased availability of Advanced APM opportunities, including through 
Medical Home models, also provides earlier avenues to earn bonus 
payments for those who choose to participate.
6. The Broader Context of Delivery System Reform and Healthcare System 
Innovation
    In January 2015, the Administration announced new goals for 
transforming Medicare by moving away from traditional FFS 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 health outcomes. The policies 
finalized in this rule are intended to continue to move Medicare away 
from a primarily volume-based FFS payment system for physicians and 
other professionals.
    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. The 
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. The Secretary may 
through rulemaking expand the duration and scope of a model being 
tested if (1) the Secretary finds that such expansion (i) is expected 
to reduce spending without reducing the quality of care, or (ii) 
improve the quality of patient care without increasing spending; (2) 
the CMS Chief Actuary certifies that such expansion would reduce (or 
would not result in any increase in) net program spending under 
applicable titles; and (3) the Secretary finds that such expansion 
would not deny or limit the coverage or provision of benefits under the 
applicable title for applicable individuals.
    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 currently participating in models 
tested by the CMS Innovation Center.
    Beyond the care improvements for these beneficiaries, the 
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 the 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.
7. Stakeholder Input
    In developing this final rule with comment period, we sought 
feedback from stakeholders and the public 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 consultation with 
tribes and tribal officials through an All Tribes' Call on May 19, 2016 
and several conversations with the CMS' Tribal Technical Advisory 
Group. Through the MIPS and APMs RFI published in the Federal Register 
on October 1, 2015 (80 FR 59102 through 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 numerous 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. On May 9, 2016, we 
published in the Federal Register a proposed rule for the Merit-based 
Incentive Payment System and Alternative Payment Model Incentive under 
the Physician Fee Schedule, and Criteria for Physician-Focused Payment 
Models (81 FR 28161 through 28586). In our proposed rule, we provided 
the public with proposed policies, implementation strategies, and 
regulation text, in addition to seeking additional comments on 
alternative and future approaches for MIPS and APMs. The comment period 
closed June 27, 2016.
    In response to both the RFI and the proposed rule, we received a 
high degree of interest from a broad spectrum of stakeholders. We thank 
our many commenters and acknowledge their valued input throughout the 
proposed rule process. We discuss and respond to the substance of 
relevant comments in the appropriate sections of this final rule with 
comment period. In general, commenters continue to support 
establishment of the Quality Payment Program and maintain optimism as 
we

[[Page 77018]]

move from FFS Medicare payment towards an enhanced focus on the quality 
and value of care. Public support for our proposed approach and 
policies in the proposed rule focused on the potential for improving 
the quality of care delivered to beneficiaries and increasing value to 
the public--while rewarding eligible clinicians for their efforts. In 
this early stage of a new program, commenters urged CMS to maintain 
flexibility and promote maximized clinician participation in MIPS and 
APMs. Commenters also expressed a willingness and desire to work with 
CMS to increase the relevance of MIPS activities and measures for 
physicians and patients and to expand the number and scope of APMs. We 
have sought to adopt these sentiments throughout relevant sections of 
this final rule with comment period. Commenters continue to express 
concern with elements of the legacy programs incorporated into MIPS. We 
appreciate the many comments received regarding the proposed measures 
and activities and address those throughout this final rule with 
comment period. We intend to work with stakeholders to continually seek 
to connect the program to activities and measures that will result in 
improvement in care for Medicare beneficiaries. Commenters also 
continue to be concerned regarding the burden of current and future 
requirements. Although many commenters recognize the reduced burden 
from streamlined reporting in MIPS compared to prior programs, they 
believe CMS could undertake additional steps to improve reporting 
efficiency. We appreciate provider concerns with reporting burden and 
have tried to reduce burden where possible while meeting the intent of 
the MACRA, including our obligations to improve patient outcomes 
through this quality program.
    In several cases, commenters made suggestions for changes that we 
considered and ultimately found to be inconsistent with the statute. In 
keeping with our objectives of maintaining transparency in the program, 
we outline in the appropriate sections of the rule suggestions from 
commenters that were considered but found to be inconsistent with the 
statute.
    Commenters have many concerns about their ability to participate 
effectively in MIPS in 2017 and the program's impacts on small 
practices, rural practitioners, and various specialty practitioner 
types. We have attempted to address these concerns by including 
transitional policies and additional flexibility in relevant sections 
of the final rule with comment period to encourage participation by all 
eligible clinicians and practitioner types, and avoid undue impact on 
any particular group.
    Commenters present substantial enthusiasm for broadening 
opportunities to participate in APMs and the development of new 
Advanced APMs. Commenters suggest a number of resources should be made 
available to assist them in moving towards participation in APMs and 
have submitted numerous proposals for enhancing the APM portfolio and 
shortening the development process for new APMs. In particular, 
commenters urged us to modify existing Innovation Center models so they 
can be classified as Advanced APMs. We appreciate commenters' eagerness 
to participate in Advanced APMs and to be a part of transforming care. 
While not within the scope of this rule, we note that CMS has developed 
in conjunction with this rule a new strategic vision for the 
development of Advanced APMs over the coming years that will provide 
significantly enhanced opportunities for clinicians to participate in 
the program. We thank stakeholders again for their considered responses 
throughout our process, in various venues, including comments to the 
MIPS and APMs RFI and the proposed rule. We intend to continue open 
communication with stakeholders, including consultation with tribes and 
tribal officials, on an ongoing basis as we develop the Quality Payment 
Program in future years.

II. Provisions of the Proposed Regulations and Analysis of and 
Responses to Comments

A. Establishing MIPS and the Advanced APM Incentive

    Section 1848(q) of the Act, as added by section 101(c) of the 
MACRA, requires establishment of MIPS. Section 101(e) of the MACRA 
promotes the development of, and participation in, Advanced APMs for 
eligible clinicians.

B. Program Principles and Goals

    Through the implementation of the Quality Payment Program, we 
strive 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 final 
score that incorporates MIPS eligible clinicians' performance on 
quality, cost, 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 final rule with 
comment period, are to expand the opportunities for participation in 
both APMs and Advanced APMs, improve care quality and reduce health 
care costs 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 is designed to 
encourage eligible clinicians to participate in Advanced APMs. The APM 
Incentive Payment will be available to eligible clinicians who qualify 
as QPs through Advanced APMs. MIPS eligible clinicians participating in 
APMs (who do not qualify as QPs) will receive favorable scoring under 
certain MIPS categories.
    Our strategic objectives in developing the Quality Payment Program 
include: (1) Improve beneficiary outcomes through patient-centered MIPS 
and APM policy development and patient engagement and achieve smarter 
spending through strong incentives to provide the right care at the 
right time; (2) enhance clinician experience through flexible and 
transparent program design and interactions with exceptional program 
tools; (3) increase the availability and adoption of alternative 
payment models; (4) promote program understanding and participation 
through customized communication, education, outreach and support; (5) 
improve data and information sharing to provide accurate, timely, and 
actionable feedback to clinicians and other stakeholders; (6) deliver 
IT systems capabilities that meet the needs of users and are seamless, 
efficient and valuable on the front- and back-end; and (7) ensure 
operational excellence in program implementation and ongoing 
development.

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 CEHRT.
    Accordingly, we are finalizing revisions to certain regulations

[[Page 77019]]

associated with these programs. We are not deleting these regulations 
entirely, as the final payment adjustments under these programs will 
not occur until the end of 2018. For PQRS, we are revising Sec.  
414.90(e) introductory text and Sec.  414.90(e)(1)(ii) to continue 
payment adjustments through 2018.
    Similarly, for the Medicare EHR Incentive Program for EPs we are 
amending 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 did not make changes to 42 CFR part 414, subpart N--Value-Based 
Payment Modifier Under the PFS (Sec. Sec.  414.1200 through 414.1285). 
These regulations are already limited to certain years.
    The following is a summary of the comments we received regarding 
sunsetting current payment adjustment programs:
    Comment: Several commenters expressed appreciation for CMS's 
decision to streamline the prior reporting programs into MIPS.
    Response: We appreciate the commenters support for our proposals.
    Comment: Some commenters were confused by the term ``sunsetting,'' 
the timeline for when the prior programs ``end,'' and whether there 
would be an overlap in reporting.
    Response: Because of the nature of regulatory text and statutory 
requirements, we cannot delete text from the public record in order to 
end or change regulatory programs. Instead, we must amend the text with 
a date that marks an end to the program, and we refer to this as 
``sunsetting.'' We would also like to clarify that the PQRS, VM, and 
Medicare EHR Incentive Program for FFS EPs will ``end'' in 2018 because 
that is the final year in which payment adjustments for each of these 
programs will be applied. As the commenters noted, however, the 
reporting periods or performance periods associated with the 2018 
payment year for each of these programs occur prior to 2018. As 
discussed in section II.E.4. of this final rule with comment period, 
beginning in 2017, MIPS eligible clinicians will report data for MIPS 
during at minimum any period of 90 continuous days within CY 2017, and 
MIPS payment adjustments will begin in 2019 based on the 2017 
performance year. Eligible clinicians may also seek to qualify as QPs 
through participation in Advanced APMs. Eligible clinicians who are QPs 
for the year are not subject to the MIPS reporting requirements and 
payment adjustment.
    We plan to provide additional educational materials so that 
clinicians can easily understand the timelines and requirements for the 
existing and the new programs.
    Based on the comments received we are finalizing the revision to 
PQRS at Sec.  414.90(e) introductory text and Sec.  414.90(e)(1)(ii) 
and to the Medicare EHR Incentive Program at Sec.  495.102(d) as 
proposed.
2. Supporting Health Care Providers With the Performance of Certified 
EHR Technology, and Supporting Health Information Exchange and the 
Prevention of Health Information Blocking
a. Supporting Health Care Providers With the Performance of Certified 
EHR Technology
    We proposed 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 and direct review of certified EHR technology under the 
ONC Health IT Certification Program, as authorized by 45 CFR part 170, 
subpart E. Similarly, we proposed 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 we note below, it is our intent to support MIPS eligible 
clinicians, eligible clinicians part of an APM Entity, EPs, eligible 
hospitals, and CAHs' (hereafter collectively referred to in this 
section as ``health care providers'') participation in health IT 
surveillance and direct review activities. While cooperating with these 
activities may require prioritizing limited time and other resources, 
we note that ONC will work with health care providers to accommodate 
their schedules and consider other circumstances (80 FR 62715). 
Additionally, ONC has established certain safeguards that can minimize 
potential burden on health care providers in the event that they are 
asked to cooperate with the surveillance of their certified EHR 
technology. Examples of these safeguards, which we described in the 
proposed rule (81 FR 28171), include: (1) Requiring ONC-Authorized 
Certification Bodies (ONC-ACBs) to use consistent, objective, valid, 
and reliable methods when selecting locations at which to perform 
randomized surveillance of certified health IT (80 FR 62715); (2) 
allowing ONC-ACBs to use appropriate sampling methodologies to minimize 
disruption to any individual provider or class of providers and to 
maximize the value and impact of ONC-ACB surveillance activities for 
all providers and stakeholders (80 FR 62715); and (3) allowing ONC-ACBs 
to excuse a health care provider from surveillance and select a 
different health care provider under certain circumstances (80 FR 
62716).
    As background to this proposal, we noted that 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 2015 Edition final rule 
made changes to the ONC Health IT Certification Program that enhance 
the testing, certification, and surveillance of health IT. Importantly, 
the rule strengthened requirements for the ongoing surveillance of 
certified EHR technology and other health IT certified on behalf of 
ONC. Under these requirements established by the 2015 Edition final 
rule, ONC-ACBs are required 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-the-field 
surveillance can take two forms: First, ONC-ACBs conduct ``reactive 
surveillance'' in response to complaints or other indications that 
certified health IT may not conform to the requirements of its 
certification (45 CFR 170.556(b)). Second, ONC-ACBs carry out ongoing 
``randomized surveillance'' based on a randomized sample of all 
certified Complete EHRs and Health IT Modules to assess certified 
capabilities and other requirements prioritized by the National 
Coordinator (45 CFR 170.556(c)). Consistent with the purpose of ONC-ACB 
surveillance--which is to verify that certified health IT performs in 
accordance with the requirements of its certification when it is 
implemented and used in the field--an ONC-ACB's assessment of a 
certified capability must be based on the use of the capability in the 
live production environment in which the capability has been 
implemented and is in use (45 CFR

[[Page 77020]]

170.556(a)(1)) and must use production data unless test data is 
specifically approved by the National Coordinator (45 CFR 
170.556(a)(2)). Throughout this section, we refer to surveillance by an 
ONC-ACB as ``surveillance.''
    On October 19, 2016, ONC will publish the ONC Enhanced Oversight 
and Accountability final rule, which enhances oversight under the ONC 
Health IT Certification Program by establishing processes to facilitate 
ONC's direct review and evaluation of the performance of certified 
health IT in certain circumstances, including in response to problems 
or issues that could pose serious risks to public health or safety (see 
the October 19, 2016 Federal Register). ONC's direct review of 
certified health IT may require ONC to review and evaluate the 
performance of health IT in the production environment in which it has 
been implemented. Throughout this section, we refer to actions carried 
out by ONC under the ONC Enhanced Oversight and Accountability final 
rule as ``direct review.''
    When carrying out ONC-ACB surveillance or ONC direct review, ONC-
ACBs and/or ONC may request that health care providers supply 
information (for example, by way of telephone inquiries or written 
surveys) about the performance of the certified EHR technology 
capabilities the provider possesses and, when necessary, may request 
access to the provider's certified EHR technology (and data stored in 
such certified EHR technology) to confirm that capabilities certified 
by the developer are functioning appropriately. Health care providers 
may also be asked to demonstrate capabilities and other aspects of the 
technology that are the focus of such efforts.
    In the Quality Payment Program proposed rule, we explained that 
these efforts to strengthen surveillance and direct review of certified 
health IT 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. We explained that effective 
ONC-ACB surveillance and ONC direct review is fundamental to providing 
basic confidence that the certified health IT used under the HHS 
programs consistently meets applicable standards, implementation 
specifications, and certification criteria adopted by the Secretary 
when it is used by health care providers, as well as by other persons 
with whom health care providers need to exchange electronic health 
information to comply with program requirements. In particular, the 
need to ensure that certified health IT consistently meets applicable 
standards, implementation specifications, and certification criteria is 
important both at the time the technology is certified (by meeting the 
requirements for certification in a controlled testing environment) and 
on an ongoing basis to ensure that the technology continues to meet 
certification requirements when it is actually implemented and used by 
health care providers in real-world production environments. We 
explained that efforts to strengthen surveillance and direct review 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. Finally, we noted that effective surveillance and direct 
review of certified EHR technology is necessary if health care 
providers 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 (81 FR 28170-28171).
    For all of these reasons, the effective surveillance and direct 
review of certified health IT, and certified EHR technology as it 
applies to providers covered by this provision, provide greater 
assurance to health care providers that their certified EHR technology 
will perform in a manner that meets their expectations and that will 
enable them 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. We stressed in the proposed rule (81 FR 
28170-28171), however, that such surveillance and direct review will 
not be effective unless health care providers are actively engaged and 
cooperate with these activities, including by granting access to and 
assisting ONC-ACBs and ONC to observe the performance of production 
systems (see also the 2015 Edition final rule at 80 FR 62716).
    Accordingly, we proposed that as part of demonstrating the use of 
certified EHR technology in a meaningful manner, a health care provider 
must demonstrate its good faith cooperation with authorized 
surveillance and direct review. We proposed 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 as part of demonstrating meaningful use under the 
Medicare and Medicaid EHR Incentive Programs. Similarly, we proposed to 
include an identical attestation requirement in the submission 
requirements for MIPS eligible clinicians under the advancing care 
information performance category proposed at Sec.  414.1375.
    We proposed that health care providers would be required to attest 
that they have cooperated in good faith with the authorized ONC-ACB 
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, we stated that such cooperation would include responding 
in a timely manner and in good faith to requests for information (for 
example, telephone inquiries and written surveys) about the performance 
of the certified EHR technology capabilities in use by the provider in 
the field (81 FR 28170 through 28171). It would also include 
accommodating requests (from ONC-ACBs or from ONC) for access to the 
provider's certified EHR technology (and data stored in such certified 
EHR technology) as deployed by the health care 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 health care provider.
    We stated that the proposed attestation would support providers in 
meeting the requirements for the meaningful use of certified EHR 
technology while at the same time minimizing burdens for health care 
providers and patients (81 FR 28170 through 28171). We requested public 
comment on this proposal.
    Through public forums, listening sessions, and correspondence 
received by CMS and ONC, and through the methods available for health 
care providers to submit \2\ technical concerns related to the function 
of their certified EHR technology, we have received requests that ONC 
and CMS assist providers in mitigating issues with the performance of 
their technology,

[[Page 77021]]

including issues that relate to the safety and interoperability of 
health IT. Our proposal was designed to help health care providers with 
these very issues by strengthening participation in surveillance and 
direct review activities that help assure that their certified EHR 
technology performs as intended. However, the comments we have 
received, and which we discuss below, suggest that the support that the 
policy provides for health IT performance was not understood by some 
stakeholders. For this reason, we are adopting a modification to the 
title and language describing this policy in this final rule with 
comment period to reflect the intent articulated in the proposed rule 
and to be responsive to the concerns raised by commenters.
    As we have explained, our proposal to require that health care 
providers cooperate with ONC-ACB surveillance of certified health IT 
and ONC direct review of certified health IT reflects the need to 
address technical issues with the functionality of certified EHR 
technology and to support health care providers with the performance of 
their certified EHR technology. By cooperating with these activities, 
health care providers would assist ONC-ACBs and ONC in working with 
health IT developers to identify and rectify problems and issues with 
their technology. In addition, a health care provider who assists an 
ONC-ACB or ONC with these activities is also indirectly supporting 
other health care providers, interoperability goals, and the health IT 
infrastructure by helping to ensure the integrity and efficacy of 
certified health IT products in health care settings. To more clearly 
and accurately communicate the context and role of health care 
providers in these activities, and consistent with our approach to 
clarifying terminology and references, we have adopted new terminology 
in this final rule with comment period that focuses on the requirements 
for the health care provider rather than ONC or ONC-ACB actions and 
processes. In this section, the activities to be engaged in by health 
care providers in cooperation with ONC direct review or ONC-ACB 
surveillance are intended to support health care providers with the 
performance of certified EHR technology. We therefore use the phrase 
``Supporting Providers with the Performance of Certified EHR technology 
activities'' (hereinafter referred to as ``SPPC activities'') to refer 
to a health care provider's actions related to cooperating in good 
faith with ONC-ACB authorized surveillance and, separately or 
collectively as the context requires, a health care provider's actions 
in cooperating in good faith with ONC direct review.
    Notwithstanding the terminology used in this final rule with 
comment period, and to avoid any confusion for health care providers 
engaging with ONC-ACBs or ONC in the future, we note that, when 
communicating with health care providers about the surveillance or 
direct review of certified health IT, ONC-ACBs and ONC will use the 
terminology in the 2015 Edition final rule, the ONC Enhanced Oversight 
and Accountability final rule, or other relevant ONC rulemakings and 
regulations, if applicable. In particular, a request for cooperation 
made by an ONC-ACB to a health care provider will not refer to ``SPPC 
activities.'' Rather, the request will typically refer to the ONC-ACB's 
need to carry out ``surveillance'' of the certified health IT used by 
the health care provider. Similarly, if ONC requests the cooperation of 
a health care provider in connection with ONC's direct review of 
certified health IT, as described in the ONC Enhanced Oversight and 
Accountability final rule scheduled for publication in the Federal 
Register on October 19, 2016, ONC will not use the terminology ``SPPC 
activities.'' Rather, ONC will request the cooperation of the health 
care provider with ONC's ``direct review'' or ``review'' of the 
certified health IT. In addition, throughout this final rule with 
comment period, we use the term ``health IT vendor'' to refer to third 
party entities supporting providers with technology requirements for 
the Quality Payment Program. In this section, we instead use the term 
``health IT developer'' to distinguish between these third parties and 
those developers of a health IT product under the ONC rules. In order 
to maintain consistency with the ONC rules, we use the term ``health IT 
developer'' for those that have presented a health IT product to ONC 
for certification.
    We received public comment on the proposals and our response 
follows.
    Comment: Several commenters expressed concern that the proposed 
attestation would be unduly burdensome for health care providers. A 
number of commenters stated that requiring health care providers to 
engage in SPPC activities related to their certified EHR technology 
would place a disproportionate burden on providers relative to other 
stakeholders who share the responsibility of advancing the use of 
health IT and the exchange of electronic health information. More 
specifically, several commenters stated that SPPC activities related to 
a provider's certified EHR technology could disrupt health care 
operations. According to one commenter, this disruption may be 
especially burdensome for small practices who may need to engage a 
third party to assist them in cooperating in good faith to a request to 
assist ONC or an ONC-ACB, such as evaluating the performance of 
certified EHR technology capabilities in the field. Another commenter 
requested clarification on how evaluations of certified EHR technology 
would be conducted in production environments without disturbing 
patient encounters and clinical workflows.
    Commenters offered a number of suggestions to reduce the potential 
burden of this proposal on health care providers. First, some 
commenters strongly endorsed the safeguards established by ONC--
including methods used to select locations, such as sampling and 
weighting considerations and the exclusion of certain locations in 
appropriate circumstances. In addition, one commenter recommended that, 
where ONC-ACB surveillance or ONC direct review involves evaluating 
certified EHR technology in the field, the ONC-ACB surveillance or ONC 
direct review should be scheduled 30 days in advance and at a time that 
is convenient to accommodate the health care providers' schedules, such 
as after hours or on weekends. The commenter suggested that this would 
avoid disruption both to administrative operations and patient care.
    Response: We understand that, if a request to assist ONC or an ONC-
ACB is received, cooperating in good faith may require providers to 
prioritize limited time and other resources--especially for in-the-
field evaluations of certified EHR technology. As we explained in the 
proposed rule, we believe that several safeguards established by ONC 
will minimize the burden of these activities (81 FR 28171). We note 
that under the 2015 Edition final rule, randomized surveillance is 
limited annually to 2 percent of unique certified health IT products 
(80 FR 62714). To illustrate the potential impact of these activities, 
for CY 2016 ONC estimates that up to approximately 24 products would be 
selected by each of its three ONC-ACBs, for a maximum of 72 total 
products selected across all ONC-ACBs (80 FR 62714). While ONC-ACB 
surveillance may be carried out at one or more locations for each 
product selected, we believe the likelihood that a health care provider 
will be asked to participate in the ONC-ACB surveillance of that 
product will in many cases be quite small due to the

[[Page 77022]]

number of other health care providers using the health IT product. 
Further, the 2015 Edition final rule states that ONC-ACBs may use 
appropriate sampling methodologies to minimize disruption to any 
individual or class of health care providers and to maximize the value 
and impact of randomized surveillance for all health care providers and 
stakeholders (80 FR 62715). In addition, we reiterate that if an ONC-
ACB is unable to complete its randomized surveillance of certified EHR 
technology at a particular location--such as where, despite a good 
faith effort, the health care provider at a chosen location is unable 
to provide the requisite cooperation--the ONC-ACB may exclude the 
location and substitute a different location for observation (see ONC 
2015 Edition final rule 80 FR 62716). ONC has also explained that in 
many cases in-the-field evaluations of certified EHR technology may be 
accomplished through an in-person site visit or may instead be 
accomplished remotely (80 FR 62708). Thus, in general, we expect that 
health care providers will be presented with a choice of evaluation 
approaches and be able to choose one that is convenient for their 
practice.
    We also understand the concerns expressed by some commenters that 
engaging in SPPC activities should not unreasonably disrupt the 
workflow or operations of a health care provider. In consultation with 
ONC, we expect that in most cases ONC and ONC-ACBs will accommodate 
providers' schedules and other circumstances, and that in most cases 
providers will be given ample notice of and time to respond to requests 
from ONC and ONC-ACBs. We note that in some cases it may be necessary 
to secure a health care provider's cooperation relatively quickly, such 
as if a potential problem or issue with certified EHR technology poses 
potentially serious risks to public health or safety (see the ONC 
Enhanced Oversight and Accountability final rule scheduled for 
publication in the Federal Register on October 19, 2016).
    Finally, through public comment on the proposed rule, we note that 
in addition to these specific concerns expressed and addressed 
regarding SPPC activities, stakeholders share a general concern over 
the risks and potential negative impact of transitioning to MIPS and 
upgrading certified health IT in a short time without adequate 
preparation and support. Stakeholders are particularly concerned about 
this impact on solo practitioners, small practices, and health care 
providers with limited resources that may be providing vital access to 
health care in under-served communities. As noted previously, we 
believe the safeguards and policies established for ONC-ACBs' 
activities, discussed above, mitigate the risk of disruption to health 
care providers under normal circumstances. However, consistent with our 
overall approach for implementing new programs and requirements such as 
the Quality Payment Program and historically under the EHR Incentive 
Programs, we are modifying our final policy from the proposal to allow 
for additional flexibility for health care providers.
    Our proposed policy would require health care providers to attest 
that they cooperated in good faith with ONC-ACB surveillance and ONC's 
direct review of certified health IT in order to demonstrate they have 
used certified EHR technology in a meaningful manner. In this final 
rule with comment period, we are finalizing a modified approach that 
splits the SPPC activities into two parts and draws a distinction 
between cooperation with ONC direct review and cooperation with ONC-ACB 
surveillance requests.
    We are finalizing as proposed the requirement to cooperate in good 
faith with a request relating to ONC direct review of certified health 
IT. We do not believe it is appropriate to modify this requirement 
because ONC direct review is designed to mitigate potentially serious 
risk to public health and safety and to address practical challenges in 
reviewing certified health IT by an ONC-ACB. However, we are finalizing 
a modification to the requirement to cooperate with a request relating 
to ONC-ACB surveillance, which is different from ONC direct review (see 
discussion above). The modification to ONC-ACB surveillance will allow 
providers to choose whether to participate in SPPC activities 
supporting ONC-ACB surveillance of certified EHR technology.
    As described in this section, ONC direct review focuses on 
situations involving (1) public health and safety and (2) practical 
challenges for ONC-ACBs, such as when a situation exceeds an ONC-ACB's 
resources or expertise. We maintain that cooperation in ONC direct 
review, when applicable, is important to demonstrating that a health 
care provider used 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 
as stated in the proposed rule (81 FR 28170 through 28171).
    We are therefore finalizing a two part attestation that splits the 
SPPC activities. As it relates to ONC direct review, the attestation is 
required. As it relates to ONC-ACB surveillance, the attestation is 
optional. The attestations are as follows:
     Health care providers must attest that they engaged in 
good faith in SPPC activities related to ONC direct review by: (1) 
Attesting their acknowledgment of the requirement to cooperate in good 
faith with ONC direct review of their health information technology 
certified under the ONC Health IT Certification Program if a request to 
assist in ONC direct review is received; and (2) if a request is 
received, attesting that they cooperated in good faith in ONC direct 
review of health IT under the ONC Health IT Certification Program to 
the extent that such technology meets (or can be used to meet) the 
definition of certified EHR technology.
     Optionally, health care providers may attest that they 
engaged in good faith in SPPC activities related to ONC-ACB 
surveillance by: (1) Attesting their acknowledgement of the option to 
cooperate in good faith with ONC-ACB surveillance of their health 
information technology certified under the ONC Health IT Certification 
Program if a request to assist in ONC-ACB surveillance is received; and 
(2) if a request is received, attesting that they cooperated in good 
faith in ONC-ACB surveillance of health IT under the ONC Health IT 
Certification Program, to the extent that such technology meets (or can 
be used to meet) the definition of certified EHR technology.
    As noted previously, only a small percentage of providers are 
likely to receive a request for assistance from ONC or an ONC-ACB in a 
given year. Therefore under this final policy, for both the mandatory 
attestation and for the optional attestation, a health care provider is 
considered to be engaging in SPPC activities related to supporting 
providers with the performance of certified EHR technology first by an 
attestation of acknowledgment of the policy and second by an 
attestation of cooperation in good faith if a request to assist was 
received from ONC or an ONC-ACB. However, we reiterate that the 
attestation requirement as it pertains to cooperation with ONC-ACB 
surveillance is optional for health care providers.
    Operationally, we expect that the submission method selected by the 
health care provider will influence how these attestations are 
accomplished (see section II.E.5.a on MIPS submission mechanisms for 
details or the 2015 EHR Incentive Programs final rule (80 FR 62896-
62901). For example, a Medicaid EP attesting to their state for the EHR 
Incentive Programs may be provided a series of statements within the

[[Page 77023]]

attestations system. In this case the attestation would be offered in 
two parts. For the first part, in order to successfully demonstrate 
meaningful use, the EP must attest that they engaged in SPPC activities 
related to ONC direct review of certified EHR technology, first by 
their acknowledgement of the policy, and second by attesting that they 
cooperated in good faith with ONC direct review of the certified EHR 
technology if a request to assist was received. For the second part in 
this example, the Medicaid EP may choose to attest that they engaged in 
SPPC activities related to ONC-ACB surveillance of certified EHR 
technology, including attesting to having cooperated in good faith if a 
request to assist was received, or the EP may choose not to so attest.
    A health care provider electronically submitting data for MIPS 
would be required to use the form and manner specified for the 
submission mechanism to indicate their attestation to the first part, 
and may indicate their attestation to the second part if they so 
choose. CMS and ONC will also offer continued support and guidance both 
through educational resources to support participating in and reporting 
to CMS programs, and through specific guidance for those health care 
providers who receive requests related to engaging in SPPC activities.
    Comment: Several commenters opposed any in-the-field observation of 
a health care provider's certified EHR technology and insisted that 
such observations be conducted with the developer of the certified EHR 
technology instead. Some commenters questioned the need to perform 
observations of certified EHR technology in production environments, 
observing that health care providers and other users of certified EHR 
technology often depend on the developer of the certified EHR 
technology to deliver required functionality and capabilities. One 
commenter recommended that the observation of certified EHR technology 
be limited to the use of test systems and test data rather than 
observation of production systems and data.
    Several commenters stated that health care providers should not be 
required to cooperate with on-premises observation of their certified 
EHR technology because an ONC-ACB should be able to access and evaluate 
the performance of certified health IT capabilities using remote access 
methods. By contrast, other commenters stated that remote observation 
could create security risks and that all observations should be 
conducted on the premises, preferably under the direction of the health 
care provider's clinical staff.
    Response: To provide adequate assurance that certified EHR 
technology meets applicable certification requirements and provides the 
capabilities health care providers need, it is critical to determine 
not only how certified EHR technology performs in a controlled testing 
environment but also how it performs in the field. Indeed, a 
fundamental purpose of ONC-ACB surveillance and ONC direct review is to 
allow ONC-ACBs and ONC to identify problems or deficiencies in 
certified EHR technology that may only become apparent once the 
technology has been implemented and is in use by health care providers 
in production environments (80 FR 62709). These activities necessarily 
require the cooperation of the clinicians and other persons who 
actually use the capabilities of certified EHR technology implemented 
in production environments, including health care providers. (See 81 FR 
28170-71). This cooperation ultimately benefits health care providers 
and is critical to provider success in the Medicare and Medicaid EHR 
Incentive Programs and MIPS because it provides confidence that 
certified EHR technology capabilities will function as expected and 
that health care providers will be able to demonstrate compliance with 
CMS program requirements.
    We decline to limit health care providers' engagement in SPPC 
activities to any particular form of observation, such as on-premises 
or remote observation of certified capabilities. We note that in the 
2015 Edition final rule, ONC explained the observation of certified 
health IT capabilities in a production environment may require a 
variety of methodologies and approaches (80 FR 62709). In addition, as 
the comments suggest, individual health care providers are likely to 
have different preferences and should have the flexibility to work with 
an ONC-ACB or ONC to identify an approach to these activities that is 
most effective and convenient. In this connection, we have consulted 
with ONC and expect that, where feasible, a health care provider's 
preference for a particular form of observation will be accommodated.
    For similar reasons, we decline to limit engagement in SPPC 
activities to the use of test systems or test data. The use of test 
systems and test data may be allowed in some circumstances, but may not 
be appropriate in all circumstances. For example, a problem with 
certified EHR technology capabilities may be difficult or impossible to 
replicate with test systems or test data. More fundamentally, limiting 
cooperation to observations of test systems and test data may not 
provide the same degree of assurance that certified EHR technology used 
by health care providers (for example, production systems used with 
production data) continue to meet applicable certification requirements 
and function in a manner that supports health care providers 
participation in the EHR Incentive Programs and MIPS.
    Comment: One commenter suggested that health care providers who 
engage in SPPC activities be able to file a formal complaint with ONC 
or CMS in the event that the ONC-ACB were to ``handle matters 
inappropriately,'' and that the ONC-ACB should not be permitted to 
continue its activities until the complaint has been resolved.
    Response: If a provider has any concerns about the propriety of an 
ONC-ACB's conduct, including in connection with a request to assist in 
ONC-ACB surveillance of certified health IT or during in-the-field 
surveillance of the certified EHR technology, the health care provider 
should make a formal complaint to ONC detailing the conduct in 
question. For further information, we direct readers to ONC's Web site: 
https://www.healthit.gov/healthitcomplaints.
    Comment: A number of commenters were opposed to or raised concerns 
regarding this proposal on the grounds that requiring health care 
providers to engage in SPPC activities would violate the HIPAA Rules. 
Relatedly, a number of commenters stated that requiring providers to 
give ONC or ONC-ACBs access to their production systems may be 
inconsistent with a health care organization's privacy or security 
policies and could introduce security risks. A few commenters stated 
that observation of certified EHR technology in the field would violate 
patients' or providers' privacy rights or expectations. Some of these 
commenters expressed the view that any requirement to engage in SPPC 
activities would be an unjustified governmental invasion of privacy or 
other interests.
    Response: As noted in the Quality Payment Program proposed rule and 
in the 2015 Edition final rule, in consultation with the Office for 
Civil Rights, ONC has clarified that as a result of ONC's health 
oversight authority a health care provider is permitted, without 
patient authorization, to disclose PHI to an ONC-ACB or directly to ONC 
for purposes of engaging in SPPC activities in cooperation with a 
request to assist from ONC or an ONC-ACB (81 FR 28171; 80 FR 62716). 
Health

[[Page 77024]]

care providers are permitted without patient authorization to make 
disclosures to a health oversight authority (as defined in 45 CFR 
164.501) for oversight activities authorized by law (as described in 45 
CFR 164.512(d)), including activities to determine compliance with 
program standards, and ONC may delegate its authority to ONC-ACBs to 
perform surveillance of certified health IT under the Program.\3\ This 
disclosure of PHI to an ONC-ACB does not require a business associate 
agreement with the ONC-ACB since the ONC-ACB is not performing a 
function on behalf of the covered entity. In the same way, a provider, 
health IT developer, or other person or entity is permitted to disclose 
PHI directly to ONC, without patient authorization and without a 
business associate agreement, for purposes of ONC's direct review of 
certified health IT or the performance of any other oversight 
responsibilities of ONC to determine compliance under the Program.
---------------------------------------------------------------------------

    \3\ See, 45 CFR 164.512(d)(1)(iii); 80 FR 62716 and ONC 
Regulation FAQ #45 [12-13-045-1]. Available at http://www.healthit.gov/policy-researchers-implementers/45-question-12-13-045.
---------------------------------------------------------------------------

    We disagree with commenters who maintained that the disclosure of 
PHI to ONC or an ONC-ACB could be inconsistent with reasonable privacy 
or other organizational policies or would otherwise be an unjustified 
invasion of privacy or any other interest. As noted, the disclosure of 
this information would be authorized by law on the basis that it is a 
disclosure to a health oversight agency (ONC) for the purpose of 
determining compliance with a federal program (the ONC Health IT 
Certification Program). In addition, we note that any further 
disclosure of PHI by an ONC-ACB or ONC would be limited to disclosures 
authorized by law, such as under the federal Privacy Act of 1974, or 
the Freedom of Information Act (FOIA), as applicable.
    Comment: Several commenters requested clarification concerning the 
types of production data that ONC or an ONC-ACB would be permitted to 
access (and that a health care provider would make accessible to ONC, 
or the ONC-ACB) when assessing certified EHR technology in a production 
environment. Several commenters recommended that production data be 
limited to the certified capabilities and not extend to other aspects 
of the health IT.
    Response: A request to assist in ONC-ACB surveillance or ONC direct 
review may include in-the-field surveillance or direct review of the 
certified EHR technology to determine whether the capabilities of the 
health IT are functioning in accordance with the requirements of the 
ONC Health IT Certification Program. We note that it is common for 
certified EHR technology to be deployed and integrated with other 
technologies (including technologies that produce data used across 
multiple systems and components). Therefore, we believe it is feasible 
that determining whether certified EHR technology is operating as it 
should could mean, for example, ONC reviewing whether the certified EHR 
technology does not operate as it should when it interacts with other 
technologies. We also refer commenters to the 2015 Edition final rule 
and the ONC Enhanced Oversight and Accountability final rule for more 
information about the scope of ONC-ACB surveillance and ONC direct 
review, and for a discussion about the types of capabilities that may 
be subject to ONC-ACB surveillance and ONC direct review.
    Comment: A commenter observed that while the proposed attestation 
would be retrospective, health care providers may be unaware of the 
requirement to engage in SPPC activities until they are presented with 
the attestation statement. The commenter suggested that health care 
providers be required to attest only that they will prospectively 
engage in SPPC activities.
    Response: The attestation is retrospective because it is part of 
health care provider's demonstration that it has used certified EHR 
technology in a meaningful manner for a certain period. Based on our 
consultation with ONC, the health care providers will be made aware of 
both their obligation to cooperate if they are contacted to assist in 
ONC direct review of certified health IT and their option to cooperate 
if they are contacted to assist an ONC-ACB in surveillance of certified 
health IT. Thus, we believe that health care providers will be able to 
appropriately engage in SPPC activities for CMS programs and attest to 
their cooperation.
    Comment: A commenter urged that health care providers be held 
harmless if engagement in SPPC activities results in a finding that 
their certified EHR technology no longer conforms to the requirements 
of the ONC Health IT Certification Program due to the actions of the 
certified EHR technology developer.
    Response: ONB-ACB surveillance and ONC direct review provide an 
opportunity to assess the performance of certified EHR technology 
capabilities in a production environment to determine whether the 
technology continues to perform in accordance with the requirements of 
the ONC Health IT Certification Program. This analysis will necessarily 
be focused on the performance of the technology, which may require the 
consideration of a provider's use of the technology. However, health 
care providers that cooperate with the analysis of the performance of 
certified EHR technology are not themselves subject to ONC or an ONC-
ACB's authority under, as applicable, the surveillance requirements of 
the 2015 Edition final rule, or the direct review requirements of the 
ONC Enhanced Oversight and Accountability final rule. As such, no 
adverse finding or determination can be made by ONC or an ONC-ACB 
against a provider in connection with ONC direct review or ONC-ACB 
surveillance. If ONC or an ONC-ACB determined that the performance 
issue being analyzed arose solely from the provider's use of the 
technology and not from a problem with the technology itself, ONC or an 
ONC-ACB would not make a nonconformity finding against the health IT, 
but may decide to notify the provider of its determination for 
information purposes only. We do acknowledge, however, that if in the 
course of ONC-ACB surveillance or ONC direct review, ONC became aware 
of a violation of law or other requirements, ONC could share that 
information with relevant federal or state entities. If a certified 
health IT product is determined to no longer conform with the 
requirements of the ONC Health IT Certification Program and the health 
IT's certification were to be terminated by ONC or withdrawn by an ONC-
ACB, there exists a process by which an affected health care provider 
may apply for exception from payment adjustments related to CMS 
programs on the basis of significant hardship or exclusion from the 
requirement. For example, we direct readers to CMS FAQ# 12657 \4\ 
related to hardship exceptions for the EHR Incentive Programs related 
to the certification of a health IT product being terminated or 
withdrawn.
---------------------------------------------------------------------------

    \4\ CMS FAQ#12657 ``What if your product is decertified?'': 
https://questions.cms.gov/faq.php?isDept=0&search=decertified&searchType=keyword&submitSearch=1&id=5005.
---------------------------------------------------------------------------

    Comment: Multiple commenters suggested that, in lieu of the 
proposed attestation, we provide incentives to encourage voluntary 
participation in SPPC activities, such as counting voluntary 
participation towards an eligible clinician's performance score for the 
advancing care information category of MIPS.
    Response: We have considered the commenters' suggestion but 
conclude

[[Page 77025]]

that it would be impracticable for two main reasons. First, a key 
component of the oversight of certified EHR technology is the 
randomized surveillance of certified EHR technology by ONC-ACBs. To 
ensure a representative sample, we believe it is important that all 
health care providers are required to use certified EHR technology as 
an EP, eligible hospital, or CAH under the Medicare and Medicaid EHR 
Incentive Programs and as a MIPS eligible clinicians under the 
advancing care information performance category be part of the pool 
from which ONC-ACBs select locations for in-the-field surveillance, not 
only those who volunteer for participation. Second, as we explained in 
connection with commenters' concerns regarding the potential impact of 
SPPC activities on providers, we anticipate that the opportunity for 
health care providers to participate in randomized surveillance of 
their certified EHR technology will arise relatively infrequently due 
to the relatively small number of practices and other locations that 
would be selected for this type of ONC-ACB surveillance. This means 
that only a limited number of health care providers would have an 
opportunity to participate in this way for reasons outside the control 
of the health care provider. Consequently, health care providers would 
not have an equal opportunity to participate in these activities, which 
would make adopting an incentive within the scoring methodology for 
these activities potentially unfair to providers who are participating 
in CMS programs but are not selected by the randomized selection 
process. This would unfairly skew scores in a manner unrelated to a 
health care provider's performance in a given program. For these 
reasons we decline to adopt such an arrangement.
    Comment: Multiple commenters stated that this proposal was 
premature because ONC has yet to finalize the ONC Health IT 
Certification Program: Enhanced Oversight and Accountability proposed 
rule. Commenters urged us to withdraw the proposal until such time as 
any changes to the ONC Health IT Certification Program have been 
finalized.
    Response: We recognize that the pendency of the ONC Health IT 
Certification Program: Enhanced Oversight and Accountability proposed 
rule, which outlines the policies for ONC direct review of certified 
health IT, at the time of our proposal may have been challenging for 
some commenters. However, health care provider engagement in SPPC 
activities is important regardless of whether a request to assist 
relates to ONC direct review of certified health IT or ONC-ACB 
surveillance of certified health IT. As we have explained, we expect 
health care providers will engage in SPPC activities because doing so 
is fundamental to ensuring that certified EHR technology performs in a 
manner that supports the goals of health care providers seeking to meet 
the requirements of the MIPS and Medicare and Medicaid EHR Incentive 
Programs. We further believe that the publication of the ONC Enhanced 
Oversight and Accountability final rule in concert with the 
flexibilities finalized in this final rule with comment period, as well 
as the timeline for implementation of these policies, which apply to 
reporting periods beginning in CY 2017, supports resolution of this 
concern.
    Comment: A commenter stated that the proposed attestation would 
compel meaningful EHR users to cooperate with far-ranging or unbounded 
inquiries into their certified health IT. Other commenters expressed 
similar concerns and pointed to what they perceived as the broad range 
of issues that could be subject to ONC's direct review under the ONC 
Health IT Certification Program: Enhanced Oversight and Accountability 
proposed rule.
    Response: We reiterate that, whatever form engagement in SPPC 
activities may take, any conclusions by ONC or ONC-ACBs will 
necessarily be focused on the performance of the technology. Moreover, 
as we have explained, health care providers will only be required to 
attest their engagement in SPPC activities in relation to requests 
received to assist in ONC direct review of certified capabilities of 
their health IT that meet (or can be used to meet) the definition of 
certified EHR technology. Further, because a health care provider's 
attestation will be retrospective as noted previously, the attestation 
relates only to acknowledgment if no request was received or the health 
care provider's cooperation with requests for assistance that have 
already been received at the time of making the attestation. The 
attestation requirement does not require that health care providers 
commit to engaging in unknown future activities.
    Comment: A commenter requested more information about the 
circumstances that would trigger direct review of certified EHR 
technology. Separately, the commenter recommended that such review be 
conducted only as part of an audit of a health care provider's 
demonstration of meaningful use or an eligible clinician's reporting 
for the advancing care information performance category.
    Response: ONC determines the requirements for and circumstances 
under which health IT may be subject to ONC-ACB surveillance or ONC 
direct review under the ONC Health IT Certification Program. We refer 
the commenter to the 2015 Edition final rule (80 FR 62601) for a 
discussion of existing requirements related to the observation of 
certified health IT by ONC-ACBs and to the ONC Enhanced Oversight and 
Accountability final rule (scheduled for publication in the Federal 
Register on October 19, 2016) for a discussion of ONC's direct review 
activities. To, be effective, ONC-ACB surveillance or ONC direct review 
of SPPC activities must be timely to identify an issue with the 
certified health IT. If these actions are limited to the timing of 
retrospective audits of a health care provider's compliance with 
program requirements, they may not reflect the current implementation 
of the technology in a production setting where the issue exists. For 
these reasons, it is not appropriate for a health care provider's 
cooperation to be limited to the context of a program audit on prior 
participation.
    Comment: To assist health care providers in complying with the 
proposed attestation, a commenter recommended that any requests for 
engagement in SPPC activities be clearly labeled as such so as to 
differentiate them from other types of communications.
    Response: We acknowledge this commenter's concern that, to support 
health care providers engaging in SPPC activities, a request to assist 
should be designed to clearly inform the recipient as to the purpose of 
the communication and avoid, as much as possible, the request being 
inadvertently overlooked or unnoticed. We have consulted with ONC and 
clarify that ONC-ACBs currently initiate contact with health care 
providers for randomized surveillance by emailing the person or office 
holder of a practice or organization that is the primary contact for 
the health IT developer whose product is being surveilled or reviewed. 
The contact information is supplied by the developer, and ONC-ACBs 
would not ordinarily contact a health care provider directly unless 
they are identified by the developer as being the most appropriate 
point of contact for a practice location. However, we note that in 
addition to clarity on the point of contact, clarity within the request 
itself is essential for the health care provider engaging in SPPC 
activities. This relates not only to clarity as to the purpose of the 
request, but also in relation to the mandatory and optional SPPC 
activities which are differentiated based on if the request is for ONC 
direct review of

[[Page 77026]]

certified health IT or ONC-ACB surveillance of certified health IT.
    As program guidance is developed, CMS and ONC will work to ensure 
that requests from ONC and ONC-ACBs provide clear context and guidance 
for health care providers when requesting that health care providers 
engage in SPPC activities as part of their participation in CMS 
programs.
    Comment: A commenter stated that some EHR contracts specifically 
prohibit customers or users of certified EHR technology from providing 
ONC or ONC-ACBs with access to the technology or data.
    Response: Developers of certified health IT are required to 
cooperate with ONC program activities such as ONC direct review or ONC-
ACB surveillance of certified health IT, which includes furnishing 
information to ONC or an ONC-ACB that is necessary to the performance 
of these activities (see 80 FR 62716-18) in order to obtain and 
maintain certification of health IT. Access to certified health IT that 
is under observation by ONC or an ONC-ACB, together with production 
data relevant to the certified capability or capabilities being 
assessed, is essential to this process. For example, in the 2015 
Edition final rule, ONC stated that a health IT developer must furnish 
to the ONC-ACB upon request, accurate and complete customer lists, user 
lists, and other information that the ONC-ACB determines is necessary 
to enable it to carry out its surveillance responsibilities (80 FR 
62716). If a health care provider reasonably believes that it is unable 
to engage in SPPC activities due to these or other actions of its 
health IT developer, the health care provider should notify ONC or the 
ONC-ACB, as applicable. If the developer has indeed limited, 
discouraged, or prevented the health care provider from cooperation in 
good faith with a request to assist ONC direct review, the health care 
provider would not be required to cooperate with such activities unless 
and until the developer removed the contractual restrictions or other 
impediments.
    Comment: A commenter expressed concern about sharing data with ONC 
or an ONC-ACB without a clear description of the data to be accessed.
    Response: The nature of the data that will need to be accessed by 
ONC or an ONC-ACB will be made clear to the health care provider at the 
time that their cooperation is sought. To alleviate any concerns 
commenters may have, we will work with ONC to provide guidance to ONC-
ACBs and to providers, as necessary, to address issues such as the 
communication protocols to be used when requesting a health care 
provider's engagement in SPPC activities.
    Comment: Several commenters requested additional guidance on 
specific actions health care providers would be expected to take to 
engage in SPPC activities and cooperate in good faith with a request to 
assist if so requested. One commenter recommended that CMS and ONC 
create a check-list tool that clinicians could use to track their 
compliance with the required activities.
    Response: As specified in the proposed rule, engaging in SPPC 
activities and cooperation in good faith may simply require the 
provision of information, such as in response to telephone inquiries 
and written surveys, about the performance of the certified EHR 
technology being used. Engagement in SPPC activities and cooperation in 
good faith might also involve facilitating requests (from ONC or ONC-
ACBs) for access to the certified EHR technology (and related data) as 
deployed in the provider's production environment and to demonstrate 
capabilities and other aspects of the technology that are the focus of 
the ONC-ACB surveillance or ONC direct review.
    Because assistance with ONC-ACB surveillance or ONC direct review 
will typically be carried out at a practice or facility level, we 
expect that it will be rare for a health care provider to be directly 
involved in the conduct of many of these activities, including in-the-
field observations of certified EHR technology capabilities. To comply 
with the attestation requirements, a health care provider should 
establish to their own satisfaction that appropriate processes and 
policies are in place in their practice to ensure that all relevant 
personnel, such as a practice manager or IT officer, are aware of the 
health care provider's obligation to engage in SPPC activities related 
to requests to assist in ONC direct review of certified health IT and 
the health care provider's option to engage in SPPC activities related 
to requests to assist in ONC-ACB surveillance of certified health IT. 
This includes understanding the requirement to cooperate in good faith 
with a request to assist in ONC direct review if received. Health care 
providers should also ensure that appropriate processes and policies 
are in place for the practice to document all requests and 
communications concerning SPPC activities as they would for other 
requirements of CMS programs in which they participate. We note that 
for a health care provider participating in a CMS program as an 
individual, if that health care provider practices at multiple 
locations or switches locations throughout the course of a year, they 
would only need to make inquiries about any requests to assist in ONC 
direct review of certified health IT during the period in which the 
eligible clinician or EP worked at the practice.
    We acknowledge the commenter's desire for a checklist tool to 
provide greater certainty for clinicians. However, as ONC explained in 
the 2015 Edition final rule, an evaluation of certified health IT in a 
production environment may require a variety of methodologies and 
approaches (80 FR 62709) and individual health care providers are able 
to express different preferences and should have the flexibility to 
work with ONC or an ONC-ACB to identify an effective approach that is 
most convenient. Because the specific actions required will be 
addressed on a case-by-case basis, the development of a checklist tool 
may not be feasible. Rather, as noted previously, if any request is 
made, ONC or an ONC-ACB will work directly with the health care 
provider to provide clear guidance on the actions needed to assist in 
the request. The health care provider would then retain any such 
documentation concerning the request for their records as they would 
for other similar requirements in CMS programs.
    Comment: A commenter asked how ONC-ACBs will identify themselves 
and how a health care provider will be able to verify that it is not 
dealing with an imposter.
    Response: Each health IT developer contracts with one or more ONC-
ACBs to provide certification services. As such, health IT developers 
should be familiar with the processes used by their ONC-ACB(s) and have 
existing practices for communicating with the personnel of their ONC-
ACB(s). A health care provider can, on receipt of a request to assist 
an ONC-ACB, contact their health IT developer and request information 
about the identity of the ONC-ACB personnel that will carry out the 
activities. Health care providers should, before providing access to 
their facility or the certified health IT, request that the ONC-ACB 
personnel provide appropriate identification that matches the 
information about the ONC-ACB provided by the provider's certified 
health IT developer.
    Comment: Several commenters requested that we elaborate on the 
requirements for engaging in SPPC activities ``in good faith'' and for 
permitting timely access to certified EHR technology.
    Response: Health care providers are required to attest to engaging 
in SPPC

[[Page 77027]]

activities which requires that they cooperate in good faith and in a 
timely manner with a request to assist in ONC direct review of 
certified health IT if such a request is received. A health care 
provider may also optionally attest to engaging in SPPC activities, 
including having cooperated in good faith, in response to a request to 
assist an ONC-ACB with surveillance of certified health IT. This 
includes cooperating in a manner that aids and assists ONC or an ONC-
ACB to perform ONC direct review or ONC-ACB surveillance activities to 
the extent that such cooperation is practicable and not unduly 
burdensome to the provider. As previously mentioned, the particular 
needs of any request for assistance from ONC or an ONC-ACB may vary 
depending on a wide range of factors. In addition, ``in good faith'' is 
necessarily dependent upon the particular facts and circumstances of 
the health care provider who attests. For example, a request for 
assistance may relate to a capability the health care provider does not 
have enabled in their EHR as it is not needed for their unique 
practice, which might be costly, time consuming, or otherwise 
unreasonable for the provider to enable solely for the purposes of ONC 
direct review of that function. In such a case, the health care 
provider who communicates these limitations to ONC, and maintains 
documentations of the request and these circumstances related to their 
practice, may be found to have cooperated in good faith based on this 
documentation. However, if the health care provider received such a 
request and provided no response to the request and did not retain 
documentation of these circumstances, they may be found not to have 
cooperated in good faith.
    Comment: One commenter asked us to clarify that a health care 
provider will have satisfied the requirements of the proposed 
attestation in the event that the health care provider was never 
approached by ONC or an ONC-ACB with a request for assistance during 
the relevant reporting period.
    Response: In the circumstances the commenter describes, the health 
care provider would be able to attest to both the mandatory attestation 
(related to ONC direct review) and the optional attestation (related to 
ONC-ACB surveillance) on the basis that they acknowledge the policy. In 
other words, for the mandatory attestation, the health care provider 
that receives no request related to ONC direct review could 
successfully meet the attestation requirement by attesting that they 
acknowledge the requirement to cooperate in good faith with all 
requests for assistance with ONC direct review of their certified EHR 
technology. Likewise, a health care provider that did not receive a 
request for assistance with ONC-ACB surveillance during the reporting 
year but still seeks to attest to the optional attestation would attest 
that they are aware of the option to cooperate in good faith with all 
requests for assistance in ONC-ACB surveillance. We have revised the 
regulation text provisions at Sec. Sec.  495.4, 495.40(a)(2)(i)(H), 
495.40(b)(2)(i)(H), and 414.1375(b)(3)(i) to state that a health care 
provider engages in SPPC activities by cooperating in good faith with 
the ONC-ACB surveillance or ONC direct review of its certified EHR 
technology, to the extent that the health care provider receives a 
request from an ONC-ACB or ONC during the relevant reporting period; 
and that in the absence of any requests being made during the reporting 
period, the health care provider would demonstrate their engagement in 
the SPPC activities simply by attesting that they are aware of the SPPC 
policy.
    Comment: Several commenters requested clarification regarding the 
documentation that would be required to demonstrate compliance with the 
terms of the attestation so that health care providers could plan and 
prepare for an audit of this requirement. Among other topics, 
commenters requested guidance on expected documentation requirements 
related to a health care provider's responsiveness to requests for 
engagement in SPPC activities and the extent of cooperation required.
    Response: We acknowledge commenters' concerns about required 
documentation in cases of an audit. We clarify that we will provide 
guidance to auditors relating to this final rule with comment period 
and the attestation process in a similar manner as guidance is provided 
for other requirements under current CMS programs. This instruction 
includes requiring auditors to work closely with health care providers 
on identifying the appropriate supporting documentation applicable to 
the health care provider's individual case. We further stress that 
audit determinations are made on a case by case basis, which allows us 
to give individual consideration to each health care provider. We 
believe that such case-by-case review will allow us to adequately 
account for the varied circumstances that may be relevant.
    Comment: Commenters requested clarification concerning the 
effective date of the attestation requirement and, more specifically, 
the period to which an attestation that a health care provider engaged 
in SPPC activities would apply. Several commenters expressed concerns 
related to the timing of the attestation, noting that health care 
providers may submit attestations for reporting periods that have 
already begun or that will have begun prior to the effective date of 
this final rule with comment period.
    Response: We understand the commenters' concerns and are finalizing 
the requirement to attest to engagement in SPPC activities for health 
care providers for MIPS performance periods or EHR reporting periods 
beginning on or after January 1, 2017. The requirement includes only 
requests to engage in SPPC activities received after the effective date 
of this final rule with comment period. In other words, if a health 
care provider receives a request from ONC or an ONC-ACB to engage in 
SPPC activities before the effective date of this final rule with 
comment period, the attestation requirement will not apply to that 
request, and the health care provider is not required to cooperate with 
the request.
    After review and consideration of public comment, we are finalizing 
revisions to the definition of a meaningful EHR user at Sec. Sec.  
495.4 and 414.1305 to include ``engaging in activities related to 
supporting providers with the performance of certified EHR 
technology.''
    We are finalizing modifications to the attestation requirements at 
Sec.  495.40(a)(2)(i)(H) and (b)(2)(i)(H) to require an EP, eligible 
hospital or CAH to attest that they engaged in SPPC activities by 
attesting that they: (1) Acknowledge the requirement to cooperate in 
good faith with ONC direct review of their health information 
technology certified under the ONC Health IT Certification Program if a 
request to assist in ONC direct review is received; and (2) if 
requested, cooperated in good faith with ONC direct review of their 
health information technology 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, including by permitting timely access to such 
technology and demonstrating its capabilities as implemented and used 
by the EP, eligible hospital, or CAH in the field.
    Additionally, we are finalizing that, optionally, the EP, eligible 
hospital, or CAH may also attest that they engaged in SPPC activities 
by attesting that they: (1) Acknowledge the option to cooperate in good 
faith with ONC-ACB surveillance of their health information technology 
certified under the ONC Health IT Certification Program if a

[[Page 77028]]

request to assist in ONC-ACB surveillance is received; and (2) if 
requested, cooperated in good faith with ONC-ACB surveillance of their 
health information technology 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, including by permitting timely access to such 
technology and demonstrating its capabilities as implemented and used 
by the EP, eligible hospital, or CAH in the field.
    We are also finalizing at Sec.  404.1375(3) that the same 
attestations be made by 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 final rule with comment 
period (see 81 FR 28170-71).
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.
    As legislative background, on December 16, 2014, in an explanatory 
statement accompanying the Consolidated and Further Continuing 
Appropriations Act,\5\ the Congress advised 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 providers to use.'' \6\ The Congress also requested a 
detailed report on health information blocking (referred to in this 
final rule with comment period as ``the Information Blocking Report''). 
In the report, which was submitted to the Congress on April 10, 
2015,\7\ ONC concluded from its experience and available evidence 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.\8\
---------------------------------------------------------------------------

    \5\ Public Law 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.
    \8\ Id. at 33.
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    We explained in the proposed rule that the demonstration required 
by section 106(b)(2) of the MACRA must provide substantial assurance 
not only that certified EHR technology was connected in accordance with 
applicable standards during the relevant EHR reporting period, but that 
the health care provider 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 (81 FR 28172). We proposed that such a demonstration 
be made through an attestation (referred to in this section of the 
preamble as the ``information blocking attestation''), which would 
comprise three statements related to health information exchange and 
information blocking, which were described in the proposed rule (81 FR 
28172). Accordingly, we proposed to revise the definition of a 
meaningful EHR user at Sec.  495.4 and to revise the corresponding 
attestation requirements at Sec.  495.40(a)(2)(i)(I) and (b)(2)(i)(I) 
to require this attestation for all EPs, eligible hospitals, and CAHs 
under the Medicare and Medicaid EHR Incentive Programs, beginning with 
attestations submitted on or after April 16, 2016. Further, we proposed 
this attestation requirement (at Sec.  414.1375(b)(3)(ii)) for 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 the proposed rule (81 FR 28181).
    We invited public comment on this proposal, including whether the 
proposed attestation 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 encouraged public comment on whether there are 
additional facts or circumstances to which eligible clinicians, EPs, 
eligible hospitals, and CAHs should be required to attest, or whether 
there is additional information that they should be required to report.
    Comment: A number of commenters expressed strong support for this 
proposal and urged us to finalize the information blocking attestation 
as proposed. Commenters anticipated that such an attestation would 
discourage information blocking; encourage more robust sharing of 
information among all members of a patient's care team; increase demand 
for more open and interoperable health IT platforms and systems; and 
strengthen efforts to enhance health care quality and value, including 
the capturing and sharing of information about quality, costs, and 
outcomes. One commenter stated that the information blocking 
attestation would also help independent physicians compete by deterring 
predatory information sharing policies or practices, especially by 
large health systems or hospitals.
    Many commenters expressed partial support for this proposal but 
voiced concerns about the particular content or form of the information 
blocking attestation as proposed. Several commenters stated that the 
language of the attestation was unclear and should provide more detail 
regarding the specific actions health care providers would be required 
to attest. Conversely, several commenters (including some of the same 
commenters) believe that the language of the attestation was too 
prescriptive. Some commenters recommended revising or removing one or 
more of the three statements that comprise the attestation. A few 
commenters suggested that we finalize only the first statement--which 
mirrors the statutory language in section 106(b)(2) of the MACRA--and 
contended that the other statements were unnecessary or, alternatively, 
go beyond what section 106(b)(2) requires.
    Some commenters were opposed in principle to requiring health care

[[Page 77029]]

providers to attest to any statement regarding information blocking. 
Most of these commenters insisted that such a requirement would impose 
unnecessary burdens or unfair obligations on health care providers, 
who, in the view of the commenters, are seldom responsible for 
information blocking.
    The majority of commenters, whether they supported or opposed the 
proposal, stressed that certain factors that prevent interoperability 
and the ability to successfully exchange and use electronic health 
information are beyond the ability of a health care provider to 
control. Many of these commenters stated that EHR vendors should be 
required to submit an information blocking attestation because they 
have greater control over these factors and, in the experience of some 
commenters, are more likely to engage in information blocking.
    Response: After consideration of the comments as well as the 
statutory provisions cited above, and in consultation with ONC, we 
believe the proposed attestation requirement is an appropriate and 
effective means to implement the demonstration required by section 
106(b)(2) of the MACRA; we are therefore finalizing this requirement as 
proposed, as discussed in greater detail below and in our responses to 
specific comments that follow.
    As many commenters recognized, the information blocking concerns 
expressed by Congress are serious and reflect a systemic problem: A 
growing body of evidence establishes that persons and entities--
including some health care providers--have strong incentives to 
unreasonably interfere with the exchange and use of electronic health 
information, undermining federal programs and investments in the 
meaningful use of certified EHR technology to improve health and the 
delivery of care.\9\ While effectively addressing this problem will 
require additional and more comprehensive measures,\10\ section 
106(b)(2) of the MACRA represents an important first step towards 
increasing accountability for certain types of information blocking in 
the specific context of meaningful EHR users.
---------------------------------------------------------------------------

    \9\ See, for example, Julia Adler-Milstein and Eric Pfeifer, 
Information Blocking: Is it occurring and what policy strategies can 
address it?, Milbank Quarterly (forthcoming Mar 2017) (reporting 
results of national survey of health information leaders in which 25 
percent of respondents experienced routine information blocking by 
hospitals and health systems and over 50 percent of respondents 
experienced routine information blocking by EHR vendors); American 
Society of Clinical Oncology, Barriers to interoperability and 
information blocking (2015), http://www.asco.org/sites/www.asco.org/files/position_paper_for_clq_briefing_09142015.pdf (describing a 
growing number of reports from members concerning information 
blocking and stating that preventing these practices ``is critically 
important to ensuring that every patient with cancer receives the 
highest quality health care services and support''); David C. 
Kendrick, Statement to the Senate, Committee on Health, Education, 
Labor, and Pensions, Achieving the promise of health information 
technology: information blocking and potential solutions, Hearing 
(Jul 23, 2015), available at http://www.help.senate.gov/hearings/achieving-the-promise-of-health-information-technology-information-blocking-and-potential-solutions (describing information blocking as 
``intentional interruption or prevention of interoperability'' by 
providers or EHR vendors and stating ``we have so many specific 
experiences with inappropriate data blocking . . . that we have 
created a nomenclature [to classify the most common types].''); 
David C. Kibbe, Statement to Senate, Committee on Health, Education, 
Labor, and Pensions, Achieving the promise of health information 
technology: information blocking and potential solutions, Hearing 
(Jul 23, 2015), available at http://www.help.senate.gov/hearings/achieving-the-promise-of-health-information-technology-information-blocking-and-potential-solutions (testifying that despite progress 
in interoperable health information exchange, ``information blocking 
by health care provider organizations and their EHRs, whether 
intentional or not, is still a problem''); H.R. 6, 114th Cong. Sec.  
3001 (as passed by House of Representatives, July 10, 2015) 
(prohibiting information blocking and providing enforcement 
mechanisms, including civil monetary penalties and decertification 
of products); see also H.R. Rep. No. 114-190, pt. 1, at 126 (2015) 
(reporting that provisions of H.R. 6 ``would refocus national 
efforts on making systems interoperable and holding individuals 
responsible for blocking or otherwise inhibiting the flow of patient 
information throughout our healthcare system.''); Connecticut Public 
Act No. 15-146 (enacted June 30, 2015) (making information blocking 
an unfair trade practice, authorizing state attorney general to 
bring civil enforcement actions for penalties and punitive damages); 
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 (``[B]ased on the evidence and 
knowledge available, it is apparent that some health care providers 
and health IT developers are knowingly interfering with the exchange 
or use of electronic health information in ways that limit its 
availability and use to improve health and health care. This conduct 
may be economically rational for some actors in light of current 
market realities, but it presents a serious obstacle to achieving 
the goals of the HITECH Act and of health care reform.'')
    \10\ See ONC, FY 2017: Justification of Estimates for 
Appropriations Committee, https://www.healthit.gov/sites/default/files/final_onc_cj_fy_2017_clean.pdf (2016), Appendix I (explaining 
that current law does not directly prohibit or provide an effective 
means to investigate and address information blocking by EHR 
vendors, health care providers, and other persons and entities, and 
proposing that Congress prohibit and prescribe appropriate penalties 
for these practices, including civil monetary penalties and program 
exclusion).
---------------------------------------------------------------------------

    The proposed information blocking attestation consists of three 
statements that contain several specific representations about a health 
care provider's implementation and use of certified EHR technology. 
These representations, taken together, will enable the Secretary to 
infer with reasonable confidence that the attesting health care 
provider acted in good faith to support the appropriate exchange of 
electronic health information and therefore did not knowingly and 
willfully limit or restrict the compatibility or interoperability of 
certified EHR technology.
    We believe that this level of specificity is necessary and that a 
more generalized attestation would not provide the necessary assurances 
described above. This does not mean, however, that the information 
blocking attestation imposes unnecessary or unreasonable requirements 
on health care providers. To the contrary, we have carefully tailored 
the attestation to the demonstration required by section 106(b)(2) of 
the MACRA. In particular, the attestation focuses on whether a health 
care provider acted in good faith to implement and use certified EHR 
technology in a manner that supports interoperability and the 
appropriate exchange of electronic health information. Recognizing that 
a variety of factors may prevent the exchange or use of electronic 
health information, and consistent with the focus of section 106(b)(2) 
on actions that are knowing and willful, this good faith standard takes 
into account health care providers' individual circumstances and does 
not hold them accountable for consequences they cannot reasonably 
influence or control.
    For these and the additional reasons set forth in our responses to 
comments immediately below, and subject to the clarifications therein, 
we are finalizing this attestation requirement as proposed.
    Comment: A number of commenters, several of whom expressed support 
for our proposal, regarded the language of the attestation as quite 
broad and stated that additional guidance may be needed to enable 
health care providers to understand the actions they would be required 
to attest.
    Response: We agree that health care providers must be able to 
understand and comply with program requirements. For this reason, the 
information blocking attestation consists of three statements related 
to health information exchange and the prevention of health information 
blocking. These statements--which we are finalizing at Sec.  
495.40(a)(2)(i)(I) for EPs, Sec.  495.40(b)(2)(i)(I) for eligible 
hospitals and CAHs, and Sec.  414.1375(b)(3)(ii) for eligible 
clinicians--contain specific representations about a health care 
provider's implementation and use of certified EHR technology. We 
believe that these statements, taken together, communicate with 
appropriate specificity the actions health care providers must attest 
to in order to

[[Page 77030]]

demonstrate that they have complied with the requirements established 
by section 106(b)(2) of the MACRA. To provide further clarity, we set 
forth and explain each of these statements in turn below.
     Statement 1: A health care provider must 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.
    This statement mirrors the language of section 106(b)(2) of the 
MACRA. We note that except for one illustrative example (concerning 
actions to disable functionality), the above statement does not contain 
specific guidance as to the types of actions that are likely to ``limit 
or restrict'' the compatibility or interoperability of certified EHR 
technology, nor the circumstances in which a health care provider who 
engages in such actions does so ``knowingly and willfully.'' The 
information blocking attestation supplements the foregoing statement 
with two more detailed statements concerning the specific actions a 
health care provider took to support interoperability and the exchange 
of electronic health information.
     Statement 2: A health care provider must 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: (1) Connected in accordance with applicable 
law; (2) compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, 
and certification criteria adopted at 45 CFR part 170; (3) 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 (4) 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 
health care providers, and with disparate certified EHR technology and 
vendors.
    This statement focuses on the manner in which a health care 
provider implemented its certified EHR technology during the relevant 
reporting period, which is directly relevant to whether the health care 
provider took any actions to limit or restrict the compatibility or 
interoperability of the certified EHR technology. By attesting to this 
statement, a health care provider represents that it acted in good 
faith to implement its certified EHR technology in a manner that 
supported--and did not limit or restrict--access to and the exchange of 
electronic health information, to the extent that such access or 
exchange was appropriate (that is, practicable under the circumstances 
and authorized, permitted, or required by law). More specifically, the 
health care provider represents that it took reasonable steps 
(including working with its health IT developer and others as 
necessary) to verify that its certified EHR technology was connected 
(that is, implemented and configured) in accordance with applicable 
standards and law.
    In addition to verifying that certified EHR technology was 
connected and accessible during the relevant reporting period, a health 
care provider must represent that it took reasonable steps to implement 
corresponding technologies, standards, policies, practices, and 
agreements to enable the use of certified EHR technology, including by 
patients and by other health care providers, and not to limit or 
restrict appropriate access to or use of information in the health care 
provider's certified EHR technology. For example, actions to limit or 
restrict compatibility or interoperability could include implementing 
or configuring certified EHR technology so as to limit access to 
certain types of data elements or to the ``structure'' of the data, or 
implementing certified EHR technology in ways that limit the types of 
persons or entities that may be able to access and exchange 
information, or the types of technologies through which they may do so.
     Statement 3: A health care provider must 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.
    This third and final statement builds on a health care provider's 
representations concerning the manner in which its certified EHR 
technology was implemented by focusing on how the health care provider 
actually used the technology during the relevant reporting period. By 
attesting to this statement, a health care provider represents that it 
acted in good faith to use the certified EHR technology to support the 
appropriate exchange and use of electronic health information. This 
includes, for example, taking reasonable steps to respond to requests 
to access or exchange information, provided that such access or 
exchange is appropriate, and not unreasonably discriminating on the 
basis of the requestor's affiliation, technology vendor, or other 
characteristics, as described in the statement.
    We provide further discussion and analysis of the foregoing 
statements and their application in our responses to the specific 
comments summarized in the remainder of this section. We believe that 
these statements, taken together, provide a clear and appropriately 
detailed description of a health care provider's obligations under 
section 106(b)(2) of the MACRA, will enable them to demonstrate 
compliance to the satisfaction of the Secretary, and will promote fair 
and consistent application of program requirements across all attesting 
health care providers.
    Comment: Several commenters asked us to identify the specific 
actions and circumstances that would support a finding that a health 
care provider has knowingly and willfully limited or restricted the 
compatibility or interoperability of certified EHR technology. Some 
commenters inquired whether this determination would turn on a health 
care provider's individual circumstances or other case-by-case 
considerations, such as a health care provider's practice size, 
setting, specialty, and level of technology adoption. Commenters also 
asked whether other circumstances could justify limitations or 
restrictions on the compatibility or interoperability of certified EHR 
technology. For example, a commenter asked whether an office-based 
clinic that periodically turns its computer network off overnight to 
perform system maintenance would be deemed to have limited the 
interoperability of its certified EHR technology on the basis that 
other health care providers might be unable to request and retrieve 
records during that time. Commenters gave other potential 
justifications for blocking access to or the exchange of information, 
such as privacy or security concerns or the need to temporarily block 
the disclosure of sensitive test results to allow clinicians who order 
tests an opportunity to discuss the results with their patients prior 
to sharing the results with other health care providers.
    One commenter suggested that we approach this question in the 
manner described in the Information Blocking Report, which focuses on 
whether actions that interfere with the exchange or use of electronic 
health information have any objectively reasonable justification.
    Response: The compatibility or interoperability of certified EHR

[[Page 77031]]

technology may be limited or restricted in ways that are too numerous 
and varied to catalog. While section 106(b)(2) of the MACRA 
specifically mentions actions to disable the functionality of certified 
EHR technology, other actions that are likely to interfere with the 
exchange or use of electronic health information could limit or 
restrict compatibility or interoperability. For example, the 
Information Blocking Report describes certain categories of business, 
technical, and organizational practices that are inherently likely to 
interfere with the exchange or use of electronic health 
information.\11\ These practices include but are not limited to:
---------------------------------------------------------------------------

    \11\ ONC, Report to Congress on Health Information Blocking 
(April 10, 2015) at 13, available at https://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf.
---------------------------------------------------------------------------

     Contract terms, policies, or other business or 
organizational practices that restrict individuals' access to their 
electronic health information or restrict the exchange or use of that 
information for treatment and other permitted purposes.
     Charging prices or fees that make exchanging and using 
electronic health information cost prohibitive.
     Implementing certified EHR technology in non-standard ways 
that are likely to substantially increase the costs, complexity, or 
burden of sharing electronic health information (especially when 
relevant interoperability standards have been adopted by the 
Secretary).
     Implementing certified EHR technology in ways that are 
likely to ``lock in'' users or electronic health information (including 
using certified EHR technology to inappropriately limit or steer 
referrals).
    Such actions would be contrary to section 106(b)(2) only when 
engaged in ``knowingly and willfully.'' We believe the purpose of this 
requirement is to ensure that health care providers are not penalized 
for actions that are inadvertent or beyond their control.
    To illustrate these concepts, we consider several hypothetical 
scenarios raised by the commenters. First, we consider the situation 
suggested by one commenter in which a health care provider disables its 
computer network overnight to perform system maintenance. In this 
situation, the health care provider knows that the natural and probable 
consequence of its actions will be to prevent access to information in 
the certified EHR technology and in this way limit and restrict the 
interoperability of the technology. However, we recognize that health 
IT requires maintenance to ensure that capabilities function properly, 
including in accordance with applicable standards and law. We also 
appreciate that in many cases it may not be practicable to implement 
redundant capabilities and systems for all functionality within 
certified EHR technology, especially for physician practices and other 
health care providers with comparatively less health IT resources and 
expertise. Assuming that a health care provider acts in good faith to 
disable functionality for the purpose of performing system maintenance, 
it is unlikely that the health care provider would knowingly and 
willfully limit or restrict the compatibility or interoperability of 
the certified EHR technology. We note that our assumption that the 
health care provider acted in good faith presupposes that it did not 
disable functionality except to the extent and for the duration 
necessary to ensure the proper maintenance of its certified EHR 
technology, and that it took reasonable steps to minimize the impact of 
such maintenance on the ability of patients and other health care 
providers to appropriately access and exchange information, such as by 
scheduling maintenance overnight and responding to any requests for 
access or exchange once the maintenance has been completed and it is 
otherwise practicable to do so.
    Next, we consider the situation in which a health care provider 
blocks access to information in its certified EHR technology due to 
concerns related to the security of the information. Depending on the 
circumstances, certain access restrictions may be reasonable and 
necessary to protect the security of information maintained in 
certified EHR technology. In contrast, restrictions that are 
unnecessary or unreasonably broad could constitute a knowing and 
willful restriction of the compatibility or interoperability of the 
certified EHR technology. Because of the complexity of these issues, 
determining whether a health care provider's actions were reasonable 
would require additional information about the health care provider's 
actions and the circumstances in which they took place.
    As a final example, we consider whether it would be permissible for 
a health care provider to restrict access to a patient's sensitive test 
results until the clinician who ordered the tests, or another 
designated health care professional, has had an opportunity to review 
and appropriately communicate the results to the patient. We assume for 
purposes of this example that, consistent with the HIPAA Privacy Rule, 
the restriction does not apply to the patient herself or to the 
patient's request in writing to send this information to any other 
person the patient designates. With that assumption and under the 
circumstances we have described, it is likely that the health care 
provider is knowingly restricting interoperability. We believe that the 
restriction may be reasonable so long as the health care provider 
reasonably believes, based on its relationship with the particular 
patient and its best clinical judgment, that the restriction is 
necessary to protect the health or wellbeing of the patient. We note 
that our analysis would be different if the restriction were not based 
on a health care provider's individualized assessment of the patient's 
best interests and instead reflected a blanket policy to block access 
to test results until released by the ordering physician. Similarly, 
while clinical judgment and the health care provider-patient 
relationship are entitled to substantial deference, they may not be 
used as a pretext for limiting or restricting the compatibility or 
interoperability of certified EHR technology.
    The examples provided in this section of the final rule with 
comment period are intended to be illustrative. We reiterate the need 
to consider the unique facts and circumstances in each case in order to 
determine whether a health care provider knowingly and willfully 
limited or restricted the compatibility or interoperability of 
certified EHR technology.
    Comment: One commenter asked whether the requirement that certified 
EHR technology complies with federal standards precludes the use of 
other standards for the exchange of electronic health information.
    Response: In general, while certified EHR technology must be 
connected in accordance with applicable federal standards, this 
requirement does not preclude the use of other standards or 
capabilities, provided the use of such standards or capabilities does 
not limit or restrict the compatibility or interoperability of the 
certified EHR technology.
    Comment: Several commenters requested that we clarify our 
expectations for timeliness of access to or exchange of information.
    Response: As we have explained, whether a health care provider has 
knowingly and willfully limited or restricted the interoperability of 
certified EHR technology will depend on the relevant facts and 
circumstances. While for this reason we decline to

[[Page 77032]]

adopt any bright-line rules, we reiterate that a health care provider 
must attest that it responded in good faith and in a timely manner to 
requests to retrieve or exchange electronic health information. What 
will be ``timely'' will of course vary based on relevant factors such 
as a health care provider's level of technology adoption and the types 
of information requested. For requests from patients, we note that 
while the HIPAA Privacy Rule provides that a covered entity may take up 
to 30 days to respond to a patient's written request for access to his 
or her PHI maintained by the covered entity, it is expected that the 
use of technology will enable the covered entity to fulfill the 
individual's request in far fewer than 30 days.\12\ Where information 
requested or directed by a patient can be readily provided using the 
capabilities of certified EHR technology, access should in most cases 
be immediate and in all cases as expeditious as is practicable under 
the circumstances.
---------------------------------------------------------------------------

    \12\ HHS Office for Civil Rights, Individuals' Right under HIPAA 
to Access their Health Information 45 CFR 164.524, http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html (last accessed Sept. 6, 2016).
---------------------------------------------------------------------------

    Comment: Many commenters stated that health care professionals and 
organizations should not be held responsible for adherence to health IT 
certification standards or other technical details of health IT 
implementation that are beyond their expertise or control. According to 
these commenters, requiring health care providers to attest to these 
technical implementation details would unfairly place them at financial 
risk for factors that are beyond the scope of their medical training. 
Additionally, many commenters took the position that EHR vendors are in 
the best position to ensure that certified EHR technology is connected 
in accordance with applicable law and compliant with applicable 
standards, implementation specifications, and certification criteria.
    Response: We reiterate that a health care provider will not be held 
accountable for factors that it cannot reasonably influence or control, 
including the actions of EHR vendors. Nor do we expect health care 
providers themselves to have any special technical expertise or to 
personally tend to the technical details of their health IT 
implementations. We do expect, however, that a health care provider 
will take reasonable steps to verify that the certified EHR technology 
is connected (that is, implemented and configured) in accordance with 
applicable standards and law and in a manner that will allow the health 
care provider to attest to having satisfied the conditions described in 
the information blocking attestation. In this respect, a health care 
provider's obligations include communicating these requirements to 
health IT developers, implementers, and other persons who are 
responsible for implementing and configuring the health care provider's 
certified EHR technology. In addition, the health care provider should 
obtain adequate assurances from these persons to satisfy itself that 
its certified EHR technology was connected in accordance with 
applicable standards and law and in a manner that will enable the 
health care provider to demonstrate that it has not knowingly and 
willfully take action to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    Comment: Several commenters supported the attestation's emphasis on 
the bi-directional exchange of structured electronic health 
information. Multiple commenters suggested that this requirement would 
expand access to relevant information by members of a patient's care 
team, allowing them to deliver more effective and comprehensive care, 
enhance health outcomes, and contribute directly to the goals of 
quality and affordability. As an example, commenters stated that the 
bi-directional exchange of information among pharmacists and other 
clinicians can provide important information for comprehensive 
medication management.
    Other commenters opposed or raised concerns regarding this aspect 
of our proposal, stating that bi-directional information exchange may 
not be feasible for many health care providers or may raise a variety 
of technical and operational challenges and potential privacy or 
security concerns.
    Some commenters requested that CMS clarify the term ``bi-
directional exchange'' and the actions a health care provider would be 
expected to take to satisfy this aspect of the attestation. One 
commenter inquired specifically whether bi-directional exchange could 
include using a health information exchange or other intermediary to 
connect disparate certified EHR technology so that users could both 
send and receive information in an interoperable manner. If so, the 
commenter asked whether a health care provider would be expected to 
participate in multiple arrangements of this kind (and, if so, how 
many). Multiple commenters stated that it is not appropriate to allow 
bi-directional exchange in all circumstances and that privacy, 
security, safety, and other considerations require health care 
providers to restrict the types of information that the certified EHR 
technology will accept and the persons or other sources of that 
information.
    Response: We appreciate that bi-directional exchange of information 
presents challenges, including the need to validate the authenticity, 
accuracy, and integrity of data received from outside sources, 
mitigating potential privacy and security risks, and overcoming 
technical, workflow, and other related challenges. We also acknowledge 
that accomplishing bi-directional exchange may be challenging for 
certain health care providers or for certain types of information or 
use cases. However, a significant number of health care providers are 
already exchanging some types of electronic health information in a bi-
directional manner. Based upon data collected in 2014, approximately 
one-fifth of non-federal acute care hospitals electronically sent, 
received, found (queried), and were able to easily integrate summary of 
care records into their EHRs.\13\ We also note that meaningful EHR 
users are required to use certified EHR technology that has the 
capacity to ``exchange electronic health information with, and to 
integrate such information from other sources,'' as required by the 
2014 and 2015 Edition Base EHR definitions at 45 CFR 170.102 and 
corresponding certification criteria, such as the transitions of care 
criteria (45 CFR 170.314(b)(1) and (2) (2014 Edition) and 45 CFR 
170.315(b)(2) (2015 Edition)).
---------------------------------------------------------------------------

    \13\ Charles D, Swain M Patel V. (August 2015) Interoperability 
among U.S. Non-federal Acute Care Hospitals. ONC Data Brief, No. 25 
ONC: Washington DC. https://www.healthit.gov/sites/default/files/briefs/onc_databrief25_interoperabilityv16final_081115.pdf Similar 
data for office-based physicians will be available in 2016. ONC, 
Request for Information Regarding Assessing Interoperability for 
MACRA, 81 FR 20651 (April 8, 2016).
---------------------------------------------------------------------------

    We expect these trends to increase as standards and technologies 
improve and as health care providers, especially those participating in 
Advanced APMs, seek to obtain more complete and accurate information 
about their patients with which to coordinate care, manage population 
health, and engage in other efforts to improve quality and value.
    We clarify that bi-directional exchange may include using certified 
EHR technology with a health information exchange or other intermediary 
to connect disparate certified EHR technology so that users could both 
send and receive information in an interoperable manner. Whether a 
health care provider could participate in

[[Page 77033]]

arrangements of this kind, or multiple arrangements, would depend on 
its particular circumstances, including its technological capabilities 
and sophistication, its financial resources, its role within the local 
health care community, and the availability of state or regional health 
information exchange infrastructure, among other relevant factors. A 
health care provider is not obligated to participate in every 
information sharing arrangement or to accommodate every request to 
connect via a custom interface. On the other hand, a health care 
provider with substantial resources that refuses to participate in any 
health information exchange efforts might invite scrutiny if, combined 
with other relevant facts and circumstances, there were reason to 
suspect that the health care provider's refusal to participate in 
certain health information exchange efforts were part of a larger 
pattern of behavior or a course of conduct to knowingly and willfully 
limit the compatibility or interoperability of the certified EHR 
technology.
    Comment: Several commenters were concerned about the requirement to 
respond to requests to retrieve or exchange electronic health 
information. Commenters stated that health care providers may have 
difficulty responding to requests from unaffiliated health care 
providers or from EHR vendors with whom they do not have a business 
associate agreement.
    A few commenters were concerned that health care providers may be 
penalized for limiting or restricting access to information despite not 
knowing whether an unaffiliated health care provider or EHR vendor is 
authorized or permitted to access a patient's PHI. Another commenter 
noted that some state laws require written patient consent before 
certain types of health information may be exchanged electronically. 
Some commenters contested the technical feasibility of exchanging 
information with unaffiliated health care providers and across 
disparate certified EHR technologies, explaining that federally-adopted 
standards such as the Direct standard do not support such robust 
information sharing. In particular, there is no widely-accepted and 
standardized method to encode requests in Direct messages, which means 
that a receiving system will often be unable to understand what 
information is being requested.
    Response: The ability to exchange and use information across 
multiple systems and health care organizations is integral to the 
concept of interoperability and, consequently, to a health care 
provider's demonstration under section 106(b)(2) of the MACRA. 
Consistent with its attestation, a health care provider must implement 
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 
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, including unaffiliated providers, and with disparate 
certified EHR technology and vendors.
    We recognize that technical, legal, and other practical constraints 
may prevent a health care provider from responding to some requests to 
access, exchange, or use electronic health information in a health care 
provider's certified EHR technology, even when the requester has 
permission or the right to access and use the information. We reiterate 
that in these circumstances a health care provider probably would not 
have knowingly and willfully limited or restricted the compatibility or 
interoperability of the certified EHR technology. We expect that these 
technical and other challenges will become less significant over time 
and that health care providers will be able to respond to requests from 
an increasing range of health care providers and health IT systems.
    In response to the concerns regarding the disclosure of PHI without 
a business associate agreement, we remind commenters that the HIPAA 
Privacy Rule expressly permits covered entities to disclose PHI for 
treatment, payment, and operations. We refer commenters to numerous 
guidance documents and fact sheets issued by the HHS Office for Civil 
Rights and ONC on this subject.\14\ We also caution that 
mischaracterizing or misapplying the HIPAA Privacy Rule or other legal 
requirements in ways that are likely to limit or restrict the 
compatibility or interoperability of certified EHR technology might be 
inconsistent with the requirements of section 106(b)(2) of the MACRA 
and a health care provider's information blocking attestation. As an 
example, a health system that maintains a policy or practice of 
refusing to share PHI with unaffiliated health care providers on the 
basis of generalized and unarticulated ``HIPAA compliance concerns'' 
could be acting contrary to section 106(b)(6) and the information 
blocking attestation. The same would be true were a health care 
provider to inform a patient that it is unable to share information 
electronically with the patient's other health care professionals ``due 
to HIPAA.''
---------------------------------------------------------------------------

    \14\ See, e.g., HHS Office for Civil Rights, Understanding Some 
of HIPAA's Permitted Uses and Disclosures, http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/permitted-uses/index.html (last 
accessed Sept. 1, 2016); see also Lucia Savage and Aja Brooks, The 
Real HIPAA Supports Interoperability, Health IT Buzz Blog, https://www.healthit.gov/buzz-blog/electronic-health-and-medical-records/interoperability-electronic-health-and-medical-records/the-real-hipaa-supports-interoperability/ (last accessed Sept. 1, 2016).
---------------------------------------------------------------------------

    Comment: A small number of commenters, primarily health IT 
developers, recommended that any requirements to exchange information 
be limited to the use of certified health IT capabilities required by 
the 2015 Edition health IT certification criteria or 2014 Edition EHR 
certification criteria (45 CFR 170.102), as applicable. In contrast, a 
commenter stated that a significant amount of health information is 
exchanged through means other than the standards and capabilities 
supported by ONC's certification criteria for health IT. The commenter 
cited as an example the widespread use of health information exchanges 
(HIEs) and network-to-network exchanges, which may or may not 
incorporate the use of certified health IT capabilities. The commenter 
insisted that these approaches should not be regarded as information 
blocking and should be treated as evidence that a health care provider 
is supporting and participating in efforts to exchange electronic 
health information. Another commenter stated that the requirement to 
respond to requests to retrieve or exchange electronic health 
information should be satisfied by connecting certified EHR technology 
to a network that can be accessed by other health care providers.
    Response: We decline to limit the attestation to the use of 
certified health IT capabilities or to give special weight to any 
particular form or method of exchange. As observed by the commenters, 
certified EHR technology may be implemented and used in many different 
ways that support the exchange and use of electronic health 
information. A health care provider's use of these forms and methods of 
exchange may be relevant to determining whether it acted in good faith 
to implement and use its certified EHR technology in a manner that 
supported and did not limit or restrict the compatibility or 
interoperability of the technology. As an example, certified

[[Page 77034]]

EHR technology may come bundled with a health information service 
provider (HISP) that limits the ability to send and receive Direct 
messages to certain health care providers, such as those whose EHR 
vendor participates in a particular trust network. To overcome this or 
other technical limitations, a health care provider may participate in 
a variety of other health information sharing arrangements, whether to 
expand the reach of its Direct messaging capabilities or to enable 
other methods of exchanging and using electronic health information in 
its certified EHR technology. We believe that these and similar actions 
may be relevant to and should not be excluded from the consideration of 
the health care provider's overall actions to enable the 
interoperability of its certified EHR technology and to respond in good 
faith to requests to access or exchange electronic health information.
    Comment: Some commenters recommended that we revise the language of 
the attestation in whole or in part. Most of these commenters suggested 
removing certain language or statements, or combining them, to make the 
requirements of the attestation easier to understand or comply with. 
One commenter suggested that we abandon the proposed language and adopt 
the commenter's alternative language, which would require health care 
providers to attest that they established a workflow for responding to 
requests to retrieve or exchange electronic health information and did 
not knowingly or willfully limit or restrict the compatibility or 
interoperability of certified EHR technology during the development or 
implementation of the workflow, or in any subsequent actions related to 
the workflow.
    Response: We appreciate commenters' suggestions, but for the 
reasons we have explained, we do not believe it is appropriate to 
remove or to further simplify the language of the attestation. Although 
we do not adopt the alternative language suggested by one commenter, we 
observe that the actions the commenter describes are consistent with 
our expectation that health care providers implement certified EHR 
technology in a manner reasonably calculated to facilitate 
interoperability, to the greatest extent practicable, and respond in 
good faith to requests to retrieve or exchange information.
    Comment: Several commenters claimed that the proposed attestation 
is not necessary because most health care providers are not knowingly 
or willfully engaging in actions to limit or restrict the 
interoperability or compatibility of certified EHR technology, or to 
otherwise interfere with the exchange or use of electronic health 
information. Some of these commenters, while acknowledging that some 
health care providers may be engaging in actions that could limit or 
restrict the interoperability or compatibility of certified EHR 
technology, maintained that such actions are justified or are beyond a 
health care provider's control. Some commenters supported an 
attestation for hospitals or health systems but not for physicians, on 
the basis that the majority of individual EHR users are not engaging in 
information blocking.
    Response: The belief that health care providers do not engage in 
information blocking is contradicted by an increasing body of evidence 
and research, by the experience of CMS and ONC, and by many of the 
comments on this proposal.\15\ It is also inconsistent with section 
106(b)(2) of the MACRA, which is entitled ``Preventing Blocking The 
Sharing Of Information'' and expressly requires health care providers 
to demonstrate that they did not knowingly and willingly take action to 
limit or restrict the interoperability of certified EHR technology.
---------------------------------------------------------------------------

    \15\ See, for example, Julia Adler-Milstein and Eric Pfeifer, et 
al. referenced in this final rule with comment period.
---------------------------------------------------------------------------

    We need not contemplate whether health systems or any other class 
of health care provider is more predisposed to engage in information 
blocking, because the attestation we are finalizing implements section 
106(b)(2) of the MACRA, which extends to all MIPS eligible clinicians, 
eligible clinicians part of an APM Entity, EPs, eligible hospitals, and 
CAHs.
    Comment: Some commenters suggested that, in lieu of an attestation, 
that CMS allow health care providers to demonstrate compliance with 
section 106(b)(2) by reporting on objectives and measures under the 
Medicare and Medicaid EHR Incentive Programs or the advancing care 
information performance category of MIPS. Commenters noted that health 
care providers participating in these programs must utilize CEHRT, 
including application programing interfaces (APIs) that provide access 
to patient data, and that participation in these programs should itself 
provide an adequate assurance that health care providers are not 
knowingly and willfully limiting or restricting the compatibility or 
interoperability of certified EHR technology.
    Response: We do not believe that a health care provider's reporting 
of objectives and measures can provide the demonstration required by 
section 106(b)(2) of the MACRA. The compatibility or interoperability 
of certified EHR technology may be limited or restricted in numerous 
and varied ways that are difficult to anticipate and that may not be 
reflected in objectives and measures under the EHR Incentive Programs 
and MIPS, which address a broad range of aspects related to the use of 
certified health IT. It is therefore entirely possible that a health 
care provider could implement and use certified EHR technology and meet 
relevant objectives and measures while still engaging in many actions 
that limit or restrict compatibility or interoperability. While in 
theory we could specify additional objectives and measures specifically 
related to the prevention of health information blocking, at this time 
we believe a less burdensome and more effective way to obtain adequate 
assurances that health care providers have not engaged in these 
prohibited practices is through the information blocking attestation we 
proposed and are finalizing.
    Comment: Many commenters stated that EHR vendors, not health care 
providers, are the primary cause of existing barriers to 
interoperability and information exchange. Many of these commenters 
stated that EHR vendors are engaging in information blocking, with some 
commenters alleging that EHR vendors are routinely engaging in these 
practices. Commenters alleged that EHR vendors are unwilling to share 
data in certain circumstances or charge fees that make such sharing 
cost-prohibitive for most physicians, which poses a significant barrier 
to interoperability and the efficient exchange of electronic health 
information.
    For these reasons, many commenters suggested that CMS or ONC to 
require EHR vendors and other health IT developers to attest to an 
information blocking attestation or to impose other requirements and 
penalties on developers to deter them from limiting or restricting the 
interoperability of certified EHR technology and to encourage them to 
proactively facilitate the sharing of electronic health information. 
For example, commenters supported the decertification of EHR vendors 
that charge excessive fees or engage in other practices that may 
constitute information blocking.
    Response: We agree that eligible clinicians, EPs, eligible 
hospitals, and CAHs are by no means the only persons or entities that 
may engage in information blocking. However, requirements for EHR 
vendors or other health IT developers are beyond the

[[Page 77035]]

scope of section 106(b)(2) of the MACRA and this rulemaking.
    We note a series of legislative proposals included in the 
President's Fiscal Year 2017 Budget would prohibit information blocking 
by health IT developers and others and to provide civil monetary 
penalties and other remedies to deter this behavior.\16\ In addition, 
ONC has taken a number of immediate actions to expose and discourage 
information blocking by health IT developers, including requiring 
developers to disclose material information about limitations and types 
of costs associated with their certified health IT (see 45 CFR 
170.523(k)(1); see also 80 FR 62719) and requiring ONC-ACBs to conduct 
more extensive and more stringent surveillance of certified health IT, 
including surveillance of certified health IT ``in the field'' (see 45 
CFR 170.556; see also 80 FR 62707). ONC has also published resources, 
including a new guide to EHR contracts that can assist health care 
providers to compare EHR vendors and products and negotiate appropriate 
contract terms that do not block access to data or otherwise impair the 
use of certified EHR technology.\17\
---------------------------------------------------------------------------

    \16\ See ONC, FY 2017: Justification of Estimates for 
Appropriations Committee, https://www.healthit.gov/sites/default/files/final_onc_cj_fy_2017_clean.pdf (2016), Appendix I (explaining 
that current law does not directly prohibit or provide an effective 
means to investigate and address information blocking by EHR 
vendors, health care providers, and other persons and entities, and 
proposing that Congress prohibit and prescribe appropriate penalties 
for these practices, including civil monetary penalties and program 
exclusion).
    \17\ ONC, EHR Contracts Untangled: Selecting Wisely, Negotiating 
Terms, and Understanding the Fine Print (Sept. 2016), available at 
https://www.healthit.gov/sites/default/files/EHR_Contracts_Untangled.pdf.
---------------------------------------------------------------------------

    Comment: Several commenters requested clarification regarding the 
documentation that would be required to demonstrate compliance with the 
terms of the attestation so that health care providers could both 
better understand and prepare for an audit of this requirement. Among 
other topics, commenters requested guidance on expected documentation 
requirements related to particular technologies or capabilities as well 
as a health care provider's responsiveness to requests to exchange 
information.
    Response: We acknowledge commenters' concerns about required 
documentation in cases of an audit. To alleviate those concerns, we 
clarify that we will provide guidance to auditors relating to the final 
policy and the attestation process. This instruction should include 
requiring auditors to work closely with health care providers on the 
supporting documentation needed applicable to the health care 
provider's individual case. We further stress that audit determinations 
are made on a case by case basis, which allows us to give individual 
consideration to each health care provider. We believe that such case-
by-case review will allow us to adequately account for the varied 
circumstances that may be relevant to assessing compliance.
    Comment: Some commenters stated that it would be inappropriate for 
ONC or an ONC-ACB to perform surveillance of a health care provider's 
certified EHR technology to determine whether the health care provider 
is limiting or restricting interoperability.
    Response: The scope of ONC-ACB surveillance or, if finalized, ONC's 
review of a health care provider's certified EHR technology is limited 
to determining whether the technology continues to perform in 
accordance with the requirements of the ONC Health IT Certification 
Program. Because this oversight focuses on the performance of the 
technology itself, not on the actions of health care providers or users 
of the technology, we do not anticipate that information obtained in 
the course of such ONC-ACB surveillance or ONC review would be used to 
audit a health care provider's compliance with its information blocking 
attestation. As a caveat, we acknowledge that if ONC became aware that 
a health care provider had submitted a false attestation or engaged in 
other actions in violation of federal law or requirements, ONC could 
share that information with relevant federal entities.
    Comment: Some commenters asked how often attestations would be 
required (for example, once per year). Commenters also stated that the 
information blocking attestation should apply prospectively, possibly 
beginning with reporting periods commencing in 2017, to provide 
reasonable notice to affected parties.
    Response: MIPS eligible clinicians, eligible clinicians part of an 
APM Entity, EPs, eligible hospitals, and CAHs must submit an 
information blocking attestation covering each reporting period during 
which they seek to demonstrate that they were a meaningful EHR user or 
for which they seek to report on the advancing care information 
performance category. We agree that the attestation requirements should 
apply only to actions occurring after the effective date of this final 
rule with comment period. For this reason and to promote alignment with 
other reporting requirements, we are finalizing the information 
blocking attestation for attestations covering EHR reporting periods 
and MIPS performance periods beginning on or after January 1, 2017.
    After review and consideration of public comment, we are finalizing 
the attestation requirement as proposed. We are finalizing this 
requirement for EPs, eligible hospitals, and CAHs under the Medicare 
and Medicaid EHR Incentive Programs and for eligible clinicians under 
the advancing care information performance category in 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. We are finalizing this requirement for attestations 
covering EHR reporting periods and MIPS performance periods beginning 
on or after January 1, 2017.
    We have revised and are finalizing the proposed regulation text 
accordingly. Specifically, we are finalizing the revisions to the 
definition of a meaningful EHR user at Sec.  495.4 and we are adding 
the same to the definition of a meaningful EHR user for MIPS at Sec.  
414.1305. We are finalizing the attestation requirements at Sec.  
495.40(a)(2)(i)(I) and (b)(2)(i)(I) to require such an attestation from 
EPs, eligible hospitals, and CAHs as part of their demonstration of 
meaningful EHR use under the Medicare and Medicaid EHR Incentive 
Programs. We are also finalizing Sec.  414.1375(b)(3) to require this 
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 final rule with comment period.

D. Definitions

    At Sec.  414.1305, in subpart O, we proposed definitions for the 
following terms:
     Additional performance threshold.
     Advanced Alternative Payment Model (Advanced APM).
     Advanced APM Entity.
     Affiliated practitioner.
     Affiliated practitioner list.
     Alternative Payment Model (APM).
     APM Entity.
     APM Entity group.
     APM Incentive Payment.
     Attestation.
     Attributed beneficiary.
     Attribution-eligible beneficiary.
     Certified Electronic Health Record Technology (CEHRT).

[[Page 77036]]

     CMS-approved survey vendor.
     CMS Web Interface.
     Covered professional services.
     Eligible clinician.
     Episode payment model.
     Estimated aggregate payment amounts.
     Final score.
     Group.
     Health Professional Shortage Areas (HPSA).
     High priority measure.
     Hospital-based MIPS eligible clinician.
     Improvement activities.
     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 eligible clinician.
     MIPS payment year.
     New Medicare-Enrolled MIPS eligible clinician.
     Non-patient facing MIPS eligible clinician.
     Other Payer Advanced APM.
     Other payer arrangement.
     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 non-process measure.
     Topped out process measure.
    Some of these terms are new in conjunction with MIPS and APMs, 
while others are used in existing CMS programs. For the new terms and 
definitions, we note that some of them have been developed alongside 
policies of this regulation while others are defined by statute. 
Specifically, the following terms and definitions were established by 
the MACRA: APM, Eligible Alternative Payment Entity (which we refer to 
as an Advanced APM Entity), Composite Performance Score (which we refer 
to as final score), Eligible professional or EP (which we refer to as 
an eligible clinician), MIPS Eligible professional or MIPS EP (which we 
refer to as a MIPS eligible clinician), MIPS adjustment factor (which 
we refer to as a MIPS payment adjustment factor), additional positive 
MIPS payment adjustment factor (which we refer to as additional MIPS 
payment adjustment factor), Qualifying APM Participant, and Partial 
Qualifying APM Participant.
    These terms and definitions are discussed in detail in relevant 
sections of this final rule with comment period.

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, 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 the proposed rule (81 FR 
28177 through 28178), section 1848(q)(1)(C)(ii) and (v) of the Act 
specifies several exclusions from the definition of a MIPS eligible 
clinician, which includes clinicians who are determined to be new 
Medicare-enrolled eligible clinicians, QPs and Partial QPs, or do not 
exceeded the low-volume threshold pertaining to the dollar value of 
billed Medicare Part B allowed charges or Part B-enrolled beneficiary 
count. 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 
payment adjustment factor (or additional MIPS payment 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. For purposes of this section of the final rule 
with comment period, we use the term ``MIPS payment adjustment'' to 
refer to the MIPS payment adjustment factor (or additional MIPS payment 
adjustment factor) as specified in section 1848(q)(1)(C)(vi) of the 
Act.
    To implement the MIPS program we must first establish and define a 
MIPS eligible clinician in accordance with the statutory definition. We 
proposed 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 
proposed that QPs and Partial QPs 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 a MIPS eligible

[[Page 77037]]

clinician to include additional eligible clinicians (as defined in 
section 1848(k)(3)(B) of the Act) through rulemaking in future years.
    Additionally, in accordance with section 1848(q)(1)(A) and 
(q)(1)(C)(vi) of the Act, we proposed 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 proposed 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 would have the 
opportunity to gain experience in the MIPS program. We were 
particularly interested in public comments regarding the feasibility 
and advisability of voluntary reporting in the MIPS program for 
entities such as RHCs and/or 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 requested comments on 
these proposals.
    The following is a summary of the comments we received regarding 
our proposed definition of the term MIPS eligible clinician and our 
proposal to allow eligible clinicians who are not MIPS eligible 
clinicians the option to voluntarily report measures and activities for 
MIPS.
    Comment: Commenters supported the option for RHCs and FQHCs to 
voluntary report, but noted that RHCs and FQHCs may not have experience 
using EHR technology or the resources to invest in CEHRT and requested 
that CMS adjust for the social determinants of health status.
    Response: We appreciate the feedback on the role of socioeconomic 
status in quality measurement. We continue to evaluate the potential 
impact of social risk factors on measure performance. One of our core 
objectives is to improve beneficiary outcomes, and we want to ensure 
that complex patients as well as those with social risk factors receive 
excellent care.
    Comment: Several commenters expressed support for the proposed 
definition of a MIPS eligible clinician and the proposal to allow 
eligible clinicians who are not MIPS eligible to voluntarily report, 
which encourages interdisciplinary and team-based services necessary to 
address the full spectrum of patient and family needs and quality of 
life concerns throughout the care continuum and across health system 
and community-based care settings. One commenter expressed appreciation 
for CMS using practitioner-neutral language and including nurse 
practitioners.
    Response: We appreciate the support from commenters.
    Comment: In regard to the definition of a MIPS eligible clinician, 
one commenter recommended that certified registered nurse anesthetists 
be removed from the list of MIPS eligible clinicians because there are 
not applicable measures for their job duties and they do not treat 
diseases. Another commenter requested that CMS align the definition of 
an eligible clinician in both the Medicare and Medicaid programs 
because nurse practitioners do not qualify for the Medicare EHR 
Incentive Program for Eligible Professionals, but do qualify for the 
Medicaid EHR Incentive Program for Eligible Professionals. One 
commenter expressed concern with the inclusion of nurse practitioners 
and physician assistants in the definition of a MIPS eligible clinician 
due to such providers needing to purchase and implement an EHR system 
in a short timeframe and requested that CMS postpone the inclusion of 
nurse practitioners and physician assistants.
    Response: We appreciate the recommendations from the commenters and 
note that section 1848(q)(1)(C)(i) of the Act defines a MIPS eligible 
clinician, for the first and second MIPS payment years, as a physician 
(as defined in section 1861(r) of the Act), a physician assistant, 
nurse practitioner, 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. We do not have discretion under 
the statute to amend the definition of a MIPS eligible clinician by 
excluding clinician types that the statute expressly includes, such as 
certified registered nurse anesthetists, nurse practitioners, and 
physician assistants. We note, however, that several policies may 
alleviate the concerns of commenters regarding the availability of 
applicable measures and activities, and health IT implementation costs. 
For example, as discussed in section II.E.3.c. of this final rule with 
comment period, we are finalizing a higher low-volume threshold to 
ensure that MIPS eligible clinicians who do not exceed $30,000 of 
billed Medicare Part B allowed charges or 100 Part B-enrolled Medicare 
beneficiaries are excluded from MIPS. Also, we note that while non-
patient facing MIPS eligible clinicians are not exempt from 
participating in MIPS or a performance category entirely, as discussed 
in section II.E.1.b. of this final rule with comment period, we are 
establishing a process that applies, to the extent feasible and 
appropriate, alternative measures or activities for non-patient facing 
MIPS eligible clinicians that fulfill the goals of the applicable 
performance category. In addition, as discussed in section II.E.6.b.(2) 
of this final rule with comment period, we may re-weight performance 
categories if there are not sufficient measures applicable and 
available to each MIPS eligible clinician to ensure that MIPS eligible 
clinicians, including those who are non-patient facing, who do not have 
sufficient alternative measures and activities that are applicable and 
available in a performance category are scored appropriately.
    In addition, we recognize that under MIPS, there will be more 
eligible clinicians subject to the requirements of EHR reporting than 
were previously eligible under the Medicare and/or Medicaid EHR 
Incentive Program, including hospital-based MIPS eligible clinicians, 
nurse practitioners, physician assistants, clinical nurse specialists, 
and certified registered nurse anesthetists. Since 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. As a result, we have provided 
additional flexibilities to mitigate negative adjustments for the first 
performance year (CY 2017) in order to allow hospital-based MIPS 
eligible clinicians, nurse practitioners, physician assistants, 
clinical nurse specialists, certified registered nurse anesthetists, 
and other MIPS eligible clinicians to familiarize themselves with the 
MIPS program. Section II.E.5.g.(8) of this final rule with comment 
period describes our final policies regarding the re-weighting of the 
advancing care information performance category within the final score, 
in which we would assign a weight of zero when there are not sufficient 
measures applicable and available.
    Comment: One commenter requested for suppliers of portable x-ray 
and

[[Page 77038]]

independent diagnostic testing facility services to be excluded from 
the definition of a MIPS eligible clinician and recommended that CMS 
create an alternate pathway allowing for adequate payment updates to 
reflect the rising cost of care.
    Response: We note that the MIPS payment adjustment applies only to 
the amount otherwise paid under Part B with respect to items and 
services furnished by a MIPS eligible clinician during a year. As 
discussed in section II.E.7. of this final rule with comment period, we 
will apply the MIPS adjustment at the TIN/NPI level. In regard to 
suppliers of portable x-ray and independent diagnostic testing facility 
services, we note that such suppliers are not themselves included in 
the definition of a MIPS eligible clinician. However, there may be 
circumstances in which a MIPS eligible clinician would furnish the 
professional component of a Part B covered service that is billed by 
such a supplier. For example, a radiologist who is a MIPS eligible 
clinician could furnish the interpretation and report (professional 
component) for an x-ray service, and the portable x-ray supplier could 
bill for the global x-ray service (combined technical and professional 
component) or bill separately for the professional component of the x-
ray service. In that case, the professional component (billed either on 
its own or as part of the global service) could be considered a service 
for which payment is made under Part B and furnished by a MIPS eligible 
clinician. Those services could be subject to MIPS adjustment based on 
the MIPS eligible clinician's performance during the applicable 
performance period. Because, however, those services are billed by 
suppliers that are not MIPS eligible clinicians, it is not 
operationally feasible for us at this time to associate those billed 
allowed charges with a MIPS eligible clinician at an NPI level in order 
to include them for purposes of applying any MIPS payment adjustment.
    Comment: One commenter indicated that the status of pathologists 
working in independent laboratories is unclear with regard to the 
definition of a MIPS eligible clinician and requested clarification as 
to whether or not they would be included given that they were 
considered EPs under PQRS.
    Response: We note that pathologists, including pathologists 
practicing in independent laboratories, are considered MIPS eligible 
clinicians and thus, required to participate in MIPS and subject to the 
MIPS payment adjustment. The MIPS payment adjustment applies only to 
the amount otherwise paid under Part B with respect to items and 
services furnished by a MIPS eligible clinician during a year, in which 
we will apply the MIPS adjustment at the TIN/NPI level (see section 
II.E.7. of this final rule with comment period). For items and services 
furnished by a pathologist practicing in an independent laboratory that 
are billed by the laboratory, such items and services may be subject to 
MIPS adjustment based on the MIPS eligible clinician's performance 
during the applicable performance period. For those billed Medicare 
Part B allowed charges we are able to associate with a MIPS eligible 
clinician at an NPI level, such items and services furnished by such 
pathologist would be included for purposes of applying any MIPS payment 
adjustment.
    Comment: A few commenters encouraged CMS to expand the list of MIPS 
eligible clinicians further to promote integrated care. One commenter 
suggested that we include certified nurse midwives as MIPS eligible 
clinicians. Another commenter encouraged CMS to ensure that specialists 
can successfully participate in the MIPS. One commenter indicated that 
MIPS accommodates the masses of physicians, but falls short in 
including consulted clinicians. A few commenters requested that we 
expand the definition of a MIPS eligible clinician to include 
therapists, dieticians, social workers, and other Medicare Part B 
suppliers as soon as possible in order for such clinicians to earn 
positive MIPS payment adjustments. One commenter recommended that the 
definition of MIPS eligible clinician be expanded to include all 
Medicare supplier types, including ambulatory services.
    Response: We appreciate the suggestions from the commenters and 
will take them into account as we consider expanding the definition of 
a MIPS eligible clinician for year 3 in future rulemaking. We interpret 
the comment regarding consulted clinicians to refer to locum tenens and 
clinicians contracted by a practice. We note that contracted clinicians 
who meet the definition of a MIPS eligible clinician are required to 
participate in MIPS. In regard to locum tenens clinicians, they bill 
for the items and services they furnish using the NPI of the clinician 
for whom they are substituting and, as such, do not bill Medicare in 
their own right for the items and services they furnish. As such, locum 
tenens clinicians are not MIPS eligible clinicians when they practice 
in that capacity.
    Comment: One commenter indicated that it is feasible to include 
physical therapists in the expanded definition of a MIPS eligible 
clinician given that physical therapists have been included in PQRS 
since 2007. The commenter noted that there will be a negative impact on 
the quality reporting rates of physical therapists if they are excluded 
from MIPS in 2017 and 2018. Another commenter recommended that CMS 
define provisions for physical therapists, occupational therapists, and 
speech language pathologists as soon as possible in order to provide 
sufficient time for building new systems for operation in year 3 of 
MIPS. A few commenters requested clarification on how MIPS will apply 
to physical therapists, occupational therapists, and speech language 
pathologists working with Medicare beneficiaries. One commenter 
suggested that therapists participating in MIPS should be scored using 
the same scoring weights for the quality and cost performance 
categories that apply to MIPS eligible clinicians in the first 2 years. 
The commenter noted that the same transition scoring would be fair and 
could mitigate severe penalties for clinicians new to MIPS.
    Response: We appreciate the concerns and recommendations from the 
commenters. In regard to expanding the definition of a MIPS eligible 
clinician for year 3, we will consider the suggestions from the 
commenters. We anticipate that some eligible clinicians who will not be 
included in the definition of a MIPS eligible clinician 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 note 
that eligible clinicians who are not included in the definition of a 
MIPS eligible clinician during the first 2 years of MIPS (or any 
subsequent year) may voluntarily report on measures and activities 
under MIPS, but will not be subject to the MIPS payment adjustment. We 
do intend however to provide informative performance feedback to 
clinicians who voluntarily report to MIPS, which would include the same 
performance category and final score rules that apply to all MIPS 
eligible clinicians. We believe this informational performance feedback 
will help prepare those clinicians who voluntarily report to MIPS.
    Comment: Some commenters requested that CMS allow facility-based 
clinicians who provide outpatient services, such as physical 
therapists, occupational therapists, and speech language pathologists, 
to participate in MIPS and earn MIPS payment

[[Page 77039]]

adjustments by the third year of the program. One commenter expressed 
concern that without inclusion in the Quality Payment Program, these 
facility-based clinicians would be disadvantaged. Another commenter 
expressed concern that the criteria for including non-physician 
clinicians later in MIPS are not clear and recommended that clarity be 
provided, including performance categories that are specific to each 
specialty and type of practice.
    Response: We appreciate the concerns and recommendations from the 
commenters, and will take them into account as we consider expanding 
the definition of a MIPS eligible clinician for year 3 in future 
rulemaking.
    Comment: One commenter did not support the expanding of the 
definition of a MIPS eligible clinician in year 3. The commenter noted 
that none of their physical therapists operate on the use of CEHRT and 
switching in year 3 would require significant capital and personnel. 
The commenter recommended postponing any expansion until year 4 or 5.
    Response: We appreciate the commenter expressing concerns and 
recognize that eligible clinicians and MIPS eligible clinicians will 
have a spectrum of experiences with using EHR technology. As we 
consider expanding the definition of a MIPS eligible clinician to 
include additional eligible clinicians in year 3, we will consider how 
such eligible clinicians would be scored for each performance category 
in future rulemaking.
    Comment: One commenter recommended that CMS convene a technical 
expert panel of eligible clinicians who will not be included in the 
definition of a MIPS eligible clinician during the first 2 years of 
MIPS to help adapt the Quality Payment Program to their needs.
    Response: We thank the commenter for the suggestion and will 
consider the recommendation as we consider expanding the definition of 
a MIPS eligible clinician to include additional eligible clinicians for 
year 3 in future rulemaking and prepare for the operationalization of 
the expanded definition. We are committed to continuously engage 
stakeholders as we implement MIPS, and establish and operationalize 
future policies.
    Comment: One commenter expressed concern about the difficulties 
hospital-based clinicians have had reporting under PQRS and recommended 
offering hospital-based clinicians more flexibility in adopting MIPS.
    Response: As previously noted, we recognize that there may not be 
sufficient measures applicable and available for certain performance 
categories for hospital-based MIPS eligible clinicians participating in 
MIPS. In section II.E.5.g.(8)(a)(i) of this final rule with comment 
period, we describe the re-weighting of the advancing care information 
performance category when there are not sufficient measures applicable 
and available for hospital-based MIPS eligible clinicians.
    Comment: A few commenters expressed concerns that our MIPS 
proposals focused on clinicians in large groups or who are hospital-
based and did not include non-physician clinicians. One commenter 
requested that non-physician clinicians be recognized for their 
critical role in the health delivery system and providing high quality, 
low cost health care to the Medicare population.
    Response: We disagree with the commenters and note that the 
definition of a MIPS eligible clinician includes non-physician 
clinicians such physician assistants, nurse practitioners, clinical 
nurse specialists, and certified registered nurse anesthetists. As 
previously noted, in future rulemaking, we will consider expanding the 
definition of a MIPS eligible clinician to include additional eligible 
clinicians starting in year 3.
    Comment: A few commenters requested clarification regarding whether 
or not Doctors of Chiropractic would be able to participate in MIPS. 
Another commenter appreciated that Doctors of Chiropractic are included 
as MIPS eligible clinicians, but believed that chiropractors would be 
put at a severe disadvantage in participating in MIPS or APMs due to 
CMS' restrictions on chiropractic coverage. The commenter encouraged 
CMS to expand the billing codes for Doctors of Chiropractic to cover 
the full scope of licensure.
    Response: We note that chiropractors are included in the definition 
of ``physician'' under section 1861(r) of the Act, and therefore, are 
MIPS eligible clinicians. In regard to the comment pertaining to the 
expansion of billing codes for chiropractors, we note that such comment 
is out-of-scope given that we did not propose any billing code policies 
in the proposed rule.
    Comment: One commenter requested clarification on whether or not 
participation in MIPS is mandatory.
    Response: We note that clinicians who are included in the 
definition of a MIPS eligible clinicians as defined in section 
II.E.1.a. of this final rule with comment period are required to 
participate in MIPS unless they are excluded from the definition of a 
MIPS eligible clinician based on one of the three exclusions described 
in sections II.E.3.a., II.E.3.b., and II.E.3.c. of this final rule with 
comment period.
    Comment: One commenter requested clarification on how CMS will 
treat hospitalist services under MIPS, specifically, what measures will 
they report, whether the hospital's PFS payment amount for the 
hospitalists' services will be subject to the MIPS payment adjustment, 
and how hospitalists should report data since they do not have an 
office practice or an EHR to participate.
    Response: We note that hospitalists are required to participate in 
MIPS unless otherwise excluded. As discussed in section II.E.6.b.(2) of 
this final rule with comment period, we may re-weight performance 
categories if there are not sufficient measures applicable and 
available to each MIPS eligible clinician to ensure that MIPS eligible 
clinicians, including hospitalists, who do not have sufficient 
alternative measures and activities that are applicable and available 
in a performance category are scored appropriately. For hospitalists 
who meet the definition of a hospital-based MIPS eligible clinician, 
section II.E.5.g.(8)(a)(i) of this final rule with comment period 
describes the re-weighting of the advancing care information 
performance category within the final score, in which we would assign a 
weight of zero when there are not sufficient measures applicable and 
available for hospital-based MIPS eligible clinicians. In section 
II.E.5.b.(5) of the proposed rule (81 FR 28192), we sought comment on 
the application of additional system measures, which would directly 
impact hospitalists, and intend to address such policies in future 
rulemaking. Also, we note that the MIPS payment adjustment would be 
applied to the Medicare Part B payments for items and services 
furnished by a hospital-based MIPS eligible clinician.
    Comment: Some commenters expressed concern regarding the exclusion 
of pharmacists under MIPS and APMs, and indicated that the payment 
models would prevent program goals from being met unless all 
practitioners, including pharmacists, are effectively integrated into 
team-based care. A few commenters noted that pharmacists are 
medication-use experts in the health care system, and directly 
contribute toward many of the quality measures under both MIPS and 
Advanced APMs. Because pharmacists are neither MIPS eligible clinicians 
nor required practitioners under APMs, pharmacist expertise and 
contributions may be underutilized and/or unavailable to certain 
patients. A few

[[Page 77040]]

commenters recommended that the definition of a MIPS eligible clinician 
include pharmacists given that they are a critical part of a patient 
care team, in which they can provide a broad array of services to 
patients and have a role in optimizing patient health outcomes as the 
number and complexity of medications continues to rise. One commenter 
recommended that the Quality Payment Program include metrics and 
payment methodologies that recognize services provided by pharmacists 
and align with other CMS and CDC programs.
    Response: We appreciate the suggestions from the commenters. We 
note that we do not have discretion under the statute to include 
clinicians who do not meet the definition of a MIPS eligible clinician. 
Thus, pharmacists would not be able to participate in MIPS.
    Comment: One commenter requested that CMS clarify whether or not 
MIPS requirements would apply to clinicians who are not Medicare-
enrolled eligible clinicians. Another commenter expressed concern that 
the proposed rule did not address how MIPS payment adjustments would be 
applied for clinicians who are not Medicare-enrolled eligible 
clinicians.
    Response: We note that clinicians who are included in the 
definition of a MIPS eligible clinician and not otherwise excluded are 
required to report under MIPS. However, a clinician who is not included 
in the definition of a MIPS eligible clinician can voluntarily report 
under MIPS and would not be subject to the MIPS payment adjustment. 
Also, we note that eligible clinicians who are not Medicare-enrolled 
eligible clinicians are not required to participate in MIPS, and would 
not be subject to the MIPS payment adjustment given that the MIPS 
payment adjustment is applied to Medicare Part B payments for items and 
services furnished by a MIPS eligible clinician.
    Comment: One commenter requested information on how locum tenens 
clinicians will be assessed under MIPS.
    Response: As previously noted, locum tenens clinicians bill for the 
items and services they furnish using the NPI of the clinician for whom 
they are substituting and, as such, do not bill Medicare in their own 
right for the items and services they furnish. As such, locum tenens 
clinicians are not MIPS eligible clinicians when they practice in that 
capacity.
    Comment: One commenter noted that facility-based clinicians in 
California face unique challenges under state law and recommended that 
rather than automatically using an eligible clinician's facility's 
performance as a proxy for the quality and cost performance categories 
as proposed, CMS should develop a voluntary option to allow eligible 
clinicians who meet criteria to be considered a facility-based 
clinician.
    Response: We appreciate the suggestions from the commenter and will 
consider them as we develop policies for applying a facility's 
performance to a MIPS eligible clinician or group.
    Comment: One commenter suggested that the types of eligible 
clinicians who are not included in the definition of a MIPS eligible 
clinician in 2017 and who have been submitting PQRS measures for years, 
should be allowed to voluntarily participate in 2017 and earn MIPS 
payment adjustments if they complete a successful attestation.
    Response: We thank the commenter for their suggestion and note that 
clinicians not included in the definition of a MIPS eligible clinicians 
have the option to voluntarily report on applicable measures and 
activities under MIPS. However, the statute does not permit such 
clinicians to be subject to the MIPS payment adjustment. Should we 
expand the definition of a MIPS eligible clinician in future 
rulemaking, such clinicians may be able to earn MIPS payment 
adjustments beginning as early as the 2021 payment year.
    Comment: A few commenters recommended that certified 
anesthesiologist assistants be included in the definition of a MIPS 
eligible clinician. One commenter stated that such inclusion would 
provide the clarification that certified anesthesiologist assistants 
are health care providers, increase the amount of quality reporting 
under MIPS, and ensure certified anesthesiologist assistant 
participation in APMs. The commenter noted that if certified 
anesthesiologist assistants are not included in the definition of a 
MIPS eligible clinician, patient access to care would be restricted. 
Another commenter requested clarification regarding whether or not 
anesthesiologist assistants would be excluded from MIPS reporting in 
2017.
    Response: We appreciate the suggestion from the commenters and note 
that section 1861(bb)(2) of the Act specifies that the term ``certified 
registered nurse anesthetist'' includes an anesthesiologist assistant. 
Thus, anesthesiologist assistants are considered eligible for MIPS 
beginning with the CY 2017 performance period.
    Comment: One commenter requested that audiologists remain active 
stakeholders in the MIPS implementation process, although they may not 
be included in the program until year 3.
    Response: We appreciate the recommendation from the commenter and 
note that we are committed to actively engaging with all stakeholders 
during the development and implementation of MIPS.
    Comment: One commenter suggested that CPC+ clinicians should be 
waived from MIPS if the group TIN is participating in CPC+.
    Response: We appreciate the suggestion from the commenter, but note 
that the exclusions in this final rule with comment period only pertain 
to new Medicare-enrolled eligible clinicians, QPs and Partial QPs who 
do not report on applicable MIPS measures and activities, and eligible 
clinicians who do not exceed the low-volume threshold. We refer readers 
to section II.E.5.h. of this final rule with comment period, which 
describes the APM scoring standard for MIPS eligible clinicians 
participating in MIPS APMs; such provisions are applicable to MIPS 
eligible clinicians participating in CPC+.
    Comment: One commenter requested that CMS allow psychiatrists who 
participate in ACOs or who work at least 30 percent of their time in 
eligible integrated care settings to opt out of the reporting 
requirements to avoid a negative MIPS payment adjustment. Another 
commenter recommended that CMS exempt from the definition of a MIPS 
eligible clinician those clinicians participating in all Alternative 
Payment Models defined in Category 3 of the HCPLAN Alternative Payment 
Models Framework. The commenter indicated that the exemption should 
include all upside-gain sharing only models defined in the Framework, 
including patient-centered medical home models, bundled payment models, 
and episode of care models.
    Response: We note that the statute only allows for certain 
exclusions for MIPS, two of which are for QPs and Partial QPs 
participating in an APM or other innovative payment model is not in 
itself sufficient for an eligible clinician to become a QP or Partial 
QP. As described in section II.F. of this final rule with comment 
period, only eligible clinicians who are identified on CMS-maintained 
lists as participants in Advanced APMs and meet the relevant QP or 
Partial QP threshold may become QPs or Partial QPs.
    After consideration of the public comments we received, we are 
finalizing the following policies. We are

[[Page 77041]]

finalizing the definition at Sec.  414.1305 of a MIPS eligible 
clinician, as identified by a unique billing TIN and NPI combination 
used to assess performance, as any of the following (excluding those 
identified at Sec.  414.1310(b)): A physician (as defined in section 
1861(r) of the Act), a physician assistant, nurse practitioner, and 
clinical nurse specialist (as such terms are defined in section 
1861(aa)(5) of the Act), a certified registered nurse anesthetist (as 
defined in section 1861(bb)(2) of the Act), and a group that includes 
such clinicians. We are finalizing our proposed policies at Sec.  
414.1310(b) and (c) that QPs, Partial QPs who do not report on 
applicable measures and activities that are required to be reported 
under MIPS for any given performance period in a year, low-volume 
threshold eligible clinicians, and new Medicare-enrolled eligible 
clinicians as defined at Sec.  414.1305 are excluded from this 
definition per the statutory exclusions defined in section 
1848(q)(1)(C)(ii) and (v) of the Act. In accordance with section 
1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we are finalizing our 
proposal at Sec.  414.1310(b)(2) to allow eligible clinicians (as 
defined at Sec.  414.1305) who are not MIPS eligible clinicians the 
option to voluntarily report measures and activities for MIPS. 
Additionally, we are finalizing our proposal at Sec.  414.1310(d) that 
in no case will a MIPS payment adjustment apply to the items and 
services furnished during a year by individual eligible clinicians, as 
described in paragraphs (b) and (c) of this section, who are not MIPS 
eligible clinicians including eligible clinicians who are not MIPS 
eligible clinicians, but who voluntarily report on applicable measures 
and activities specified under MIPS.
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.b.(2) of this final rule with comment 
period for the discussion regarding how we addressed performance 
categories weighting for MIPS eligible clinicians for whom no measures 
exist in a given category.
    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). Specialty 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 (80 FR 63484), 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 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 specialty codes other than ``cardiology'' (for example, internal 
medicine) may perform cardiovascular imaging services. Therefore, using 
the 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

[[Page 77042]]

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.
    After reviewing current policies, we proposed to define a non-
patient facing MIPS eligible clinician 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 considered 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 procedure codes under the PFS. We intend to 
publish the 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 believed 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 Healthcare Common Procedure Coding System (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 telehealth 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.
    Therefore, the 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.
    In response to the MIPS and APMs RFI, 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 specialty codes, may be a more 
appropriate way to identify MIPS eligible clinicians that have no 
patient interaction.
    We also proposed 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 was intended to 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, we believed that this proposed 
definition of a non-patient facing MIPS eligible clinician for MIPS 
could 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 
was tied to the same list of patient-facing encounter codes discussed 
in this section of this final rule with comment period. 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 did 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 specialty 
codes alone. Additionally, we believed 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 clinician 
despite furnishing a small number of patient-facing services.
    In the MIPS and APMs RFI (80 FR 63484), we also requested comments 
on what types of measures and/or improvement activities (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

[[Page 77043]]

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 those who are non-patient facing, who do 
not have sufficient alternative measures that are applicable and 
available in a performance category are scored appropriately. We 
proposed to apply the Secretary's authority under section 1848(q)(5)(F) 
of the Act to re-weight 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 the 
proposed rule for details on the re-weighting proposals. Accordingly, 
we proposed alternative requirements for non-patient facing MIPS 
eligible clinicians across the proposed rule (see sections II.E.5.b., 
II.E.5.e., and II.E.5.f. of the 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 requested comments on these proposals.
    The following is a summary of the comments we received regarding 
our proposal that defines non-patient facing MIPS eligible clinicians 
for MIPS as an individual MIPS eligible clinician or group that bills 
25 or fewer patient-facing encounters (including telehealth services) 
during a performance period.
    Comment: A few commenters supported the proposed definition of non-
patient facing MIPS eligible clinicians.
    Response: We appreciate the support from commenters.
    Comment: One commenter requested that pathologists (as identified 
in PECOS) be automatically identified as non-patient facing MIPS 
eligible clinicians at the beginning of each year. The commenter noted 
that it seems reasonable to use PECOS to identify non-patient facing 
specialties.
    Response: We appreciate the commenter expressing the importance for 
MIPS eligible clinicians to be identified as non-patient facing MIPS 
eligible clinicians at the beginning of each year. We believe that it 
would be beneficial for individual MIPS eligible clinicians and groups 
to know in advance of a performance period whether or not they qualify 
as a non-patient facing MIPS eligible clinician. For purposes of this 
section, we are coining the term ``non-patient facing determination 
period'' to refer to the timeframe used to assess claims data for 
making eligibility regarding non-patient facing status. We define the 
non-patient facing determination period to mean a 24-month assessment 
period, which includes a two-segment analysis of claims data regarding 
patient-facing encounters during an initial 12-month period prior to 
the performance period followed by another 12-month period during the 
performance period.
    The initial 12-month segment of the non-patient facing 
determination period would span from the last 4 months of a calendar 
year 2 years prior to the performance period followed by the first 8 
months of the next calendar year and include a 60-day claims run out, 
which will allow us to inform eligible clinicians and groups of their 
non-patient status during the month (December) prior to the start of 
the performance period. We believe that the initial non-patient facing 
determination period enables us to make eligibility determinations 
based on 12 months of data that is as close to the performance period 
as possible while informing eligible clinicians of their non-patient 
facing status prior to the performance period. The second 12-month 
segment of the non-patient facing determination period would span from 
the last 4 months of a calendar year 1 year prior to the performance 
period followed by the first 8 months of the performance period in the 
next calendar year and include a 60-day claims run out, which will 
allow us to inform additional eligible clinicians and groups of their 
non-patient status during the performance period.
    Thus, for purposes of the 2019 MIPS payment adjustment, we will 
initially identify individual eligible clinicians and groups who are 
considered non-patient facing MIPS eligible clinicians based on 12 
months of data starting from September 1, 2015 to August 31, 2016. In 
order to account for the identification of additional individual 
eligible clinicians and groups that may qualify as non-patient facing 
during the 2017 performance period, we will conduct another eligibility 
determination analysis based on 12 months of data starting from 
September 1, 2016 to August 31, 2017.
    Comment: One commenter requested that CMS consider allowing 
physicians in other specialties to declare by exception that they 
deserve a similar exemption as those that are identified in the 
proposed rule as non-patient facing MIPS eligible clinicians, which can 
be confirmed by CMS through coding analysis.
    Response: We disagree with the approach described by the commenter 
because the statute does not provide discretion in establishing 
exclusions other than the three exclusions specified in section II.E.3. 
of this final rule with comment period. Also, we note that non-patient 
facing MIPS eligible clinicians are identified based on an analysis we 
conduct using claims data to determine such status; this is not a 
status that clinicians make an election for purposes of MIPS.
    Comment: Many commenters expressed concerns that the threshold set 
forth in the proposed definition of a non-patient facing MIPS eligible 
clinician (for example, an individual MIPS eligible clinician or group 
that bills 25 or fewer patient-facing encounters during a performance 
period) was too low. The commenters believed that many clinicians in 
certain specialties would be classified as patient-facing even though 
clinicians in those specialties are predominately non-patient facing. 
One commenter stated that MIPS eligible clinicians with such a low 
number of patient-facing encounters may not realize they would be 
considered patient-facing and subject to additional reporting 
requirements. Many commenters recommended alternative options for 
establishing a threshold relating to the billing of patient-facing 
encounters, including the following: A threshold of 50 or fewer 
patient-facing encounters; a threshold of 100 or fewer patient-facing 
encounters, which would represent a somewhat larger portion of the MIPS 
eligible clinician's practice, averaging approximately two patient-
facing encounters per week; and a threshold of 150 or fewer billed 
Medicare patient-facing encounters. Other commenters suggested that CMS 
consider automatically designating certain specialties, such as 
anesthesiology or radiology, as non-patient facing unless a clinician 
in such specialty bills more than 100 patient-facing encounters. One 
commenter suggested that CMS base the threshold on a percentage of 
patients seen (for example, 80 percent of services furnished are 
determined to be non-patient facing) or claims or allowed

[[Page 77044]]

charges (for example, 85 percent of claims or charges are for non-
patient facing services), or a combination of the two percentage-based 
options.
    Response: We thank the commenters for expressing their concerns and 
recommendations regarding the proposed threshold used to define a non-
patient facing MIPS eligible clinician. Based on the comments 
indicating that the proposed threshold would misclassify certain 
specialties that are predominately non-patient facing, and in order to 
more accurately identify MIPS eligible clinicians who are non-patient 
facing, we are modifying our proposal and increasing the threshold to 
determine when a MIPS eligible clinician is considered non-patient 
facing. Therefore, we are finalizing a modification to our proposal to 
define a non-patient facing MIPS eligible clinician as an individual 
MIPS eligible clinician that bills 100 or fewer patient-facing 
encounters (including Medicare telehealth services defined in section 
1834(m) of the Act) during the non-patient facing determination period, 
and a group provided that more than 75 percent of the NPIs billing 
under the group's TIN meet the definition of a non-patient facing 
individual MIPS eligible clinician during the non-patient facing 
determination period. We believe that the 100 or fewer billed patient-
facing encounters as a threshold more accurately reflects a 
differentiation of annual patient-facing encounters between MIPS 
eligible clinicians who furnish a majority of patient-facing services 
and considered patient-facing and MIPS eligible clinicians who provide 
occasional patient-facing services that do not reflect the bulk of 
services provided by the practice or would traditionally be considered 
non-patient facing. This modified threshold that applies at the 
individual level would reduce the risk of identifying individual MIPS 
eligible clinicians as patient-facing who would otherwise be considered 
non-patient facing. Similarly, the modified threshold that applies at 
the group level as previously noted, would reduce the risk of 
identifying groups as patient-facing that would otherwise be considered 
non-patient facing. Also, we considered increasing the threshold based 
on different approaches. As previously described, one option was basing 
the definition of a non-patient facing MIPS eligible clinician on a set 
percentage of patient-facing encounters, such as 5 to 10 percent, that 
was tied to the same list of patient-facing encounter codes discussed 
in this section of the final rule with comment period. We did not 
pursue this approach because a percentage would not apply consistency, 
which could miscategorize MIPS eligible clinicians who would otherwise 
be considered patient-facing. Another option we considered was the 
identification of non-patient facing MIPS eligible clinicians only by 
specialty, which might be a simpler approach. However, we did 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. Thus, we did not modify our 
approach along these lines.
    Comment: In regard to the illustrative list of specific types of 
clinicians within the non-patient facing spectrum outlined in the 
proposed rule, one commenter requested that CMS remove the reference to 
anesthesiologist supervision and ensure that the Quality Payment 
Program would not impose any unnecessary supervision. The commenter 
noted that physician supervision of nurse anesthetists did not improve 
care outcomes and was therefore unnecessary. Another commenter stated 
that most anesthesiologists should be designated as non-patient facing 
and recommended that CMS reconsider the non-patient facing 
determination criteria while another commenter requested that CMS 
ensure the equal treatment of certified registered nurse anesthetists 
and anesthesiologists when determining who qualifies as a non-patient 
facing MIPS eligible clinician. One commenter suggested that CMS 
publish the list of patient-facing services as quickly as possible in 
order for anesthesiologists to determine if they are considered non-
patient facing MIPS eligible clinicians. The commenter requested that 
CMS provide details on how it estimated that a majority of 
anesthesiologists would qualify as non-patient facing.
    Response: We appreciate the suggestions from commenters regarding 
the types of MIPS eligible clinicians to be considered non-patient 
facing. We want to clarify that our proposed definition of a non-
patient facing MIPS eligible clinician did not include the 
identification of any specific type of physician or clinician 
specialty, and note that the statutory definition of an 
anesthesiologist does not specify a supervision requisite as a 
requirement. However, our proposed definition of a non-patient facing 
MIPS eligible clinician is based on a methodology that 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 
clinician despite furnishing a small number of patient-facing services. 
Our methodology used to identify non-patient facing MIPS eligible 
clinicians included a quantitative, comparative analysis of claims and 
HCPCS code data. Contrary to the commenter's belief, we believe that 
our proposed definition of a non-patient facing clinician would not 
capture the majority of MIPS eligible clinicians or groups within 
specialties such as anesthesiology, pathology, radiology, and nuclear 
medicine who may provide a small portion of services that would be 
considered patient-facing, but would otherwise be considered non-
patient facing MIPS eligible clinicians. As a result of this dynamic, 
we are finalizing a modification to our proposed definition of a non-
patient facing MIPS eligible clinician. As previously noted, we will 
identify MIPS eligible clinicians who are considered non-patient facing 
in advance of the performance period.
    Comment: One commenter requested that MIPS eligible clinicians 
within the interventional pain management specialty be exempt from 
negative, but not positive, MIPS payment adjustments. The commenter 
noted that MIPS will destroy independent practices and increase the 
costs of Medicare, making Medicare insolvent even sooner than expected.
    Response: We thank the commenter for the suggestion. We note that 
the statute does not grant the Secretary discretion to exclude non-
patient facing MIPS eligible clinicians from the requirement to 
participate in MIPS. However, non-patient facing MIPS eligible 
clinicians will benefit from other policies that we are finalizing 
throughout this final rule with comment period such as reduced 
performance requirements and lower performance threshold. Accordingly, 
we describe alternative requirements for non-patient facing MIPS 
eligible clinicians across this final rule with comment period (see 
sections II.E.5.b., II.E.5.e., and II.E.5.f. of this final rule with 
comment period for more details). We disagree with the comment 
regarding MIPS negatively impacting independent practices. We

[[Page 77045]]

believe that independent practices will benefit from other policies 
that we are finalizing throughout this final rule with comment period 
such as reduced performance requirements and lower performance 
threshold.
    Comment: One commenter requested that CMS abandon the term ``non-
patient facing'' in reference to MIPS eligible clinicians or physician 
specialties. The commenter indicated that the patient-facing/non-
patient facing terminology is appropriate for describing the Current 
Procedural Terminology (CPT) code, but not appropriated for describing 
a clinician relative to quality improvement. Another commenter 
recommended that CMS consider an alternative term to ``non-patient 
facing'' as it applies to anesthesiologists. One commenter expressed 
concern that the term non-patient facing diminishes the importance of 
specialists.
    Response: We appreciate the commenters expressing their concerns 
regarding the use of the term ``non-patient facing'' and as a result of 
the concerns from commenters, we are interested in obtaining further 
input from stakeholders regarding potential terms that could be used to 
describe ``non-patient facing'' under MIPS. Therefore, we are seeking 
additional comment on modifying the terminology used to reference 
``non-patient facing'' MIPS eligible clinicians for future 
consideration. What alternative terms could be used to describe ``non-
patient facing''?
    Comment: One commenter indicated that the proposed definition of 
non-patient facing clinicians is overly stringent and does not 
recognize a number of ``hybrid'' physicians such as nuclear 
cardiologists, who split time between patient-facing and non-patient 
facing activity. The commenter requested an alternative pathway for 
``hybrid'' physicians in order for nuclear cardiologists and others to 
successfully participate in MIPS, which is important for medical 
specialists with no alternative payment models. As an interim solution, 
the commenter requested that the reporting period be shortened and be 
flexibility for MIPS eligible clinicians to select the reporting period 
within the applicable calendar year.
    Response: We thank the commenter for expressing concerns and 
recognize that MIPS eligible clinicians in certain specialties may not 
have a majority of their services categorized as non-patient facing. We 
want to ensure that MIPS eligible clinicians, including non-patient 
facing MIPS eligible clinicians are able to participate in MIPS 
successfully and thus, in this final rule with comment period, we not 
only establish requirements for MIPS eligible clinicians in each 
performance category, but we apply, to the extent feasible and 
appropriate, alternative measures or activities that fulfill the goals 
of each performance category. In sections II.E.5.b., II.E.5.e., and 
II.E.5.f. of this final rule with comment period, we describe the 
alternative requirements for non-patient facing MIPS eligible 
clinicians. Also, as described in section II.E.4. of this final rule 
with comment period, we are finalizing a modification to the MIPS 
performance period to be a minimum of one continuous 90-day period 
within CY 2017.
    Comment: Several commenters indicated that the definition of a non-
patient facing MIPS eligible clinician is inadequate since the 
definition is dependent on the codes that define patient-facing 
encounters, which are not yet available. The commenters requested that 
CMS provide the applicable CPT codes as soon as possible in order for 
affected MIPS eligible clinicians to have sufficient time to assess the 
alignment of the codes. One commenter recommended that only evaluation 
and management services (the denominators of the cross-cutting measures 
as specified in Table C: Proposed Individual Quality Cross-Cutting 
Measures for the MIPS to Be Available to Meet the Reporting Criteria 
Via Claims, Registry, and EHR Beginning in 2017 of the proposed rule 
(81 FR 28447 through 28449)) be considered when determining whether a 
MIPS eligible clinician provides face-to-face services. The commenter 
indicated that the inclusion of other services, particularly 000 global 
codes, will inappropriately classify many radiologists as patient-
facing and put small and rural practices at a distinct disadvantage.
    Response: We thank the commenters for their support and expressing 
their concerns. While we did not propose specific patient-facing 
encounter codes in the proposed rule, we considered a patient-facing 
encounter to be an instance in which the MIPS eligible clinician or 
group billed for items and services furnished such as general office 
visits, outpatient visits, and procedure codes under the PFS. We agree 
with the commenters that a non-patient facing MIPS eligible clinician 
is identified based on the evaluation and management of services, which 
reflects the list of patient-facing encounter codes. We note that the 
denominators, as specified in Table C of the proposed rule, used for 
determining the non-patient facing status of MIPS eligible clinicians 
are the same as the denominators of the cross-cutting measures. Based 
on our experience with PQRS, we believe that the use of patient-facing 
encounter codes is the most appropriate approach for determining 
whether or not MIPS eligible clinicians are non-patient facing. We 
intend to publish a list of patient-facing encounters on the CMS Web 
site located at QualityPaymentProgram.cms.gov.
    In regard to the comment pertaining to misclassification, we note 
that the definition of non-patient facing MIPS eligible clinicians 
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. This approach allows for 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. We believe our modified policy will allow us to more 
accurately identify MIPS eligible clinicians who are non-patient facing 
by applying a threshold in recognition of the fact that a MIPS eligible 
clinician who furnishes almost exclusively non-patient facing services 
should be treated as a non-patient facing MIPS eligible clinician 
despite furnishing a small number of patient-facing services.
    Comment: One commenter requested clarification on whether or not 
the definition of a patient-facing encounter includes procedures such 
as peripheral nerve blocks (64400-64530) and epidural injections 
(62310-62319).
    Response: We intend to publish the list of patient-facing 
encounters on the CMS Web site located at 
QualityPaymentProgram.cms.gov, which will include procedures such as 
peripheral nerve blocks (64400-64530) and epidural injections (62310-
62319).
    Comment: One commenter requested that CMS justify how 25 or fewer 
patient-facing encounters was determined as the threshold for non-
patient facing MIPS eligible clinicians.
    Response: As previously noted, we believed 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 was appropriate. We selected 
this threshold based on an analysis of

[[Page 77046]]

non-patient facing HCPCS codes billed by MIPS eligible clinicians. 
Using these codes and this threshold, we determined that approximately 
one quarter of MIPS eligible clinicians would be identified as non-
patient facing before MIPS exclusions, such as the low-volume threshold 
and new Medicare-enrolled eligible clinician policies, were applied. 
Based on our analysis, a significant portion of clinicians enrolled in 
Medicare with specialties such as anesthesiology, nuclear medicine, and 
pathology were identified as non-patient facing in this analysis. We 
believe that our 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.
    However, as discussed above, we are finalizing a modification to 
our proposal to define a non-patient facing MIPS eligible clinician as 
an individual MIPS eligible clinician that bills 100 or fewer patient-
facing encounters (including Medicare telehealth services defined in 
section 1834(m) of the Act) during the non-patient facing determination 
period, and a group provided that more than 75 percent of the NPIs 
billing under the group's TIN meet the definition of a non-patient 
facing individual MIPS eligible clinician during the non-patient facing 
determination period. When we applied our prior methodology to make 
determinations at the group level, the percentage of MIPS eligible 
clinicians classified as non-patient facing at the group level was 
higher because at the group level, MIPS eligible clinicians with less 
than 100 encounters who would otherwise be considered patient-facing 
(for example, pediatricians) are included in the group level 
calculation for the non-patient facing determination. Thus, there would 
be more specialists classified as non-patient facing when we make 
determinations at the group level, particularly when the percentage of 
specialists identified as non-patient facing at the group level is 
compared to the overall percentage of individual MIPS eligible 
clinicians. We note that the reason for the increase in the number of 
non-patient facing determinations is due to individual MIPS eligible 
clinicians in groups who have with less than 100 encounters would be 
classified as non-patient facing and would otherwise be considered 
patient-facing.
    Comment: Several commenters disagreed with CMS's proposal to apply 
the same billing threshold for patient-facing encounters to both 
individual MIPS eligible clinicians and groups. One commenter noted 
that such a policy would force groups of non-patient facing MIPS 
eligible clinicians to be required to report on inapplicable outcomes 
and cross-cutting measures if several individuals' rare face-to-face 
patient encounters are summed as a group (for example, a group of 10 
physicians with 2 to 3 face-to-face patient encounters per year per 
MIPS eligible clinician). Another commenter specifically indicated that 
if the proposed non-patient facing threshold is applied at a group 
level, specialties such as diagnostic radiology, pathology, nuclear 
medicine, and anesthesiology would be considered patient-facing even 
though practices in these specialties could be considered non-patient 
facing if evaluated individually.
    A few commenters indicated that when the proposed threshold is 
applied to groups without scaling the threshold by the number of 
clinicians in a group, a single individual clinician could push the 
entire group into the patient-facing category, even if the other 
individual clinicians in the group would, otherwise, be considered non-
patient facing. One commenter indicated that the proposed definition of 
a non-patient facing MIPS eligible clinician would impact small and 
rural practices whose general radiologists perform more interventional 
procedures even though such patient-facing encounters represent only a 
very small fraction of the group's total Medicare services.
    Several commenters provided alternative options for determining how 
the definition of non-patient facing MIPS eligible clinicians could be 
applied to groups. One commenter suggested scaling the patient-facing 
encounter threshold by the number of clinicians in a group practice 
while another commenter suggested doing so by patient-facing encounter 
codes. A few other commenters recommended one or more of the following 
alternatives: (1) Apply a patient-facing encounter threshold that is 
proportional to the group size, and, for non-patient facing MIPS 
eligible clinicians who meet the definition, identify such MIPS 
eligible clinicians at the beginning of the performance year; (2) 
classify groups based on whether the majority of individual MIPS 
eligible clinicians meet the threshold; (3) compare a group's average 
number of patient-facing encounters to the threshold, where a group's 
average would be defined by the total number of patient-facing 
encounters billed by the group divided by the number of MIPS eligible 
clinicians in the group and as a result, would not be skewed by a few 
MIPS eligible clinicians; or (4) redefine a non-patient facing MIPS 
eligible clinician by using the threshold of 50 or fewer patient-facing 
encounters per individual such that, if 51 percent or more members of 
the group individually fall below the threshold, then the entire group 
is considered non-patient facing.
    Response: We thank the commenters for expressing their concerns 
regarding the proposed definition of a non-patient facing MIPS eligible 
clinician. Based on the comments received, we recognize that having a 
similar threshold applied at the individual and group levels would 
inadvertently identify groups composed of certain specialties or multi-
specialties as patient-facing that would traditionally be considered 
non-patient facing or provide occasional patient-facing services that 
do not represent the bulk of their group. Thus, we are modifying our 
proposed definition of a non-patient facing MIPS eligible clinician to 
establish two separate thresholds that apply at the individual and 
group level.
    Specifically, we are modifying our proposal to define a non-patient 
facing MIPS eligible clinician for MIPS as an individual MIPS eligible 
clinician that bills 100 or fewer patient-facing encounters (including 
Medicare telehealth services defined in section 1834(m) of the Act) 
during the non-patient facing determination period, and a group 
provided that more than 75 percent of the NPIs billing under the 
group's TIN meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period.
    In regard to the threshold applying at the group level, we 
recognize that groups vary in size and composition and thus, we believe 
that a percentage-based approach applies such a threshold equally 
across all types of groups. Also, we believe that a percentage-based 
threshold for groups is a more appropriate and accurate approach for 
distinguishing between groups composed of certain specialty or multi-
specialty practices that should be considered non-patient facing. We 
are establishing a percentage-based threshold pertaining to groups 
above 75 percent in order to succinctly identify whether or not the 
majority of services furnished by groups are non-patient facing. We are 
specifying that more than 75 percent of the NPIs billing under the 
group's TIN would need to meet the

[[Page 77047]]

definition of a non-patient facing individual MIPS eligible clinician 
in order for the group to be considered non-patient facing because such 
a threshold is applicable to any group size and composition and clearly 
delineates which groups furnish primarily non-patient facing services 
while remaining consistent with the individual-level threshold. For 
purposes of defining a non-patient facing MIPS eligible clinician as it 
relates to groups, we believe that more than 75 percent is an adequate 
percentage threshold. Based on the comments received regarding the 
establishment of a separate non-patient facing threshold for groups, we 
are seeking additional comment on our modified policy for future 
consideration, which determines that a group would be considered non-
patient facing if more than 75 percent of the NPIs billing under the 
group's TIN meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period.
    Comment: One commenter indicated that clarification is needed on 
how the requirements for each performance category would apply to 
clinicians who do not have face-to-face encounters with patients.
    Response: We refer readers to sections II.E.5.b., II.E.5.e., and 
II.E.5.f. of this final rule with comment period, which describe the 
requirements for each performance category pertaining to non-patient 
facing MIPS eligible clinicians.
    Comment: One commenter inquired about whether or not CMS would be 
able to distinguish claims for patient-facing encounters from claims 
for non-patient facing encounters to ensure that Part B claims for non-
patient facing encounters are not subject to the MIPS payment 
adjustment.
    Response: The statute makes it clear that the MIPS payment 
adjustment applies to the amount otherwise paid under Medicare Part B 
charges with respect to items and services furnished by a MIPS eligible 
clinician during a year. We note that here is no carve-out for amounts 
paid for claims for non-patient facing services given that the statute 
does not grant the Secretary discretion to establish such a carve-out 
through rulemaking.
    Comment: One commenter requested that CMS include safeguards that 
prevent unintended consequences of scoring newly introduced quality 
measures. Specifically, the commenter indicated that the three proposed 
population-based measures have rarely been, or ever, reported by 
physician anesthesiologists. The three measures--Acute Conditions 
Composite (Bacterial Pneumonia, Urinary Tract Infection and 
Dehydration), Chronic Conditions Composite (Diabetes, Chronic 
Obstructive Pulmonary Disease or Asthma, Heart Failure) and All-cause 
Hospital Readmission Measure are measures that the physician 
anesthesiologist would have little control over, especially since these 
measures are calculated by CMS using administrative claims data. The 
commenter indicated that the use of these measures would place 
anesthesiology at a disadvantage to other MIPS eligible clinicians. The 
commenter expressed concern that attribution of these measures to 
individual physician anesthesiologists may prove to be equally or less 
transparent than current measures under VM.
    Response: We appreciate the commenter's concerns and note that, as 
discussed in section II.E.5.b.(4) of this final rule with comment 
period, we are establishing alternative requirements under the quality 
performance category for non-patient facing MIPS eligible clinicians. 
As discussed in section II.E.6.b.(2) of this final rule with comment 
period, we may re-weight performance categories if there are not 
sufficient measures applicable and available for each MIPS eligible 
clinician in order to ensure that all MIPS eligible clinicians, 
including those who are non-patient facing, are scored appropriately. 
Lastly, as discussed in section II.E.5.b.(6) of this final rule with 
comment period, we note that 2 of the 3 proposed population measures 
are not being finalized. In section II.E.8.e. of this final rule with 
comment period, we describe a validation process for claims and 
registry submissions to validate whether MIPS eligible clinicians have 
submitted all applicable measures when MIPS eligible clinicians submit 
fewer than six measures.
    Comment: One commenter requested clarification on how MIPS 
incentives or penalties would be applied when facilities (for example, 
hospitals) bill and collect the Medicare Part B payments through 
reassignment from their hospital-based MIPS eligible clinicians. The 
commenter indicated that as hospitals continue to employ primary care 
clinicians and specialists and bill payers on their behalf, hospitals 
are concerned that their Medicare Part B payments will be subject to 
MIPS payment adjustments for poor final scores. The commenter inquired 
about whether a hospital-based clinician would be required to 
participate in MIPS. The commenter recommended that CMS consider the 
consequences of applying a MIPS payment adjustment factor that may 
adversely affect financially vulnerable hospitals, such as safety net 
hospitals.
    Response: We appreciate the commenter expressing concerns. We note 
that the requirements described in this final rule with comment period 
apply to MIPS eligible clinicians participating in MIPS as individual 
MIPS eligible clinicians or groups and do not apply to hospitals 
directly. In regard to the commenter's concern about the MIPS payment 
adjustment affecting financially vulnerable hospitals and safety net 
hospitals, section 1848(q)(6)(E) of the Act provides that the MIPS 
payment 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). Thus, the MIPS payment adjustment 
would apply to payments made for items and services furnished by MIPS 
eligible clinicians for Medicare Part B charges billed such as those 
under the PFS, but it would not apply to the facility payment to the 
hospital itself under the inpatient prospective payment system (IPPS) 
or other facility-based payment methodology. We refer readers to 
sections II.E.1.c. and II.E.1.d. of this final rule with comment 
period, which address MIPS eligible clinicians who practice in Method I 
CAHs, Method II CAHs, RHCs, and FQHCs.
    Comment: A commenter suggested that CMS focus on inpatient care, 
rather than outpatient care, because savings are more achievable in the 
inpatient setting (particularly in the last 6 months of life). The 
commenter noted that the MIPS program should track hospitals, rather 
than clinicians.
    Response: We appreciate the suggestions from the commenter and will 
consider them into consideration in future rulemaking.
    Comment: Several commenters supported the inclusion of telehealth 
services as patient-facing encounters. A few commenters described the 
potential benefits of telehealth, including: Increasing access to 
health care services that otherwise may not be available to many 
patients, reducing avoidable hospitalizations for nursing facility 
residents who otherwise may not receive early enough treatment, and 
providing an option to help address clinician shortages. Another 
commenter expressed concern that telehealth would become common and is 
not a viable substitute for face-to-face patient care.
    A few commenters discussed the definition of telehealth. One 
commenter recommended a revision to the current Medicare telehealth 
definition to reflect simple, plain language for MIPS

[[Page 77048]]

reporting and suggested the following, ``Telehealth means a health care 
service provided to a patient from a provider at other location.'' 
Another commenter requested that CMS define and adopt a technology 
neutral definition of telehealth that would allow MIPS eligible 
clinicians to report the full range of evidence-based telehealth 
services they provide, rather than limiting MIPS telehealth reporting 
to be ``Medicare eligible telehealth services'' as defined at 42 CFR 
410.78. One commenter requested that CMS expand the definition, use, 
and reporting of telehealth services, and clearly distinguish between 
MIPS eligible clinicians who are and are not patient-facing (for 
example, radiology, physician-to-physician consult). Another commenter 
suggested that CMS publish, at the beginning of a performance year, a 
comprehensive list of each telehealth service cross-mapped to whether 
it is determined to be patient-facing or non-patient facing.
    Also, a few commenters recommended that telehealth services should 
be restricted to true direct patient encounters (which would count 
toward a threshold of patient-facing encounters) and exclude the use of 
telehealth services by clinicians to consult with one another. One 
commenter disagreed with the eligibility criteria for telehealth 
services in contributing towards the scoring of the four performance 
categories and recommended that CMS treat telehealth services the same 
as all other in-person services for purposes of calculating MIPS 
program requirements.
    Response: We appreciate the support from commenters regarding our 
proposal to include telehealth services in the definition of patient-
facing encounters. We note that telehealth services means the Medicare 
telehealth services defined in section 1834(m) of the Act. Under the 
PFS and for purposes of this final rule with comment period, Medicare 
telehealth services that are evaluation and management services (the 
denominators for the cross-cutting measures) are considered patient-
facing encounters, which will be made available at 
QualityPaymentProgram.cms.gov. The list of all Medicare telehealth 
services is located on the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.html. 
For eligible telehealth services, the use of telecommunications 
technology (real-time audio and video communication) substitutes for an 
in-person encounter. Services furnished with the use of 
telecommunications technology that do not use a real-time interactive 
communication between a patient and clinician are not considered 
telehealth services. Such services encompass circumstances in which a 
clinician would be able to assess an aspect of a patient's condition 
without the presence of the patient or without the interposition of 
another clinician. In regard to the recommendation from commenters 
requesting CMS to modify the definition of telehealth, we note that 
section 1834(m) of the Act defines Medicare telehealth services and we 
believe this is the appropriate definition for purposes of delineating 
the scope of patient-facing encounters.
    Comment: One commenter requested that the registration process for 
non-patient facing MIPS eligible clinicians be very clear, and noted 
that it is difficult to register in more than one place with multiple 
logins and passwords. The commenter requested that CMS make sure that 
the personnel handling the Quality Payment Program Service Center have 
knowledge of areas such as pathology and radiology. The commenter also 
recommended that CMS reach out to the specialty clinician community in 
order for specialists to know that they need to register.
    Response: We did not propose a registration process for non-patient 
facing MIPS eligible clinicians. All MIPS eligible clinicians who meet 
the definition of a non-patient facing MIPS eligible clinician will be 
considered non-patient facing for the duration of a performance period. 
In order for non-patient facing MIPS eligible clinicians to know in 
advance of a performance period whether or not they qualify as a non-
patient facing MIPS eligible clinician, we will identify non-patient 
facing individual MIPS eligible clinicians and groups based on the 24-
month non-patient facing determination period. The non-patient facing 
determination period has an initial 12-month segment that would span 
from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and include a 60-day claims run out, which will allow us to inform 
MIPS eligible clinicians and groups of their non-patient facing status 
during the month (December) prior to the start of the performance 
period.
    For purposes of the 2019 MIPS payment adjustment, we will initially 
identify individual MIPS eligible clinicians and groups who are 
considered non-patient facing MIPS eligible clinicians based on 12 
months of data starting from September 1, 2015 to August 31, 2016. In 
order to account for the identification of additional individual MIPS 
eligible clinicians and groups that may qualify as non-patient facing 
during the 2017 performance period, we will conduct another eligibility 
determination analysis based on 12 months of data starting from 
September 1, 2016 to August 31, 2017. In regard to the suggestion 
regarding the Quality Payment Program Service Center, we strive to 
ensure that any MIPS eligible clinician or group that will seeks 
assistance through the Quality Payment Program Service Center will be 
provided with adequate and consistent information pertaining to the 
various components of MIPS.
    After consideration of the public comments we received, we are 
finalizing a modification to our proposal to define a non-patient 
facing MIPS eligible clinician for MIPS at Sec.  414.1305 as an 
individual MIPS eligible clinician that bills 100 or fewer patient-
facing encounters (including Medicare telehealth services defined in 
section 1834(m) of the Act) during the non-patient facing determination 
period, and a group provided that more than 75 percent of the NPIs 
billing under the group's TIN meet the definition of a non-patient 
facing individual MIPS eligible clinician during the non-patient facing 
determination period. As noted above, we believe that it would be 
beneficial for individual MIPS eligible clinicians and groups to know 
in advance of a performance period whether or not they qualify as a 
non-patient facing MIPS eligible clinician.
    We establish the non-patient facing determination period for 
purposes of identifying non-patient facing MIPS eligible clinicians in 
advance of the performance period using historical claims data. This 
eligibility determination process will allow us to identify non-patient 
facing MIPS eligible clinicians prior to or shortly after the start of 
the performance period. In order to conduct an analysis of the data 
prior to the performance period, we are establishing an initial non-
patient facing determination period consisting of 12 months. The 
initial 12-month segment of the non-patient facing determination period 
would span from the last 4 months of a calendar year 2 years prior to 
the performance period followed by the first 8 months of the next 
calendar year and include a 60-day claims run out, which will allow us 
to inform MIPS eligible clinicians and groups of their non-patient 
facing status during the month (December) prior to the start of the 
performance period. The second 12-month segment of the non-patient 
facing determination period would span from the last 4 months of a 
calendar year 1 year prior to the performance period followed by the 
first

[[Page 77049]]

8 months of the performance period in the next calendar year and 
include a 60-day claims run out, which will allow us to inform 
additional eligible clinicians and groups of their non-patient status 
during the performance period.
    Thus, for purposes of the 2019 MIPS payment adjustment, we will 
initially identify individual MIPS eligible clinicians and groups who 
are considered non-patient facing MIPS eligible clinicians based on 12 
months of data starting from September 1, 2015 to August 31, 2016. In 
order to account for the identification of additional individual MIPS 
eligible clinicians and groups that may qualify as non-patient facing 
during the 2017 performance period, we will conduct another eligibility 
determination analysis based on 12 months of data starting from 
September 1, 2016 to August 31, 2017.
    Similarly, for future years, we will conduct an initial eligibility 
determination analysis based on 12 months of data (consisting of the 
last 4 months of the calendar year 2 years prior to the performance 
period and the first 8 months of the calendar year prior to the 
performance period) to determine the non-patient facing status of 
individual MIPS eligible clinicians and groups, and conduct another 
eligibility determination analysis based on 12 months of data 
(consisting of the last 4 months of the calendar year prior to the 
performance period and the first 8 months of the performance period) to 
determine the non-patient facing status of additional individual MIPS 
eligible clinicians and groups. We will not change the non-patient 
facing status of any individual MIPS eligible clinician or group 
identified as non-patient facing during the first eligibility 
determination analysis based on the second eligibility determination 
analysis. Thus, an individual MIPS eligible clinician or group that is 
identified as non-patient facing during the first eligibility 
determination analysis will continue to be considered non-patient 
facing for the duration of the performance period regardless of the 
results of the second eligibility determination analysis. We will 
conduct the second eligibility determination analysis to account for 
the identification of additional, previously unidentified individual 
MIPS eligible clinicians and groups that are considered non-patient 
facing.
    In addition, we consider a patient-facing encounter as the 
evaluation and management services (the denominators for the cross-
cutting measures). Lastly, as noted above, we are finalizing our 
proposal to include Medicare telehealth services (as defined in section 
1834(m) of the Act) in the definition of patient-facing encounters. We 
intend to publish a list of patient-facing encounters on the CMS Web 
site located at QualityPaymentProgram.cms.gov.
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 payment 
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 
payment 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 payment 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 Part B if such services were not included in 
outpatient CAH 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 and payment is ``based on'' 
the PFS. Moreover, this is consistent with the precedent CMS has 
established by applying the PQRS and meaningful use payment adjustments 
to Method II CAH payments. Therefore, we proposed that the MIPS payment 
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 
requested comments on this proposal.
    The following is a summary of the comments we received regarding 
our proposal that the MIPS payment 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.
    Comment: One commenter requested clarification regarding whether or 
not clinicians who are part of a CAH would be considered a group and 
required to participate MIPS.
    Response: We note that clinicians meeting the definition of a MIPS 
eligible clinician unless eligible for an exclusion, are generally 
required to participate in MIPS. For MIPS eligible clinicians who 
practice in Method I CAHs, the MIPS payment adjustment would apply to 
payments made for items and services that are Medicare Part B charges 
billed by MIPS eligible clinicians, but it would not apply to the 
facility payment to the CAH itself. For MIPS eligible clinicians who 
practice in Method II CAHs and have not assigned their billing rights 
to the CAH, the MIPS payment adjustment would apply in the same manner 
as for MIPS eligible clinicians who bill for items and services in 
Method I CAHs. Moreover, in this final rule with comment period, we are 
finalizing our proposal that the MIPS payment 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 note that if a CAH is reporting as a 
group, then MIPS eligible clinicians part of a CAH would be considered 
a group as defined at Sec.  414.1305.
    Comment: Several commenters stated that CMS must address the 
problems with Method II Critical Access Hospital reporting prior to 
Quality Payment Program implementation, particularly relating to the 
attribution methodology and data capture issues. For example, 
commenters suggested that CMS examine whether there are mechanisms for 
better capturing information on MIPS eligible clinicians from the CMS-
1450 form. Another commenter expressed concerns that Method II CAH 
participation in PQRS did not work as planned and the same issues may 
affect Method II CAH participation in the Quality Payment Program such 
as attribution issues may arise when any portion of the items and 
services furnished by eligible clinicians are excluded from Medicare's 
claims data database. The commenter believed that cost and quality 
measures are skewed because most patients attributed to Method II CAH 
facilities are institutionalized, causing them to appear to have much 
higher costs and lower quality than the average, and because not all 
CAH services are reported on CMS-1500 claim forms. Specifically, 
commenters indicated that Method II CAHs see only a small portion of 
their services reimbursed

[[Page 77050]]

under Medicare Part B, including hospital inpatient, swing bed, nursing 
home, psychiatric and rehabilitation inpatient, and hospital outpatient 
services rendered in non-CAH settings. Services rendered for 
outpatients in the CAH setting (for example provider-based clinic, 
observation, emergency room, surgery, etc.) are reimbursed through Part 
A and are exempt from the Quality Payment Program. The commenters noted 
that this results in beneficiaries who are less acute and low cost to 
the Medicare program (those seen in clinic settings and those who have 
avoided inpatient and post-acute care settings) being excluded in the 
Quality Payment Program attribution, with only potentially high-cost 
beneficiaries being counted. Therefore, while a CAH-based eligible 
clinician may have a substantial portion of his or her patient 
population in a low-cost category, the use of the PQRS attribution 
methodology for MIPS could still easily result in the MIPS eligible 
clinician being reported as high-cost if only high-cost patients are 
included in the Quality Payment Program attribution. The commenters 
recommended that all Method II CAH ambulatory services be included in 
the attribution methodology of the Quality Payment Program.
    For Method II claims, this would involve scrubbing outpatient 
claims for services reported with professional revenue codes (96X, 97X 
and 98X) that are matched up with the applicable CPT codes. Commenters 
recommended an alternative, in which the Method II CAHs could be 
benchmarked only against themselves. Commenters indicated that the 
penalties would be relatively small, given that Method II CAHs bill 
primarily under Part A, but the publishing of these negative scores on 
Physician Compare will cause patients to seek care elsewhere, further 
destabilizing the rural delivery system.
    Response: We appreciate the commenters expressing their concerns 
and note that MIPS eligible clinicians who practice in Method II CAHs 
may be eligible for the low-volume threshold exclusion, in which such 
eligible clinicians who do not exceed $30,000 of billed Medicare Part B 
allowed charges or 100 Part B-enrolled Medicare beneficiaries would be 
excluded from MIPS. We believe this exclusion will benefit eligible 
clinicians who practice in Method II CAHs. We refer readers to section 
II.E.10. of this final rule with comment period for final policies 
regarding public reporting on Physician Compare.
    Comment: One commenter suggested that CMS delay the start of the 
MIPS program for MIPS eligible clinicians who practice in Method II 
CAHs and have assigned their billing rights to the CAH.
    Response: We appreciate the suggestion from the commenter. However, 
we do not deem it necessary or justifiable to delay the participation 
of MIPS eligible clinicians who provide services in Method II CAHs and 
have assigned their billing rights to the CAH given that Method II CAHs 
were required to participate in PQRS and the Medicare EHR Incentive 
Program.
    Comment: One commenter indicated that many clinicians who practice 
in Method II CAHs would provide their clinical care in RHCs/FQHCs, and 
as such, their only qualifying Part B charges would be documented in 
the CAH's inpatient CEHRT. The commenter noted that while PQRS was 
mandated for these clinicians, facilities face difficulty creating 
quality PQRS reports based on extremely limited encounters. The 
commenter also indicated that it is overly burdensome to require these 
low-volume ``inpatient only'' CAH providers to participate in the MIPS 
program until inpatient CEHRT software is required through the 
certification process to produce NQF measure reports (on a clinician by 
clinician basis) relevant to any and all CMS quality programs. The 
commenter recommended that all clinicians who practice in Method II 
CAHs be exempt from reporting under MIPS, similar to the provisions 
established under the EHR Incentive Program that exempt hospital-based 
EPs from the application of the meaningful use payment adjustment.
    Response: We appreciate the concerns expressed by the commenter 
regarding MIPS eligible clinicians who practice in Method II CAHs and 
note that clinicians meeting the definition of a MIPS eligible 
clinician, unless eligible for an exclusion, are generally required to 
participate in MIPS (section II.E.3. of this final rule with comment 
period describes the provisions pertaining to the exclusions from MIPS 
participation). For MIPS eligible clinicians who practice in Method II 
CAHs and have not assigned their billing rights to the CAH, the MIPS 
payment 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. However, for MIPS 
eligible clinicians who practice in Method II CAHs and have assigned 
their billing rights to the CAH, the MIPS payment adjustment applies to 
Method II CAH payments under section 1834(g)(2)(B) of the Act.
    In section II.E.5.g.(8)(a)(i) of this final rule with comment 
period, we noted that CAHs (and eligible hospitals) 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. CAHs (and eligible hospitals) 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. The objectives and measures of the EHR Incentive Programs for 
CAHs (and eligible hospitals) are specific to these facilities, and are 
more applicable and better represent the EHR technology available in 
these settings. Section 1848(a)(7)(D) of the Act exempts hospital-based 
EPs from the application of the payment adjustment under the EHR 
Incentive Program and section 1848(a)(7)(B) of the Act provides the 
authority to exempt an EP who is not a meaningful EHR user from the 
application of the payment adjustment if it is determined that 
compliance with the meaningful EHR user requirements 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 exceptions for the advancing care information 
performance category under 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 program.
    Section 1848(q)(5)(F) of the Act provides the authority to assign 
different scoring weights (including a weight of zero) for each 
performance category if there are not sufficient measures and 
activities applicable and available to each type of MIPS eligible 
clinician, including hospital-based clinicians. Accordingly, as 
described in section II.E.5.g.(8)(a)(i) of this final rule with comment 
period, we may assign a weight of zero percentage for the advancing 
care information performance category for hospital-based MIPS eligible 
clinicians. Under MIPS, we define a hospital-based MIPS eligible 
clinician as a MIPS eligible clinician who furnishes 75 percent or more 
of his or her covered professional services in sites of service 
identified by the Place of Service (POS) codes 21, 22, and 23 used in 
the HIPAA standard transaction as an inpatient hospital, on campus 
outpatient hospital or emergency room setting in the year preceding the 
performance period. Consistent with the

[[Page 77051]]

EHR Incentive Program, we will determine which MIPS eligible clinicians 
qualify as ``hospital-based'' for a MIPS payment year.
    Comment: One commenter requested that CMS address data capture 
issues for CAHs that may be required to participate in the MIPS and 
examine whether there are mechanisms for better capturing information 
on eligible clinicians from the CMS-1450 form. Some CAHs have reported 
issues with capturing full information about eligible clinicians from 
the institutional billing form used by CAHs (UB-04/CMS-1450). Under 
existing billing rules, CAHs may bill one CMS-1450 per day, with claims 
from multiple providers are combined into one submission.
    Response: We appreciate the commenter expressing these concerns and 
intend to address operational and system-infrastructure issues 
experienced under previously established CMS programs and ensure that 
MIPS eligible clinicians have an improved experience when participating 
in the MIPS program.
    After consideration of the public comments we received, we are 
finalizing our proposal that the MIPS payment adjustment will 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.
d. MIPS Eligible Clinicians Who Practice in Rural Health Clinics (RHCs) 
and/or Federally Qualified Health Centers (FQHCs)
    As noted in section II.E.1.d. of the proposed rule (81 FR 28176), 
section 1848(q)(6)(E) of the Act provides that the MIPS payment 
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 clinicians may not receive MIPS 
payment 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. We note that eligible clinicians providing services 
for a RHC or FQHC as an employee or contractor is paid by the RHC or 
FQHC, not under the PFS. When a MIPS eligible clinician furnishes 
professional services in an RHC and/or FQHC, the RHC bills for those 
services under the RHC's all-inclusive rate methodology and the FQHC 
bills for those services under the FQHC prospective payment system 
methodology, in which the MIPS payment adjustment would not apply to 
the RHC or FQHC payment. Therefore, we proposed that 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, in which the 
data received would not be used to assess their performance for the 
purpose of the MIPS payment adjustment. We requested comments on this 
proposal.
    The following is a summary of the comments we received regarding 
our proposal that services rendered by an eligible clinician that are 
payable under the RHC or FQHC methodology would not be subject to the 
MIPS payments adjustments.
    Comment: Several commenters supported CMS' proposal that items and 
services furnished by a MIPS eligible clinician that are payable under 
the RHC or FQHC methodology would not be subject to the MIPS payment 
adjustments.
    Response: We appreciate the support from commenters.
    Comment: One commenter noted that it is unclear what the 
participation requirements are for MIPS eligible clinicians who 
practice in FQHCs.
    Response: In this final rule with comment period, we note that 
items and services furnished by a MIPS eligible clinician that are 
payable under the RHC or FQHC methodology would not be subject to the 
MIPS payments adjustment. These MIPS eligible clinicians have the 
option to voluntarily report on applicable measures and activities for 
MIPS. If such MIPS eligible clinicians voluntarily participate in MIPS, 
they would follow the requirements established for each performance 
category. We note that the data received from such MIPS eligible 
clinicians would not be used to assess their performance for the 
purpose of the MIPS payment adjustment. However, items and services 
furnished by a MIPS eligible clinician that are billed Medicare Part B 
charges by the MIPS eligible clinician would be subject to the MIPS 
payment adjustment. Also, we note that such MIPS eligible clinicians 
who furnished items and services that are billed Medicare Part B 
allowed charges by such MIPS eligible clinicians may be excluded from 
the requirement to participate in MIPS if they do not exceed the low-
volume threshold as described in section II.E.3.c. of this final rule 
with comment period.
    Comment: Several commenters agreed with voluntary reporting of MIPS 
data for FQHC and RHC clinicians as described in the proposed rule, and 
recommended that quality reporting requirements should be matched with 
HRSA measures. Commenters noted that drawing conclusions from the 
initial data could be problematic based upon coding and documentation 
differences compared to other clinicians reporting MIPS data. One 
commenter requested that CMS not request FQHCs and RHCs to voluntarily 
submit data. The commenter indicated such organizations have neither 
the IT support nor administrative staff to submit extended data.
    Response: We thank the commenters for expressing their concerns 
regarding the comparability of data submitted by MIPS eligible 
clinicians who practice in RHCs and FQHCs. We want to reiterate that 
such MIPS eligible clinicians have the option to decide whether or not 
they voluntarily participate in MIPS.
    Comment: A few commenters requested CMS to ensure that FQHC 
clinicians are not subject to MIPS for the limited number of FQHC-
related claims submitted under the PFS. Alternatively, one commenter 
requested that fee service claims for non-specialty services furnished 
by clinicians practicing in FQHCs or RHCs not be counted when 
determining eligibility for the low-volume threshold.
    Response: We appreciate the concern expressed by the commenter and 
note that section 1848(q)(6)(E) of the Act provides that the MIPS 
payment adjustment is applied to the amount otherwise billed under 
Medicare Part B charges with respect to the items and services 
furnished by a MIPS eligible clinician during a year. With respect to 
the comment regarding the low-volume threshold, we refer readers to 
section II.E.3.c. of this final rule with comment period, in which we 
establish a low-volume threshold to identify MIPS eligible clinicians 
excluded from participating in MIPS. We disagree with the 
recommendation that the fee for service claims for non-specialty items 
and services furnished by clinicians practicing in FQHCs or RHCs should 
be excluded from the low-volume threshold eligibility determination. We 
believe that the low-volume threshold established in this final rule 
with comment period retains as MIPS eligible

[[Page 77052]]

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. 
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. Clinicians practicing in a 
RHC or FQHC not exceeding the low-volume threshold would be excluded 
from the MIPS requirements.
    Comment: Several commenters indicated that RHCs should be 
incentivized to participate and report quality data under the Quality 
Payment Program. One commenter indicated that the voluntary 
participation option is unlikely to be used without an incentive. 
Another commenter recommended that CMS conduct a survey of RHCs before 
it makes the effort to set up a voluntary reporting program that no one 
is likely to use. The commenter's own survey found that without 
incentives or penalties, very few RHCs would voluntarily participate in 
MIPS, and found that an incentive payment of $10,000 per clinic per 
year would prompt about half of RHCs to report under MIPS. A few 
commenters suggested that CMS include RHCs in MIPS, as these are the 
only primary care system left in the country with no tie to value.
    Response: We appreciate the suggestions from commenters and will 
consider them as we assess the volume of voluntary reporting under 
MIPS.
    Comment: One commenter expressed concern that under CMS' proposal 
to exclude RHCs from MIPS, RHCs' patients will fail to benefit from the 
rigorous quality measurement that comparable practices under MIPS 
program will experience. The commenter is concerned about the growing 
disparities in quality and life expectancy between rural and urban 
patients. The commenter notes that the number of RHCs has grown from 
400 in 1990 to more than 4,000 today, with new conversions continuing 
as more rural providers realize they can get paid more than FFS under 
this model.
    Response: We thank the commenter for expressing concerns and note 
that MIPS eligible clinicians who practice in RHCs and furnish items 
and services that are payable under the RHC methodology have the option 
to voluntarily report on applicable measures and activities for MIPS.
    Comment: A few commenters requested that consideration be given to 
phase-in requests for FQHC voluntary reporting to allow for the 
development of social determinants of health status measure 
adjustments.
    Response: We appreciate the feedback on the role of socioeconomic 
status in quality measurement. We continue to evaluate the potential 
impact of social risk factors on measure performance. One of our core 
objectives is to improve beneficiary outcomes, and we want to ensure 
that complex patients as well as those with social risk factors receive 
excellent care.
    Comment: A few commenters supported CMS' proposal to be inclusive 
of rural practices, but encouraged CMS to have special conditions for 
such rural clinicians that have not participated in PQRS, VM, or the 
Medicare EHR Incentive Program for EPs in the past and suggested a 
phased approach for full participation that protects safety net 
clinicians from downside risk.
    Response: We appreciate the support from commenters and note that 
MIPS eligible clinicians who practice in RHCs and furnish items and 
services that are payable under the RHC methodology would not be 
subject to the MIPS payments adjustments for such items and services, 
but would have the option to voluntarily report on applicable measures 
and activities for MIPS. For such MIPS eligible clinicians who 
voluntarily participate in MIPS, the data submitted to CMS would not be 
used to assess their performance for the purpose of the MIPS payment 
adjustment.
    Comment: One commenter recommended that CMS create a system 
permitting the voluntary reporting of performance information by 
excluded clinicians, and that the data reported be used to help define 
rural-specific measures and standards for these clinicians and for all 
rural clinicians. Under this system, data would be released only on an 
aggregate basis, protecting the privacy of individual entities 
reporting.
    Response: We thank the commenter for the suggestions and will 
consider them as we establish policies pertaining to MIPS eligible 
clinicians who practice in RHCs and FQHCs in future rulemaking.
    Comment: One commenter noted that in certain communities, clinical 
services are delivered in RHCs, small independent practices and 
community health centers, in which hospital-based services billed under 
the PFS may only represent a small portion of total care provided. The 
commenter requested that CMS develop a method for rural clinicians such 
as those practicing in RHCs and FQHCs to have a meaningful avenue to 
participate in the Quality Payment Program. Another commenter indicated 
that RHCs, CAHs, and FQHCs were created to assure the availability of 
health care services to remote and underserved populations, and while a 
majority of clinicians who practice in RHCs, CAHs, and FQHCs bill under 
Medicare Part A, may have a limited number of encounters for which 
services are billed under Medicare Part B. Thus, such clinicians may 
exceed the low-volume threshold and therefore be subject to the MIPS 
payment adjustment. The commenter expressed concerns that RHCs, CAHs, 
and FQHCs would be negatively impacted by having their resources 
stretched even further if required to meet the requirements under MIPS 
or be subject to a negative MIPS payment adjustment. The commenter also 
noted that many RHCs and FQHCs have not implemented EHR technology due 
to the lack of available resources and struggle to recruit qualified 
clinicians and staff, and as a result, such clinicians and staff are 
disproportionately older than the average health care workforce. If 
RHCs and FQHCs are required to participate in MIPS and meet all 
requirements or be subject to a negative MIPS payment adjustment, the 
fiscal resources reduced by either a MIPS payment adjustment or 
investment in EHR technology would significantly impact and reduce the 
availability of services available to remote and underserved 
populations. The commenter recommended that CMS consider permanent 
exclusions for clinicians practicing in RHCs and FQHCs from the 
requirement to participate in the MIPS program. One commenter noted 
that CMS should provide exemptions from entire performance categories, 
not just individual measures and activities, consider the feasibility 
of shorter reporting timeframes, and ensure that there are free or low 
cost reporting options within each MIPS performance category.
    Response: We appreciate the commenters expressing their concerns 
and providing recommendations. We will take into consideration the 
suggestions from commenters in future rulemaking. We note that the MIPS 
payment adjustment is limited to items and services furnished by MIPS 
eligible clinicians for billed Medicare Part B charges such as those 
under the PFS. We note that MIPS eligible clinicians practicing in RHCs 
and FQHCs will benefit from other policies that we are finalizing 
throughout this final rule with

[[Page 77053]]

comment period such as the higher low-volume threshold, lower reporting 
requirements, and lower performance threshold.
    Comment: One commenter requested clarification on how CMS would 
define rural areas and suggested that CMS adopt a consistent definition 
for the term ``small practices'' across all CMS programs. The commenter 
suggested that a small practice be defined as having 25 or fewer 
clinicians. Another commenter recommended that the low-volume threshold 
be set at an even higher level for rural and underserved areas to 
ensure that MIPS does not endanger the financial stability of rural 
safety net practices or reduce access to services for rural Medicare 
beneficiaries.
    Response: We note that we define rural areas as clinicians in zip 
codes designated as rural, using the most recent HRSA Area Health 
Resource File data set available as described in section II.E.5.f.(5) 
of this final rule with comment period. Also, in section II.E.5.f.(5) 
of this final rule with comment period, we define small practices as 
practices consisting of 15 or fewer clinicians. We are finalizing our 
proposed definition of small practices because the statute provides 
special considerations for small practices consisting of 15 or fewer 
clinicians. In regard to the commenter's suggestion pertaining to the 
low-volume threshold, we are finalizing a modification to our proposal, 
which establishes a higher low-volume threshold as described in section 
II.E.3.c. of this final rule with comment period.
    Comment: Some commenters recommended that CMS follow the 
recommendations of the NQF Report on Performance Measurement for Rural 
Low-Volume Providers and establish rural peer groups and rural-specific 
standards for assessment of rural provider performance in all domains. 
Commenters noted that the NQF developed specific recommendations for 
how pay-for-performance mechanisms should be implemented for rural 
providers. The NQF Report on Performance Measurement for Rural Low-
Volume Providers sets out both overarching and specific approaches for 
how rural provider performance measurement should be handled. The NQF 
Report on Performance Measurement for Rural Low-Volume Providers also 
makes recommendations about rural performance measures of domains other 
than quality, including cost. One commenter noted that as rural-
specific quality measures are developed, such measures should be both 
mandatory core measures and elective supplementary measures.
    Response: We appreciate the recommendations provided by the 
commenters and will take them into consideration for future rulemaking.
    Comment: One commenter agreed with the goals of the proposed rule, 
but believed that the proposed rule had one thematic deficiency as a 
result of the quality reporting constructs, which implied a dichotomy 
of ``primary care'' versus ``specialist'' with the correlate 
implication that all specialists and specialties impact value of 
current health care similarly (and generally adversely) and 
marginalized specialties as leaders in care quality and efficiency 
improvement. The commenter recommended that CMS create specialty-
specific quality and efficiency targets that incentivize specialists 
caring for high risk, high-cost chronically ill patients to provide the 
best long-term care and coordinate care with primary care physicians 
(including chronic care subspecialists practicing across multiple 
health systems rather than as part of a larger provider entity) with 
each specialty having specific quality goals and efficiency targets.
    Response: We appreciate the feedback from the commenter, but 
disagree with commenter's assessment that our policies marginalize 
specialists. We will take into consideration the recommendations 
provided by the commenter for future rulemaking.
    Comment: Due to complexity of the proposed rule and the extremely 
short projected turnaround time before the start of the 2017 
performance period, a few commenters recommended that Frontier Health 
Professional Shortage Area (HPSA) clinicians should be exempt from 
mandatory MIPS/APM participation until 2019, when the program has had a 
chance to evaluate its successes and failures with respect to larger, 
more economically stable participants. The commenters suggested that 
Frontier HPSA clinicians should be allowed to voluntarily participate 
if they want to, but they should not be penalized due to the low-
income, low-population challenges faced in extremely rural areas until 
payment year 2021 or later.
    Response: We note that the statute does not grant the Secretary 
discretion to establish exclusions other than the three exclusions 
described in section II.E.3. of this final rule with comment period. 
Thus, Frontier HPSA clinicians who are MIPS eligible clinicians are 
required to participate in MIPS. However, we believe that Frontier HPSA 
clinicians will benefit from other policies that we are finalizing 
throughout this final rule with comment period such as the higher low-
volume threshold, lower reporting requirements, and lower performance 
threshold.
    After consideration of the public comments we received, we are 
finalizing our proposal that services rendered by an eligible clinician 
under the RHC or FQHC methodology, will 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, in which the data received will not be used to assess their 
performance for the purpose of the MIPS payment adjustment.
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 the proposed rule (81 FR 
28177), we proposed 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 the proposed rule 
(81 FR 28177), we proposed to define an APM Entity group at Sec.  
414.1305 identified by a unique APM participant identifier. However, we 
are finalizing a modification to the definition of a group as described 
in section II.E.2.b. of this final rule with comment period and 
finalizing the definition of an APM Entity group as described in 
section II.E.2.c. of this final rule with comment period.
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

[[Page 77054]]

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 (80 FR 63484), 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 (80 FR 63484), 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 suggested that MIPS eligible clinicians who bill 
under more than one TIN can be assigned the performance and MIPS 
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 believed 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 believed 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 attempting to change 
their identifier for MIPS performance purposes.
    In the MIPS and APMs RFI (80 FR 63484), 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 did not propose to create a new 
MIPS eligible clinician identifier. However, we appreciated the various 
ways a MIPS eligible clinician may engage with MIPS, either 
individually or through a group. Therefore, we proposed to use multiple 
identifiers that allow MIPS eligible clinicians to be measured as an 
individual or collectively through a group's performance. We also 
proposed 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, cost, improvement activities, and 
advancing care information. As discussed in the final score methodology 
section II.E.6. of the proposed rule (81 FR 28247 through 28248), we 
proposed to use a single identifier, TIN/NPI, for applying the MIPS 
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, we proposed to use the TIN/NPI when 
applying the MIPS payment adjustment. We requested comments on these 
proposals.
    The following is a summary of the comments we received regarding 
our proposals to use multiple identifiers that allow MIPS eligible 
clinicians to be measured as an individual or collectively through a 
group's performance and use a single identifier, TIN/NPI, for applying 
the MIPS payment adjustment.
    Comment: Several commenters supported the proposal to have each 
unique TIN/NPI combination considered a different MIPS eligible 
clinician and to use the TIN to identify group practices. One commenter 
noted that using a group's billing TIN to identify a group is 
consistent with the current CMS approach under PQRS and VM, and is 
preferable to creating a new MIPS-specific identifier for groups.
    Response: We appreciate the support from commenters.
    Comment: One commenter noted that the proposed MIPS identifiers 
(combination of TIN/NPI, etc.) would be sufficient for individual, 
group, and APM reporting to MIPS, but requested that CMS establish an 
identifier for virtual groups. Another commenter questioned the use of 
these identifiers beyond their original purposes.
    Response: We appreciate the feedback from the commenters. We did 
not propose an identifier for virtual groups, but in future rulemaking, 
we will take into consideration the establishment of a virtual group 
identifier. As noted in this final rule with comment period, the use of 
the identifiers enables us to identify individual MIPS eligible 
clinicians at the TIN/NPI level and groups at the TIN level.
    Comment: A few commenters opposed the approach of creating a new 
MIPS eligible clinician identifier at the initiation of the Quality 
Payment Program because it would be premature and cause confusion. The 
commenter further noted that there may be times when a clinician is not 
MIPS eligible and then becomes MIPS eligible. Also, the commenter 
indicated that there is currently not a way to report the identifier on 
claims.
    Response: We disagree with the commenter and believe that it is

[[Page 77055]]

essential for us to be able to identify individual MIPS eligible 
clinicians using a unique identifier because the MIPS payment 
adjustment would be applied to the Medicare Part B charges billed by 
individual MIPS eligible clinicians at the TIN/NPI level. We note that 
we will be able to identify, at the NPI level, individual eligible 
clinicians who are excluded from the MIPS requirements and not subject 
to the MIPS payment adjustment for exclusions pertaining to new 
Medicare-enrolled eligible clinicians and QPs and Partial QPs not 
participating MIPS. In our analyses of claims data, we will be able to 
identify individual MIPS eligible clinicians at the TIN/NPI level given 
that billing is associated with a TIN or TIN/NPI.
    Comment: One commenter recommended the use of TINs plus 
alphanumeric codes as identifiers.
    Response: We disagree with the commenter's suggestion to use a TIN 
with an alphanumeric code because it would add complexity and not 
facilitate the identification of individual eligible clinicians at the 
NPI level who are associated with a group at the TIN level. For certain 
exclusions (for example, new Medicare-enrolled eligible clinicians, and 
QPs and Partial QPs who are not participating in MIPS), eligibility 
determinations will be made and applied at the NPI level.
    Comment: Several commenters requested that small physician 
practices be exempt from MIPS. A few commenters indicated that 
penalizing small practices would decrease access to care for patients. 
One commenter indicated that small groups and independent physicians 
are unfairly penalized and are being forced to integrate into larger 
hospital or corporations. Another commenter expressed concern that 
additional administrative duties will affect patient care and will not 
improve healthcare. One commenter indicated that the proposed rule was 
discriminatory toward solo or small group practices. The commenter 
noted that the financial burden of MACRA will result in the closure of 
many solo and small group practitioners.
    Response: We appreciate the concerns expressed by the commenters. 
We note that the statute does not grant the Secretary with discretion 
to establish exclusions other than the exclusions described in section 
II.E.3. of this final rule with comment period. However, we believe 
that small practices will benefit from policies we are finalizing 
throughout this final rule with comment period such as the higher low-
volume threshold, lower performance requirements, and lower performance 
threshold.
    Comment: A few commenters requested that CMS determine and state 
eligibility status for clinicians providing services at independent 
diagnostic testing facilities (IDTFs) and to provide clear, detailed 
guidance under what circumstances eligibility would occur under MIPS. 
The commenter noted that CMS has issued similar guidance under the PQRS 
system of ``eligible but not able to participate''; however, the 
commenter indicated that the guidance provided in PQRS does not address 
all variations of billing and coding practices of IDTFs.
    Response: We note that the MIPS payment adjustment applies only to 
the amount otherwise paid under Part B with respect to items and 
services furnished by a MIPS eligible clinician during a year. As 
discussed in section II.E.7. of this final rule with comment period, we 
will apply the MIPS adjustment at the TIN/NPI level. In regard to 
suppliers of independent diagnostic testing facility services, we note 
that such suppliers are not themselves included in the definition of a 
MIPS eligible clinician. However, there may be circumstances in which a 
MIPS eligible clinician would furnish the professional component of a 
Part B covered service that is billed by such a supplier. Those 
services could be subject to MIPS adjustment based on the MIPS eligible 
clinician's performance during the applicable performance period. 
Because, however, those services are billed by suppliers that are not 
MIPS eligible clinicians, it is not operationally feasible for us at 
this time to associate those billed allowed charges with a MIPS 
eligible clinician at an NPI level in order to include them for 
purposes of applying any MIPS payment adjustment.
    Comment: One commenter expressed concern regarding the definition 
of a group (unique TIN) because large health systems and hospitals 
operate large medical groups spanning practices and specialties, and 
all of them share a TIN and EHRs. The commenter indicated that grouping 
all clinicians together takes away the advantages of group 
participation. The commenter noted that CMS should generate another way 
for group practices to differentiate themselves.
    Response: We thank the commenter for expressing their concern. We 
disagree with the commenter because we believe that group level 
reporting is advantageous for groups in that it encourages 
coordination, teamwork, and shared responsibility. However, we 
recognize that we are not able to identify groups with eligible 
clinicians who are excluded from the MIPS requirements both at the 
individual level and group level such as new Medicare-enrolled 
clinicians. We note that we could establish new identifiers to more 
accurately identify such eligible clinicians. For future consideration, 
we are seeking additional comment on the identifiers. What are the 
advantages and disadvantages of identifying new Medicare-enrolled 
eligible clinicians and eligible clinicians not included in the 
definition of a MIPS eligible clinician until year 3 such as 
therapists? What are the possible identifiers that could be established 
for identifying such eligible clinicians?
    Comment: One commenter requested clarification about how CMS 
intends to treat group practices participating in MIPS in regard to 
satisfying the ``hospital-based clinician'' definition, and questioned 
if it would evaluate the group as a whole, or each individual within 
the group. And if the latter, the commenter questioned if CMS would 
adopt a process for scoring individuals in a group differently than the 
overall group. Another commenter requested that CMS consider how the 
definition of a group, and use of a single TIN, could represent 
facility-based outpatient therapy clinicians. Currently, many facility-
based outpatient clinicians operate under the facility's TIN.
    Response: We note that hospital-based MIPS eligible clinicians are 
considered MIPS eligible clinicians are required to participate in 
MIPS. However, section II.E.5.g.(8)(a)(i) of this final rule with 
comment period describes our final policies regarding the re-weighting 
of the advancing care information performance category within the final 
score, in which we would assign a weight of zero when there are not 
sufficient measures applicable and available for hospital-based MIPS 
eligible clinicians.
    In regard to how the definition of a group corresponds facility-
based outpatient clinicians, we noted that the MIPS payment adjustment 
applies only to the amount otherwise paid under Part B with respect to 
items and services furnished by a MIPS eligible clinician during a 
year, in which we will apply the MIPS adjustment at the TIN/NPI level 
(see section II.E.7. of this final rule with comment period). For items 
and services furnished by such clinicians practicing in a facility that 
are billed by the facility, such items and services may be subject to 
MIPS adjustment based on the MIPS eligible clinician's performance 
during the applicable performance period. For those billed Medicare 
Part B allowed charges we are

[[Page 77056]]

able to associate with a MIPS eligible clinician at an NPI level, such 
items and services furnished by such clinicians would be included for 
purposes of applying any MIPS payment adjustment.
    Comment: Several commenters recommended that CMS extend groups to 
include multiple TINs and require that those TINs share and have access 
to the same EHR. Commenters noted that group reporting would be 
complicated by clinicians joining the group, and clinicians assigned to 
multiple TINs using different EHR systems. The commenters also 
expressed concern about the ability for groups to submit quality data 
under the group reporting option using different types of EHRs. 
Commenter requested the submission of multiple specialty specific data 
sets and to alter the scoring methodology.
    Response: We appreciate the commenters expressing their concerns 
and providing their suggestions. We are finalizing the definition of a 
group as proposed. We disagree with commenters that the definition of a 
group should be modified in order to account for operational and 
technical data mapping issues. We believe that the finalized definition 
of a group provides groups with the opportunity to utilize its 
performance data in ways that can improve coordination, teamwork, and 
shared responsibility.
    We do not believe that the definition of a group would create 
complications for eligible clinicians associated with multiple TINs. We 
note that individual eligible clinicians would be required to meet the 
MIPS requirements for each TIN/NPI association unless they are excluded 
from MIPS based on an exclusion established in section II.E.3. of this 
final rule with comment period.
    Comment: One commenter requested CMS to ensure that each service 
provided to a patient is associated with the actual clinician 
furnishing that service.
    Response: We note that the MIPS payment adjustment for individual 
MIPS eligible clinicians is applied to the Medicare Part B payments for 
items and services furnished by each MIPS eligible clinician. For 
groups reporting at the group level, scoring and the application of the 
MIPS payment adjustment is applied at the TIN level for Medicare Part B 
payments for items and services furnished by the eligible clinicians of 
the group.
    Comment: One commenter supported CMS' proposal for optional group 
performance tracking and submission, but recommended that CMS provide 
additional guidelines for clinicians who practice under multiple 
identifiers. The commenter requested additional clarification on how 
MIPS payment adjustments would impact clinicians working under multiple 
identifiers at multiple organizations.
    Response: We appreciate the support from the commenter. As 
previously noted, individual eligible clinicians who are part of 
several groups and thus, associated with multiple TINs, such individual 
eligible clinicians would be required to participate in MIPS for each 
group (TIN) association unless the eligible clinician (NPI) is excluded 
from the MIPS. Section II.E.3.e. of this final rule with comment period 
describes how the exclusion policies relate to groups with eligible 
clinicians excluded from MIPS.
    Comment: With many clinicians practicing within multiple TINs, one 
commenter suggested that even though it is unclear how multiple-TIN 
clinicians who choose individual reporting would be scored, CMS should 
use the clinician's highest TIN performance score for each of the four 
performance categories. Another commenter requested clarification on 
how the Quality Payment Program rule will apply to clinicians who work 
under multiple TINs, including the scenario where one TIN is 
participating in an ACO and another is not.
    Response: We note that groups have to the option to report at the 
individual or group level. For individual eligible clinicians 
associated with multiple TINs, the individual eligible clinician will 
either report at the individual level if the group elects to report at 
the individual or be included in the group-level reporting if the group 
elects group-level reporting. As previously noted, individual eligible 
clinicians who are associated with multiple TINs would be required to 
participate in MIPS for each group (TIN) association unless the 
eligible clinician (NPI) is excluded from the MIPS.
    Comment: One commenter noted as a reminder to CMS that using TINs 
as identifiers has caused some problems in the past such as the 
accuracy of TINs. When TINs are not accurate, performance rates and 
program metrics may be incorrect. The commenter recommended that CMS 
establish clear and efficient mechanisms for groups to resolve 
inconsistencies.
    Response: We appreciate the feedback from the commenter and will 
take into consideration the commenter's suggestions in future 
rulemaking.
    Comment: Several commenters supported the proposal to permit 
clinicians to report either at the individual or group level. However, 
one commenter expressed concern about limitations on the ability of 
clinicians, in the context of group-level reporting, to report the most 
appropriate and meaningful specialty measures. Another commenter 
indicated that it was not clear how group reporting would allow for 
specialty specific reporting, given the lack of a TIN for individual 
departments within a larger faculty practice plan or physician group. 
The commenter noted that this could cause thousands of providers to 
miss out on the best use of MIPS because their facilities chose 
reporting measures and activities that would not reflect the care they 
individually provide. Therefore, the commenter suggested that CMS 
create a reporting option within MIPS that would allow specialty-
specific groups to self-designate as ``group'' under MIPS even if they 
were part of the TIN for a larger facility practice plan or physician 
group. The commenter noted that this would facilitate the comparison of 
physicians providing a similar mix of procedures for comparison for the 
purpose of assigning a final score. Another commenter recommended that 
CMS consider the common business model where large hospitals and health 
systems acquire multiple physician practices.
    Response: We appreciate the support from the commenters. We will 
consider the recommendations from the commenters in future rulemaking. 
We note that group-level reporting does not provide the option for 
groups to report at sub-levels of the group by specialty. We believe 
that group-level reporting ensures coordination, teamwork, and shared 
responsibility.
    Comment: A few commenters expressed concern regarding MIPS eligible 
clinicians moving practices in the middle of a reporting period. One 
commenter recommended that if a clinician changes TINs during the 
course of a year, their final composite score should be attributed to 
their final TIN on December 31 of that year. Another commenter 
indicated that by using a TIN/NPI combination, CMS could accurately 
match reporting data to an individual clinician because often the NPI 
of the clinician will not change, and CMS could match the new TIN to 
ensure accurate attribution.
    Response: We appreciate the concerns and suggestions from the 
commenters and note that individual MIPS eligible clinicians may be 
associated with more than one TIN during the performance period due to 
a variety of reasons with differing timeframes. In sections II.E.6. and 
II.E.7. of this final rule with comment period, we describe how 
individual MIPS eligible will have their performance assessed and 
scored and

[[Page 77057]]

how the MIPS payment adjustment would be applied if a MIPS eligible 
clinician changes TINs during the performance period.
    Comment: One commenter expressed concern regarding how group size 
would be calculated, particularly how clinicians that are not subject 
to MIPS would be included in the size of the group.
    Response: CMS does not make an eligibility determination regarding 
a group size. We note that groups attest to their group size for 
purpose of using the CMS Web Interface or a group identifying as a 
small practice. In order for groups to determine their group size, we 
note that a group size would be determined before exclusions are 
applied.
    Comment: One commenter recommended that CMS allow validation or 
updating of clinicians' identifying information in the PECOS system, 
and not a separate system.
    Response: We appreciate the suggestion from the commenter and will 
consider it as we operationalize the use of PECOS for MIPS.
    After consideration of the public comments we received, we are 
finalizing the use of multiple identifiers that allow MIPS eligible 
clinicians to be measured as an individual or collectively through a 
group's performance. Additionally, we are finalizing our proposal 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, cost, improvement activities, and advancing care information. 
While we have multiple identifiers for participation and performance, 
we are finalizing the use of a single identifier, TIN/NPI, for applying 
the MIPS payment adjustment, regardless of how the MIPS eligible 
clinician is assessed (see final score methodology outlined in section 
II.E.6. of this final rule with comment period). Specifically, if the 
MIPS eligible clinician is identified for performance only using the 
TIN, we will use the TIN/NPI when applying the MIPS payment adjustment.
a. Individual Identifiers
    We proposed 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 
MIPS 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 proposed 
group identifiers 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.7.a. of the proposed rule describes in 
more detail how we proposed to match performance in cases where the 
TIN/NPI changes. We requested comments on this proposal.
    The following is a summary of the comments we received regarding 
our proposal to use a combination of billing TIN/NPI as the identifier 
to assess performance of an individual MIPS eligible clinician.
    Comment: One commenter expressed concern that independent 
physicians would not fare well as a result of the proposed rule.
    Response: We appreciate the concern expressed by the commenter. We 
believe that independent clinicians will benefit from policies we are 
finalizing throughout this final rule with comment period such as the 
higher low-volume threshold, lower performance requirements, and lower 
performance threshold.
    Comment: One commenter found the MIPS terminology confusing and 
believed that tracking individual clinicians for reimbursement, as 
outlined in the proposed rule, would be difficult.
    Response: We appreciate the feedback from the commenter and will 
consider the ways we can explain the MIPS requirements to ensure that 
information is clear, understandable, and consistent.
    Comment: Several commenters requested clarification regarding how 
individual MIPS eligible clinicians who bill to multiple TINs would 
have their performance assessed. Commenters questioned if they are 
eligible for MIPS payment adjustment under multiple TINs, if they are 
expected to perform under all four categories for each TIN where they 
practice, and how a Partial QP and individual in a group practice would 
be assessed for purposes of the 2019 MIPS payment adjustment based on 
the TIN/NPI combination.
    Response: For MIPS eligible clinicians associated with multiple 
TINs, we note that MIPS eligible clinicians will need to meet the MIPS 
requirements for each TIN they are associated with unless they are 
excluded from the MIPS requirements based on one of the three 
exclusions (as described in section II.E.3. of this final rule with 
comment period) at the individual and/or group level.
    Comment: One commenter questioned the benefit to clinicians 
reporting at the TIN/NPI level compared to the NPI level.
    Response: We note that groups have the option to report at the 
individual (TIN/NPI) level or the group (TIN) level. Depending on the 
composition of groups, groups may find that reporting at the individual 
level may be more advantageous for the group than the reporting at the 
group level and vice versa. Individual eligible clinicians who are not 
part of a group, would report at the individual level.
    Comment: To facilitate individual clinician-level information, one 
commenter recommended that CMS use the NPI identifier throughout the 
MIPS program. The commenter noted that the NPI is also used by the 
private sector, promoting greater alignment than would a newly created 
MIPS clinician identifier.
    Response: We appreciate the suggestion from the commenter, but 
disagree with the commenter that we should establish an identifier only 
at the NPI level because we need to be able to not only account for 
individual NPIs, but we need to have a capacity that allows us to 
identify eligible clinicians and MIPS eligible clinicians who are 
associated with a group given that group level reporting is an option 
and scoring and MIPS payment adjustments would need be applied 
accordingly. As a result, we are finalizing the individual MIPS 
eligible clinician identifier using the TIN/NPI combination.
    Comment: One commenter requested clarification on how clinicians 
using only a TIN will be scored, and then have their payment adjusted 
based on the TIN/NPI.
    Response: We note that groups reporting at the group level will be 
assessed and scored, at the TIN level and have a MIPS payment 
adjustment applied at the TIN/NPI level. We note that the MIPS payment 
adjustment is applied to the MIPS eligible clinicians within the TIN 
for billed Medicare Part B charges.

[[Page 77058]]

    After consideration of the public comments we received, we are 
finalizing our proposed definition of a MIPS eligible clinician at 
Sec.  414.1305 to use a combination of unique billing TIN and NPI 
combination as the identifier to assess performance of an individual 
MIPS eligible clinician. Each unique TIN/NPI combination will be 
considered a different MIPS eligible clinician, and MIPS performance 
will be assessed separately for each TIN under which an individual 
bills. 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. We refer readers to section II.E.7.a. of 
this final rule with comment period, which describes our final policy 
for matching performance in cases where the TIN/NPI changes.
b. Group Identifiers for Performance
    We proposed the following way a MIPS eligible clinician may have 
their performance assessed as part of a group under MIPS. We proposed 
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 to participate in 
MIPS as described in section II.E.5.b. of the proposed rule.
    We proposed 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 requested comments on 
this proposal.
    The following is a summary of the comments we received regarding 
our proposal establishing the way a MIPS eligible clinician may have 
their performance assessed as part of a group under MIPS.
    Comment: Several commenters expressed concern regarding the group 
identifier. Commenters indicated that a group identifier restricts 
group reporting to TIN-level identification because TINs may represent 
many different specialties and subspecialists that have elected to join 
together for non-practice related reasons, such as billing purposes. 
Commenters recommended that CMS allow TINs to subdivide into smaller 
groups for the purposes of participating in MIPS. A few commenters 
recommended that CMS expand the definition of a group to include 
subsets in a TIN so that groups of specialists or sub-specialists 
within a TIN can be allowed to group accordingly. One commenter 
suggested expanding the allowable group identifiers for physician 
groups to include a group's sub-tax identification numbers based on the 
Medicare PFS area or the hospital payment area in which they provide 
care. A few commenters encouraged CMS to consider providing additional 
flexibility to allow clinicians to submit group rosters of TIN/NPI 
combinations to CMS to define a MIPS reporting group. The commenters 
noted that this approach would allow a large, multispecialty group 
under one TIN to split into clinically-relevant reporting groups, or 
multiple TINs within a delivery system to group report under a common 
group. In addition to the options that CMS proposed regarding use of 
multiple identifiers to assess physician/group performance under MIPS, 
one commenter recommended that CMS permit groups to ``split'' TINs for 
this purpose. Another commenter noted that such flexibility would be a 
very useful precursor to future APM participation.
    Response: We appreciate the commenters expressing their concerns 
and providing recommendations. We recognize that groups have varying 
compositions of eligible clinicians and will consider the suggestions 
from commenters in future rulemaking. We disagree with commenters 
regarding their suggested approach for defining a group because 
multiple sublevel identifiers create more complexity given that it 
would require the establishment of numerous identifiers in order to 
account for all types of group compositions. We note that except for 
groups that contain APM participants, we are not permitting groups to 
``split'' TINs if they choose to participate in MIPS as a group. We 
believe it is critical to establish the definition of a group that 
ensures coordination, teamwork, and shared responsibility at the group 
level, in which our proposed definition achieves this objective. We 
note that groups have the opportunity to analyze its data in ways that 
are meaningful to the group, which may include analyses for each 
segment of a group to promote and enhance the coordination of care and 
improve the quality of care and health outcomes.
    Comment: Several commenters supported the proposed approach to 
reduce the participation burden by allowing large groups to report as a 
group. One commenter requested clarification on how a group's 
performance and final score would be applied to all NPIs in the TIN, 
particularly whether CMS would assess each individual across the four 
performance categories and then cumulatively calculate the final score 
or whether CMS would assess a group-based collective set of objectives 
that could be met by any combination of individual clinicians inside 
the group to calculate the final score.
    Response: In section II.E.3.d. of this final rule with comment 
period, we note that groups reporting at the group level (TIN) must 
meet the definition of a group at all times during the performance 
period for the MIPS payment year. In order for groups to have their 
performance assessed as a group across all performance categories, 
individual eligible clinicians and MIPS eligible clinicians within a 
group must aggregate their performance data across the TIN.
    Comment: One commenter indicated that the scoring methodology for 
large TINs is ambiguous.
    Response: We note that the scoring methodology for groups, 
regardless of size, is the same as described in section II.E.6. of this 
final rule with comment period.
    Comment: One commenter requested further clarification of 
attribution of eligible activities (for example, improvement 
activities) for one organization with one TIN that participates in MIPS 
and multiple APMs.
    Response: For those TINs that have MIPS eligible clinicians that 
are subject to the APM scoring standard, we refer readers to section 
II.E.5.h. of this final rule with comment period for our discussion 
regarding policies pertaining to the APM scoring standard.
    Comment: Several commenters agreed with our proposal to not require 
an additional identifier for qualified clinicians and instead use a 
combination of MIPS eligible clinician NPI and group billing TIN. To 
ease the administrative burden, commenters recommended the following: 
have attribution of a qualified clinician to a group's billing TIN be 
done automatically by CMS based on billing PECOS data; do not require 
individual third party rights for qualified clinicians, but instead let 
program administrators at each health system register for their groups 
and automatically have access to qualified

[[Page 77059]]

clinicians associated with that TIN; and provide for the ability to 
look up statuses, eligibility, program history and other information by 
both individual NPI and group TIN.
    Response: We appreciate the recommendations from the commenters and 
will consider them as we establish subregulatory guidance regarding the 
voluntary registration process for groups and the registration process 
for groups electing to use the CMS Web Interface data submission 
mechanism and/or administer the CAHPS for MIPS survey.
    Comment: Several commenters requested that CMS consistently define 
``small'' practices and consider additional accommodations for such 
practices. Commenter noted that the proposal may overburden smaller 
groups. There were a few commenters indicating that solo or small 
practices with less than 25 clinicians should be exempt from MIPS while 
other commenters recommended that group practices of 15 or fewer 
clinicians be exempt from MIPS. One commenter suggested that CMS review 
opportunities to provide incentives targeted around quality metrics 
reflective of the patient population served.
    Response: We note that a small practice is defined as a practice 
consisting of 15 or fewer eligible clinicians. We note that the statute 
does not provide the discretion to establish exclusions other than the 
exclusions pertaining to new Medicare-enrolled eligible clinicians, QPs 
and Partial QPs who do not participate in MIPS, and eligible clinicians 
who do not exceed the low-volume threshold. However, small groups may 
be excluded from MIPS if they do not exceed the low-volume threshold as 
established in section II.E.3.c. of this final rule with comment 
period.
    Comment: One commenter requested that post-acute and long-term care 
practices be considered separately in this proposal. The commenter 
indicated that grouping them with their specialty peers practicing in a 
traditional ambulatory setting creates inequities. In particular, the 
commenter noted that benchmarks and thresholds are not comparable due 
to the different natures of the types of practice.
    Response: We recognize that groups will have varying compositions 
and note that groups have the option to report at the individual level 
or group level. In section II.E.3.c. of this final rule with comment 
period, we describe the low-volume threshold exclusion which is applied 
at the individual eligible clinician level or the group level. A group 
that would not be excluded from MIPS when reporting at a group level 
may find it advantageous to report at the individual level.
    After consideration of the public comments we received, we are 
finalizing a modification to our proposal regarding the use of a 
group's billing TIN to identify a group. Thus, we are codifying the 
definition of a group at Sec.  414.1305 to mean a group that consists 
of a single TIN with two or more eligible clinicians (including at 
least one MIPS eligible clinician), as identified by their individual 
NPI, who have reassigned their billing rights to the TIN.
c. APM Entity Group Identifier for Performance
    We proposed the following way to identify a group to support APMs 
(see section II.F.5.b. of this rule). To ensure we have accurately 
captured all of the eligible clinicians identified as participants that 
are participating in the APM Entity, we proposed 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 proposed 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 requested comments on these proposals. See section 
II.E.5.h. of the proposed rule for proposed policies regarding 
requirements for APM Entity groups under MIPS.
    The following is a summary of the comments we received regarding 
our proposal establishing the way each eligible clinician who is a 
participant of an APM Entity would be identified by a unique APM 
participant identifier.
    Comment: Several commenters supported the approach to identify APM 
professionals by a combination of APM identifier, APM entity 
identifier, TIN and NPI. Commenters requested that CMS make the QP 
identifiers available via an application program interface (API), which 
would improve an APM participant's ability to provide accurate and 
timely reports. However, one commenter recommended that an APM Entity 
group be defined using a unique APM participant identifier composed of 
a combination of four, cross-referenced identifiers: APM ID, MIPS ID, 
TIN, and NPI. The commenter shared that their Shared Savings Program 
experience with their ACO Identifier has been very positive, and 
suggested that MIPS adopt a similar definition and use the APM-MIPS ID 
for day-to-day APM identification, versus the proposed alternative.
    Response: We appreciate the support and suggestions from the 
commenters. As we operationalize the process for APM Entity 
identifiers, we will taking into consideration the recommendation of 
making the QP identifier available via an API. In regard to suggestion 
regarding the APM Entity group identifier, we do not believe it is 
necessary to create an additional MIPS ID for the purposes of tracking 
APM Entities under MIPS. We further note that for all APMs, the APM 
Entity identifiers are the same identifiers that are currently used by 
CMS for other purposes. For example, in the case of the Shared Savings 
Program, since ACOs are the participating APM Entity, the APM Entity 
identifier would be the same as the ACO Identifier. We believe that 
tracking APM Entity participation in this way is most consistent with 
how CMS currently tracks APM Entity participation, and eliminates any 
unnecessary burden of tracking any new, additional identifiers.
    Comment: One commenter requested clarification on the use of the 
APM participant identifier and whether the APM participant identifier 
would be a required data element for submission.
    Response: We note that the APM Identifier will be used to ensure 
accurate tracking of all APM participants and comprised of the four 
already existing identifiers that are described in this section. In 
regard to the data elements required for the submission of data via a 
submission mechanism, the required data elements will depend on the 
requirements for each data submission mechanism. The submission 
procedures for each data submission mechanism will be further outlined 
in subregulatory guidance.
    Comment: One commenter did not support the proposal regarding how 
an APM Entity group would be defined. The commenter requested 
clarification as to why an APM participant could not be identified by a 
combination of TIN/NPI, and a single character prefix or suffix to 
denote the eligible clinician is part of an APM entity.
    Response: We appreciate the feedback from the commenter. We note 
that our proposal to use the APM ID, APM Entity Identifier, TIN and NPI 
is most consistent with how APM participation

[[Page 77060]]

is currently tracked within our systems. Introducing another method of 
identification, such as a single character prefix or suffix, would be a 
deviation from our already existing operational processes, and we do 
not foresee that such a deviation would add any program efficiencies or 
facilitate participant tracking.
    Comment: One commenter did not support mandatory reporting and 
participation, and indicated that ACOs are an example of forcing 
participation in alternative payment models resulting in the failure to 
save money and difficulties to retain participants.
    Response: We appreciate the concerns from the commenter and note 
that participation in MIPS is mandatory while participation in an ACO 
(or APM) is voluntary. Based on the results generated to date under the 
Shared Savings Program, the data suggests that the longer organizations 
stay in the Shared Savings Program, the more likely they are able to 
achieve savings. Also, the number of organizations participating in the 
Shared Savings Program is increasing annually.
    Comment: One commenter recommended that CMS take into account the 
burden placed on certain subspecialties that may not and will not have 
the flexibility to participate in many current APMs. Another commenter 
recommended that CMS identify specialties and subspecialties currently 
unable to participate in Advanced APMs and establish ways to minimize 
their burden and risk of receiving a penalty under MIPS.
    Response: We thank the commenters for expressing their concerns. As 
we develop the operational elements of the MIPS program, we strive to 
establish a process ensuring that participation in MIPS can be 
successful. Based on the experience and feedback provided by 
stakeholders regarding previously established CMS programs, we are 
improving and enhancing the user-experience for MIPS. We will continue 
to seek stakeholder feedback as we implement the MIPS program.
    After consideration of the public comments we received, we are 
finalizing our proposal that each eligible clinician who is a 
participant of an APM Entity will be identified by a unique APM 
participant identifier. The unique APM participant identifier will 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. Thus, we are codifying the definition of an APM Entity 
group at Sec.  414.1305 to mean a group of eligible clinicians 
participating in an APM Entity, as identified by a combination of the 
APM identifier, APM Entity identifier, Taxpayer Identification Number 
(TIN), and National Provider Identifier (NPI) for each participating 
eligible clinician.
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 payment adjustment. Accordingly, we proposed 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 the proposed rule 
(81 FR 28179 through 28181), we proposed 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 payment 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 payment adjustment 
in 2019. The same eligible clinician would be required to participate 
in MIPS in 2018 and would receive a MIPS payment 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 payment adjustment applied for that year. We 
also proposed at Sec.  414.1310(d) that in no case would a MIPS payment 
adjustment apply to the items and services furnished by new Medicare-
enrolled eligible clinicians. We requested comments on these proposals.
    The following is a summary of the comments we received regarding 
our proposals to define a new Medicare-enrolled eligible clinician 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 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 would not be 
treated as a MIPS eligible clinician until the subsequent year and 
performance period for such subsequent year, that a MIPS payment 
adjustment would not be applied in the case of items and services 
furnished during a year by an individual who is not an MIPS eligible 
clinician, and that in no case would a MIPS payment adjustment apply to 
the items and services furnished by new Medicare-enrolled eligible 
clinicians.
    Comment: One commenter recommended postponing the implementation of 
the ``new'' types of clinicians to a later effective date.
    Response: We appreciate the suggestion from the commenter, but note 
that we do not find it necessary or justifiable to postpone the 
implementation of the new Medicare-enrolled eligible clinician 
provision.
    Comment: One commenter requested clarification on how CMS would 
require clinicians who are new Medicare-enrolled eligible clinicians to 
participate in MIPS after their first 12 months of Medicare enrollment 
passed.
    Response: We note that 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. We note that new 
Medicare-enrolled eligible clinicians are excluded from MIPS during the 
performance period in which they are

[[Page 77061]]

identified as being a new Medicare-enrolled eligible clinicians. For 
example, if an eligible clinician becomes a new Medicare-enrolled 
eligible clinician in April of a particular year, such eligible 
clinician would be excluded from MIPS until the subsequent year and 
performance period for that year, in which such eligible clinician 
would be required to participate in MIPS starting in January of the 
next year.
    Moreover, 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 payment adjustment. Accordingly, we define a new 
Medicare-enrolled eligible clinician 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. Thus, such 
eligible clinicians would be treated as a MIPS eligible clinician in 
their subsequent year of being a Medicare-enrolled eligible clinician, 
required to participate in MPS, and subject to the MIPS payment 
adjustment for the performance period of that subsequent year.
    Comment: One commenter requested clarification on clinicians' 
eligibility under MIPS and their designation on whether they are 
Medicare or Medicaid-enrolled from year to year.
    Response: In section II.E.1.a. of this final rule with comment 
period, we define a MIPS eligible clinician. Clinicians meeting the 
definition of a MIPS eligible clinician are required to participate in 
MIPS unless eligible for an exclusion as defined in section II.E.3. of 
this final rule with comment period. For purposes of MIPS, we are able 
to identify an eligible clinician 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.
    Comment: Several commenters supported the exclusion of new 
Medicare-enrolled eligible clinicians from MIPS; however, commenters 
indicated that it is unreasonable to require new Medicare-enrolled 
eligible clinicians to begin participating in MIPS during the next 
performance period, especially those that become new Medicare-enrolled 
eligible clinicians later in the year. The commenters recommended 
giving new Medicare-enrolled eligible clinicians the option of being 
excluded from MIPS in both the performance period in which they begin 
treating Medicare patients and in the following performance period. One 
commenter opposed CMS's proposal that clinicians newly enrolling in 
Medicare in 2017 would have to participate in MIPS starting January 1, 
2018, and requested that CMS instead extend the window so that 
clinicians enrolling in Medicare in 2017 would not begin participation 
until January 1, 2019. Another commenter suggested that CMS consider 
new Medicare-enrolled eligible clinicians ineligible for MIPS until the 
first performance period following at least 12 months of enrollment in 
Medicare.
    Response: We thank the commenters for expressing their concerns. 
While the statute does not give the Secretary discretion to further 
delay MIPS participation for these eligible clinicians, we note that in 
the transition year (CY 2017) and performance period for such year in 
which an eligible clinician is treated as a MIPS eligible clinician, 
the clinician may qualify for an exclusion under the low-volume 
threshold. We refer readers to section II.E.3.c. of this final rule 
with comment period, which further describes the low-volume threshold 
provision.
    Comment: A few commenters supported CMS' proposal that a new 
Medicare-enrolled eligible clinician would not be eligible to 
participate in the MIPS program until the subsequent performance 
period.
    Response: We appreciate the support from the commenters.
    Comment: A few commenters offered recommendations pertaining to 
exemptions that CMS should consider. One commenter suggested that 
medical/surgical practices of 15 professionals or fewer be fully exempt 
from MIPS; otherwise, many Medicare patients risk losing access to 
physicians who have cared for them for many years. Another commenter 
recommended that MIPS eligible clinicians who are a Tier 1 or part of a 
Center of Excellence or a High Quality Provider with a private insurer 
should be exempt from penalties because they are a proven benefit to 
the system already and should not be penalized.
    Response: We appreciate the commenters providing their 
recommendations. We note that the suggestions are out-of-scope to 
proposals described in the proposed rule (81 FR 28161) and iterate that 
the statute only allows for limited exceptions for eligible clinicians 
to be exempt from the MIPS requirements.
    Comment: One commenter encouraged CMS to only use exceptions and 
special cases as outlined in the proposed rule when absolutely 
necessary because the creation of exceptions, exclusions, and multiple 
performance pathways would introduce unnecessary reporting burden for 
participating MIPS eligible clinicians.
    Response: We thank the commenter for the suggestion and note that 
in this final rule with comment period, we are finalizing our proposed 
exclusions pertaining to new Medicare-enrolled eligible clinicians and 
QPs and Partial QPs, and modifying our proposed exclusion pertaining to 
the low-volume threshold, as discussed in sections II.E.3.a., 
II.E.3.b., and II.E.3.c., of this final rule with comment period.
    After consideration of the public comments we received, we are 
finalizing the definition of a new Medicare-enrolled eligible clinician 
at Sec.  414.1305 as a professional who first becomes a Medicare-
enrolled eligible clinician within the PECOS during the performance 
period for a year and had not previously submitted claims under 
Medicare such as an individual, an entity, or a part of a physician 
group or under a different billing number or tax identifier. We are 
finalizing our proposal at Sec.  414.1310(c) that 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 
outlined in section II.E.4. of this final rule with comment period, we 
are finalizing a modification to the MIPS performance period to be a 
minimum of one continuous 90-day period within CY 2017. In the case of 
items and services furnished during a year by an individual who is not 
a MIPS eligible clinician during the performance period, there will not 
be a MIPS payment adjustment applied for that payment adjustment year. 
Additionally, we are finalizing our proposal at Sec.  414.1310(d) that 
in no case would a MIPS payment adjustment apply to the items and 
services furnished during a year by new Medicare-enrolled eligible 
clinicians for the applicable performance period.
    We believe that it would be beneficial for eligible clinicians to 
know during the performance period of a calendar year whether or not 
they are identified as a new Medicare-enrolled eligible clinician. For 
purposes of this section,

[[Page 77062]]

we are coining the term ``new Medicare-enrolled eligible clinician 
determination period'' and define it to mean the 12 months of a 
calendar year applicable to the performance period. During the new 
Medicare-enrolled eligible clinician determination period, we will 
conduct eligibility determinations on a quarterly basis to the extent 
that is technically feasible in order to identify new Medicare-enrolled 
eligible clinicians that would be excluded from the requirement to 
participate in MIPS for the applicable performance period. Given that 
the performance period is a minimum of one continuous 90-day period 
within CY 2017, we believe it would be beneficial for such eligible 
clinicians to be identified as being excluded from MIPS requirements on 
a quarterly basis in order for individual eligible clinicians or groups 
to plan and prepare accordingly. For future years of the MIPS program, 
we will conduct similar eligibility determinations on a quarterly basis 
during the new Medicare-enrolled eligible clinician determination 
period, which consists of the 12 months of a calendar year applicable 
to the performance period, in order to identify throughout the calendar 
year eligible clinicians who would excluded from MIPS as a result of 
first becoming new Medicare-enrolled eligible clinicians during the 
performance period for a given year.
b. Qualifying APM Participant (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 the proposed rule 
provides detailed information on the determination of QPs and Partial 
QPs.
    We proposed that the definition of a MIPS eligible clinician at 
Sec.  414.1310 does not include QPs (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 payment adjustments. Please refer to the 
section II.F.5.c. of the proposed rule where this election is discussed 
in greater detail. We requested comments on this proposal.
    The following is a summary of the comments we received regarding 
our proposal that the definition of a MIPS eligible clinician does not 
include QPs (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, in which Partial QPs will have the option to elect whether or 
not to report under MIPS.
    Comment: One commenter recommended that CMS consider presumptive QP 
status in the first performance year, and prospective notification of 
QP status based on prior year thresholds. Alternatively, if in the year 
following the performance year CMS determines the Advanced APM Entity 
has not yet met the required threshold score, the commenter indicated 
that CMS could either: Assign the entity's participating clinicians a 
neutral MIPS score without a penalty or reward; or allow them to 
complete two of the four MIPS performance categories in 2018 and have 
the results count for 2019 payments.
    Response: We refer readers to section II.F.5 of this final rule 
with comment period for policies regarding QP and Partial QP 
determinations.
    After consideration of the public comments we received, we are 
finalizing our proposal at Sec.  414.1305 that the definition of a MIPS 
eligible clinician does not include QPs (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 in a year. Also, we are finalizing our 
proposed policy at Sec.  414.1310(b) that for a year, QPs (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 in a year are 
excluded from MIPS. 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 payment adjustments.
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 proposed 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 
believed this strategy holds more merit 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 to 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 requested 
comments on this proposal including alternative patient threshold, case 
thresholds, and dollar values.
    The following is a summary of the comments we received regarding 
our proposal 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.

[[Page 77063]]

    Comment: A few commenters supported the proposed policy to exempt 
MIPS eligible clinicians or groups from MIPS requirements who do not 
exceed the low-volume threshold of having Medicare billing charges less 
than or equal to $10,000 and providing care for 100 or fewer Part B-
enrolled Medicare beneficiaries. In particular, one commenter expressed 
support for the dual criteria of the low-volume threshold (Medicare 
billing charges less than or equal to $10,000 and providing care for 
100 or fewer Part B-enrolled Medicare beneficiaries).
    Response: We appreciate the support from the commenters.
    Comment: A significant portion of commenters expressed concern 
regarding our proposed low-volume threshold provision, particularly the 
requirement for MIPS eligible clinicians and groups to meet both the 
low-volume threshold pertaining to the dollar value of Medicare billing 
charges and the number of Medicare Part B beneficiaries cared for 
during a performance period. The commenters requested that CMS modify 
the criteria under the definition of MIPS eligible clinicians or groups 
who do not exceed the low-volume threshold to require that an 
individual MIPS eligible clinician or group would need to meet either 
the low-volume threshold pertaining to the dollar value of Medicare 
billing charges or the number of Medicare Part-B beneficiaries cared 
for during a performance period in order to determine whether or not an 
individual MIPS eligible clinician or group exceeds the low-volume 
threshold. Several commenters noted that such a change would provide 
greater flexibility for specialty clinicians.
    Response: We appreciate the concerns expressed by commenters. We 
agree with the commenters and have modified our proposal to not require 
that MIPS eligible clinicians and groups must meet both the dollar 
value of Medicare billing charges and the number of Medicare Part B 
beneficiaries cared for during a performance period. Instead, we are 
finalizing that individual MIPS eligible clinicians and groups meet 
either the threshold of $30,000 in billed Medicare Part B allowed 
charges or the threshold of 100 or fewer Part B-enrolled Medicare 
beneficiaries. Also, we believe that the modified proposal reduces the 
risk of clinicians withdrawing as Medicare suppliers and minimizing the 
number of Medicare beneficiaries that they treat in a year. We will 
monitor any effect on Medicare participation. Similar to the goal of 
the proposed low-volume threshold, we believe that this modified 
approach holds more merit 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. We 
believe that the modified proposal would also ensure that we can 
meaningfully measure the performance and drive quality improvement 
across a broad range of MIPS eligible clinician types and specialties. 
We note that eligible clinicians who are excluded from the definition 
of a MIPS eligible clinician under the low-volume threshold or another 
applicable exclusion can still participate voluntarily in MIPS, but are 
not subject to positive or negative MIPS adjustments. For future 
consideration, we are seeking additional comment on possible ways that 
excluded eligible clinicians might be able to opt-in to the MIPS 
program (and the MIPS payment adjustment) in future years in a manner 
consistent with the statute.
    Comment: The majority of commenters recommended that CMS increase 
the low-volume threshold. A signification portion of commenters 
requested that MIPS eligible clinicians or groups who do not exceed the 
low-volume threshold should have Medicare billing charges less than or 
equal to $30,000 or provide care for 100 or fewer Part B-enrolled 
Medicare beneficiaries. Many commenters noted that raising the low-
volume threshold would allow more physicians with a small number of 
Medicare patients to be recognized as MIPS eligible clinicians or 
groups who do not exceed the low-volume threshold, particularly MIPS 
eligible clinicians providing specialty services or high risk services. 
Several commenters indicated that women on Medicare receive expensive 
surgical care from OB/GYNs, which could cause MIPS eligible clinicians 
and groups to exceed the proposed low-volume threshold despite a very 
small number of Medicare patients. The commenters suggested that CMS 
exempt MIPS eligible clinicians and groups from the MIPS program who 
have less than $30,000 in Medicare allowed charges per year or provide 
care for fewer than 100 unique Medicare Part-B beneficiaries.
    A few commenters indicated that an increase in the low-volume 
threshold would mitigate an undue burden on small practices. One 
commenter stated that RHCs and such clinicians will have fewer than 
$10,000 in Medicare billing charges, but many of them will have more 
than 100 Part B beneficiaries under their care. The commenter expressed 
concern that RHCs may be burdened with MIPS requirements for a low 
level of Part B claims and thus, may either face penalties or the cost 
of implementing the MIPS requirements. A few commenters indicated that 
the low-volume threshold should be high enough to exempt physicians who 
have no possibility of a positive return on their investment in the 
cost of reporting.
    Other recommendations from commenters included the following: align 
the patient cap with the CPC+ patient panel requirements, which would 
increase the number of Medicare Part B beneficiaries cared for to 150 
(and would prevent clinicians from having two different low-volume 
thresholds within the same program); exclude groups from participation 
in MIPS based on an aggregated threshold for the group with the rate of 
$30,000 and 100 patients per clinician, in which a group of two 
eligible clinicians would be excluded if charging under $60,000 and 
caring for under 200 Medicare Part B-enrolled Medicare beneficiaries; 
exempt MIPS eligible clinicians for the transition year of MIPS who 
bill under Place of Service 20, which is the designation for a place 
with the purpose of diagnosing and treating illness or injury for 
unscheduled, ambulatory patients seeking immediate medical attention; 
and exempt facilities operating in Frontier areas from MIPS 
participation, at least until 2019 when the list of MIPS eligible 
clinicians expands and additional MIPS eligible clinicians are able to 
participate in MIPS.
    There were other commenters who requested that the threshold 
criteria regarding the dollar value of Medicare billed charges and the 
number of Medicare Part B beneficiaries cared for be increased to the 
following: $25,000 Medicare billed charges or 50 or 100 Part B 
beneficiaries; $50,000 Medicare billed charges or 100 or 150 Part B 
beneficiaries; $75,000 Medicare billed charges or 100 or 750 Part B 
beneficiaries; $100,000 Medicare billed charges or 1000 Part B 
beneficiaries; $250,000 Medicare billed charges or 150 Part B 
beneficiaries; and $500,000 Medicare billed charges or 400 or 500 Part 
B beneficiaries.
    Several commenters requested that CMS temporarily increase the low-
volume threshold in order for small practices to not be immediately 
impacted by the implementation of MIPS. One commenter suggested that 
the threshold be increased to 250 unique Medicare patients and a total 
Medicare billing not to exceed $200,000 for 5 years. Another commenter 
recommended that CMS set the low-volume threshold in 2019 at $250,000 
of

[[Page 77064]]

Medicare billing charges. The commenter explained that at such amount, 
the avoided penalties at 4 percent would approximately equal the 
$10,000 cost of reporting and below such amount, there would not likely 
be a return that exceeds the costs of reporting. Below such amount, the 
commenter suggested CMS make MIPS participation optional, but MIPS 
eligible clinicians that participate would be exempt from any 
penalties.
    Response: We appreciate the concerns and recommendations provided 
by the commenters. We received a range of suggestions and considered 
the various options. We agree with commenters that the dollar value of 
the low-volume threshold should be increased and that the low-volume 
threshold should not require MIPS eligible clinicians and groups to be 
required to meet both the dollar value of billed Medicare Part B 
allowed charges and the Part B Medicare-enrolled beneficiary count 
thresholds at this time. We believe it is important to establish a low-
volume threshold that is responsive to stakeholder feedback. Some of 
the recommended options would have established a threshold that would 
exclude many eligible clinicians who would otherwise want to 
participate in MIPS. The majority of commenters suggested that the low-
volume threshold be changed to reflect $30,000 or less billed Medicare 
Part B allowed charges. As a result, we are modifying our proposal. We 
are defining MIPS eligible clinicians or groups who do not exceed the 
low-volume threshold as an individual MIPS eligible clinician or group 
who, during the low-volume threshold determination period, has billed 
Medicare Part B allowed charges less than or equal to $30,000 or 
provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. 
This policy would be more robust and effective at excluding clinicians 
for whom submitting data to MIPS may represent a disproportionate 
burden with a secondary effect of allowing greater concentration of 
technical assistance on a smaller cohort of practices. We believe that 
the higher low-volume threshold addresses the concerns from commenters 
while remaining consistent with the proposal and having a policy that 
is easy to understand.
    Comment: A few commenters indicated that it would be difficult for 
psychologists to determine ahead of time if they met the low-volume 
threshold relating to the dollar value of $10,000 Medicare billing 
charges in order to be exempt from MIPS, yet it would be relatively 
easy for psychologists to determine whether they are likely to have 
fewer than 100 Medicare patients in a given year based on their 
historical volume of Medicare patients. Several commenters requested 
CMS to change the low-volume threshold requirement to state ``$10,000 
in Medicare charges or fewer than 100 beneficiaries,'' making it 
possible for psychologists to be exempt from MIPS, which is essential 
in keeping them enrolled in Medicare provider panels. A few commenters 
expressed concerns that if the proposed low-volume threshold was 
finalized as is, psychologists and psychotherapists who see Medicare 
beneficiaries weekly or bi-weekly would be unable to meet Medicare 
patients' demand for psychotherapy, would discontinue seeing Medicare 
beneficiaries altogether, and would be reluctant to participate in MIPS 
if they were not exempted from MIPS participation. Commenters stated 
that CMS violates the Mental Health Parity and Addiction Equity Act of 
2008 by having separate rules for medical versus psychological 
illnesses.
    Response: As previously noted, we are finalizing a modification to 
proposal, in which we are defining 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, has 
billed Medicare Part B allowed charges less than or equal to $30,000 or 
provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. 
Thus, a MIPS eligible clinician or a group would only need to meet the 
dollar value or the beneficiary count for the low-volume threshold 
exclusion. As a result, psychologists will be able to easily discern 
whether or not they exceed the low-volume threshold. In addition, we 
intend to provide a NPI level lookup feature prior to or shortly after 
the start of the performance period that will allow clinicians to 
determine if they do not exceed the low-volume threshold and are 
therefore excluded from MIPS. More information on this NPI level lookup 
feature will be made available at QualityPaymentProgram.cms.gov.
    In regard to the comment pertaining to the Mental Health Parity and 
Addiction Equity Act of 2008 (MHPAEA), we note that the MHPAEA 
generally prevents group health plans and health insurance issuers that 
provide mental health or substance use disorder benefits from imposing 
less favorable benefit limitations on those benefits than on medical/
surgical benefits. The mental health parity requirements of MHPAEA do 
not apply to Medicare.
    Comment: One commenter indicated that the low-volume threshold is 
too low for a group and requested that CMS either establish a certain 
exclusion threshold based on group size, or exclude a group if more 
than 50 percent of its MIPS eligible clinicians meet the low-volume 
threshold. Another commenter recommended CMS to establish a low-volume 
threshold based upon practice size, so that solo practices and those 
with less than 10 clinicians are ineligible for MIPS. The commenter 
noted that the financial and reporting burden of participating in MIPS 
would be too great for such clinicians.
    Response: We appreciate the concern and suggestions from the 
commenters and note that we are modifying our proposed low-volume 
threshold by increasing the dollar value of the billed Medicare Part B 
allowed charges and eliminating the requirement that the clinician meet 
both the dollar value and beneficiary count thresholds. MIPS eligible 
clinicians or groups that do not exceed the low-volume threshold of 
$30,000 billed Medicare Part B allowed charges or provide care for 100 
or fewer Part B-enrolled Medicare beneficiaries would be excluded from 
MIPS. We apply the same low-volume threshold to both individual MIPS 
eligible clinicians and groups because groups have the option to elect 
to report at an individual or group level. A group that would be 
excluded from MIPS when reporting at a group level may find it 
advantageous to report at the individual level.
    Comment: One commenter suggested that CMS exclude Part B and Part D 
drug costs from the low-volume threshold determination to mitigate the 
impacts of MIPS on community practices in rural and underserved areas.
    Response: We appreciate the suggestion from the commenter and note 
that the low-volume threshold applies to Medicare Part B allowed 
charges billed by the eligible clinician, such as those under the PFS.
    Comment: One commenter stated that CMS should provide education and 
training to MIPS eligible clinicians and groups meeting the low-volume 
threshold.
    Response: We are committed to actively engaging with all 
stakeholders, including tribes and tribal officials, throughout the 
process of establishing and implementing MIPS and using various means 
to communicate and inform MIPS eligible clinicians and groups of the 
MIPS requirements. In addition, we intend to provide a NPI level lookup 
feature prior to or shortly after the start of the performance period 
that will allow clinicians to determine

[[Page 77065]]

if they do not exceed the low-volume threshold and are therefore 
excluded from MIPS. More information on this NPI level lookup feature 
will be made available at QualityPaymentProgram.cms.gov.
    Comment: One commenter requested that a definition of ``Medicare 
billing charges'' be established under the low-volume threshold policy. 
The commenter also requests a modification to this term so that it 
reads ``allowed amount'' so that it is clear that the $10,000 threshold 
is calculated based on $10,000 of Medicare-allowed services.
    Response: We appreciate the suggestions from the commenter and note 
that the low-volume threshold pertains to Medicare Part B allowed 
charges billed by a MIPS eligible clinician, such as those under the 
PFS. In order to be consistent with the statute, we assess the allowed 
charges billed to determine whether or not an eligible clinician 
exceeds the low-volume threshold. Also, we specify that the allowed 
charges billed relate to Medicare Part B.
    Comment: One commenter noted that since MIPS eligibility is based 
on the current reporting period, a clinician would not definitively 
know if he or she is excluded until the end of the year. It would be 
helpful if eligibility would be based on a prior period, as is 
currently done for hospital-based determinations for EPs under the EHR 
Incentive Program. This is especially problematic for low-volume 
clinicians such as OB/GYN, because eligibility might change from year 
to year. Another commenter questioned why the low-volume threshold for 
a MIPS eligible clinician is calculated based on the performance year 
rather than basing the calculation on the previous year.
    Response: We agree that it would be beneficial for individual 
eligible clinicians and groups to know whether they are excluded under 
the low-volume threshold prior to the start of the performance period 
and thus, we are finalizing a modification to our proposal to allow us 
to make eligibility determinations regarding low-volume status using 
historical claims data. This modification will allow us to inform 
individual MIPS eligible clinicians and groups of their low-volume 
status prior to or shortly after the start of the performance period. 
For purposes of this section, we are coining the term ``low-volume 
threshold determination period'' to refer to the timeframe used to 
assess claims data for making eligibility determinations for the low-
volume threshold exclusion. We define the low-volume threshold 
determination period to mean a 24-month assessment period, which 
includes a two-segment analysis of claims data during an initial 12-
month period prior to the performance period followed by another 12-
month period during the performance period. The initial 12-month 
segment of the low-volume threshold determination period would span 
from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and include a 60-day claims run out, which will allow us to inform 
eligible clinicians and groups of their low-volume status during the 
month (December) prior to the start of the performance period. To 
conduct an analysis of the claims data regarding Medicare Part B 
allowed charges billed prior to the performance period, we are 
establishing an initial segment of the low-volume threshold 
determination period consisting of 12 months. We believe that the 
initial low-volume threshold determination period enables us to make 
eligibility determinations based on 12 months of data that is as close 
to the performance period as possible while informing eligible 
clinicians of their low-volume threshold status prior to the 
performance period. The second 12-month segment of the low-volume 
threshold determination period would span from the last 4 months of a 
calendar year 1 year prior to the performance period followed by the 
first 8 months of the performance period in the next calendar year and 
include a 60-day claims run out, which will allow us to inform 
additional eligible clinicians and groups of their low-volume status 
during the performance period.
    Thus, for purposes of the 2019 MIPS payment adjustment, we will 
initially identify the low-volume status of individual eligible 
clinicians and groups based on 12 months of data starting from 
September 1, 2015 to August 31, 2016, with a 60 day claims run out. To 
account for the identification of additional individual eligible 
clinicians and groups who do not exceed the low-volume threshold during 
the 2017 performance period, we will conduct another eligibility 
determination analysis based on 12 months of data starting from 
September 1, 2016 to August 31, 2017, with a 60 day claims run out. For 
example, MIPS eligible clinicians who may have exceeded the low-volume 
threshold during the first determination assessment, but fall below the 
threshold during the performance period because their practice changed 
significantly, they changed practices from a prior year, etc.
    In addition, we note that the low-volume threshold exclusion is 
determined at the individual (TIN/NPI) level for individual reporting 
and at the group (TIN) level for group reporting. An eligible clinician 
may be identified as having a status that does not exceed the low-
volume threshold at the individual (TIN/NPI) level, but if such 
eligible clinician is part of a group that is identified as having a 
status exceeding the low-volume threshold, such eligible clinician 
would be required to participate in MIPS as part of the group because 
the low-volume threshold is determined at the group (TIN) level for 
groups. For eligibility determinations pertaining to the low-volume 
threshold exclusion, we will be conducting our analysis for each TIN/
NPI and TIN identified in the claims data and make a determination 
based on the Medicare Part B allowed charges billed. Since we are 
making eligibility determinations for each TIN/NPI and TIN identified 
in the claims data, we do not need to know whether or not a group is 
reporting at the individual or group level prior to our analyses. Thus, 
groups can use the eligibility determinations we make for each TIN/NPI 
and TIN to determine whether or not their group would be reporting at 
the individual or group level. Subsequently, groups reporting at the 
group level would need to meet the group requirements as discussed in 
section II.E.3.d. of this final rule with comment period.
    Comment: One commenter requested that CMS ensure that low-volume 
threshold exclusion and other exclusions would not penalize practices 
with more pediatric, women's health, Medicaid, or private insurance 
patients.
    Response: We recognize that groups will have different patient 
populations. As previously noted, we are finalizing a modified low-
volume threshold policy that will increase the number of individual 
eligible clinicians and groups excluded from the requirement to 
participate in MIPS, which would include individual eligible clinicians 
and groups with more pediatric, women's health, Medicaid, or private 
insurance patients if they have not billed more than $30,000 of 
Medicare Part B allowed charges or provided care for more than 100 Part 
B-enrolled Medicare beneficiaries. We note that MIPS eligible 
clinicians who are excluded from MIPS have the option to voluntarily 
participate in MIPS, but would not receive a MIPS payment adjustment.
    Comment: One commenter requested more information about whether the 
low-volume threshold will be

[[Page 77066]]

eliminated in future years and if there is a potential for an incentive 
payment when an eligible clinician meets the low-volume threshold but 
elects to report anyway.
    Response: We intend to monitor the low-volume threshold requirement 
and anticipate that the specific threshold will evolve over time. For 
eligible clinicians who do not exceed the low-volume threshold and are 
thus excluded from MIPS, they could voluntarily participate in MIPS, 
but would not be subject to the MIPS payment adjustment (positive or 
negative).
    Comment: A few commenters requested clarification on the definition 
of the low-volume threshold including whether the $10,000 limit 
pertains to all Medicare billing charges or solely Medicare Part B 
charges, how this low-volume threshold applies to low-volume clinicians 
practicing in and reporting as a group, how beneficiaries are 
attributed to clinicians, and if there is a timeframe in which a 
patient was last seen.
    Response: We note that the dollar value of low-volume threshold 
applies to Medicare Part B allowed charges billed by the eligible 
clinician. We note that eligibility determinations regarding low-volume 
threshold exclusion are based on claims data. As a result, we are able 
to identify Medicare Part B allowed charges billed by the eligible 
clinician and the number of Part B-enrolled Medicare beneficiaries 
cared for by an eligible clinician during the first and second low-
volume threshold determination periods. For eligibility determinations 
regarding the low-volume threshold exclusion, we do not consider the 
timeframes of when a patient was last seen. In regard to how the low-
volume threshold applies to MIPS eligible clinicians in groups, we 
apply the same low-volume threshold to both individual MIPS eligible 
clinicians and groups since groups have the option to report at an 
individual or group level. As a result of the low-volume threshold 
exclusion being determined at the individual (TIN/NPI) level for 
individual reporting and at the group (TIN) level for group reporting, 
there will be some eligible clinicians with a low-volume status that 
does not exceed the low-volume threshold who would be excluded from 
MIPS at the individual (TIN/NPI) level, but if such eligible clinicians 
are part of a group with a low-volume status that exceeds the low-
volume threshold, such eligible clinicians would be required to 
participate in MIPS as part of the group. Section II.E.3.d. of this 
final rule with comment period describes how a group's (TIN) 
performance is assessed and scored at the group level and how the MIPS 
payment adjustment is applied at the group level when a group includes 
clinicians who are excluded from MIPS at the individual level.
    Comment: Several commenters opposed holding individuals and groups 
to the same low-volume threshold standards. One commenter stated that 
basing the exclusion on two thresholds simultaneously would be 
antithetical to measurements of quality based on outcomes. The 
commenter noted that patient care can be very expensive and some 
eligible clinicians could be denied the low-volume threshold exclusion 
after seeing only a few very complex patients over the course of the 
performance period. Another commenter indicated that the proposed 
exclusionary criteria may lead to eligible clinicians in solo or small 
practices withdrawing as Medicare suppliers, or limiting the number of 
Medicare patients they treat over a performance period.
    One commenter requested that CMS issue a clarification stating that 
when clinicians choose to have their performance assessed at the group 
level, the low-volume threshold would also be assessed at the group 
level. This would ensure consistent treatment. Another commenter 
requested clarity regarding the low-volume threshold exclusion 
definition for groups, and recommended that CMS apply a multiplying 
factor for each enrolled Medicare clinician in the group definition. 
One commenter recommended that CMS scale the minimum number of Part B-
enrolled Medicare beneficiaries and Medicare billed charges to the 
number of physician group members while another commenter requested 
that if a practice reports as a group, the low-volume threshold should 
be multiplied by the number of clinicians in the group. Commenters 
recommended a higher threshold for groups.
    A few commenters indicated that the current proposal does not 
provide a meaningful exclusion for small and rural practices that 
cannot afford the upfront investments (including investments in EHR 
systems) and as a result of the high costs to report for small 
practices, the threat of negative MIPS payment adjustments or low 
positive MIPS payment adjustments that do not cover the costs to report 
would deter small practices from participating in MIPS.
    Response: We thank the commenters for their concerns and 
recommendations regarding the low-volume threshold. We recognize that 
the low-volume threshold proposed in section II.E.3.c. of the proposed 
rule (81 FR 28178) is a concern and as previously noted, we are 
modifying our proposal by increasing the dollar value of the billed 
Medicare Part B allowed charges and eliminating the requirement for 
MIPS eligible clinicians and groups to meet both the dollar value 
threshold and the 100 beneficiary count. In this final rule with 
comment period, we continue to apply the same low-volume threshold for 
both individual MIPS eligible clinicians and groups. We disagree with 
the comment regarding a percentage-based approach for groups because 
groups have the option of electing to report at an individual or group 
level. If a group elects not to report as a group, then each MIPS 
eligible clinician would report individually.
    In addition, we believe that the modified proposal reduces the risk 
of clinicians withdrawing as Medicare suppliers and minimizing the 
number of Medicare beneficiaries that they treat in a year. We will 
monitor any effect on Medicare participation in CY 2017 and future 
calendar years.
    Comment: Several commenters expressed concern that clinicians 
working in solo practices or small groups, especially in rural areas 
and HPSAs, would have difficulty meeting the requirements for MIPS. One 
commenter noted that non-board-certified doctors often work in these 
areas and are reimbursed at a lower rate than board-certified doctors. 
The commenters recommended that CMS make similar concessions for this 
category of clinicians as it proposed to do for non-patient facing MIPS 
eligible clinicians in the proposed rule. One commenter requested that 
small practice physicians and solo physicians in HPSAs be exempt from 
MIPS. The commenters requested that CMS ensure that small and solo 
practices have an equal opportunity to participate successfully in MIPS 
and Advanced APMs.
    Response: We appreciate the concerns expressed by commenters and 
recognize that certain individual MIPS eligible clinicians and groups 
may only be able to report on a few, or possibly no, applicable 
measures and activities for the MIPS requirements. In section 
II.E.6.b.(2) of this final rule with comment period, we describe the 
re-weighting of each performance category when there are not sufficient 
measures and activities that are applicable and available. Also, our 
modified low-volume threshold exclusion policy increases the dollar 
value of Medicare Part B allowed charges billed by an eligible 
clinician, which will increase the number of eligible clinicians and 
groups excluded from MIPS and not subject to a negative MIPS payment

[[Page 77067]]

adjustment, which may include additional solo or small rural or HPSA 
practices. We believe that rural areas, small practices, and HPSAs will 
benefit from other policies that we are finalizing throughout this 
final rule with comment period such as lower reporting requirements and 
lower performance threshold.
    Comment: One commenter expressed concern that the MIPS program as 
outlined in the proposed rule would limit referrals to necessarily 
higher-cost small and rural providers. The commenter indicated that 
comparisons between small, rural practices and larger practices does 
not take into account differences in infrastructure and technological 
capabilities and patient populations which the commenter believed are 
more likely to be sick and poor in the rural settings. Another 
commenter expressed concern that rural clinicians who serve 
impoverished communities and do not have additional resources (for 
example, dieticians who can provide more hands-on care for diabetic 
patients) would be unfairly penalized if their patients do not comply 
with medical advice.
    Response: We appreciate the concern expressed by the commenter and 
recognize that groups vary in size, clinician composition, patient 
population, resources, technological capabilities, geographic location, 
and other characteristics. While we believe the MIPS measures are valid 
and reliable, we will continue to investigate methods to ensure all 
clinicians are treated as fairly as possible within MIPS. As noted in 
this final rule with comment period, 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. Under the IMPACT Act, the Office 
of the Assistant Secretary for Planning and Evaluation (ASPE) has been 
conducting studies on the issue of risk adjustment for sociodemographic 
factors on quality measures and cost, as well as other strategies for 
including social determinants of health status evaluation in CMS 
programs. We will closely examine the ASPE studies when they are 
available and incorporate findings as feasible and appropriate through 
future rulemaking. Also, we will monitor outcomes of beneficiaries with 
social risk factors, as well as the performance of the MIPS eligible 
clinicians who care for them to assess for potential unintended 
consequences such as penalties for factors outside the control of 
clinicians. We believe that rural clinicians and practices will benefit 
from other policies that we are finalizing throughout this final rule 
with comment period such as lower reporting requirements and lower 
performance threshold.
    Comment: One commenter requested clarification as to whether or not 
non-patient facing MIPS eligible clinicians who are not based in a 
rural practice or not a member of a FQHC, but see fewer than 25 
patients, would be exempt from MIPS. Another commenter requested 
clarification regarding whether or not the low-volume threshold applies 
if a physical therapist, occupational therapist, or speech-language 
pathologist is institution-based or nursing home-based.
    Response: In both situations that the commenter raises, the 
clinician would be excluded from MIPS, however they would be excluded 
for different reasons. For the first example, the non-patient facing 
MIPS eligible clinician would be excluded due to seeing fewer than 25 
patients, which falls below our finalized low-volume threshold 
exclusion. For the second example, the physical therapists, 
occupational therapists, or speech-language pathologist cannot be 
considered MIPS eligible clinicians until as early as the third year of 
the MIPS program.
    Comment: One commenter proposed a phase-in period for small 
practices in addition to an increased low-volume threshold because the 
proposed rule did not immediately allow the opportunity for virtual 
groups that could provide the infrastructure to assist small practices. 
Additionally, the commenter believed that most small practices and solo 
physicians would not be ready to report on January 1, 2017. The 
commenter's recommended phase-in period would exempt the 40th 
percentile of all small and rural practices in each specialty in year 
1; the 30th percentile of all small and rural practices in each 
specialty in year 2; the 20th percentile of all small and rural 
practices in each specialty in year 3; and the 10th percentile of all 
small and rural practices in each specialty in year 4. The commenter's 
recommended phase-in would be voluntary, and they believe it would 
provide more time for resource-limited small practices to prepare, 
finance new systems and upgrades, change workflows, and transition to 
MIPS.
    Response: We appreciate the concerns and recommendations provided 
by the commenter. We recognize that small and rural practices may not 
have experience using CEHRT and/or may not be prepared to meet the MIPS 
requirements for each performance category. As described in this 
section of the final rule with comment period, we are modifying our 
proposal by increasing the dollar value of billed Medicare Part B 
allowed charges and eliminating the requirement for MIPS eligible 
clinicians and groups to meet both the dollar value threshold and the 
100 beneficiary count, in which groups not exceeding the low-volume 
threshold would be excluded from the MIPS requirements. We believe our 
modified low-volume threshold is less complex with potentially a 
singular parameter determining low-volume status and addresses the 
commenter's concerns by providing exclusions for more individual MIPS 
eligible clinicians and groups, including small and rural practices. 
Also, in section II.E.5.g.(8)(a) of this final rule with comment 
period, we describe our final policies regarding the re-weighting of 
the advancing care information performance category within the final 
score, in which we would assign a weight of zero when there are not 
sufficient measures applicable and available.
    Comment: A few commenters expressed concern that the proposed rule 
favored large practices, and requested that group practices with fewer 
than 10 or 15 physicians be excluded from MIPS. One commenter 
recommended that it may be more beneficial to expand the exclusion to 
practices under 15 physicians, thus reducing the number of 
practitioners that are going to opt out of Medicare altogether 
following MACRA and retaining a fairer adjustment distribution among 
the moderate and large practices.
    Response: We thank the commenters for expressing their concerns and 
note that we are modifying our proposed low-volume threshold to apply 
to an individual MIPS eligible clinician or group who, during the low-
volume threshold determination period, has billed Medicare Part B 
allowed charges less than or equal to $30,000 or provides care for 100 
or few Part B-enrolled Medicare beneficiaries. We believe our modified 
proposal would increase the number of groups excluded from 
participating in MIPS based on the low-volume threshold, including 
group practices with fewer than 10 or 15 clinicians.
    Comment: One commenter requested that CMS provide the underlying 
data that shows the distribution of spending and volume of cases on 
which the low-volume threshold is based. The commenter expressed 
concern that if the low-volume threshold is set too low, it may place 
too many clinicians close to the minimum of 20 attributable cases for 
resource use, which lacks statistical

[[Page 77068]]

robustness. Another commenter suggested that CMS increase the low-
volume threshold, as the commenter believed that counties with skewed 
demographics will give clinicians no chance to avoid negative MIPS 
payment adjustments. The commenter requested a moratorium on the 
implementation of MIPS until a study can be done that examines the 
potential effects of the law in such counties or for CMS to exempt 
practices that have a patient-population with more than 30 percent of 
its furnished services provided to Medicare Part B beneficiaries until 
the effects of the law are studied on the impact to these groups.
    Response: We appreciate the concerns expressed by commenters 
regarding the proposed low-volume threshold and intend to monitor the 
effects of the low-volume threshold and anticipate that the specific 
thresholds will evolve over time. In this section of the final rule 
with comment period, we are modifying our proposed low-volume 
threshold, in which we are defining MIPS eligible clinicians or groups 
that do not exceed the low-volume threshold as an individual MIPS 
eligible clinician or group who, during the low-volume threshold 
determination period, has billed Medicare Part B allowed charges less 
than or equal to $30,000 or see fewer than 100 beneficiaries. In regard 
to the commenter's concern on having too many MIPS eligible clinicians 
near the minimum number of attributable cases for the cost performance 
category; we believe the increased low-volume threshold policy would 
reduce such risk and ensure statistical robustness. We also note that 
we have made a number of modifications within the cost performance 
category and refer readers to section II.E.5.e. of this final rule with 
comment period for the discussion of our modified policies.
    Comment: One commenter requested that CMS calculate the projected 
data collection and reporting costs, the number of cases necessary to 
achieve statistical significance or reliability and comparison 
purposes, and the administrative costs on the agency to manage and 
calculate MIPS scores. With such costs in mind, the commenter requested 
that CMS adjust the low-volume threshold to a level such that MIPS 
would only apply to eligible clinicians for whom the costs of 
participating in the MIPS program outweighed the costs of refusing to 
accept Medicare patients. Otherwise, commenter was concerned that solo 
practitioners and small practices would opt out of treating Medicare 
patients.
    Response: We thank the commenter for their suggestions and note 
that we are modifying our proposed low-volume threshold by increasing 
the dollar value of billed Medicare Part B allowed charges and 
eliminating the requirement for MIPS eligible clinicians and groups to 
meet both the dollar value threshold and the 100 beneficiary count. We 
believe our modified proposal would increase the number of groups 
excluded from participating in MIPS based on the low-volume threshold 
and prevent the low-volume threshold from being a potential factor that 
could influence a MIPS eligible clinician's decision to deny access to 
care for Medicare Part B beneficiaries or opt out of treating Medicare 
Part B beneficiaries. We refer readers to section III.B. of this final 
rule with comment period for our discussion regarding burden reduction.
    Comment: For those eligible clinicians not participating in an ACO, 
one commenter requested clarification on the proposed $10,000 
threshold, specifically, whether this includes payments made under the 
RHC all-inclusive rate (AIR) or FQHC prospective payment system. The 
commenter suggested that the $10,000 threshold should only include Part 
B PFS allowed charges because the other payment methodologies already 
are alternatives to fee schedules.
    Response: In this section of the final rule with comment period, we 
are modifying our proposed low-volume threshold to be based on a dollar 
value of $30,000 of billed Medicare Part B allowed charges during a 
performance period or 100 Part B-enrolled beneficiary count, which 
would apply to clinicians in RHCs and FQHCs with billed Medicare Part B 
allowed charges.
    Comment: A few commenters requested clarification on the low-volume 
threshold for clinicians who change positions frequently or work as 
locum tenens. The commenters requested CMS to clarify whether or not 
the threshold would be cumulative for these clinicians throughout the 
year as they bill under different TINs, or whether the threshold be 
specific to a TIN/NPI combination. Commenters recommended that the low-
volume threshold be for a specific TIN in which a clinician may work.
    Response: In sections II.E.2.a. and II.E.2.b. of this final rule 
with comment period, we describe the identifiers for MIPS eligible 
clinicians participating in MIPS at the individual or group level. For 
MIPS eligible clinicians reporting as individuals, we use a combination 
of billing TIN/NPI as the identifier to assess performance. In order to 
determine the low-volume status of eligible clinicians reporting 
individually, we will calculate the low-volume threshold for each TIN/
NPI combination. For individual MIPS eligible clinicians billing under 
multiple TINs, the low-volume threshold is calculated for each TIN/NPI 
combination. In the case of an individual eligible clinician exceeding 
the low-volume threshold under any TIN/NPI combination, the eligible 
clinician would be considered a MIPS eligible clinician and required to 
meet the MIPS requirements for those TIN/NPI combinations.
    Comment: One commenter suggested that CMS develop a MIPS hardship 
exception in addition to a low-volume threshold.
    Response: We thank the commenter for the suggestion. We note that 
the section II.E.5.g.(8)(a)(ii) of this final rule with comment period 
describes our final policies regarding the re-weighting of the 
advancing care information performance category within the final score, 
in which we would assign a weight of zero when there are not sufficient 
measures applicable and available for MIPS eligible clinicians facing a 
significant hardship.
    Comment: One commenter stated that the low-volume threshold should 
also take into account total Medicare patients and billing, including 
Medicare Advantage enrollees, not just Part B.
    Response: We appreciate the suggestion from the commenter, but note 
that section 1848(q)(1)(C)(iv) of the Act establishes provisions 
relating to the low-volume threshold, in which the low-volume threshold 
only pertains to the number of Part B-enrolled Medicare beneficiaries, 
the number of items and services furnished to such individuals, or the 
amount of allowed charges billed under Part B. To the extent that 
Medicare Part B allowed charges are incurred for beneficiaries enrolled 
in section 1833(a)(1)(A) or 1876 Cost Plans, those the Medicare 
beneficiaries would be included in the beneficiary count; however, 
beneficiaries enrolled in Medicare Advantage plans that receive their 
Part B services through their Medicare Advantage plan will not be 
included in allowed charges billed under Medicare Part B for 
determining the low-volume threshold.
    Comment: Regarding partial year performance data, one commenter 
indicated that the low-volume reporting threshold and ``insufficient 
sample size'' standard already proposed for MIPS are adequate, and no 
additional ``partial year'' criteria would be needed. For example, a 
clinician who only began billing Medicare in November and did not meet 
the low-volume threshold would not be eligible for MIPS. Another 
clinician who began billing Medicare in

[[Page 77069]]

November who exceeds the low-volume threshold, even in such a short 
time period, would be eligible for MIPS. The commenter supported this 
approach because it is simple and straightforward and does not require 
any additional calculations.
    Response: We appreciate the support from the commenter.
    Comment: One commenter requested that CMS provide an exemption for 
physicians over 60 or 65 years old as they cannot afford to implement 
the necessary changes, particularly if they are working part-time.
    Response: We appreciate the concerns expressed by the commenter and 
note that all MIPS eligible clinicians (as defined in section 1861(r) 
of the Act) practicing either full-time or part-time are required to 
participate in MIPS unless determined eligible for an exclusion. A MIPS 
eligible clinician, whether practicing full-time or part-time, who does 
not exceed the low-volume threshold would be excluded from 
participating in MIPS.
    After consideration of the public comments we received, we are 
finalizing a modification to our proposal to define MIPS eligible 
clinicians or groups who do not exceed the low-volume threshold. At 
Sec.  414.1305, we are defining MIPS eligible clinicians or groups who 
do not exceed the low-volume threshold as an individual MIPS eligible 
clinician or group who, during the low-volume threshold determination 
period, has Medicare Part B billing charges less than or equal to 
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare 
beneficiaries. We are finalizing our proposed policy at Sec.  
414.1310(b) that for a year, MIPS eligible clinicians who do not exceed 
the low-volume threshold (as defined at Sec.  414.1305) are excluded 
from MIPS for the performance period with respect to a year. The low-
volume threshold also applies to MIPS eligible clinicians who practice 
in APMs under the APM scoring standard at the APM Entity level, in 
which APM Entities that do not exceed the low-volume threshold would be 
excluded from the MIPS requirements and not subject to a MIPS payment 
adjustment. Such an exclusion will not affect an APM Entity's QP 
determination if the APM Entity is an Advanced APM. Additionally, 
because we agree that it would be beneficial for individual eligible 
clinicians and groups to know whether they are excluded under the low-
volume threshold prior to the start of the performance period, we are 
finalizing a modification to our proposal to allow us to make 
eligibility determinations regarding low-volume status using historical 
data. This modification will allow us to inform individual MIPS 
eligible clinicians and groups of their low-volume status prior to the 
performance period. We establish the low-volume threshold determination 
period to refer to the timeframe used to assess claims data for making 
eligibility determinations for the low-volume threshold exclusion. We 
define the low-volume threshold determination period to mean a 24-month 
assessment period, which includes a two-segment analysis of claims data 
during an initial 12-month period prior to the performance period 
followed by another 12-month period during the performance period. In 
order to conduct an analysis of the data prior to the performance 
period, we are establishing an initial low-volume threshold 
determination period consisting of 12 months. The initial 12-month 
segment of the low-volume threshold determination period would span 
from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and include a 60-day claims run out, which will allow us to inform 
eligible clinicians and groups of their low-volume status during the 
month (December) prior to the start of the performance period. The 
second 12-month segment of the low-volume threshold determination 
period would span from the last 4 months of a calendar year 1 year 
prior to the performance period followed by the first 8 months of the 
performance period in the next calendar year and include a 60-day 
claims run out, which will allow us to inform additional eligible 
clinicians and groups of their low-volume status during the performance 
period.
    Thus, for purposes of the 2019 MIPS payment adjustment, we will 
initially identify the low-volume status of individual eligible 
clinicians and groups based on 12 months of data starting from 
September 1, 2015 to August 31, 2016. In order to account for the 
identification of additional individual eligible clinicians and groups 
that do not exceed the low-volume threshold during the 2017 performance 
period, we will conduct another eligibility determination analysis 
based on 12 months of data starting from September 1, 2016 to August 
31, 2017. For example, eligible clinicians who may have exceeded the 
low-volume threshold during the first determination assessment, but 
fall below the threshold during the performance period because their 
practice changed significantly, they changed practices from a prior 
year, etc. Similarly, for future years, we will conduct an initial 
eligibility determination analysis based on 12 months of data 
(consisting of the last 4 months of the calendar year 2 years prior to 
the performance period and the first 8 months of the calendar year 
prior to the performance period) to determine the low-volume status of 
individual eligible clinicians and groups, and conduct another 
eligibility determination analysis based on 12 months of data 
(consisting of the last 4 months of the calendar year prior to the 
performance period and the first 8 months of the performance period) to 
determine the low-volume status of additional individual MIPS eligible 
clinicians and groups. We will not change the low-volume status of any 
individual eligible clinician or group identified as not exceeding the 
low-volume threshold during the first eligibility determination 
analysis based on the second eligibility determination analysis. Thus, 
an individual eligible clinician or group that is identified as not 
exceeding the low-volume threshold during the first eligibility 
determination analysis will continue to be excluded from MIPS for the 
duration of the performance period regardless of the results of the 
second eligibility determination analysis. We will conduct the second 
eligibility determination analysis to account for the identification of 
additional, previously unidentified individual eligible clinicians and 
groups who do not exceed the low-volume threshold.
    We recognize that the low-volume threshold determination period 
effectively combines two 12-month segments from 2 consecutive calendar 
years, in which the two 12-month periods of data that would be used for 
our analysis will not align with the calendar years. Also, we note that 
the low-volume threshold determination period may impact new Medicare-
enrolled eligible clinicians who are excluded from MIPS participation 
for the performance period in which they are identified as new 
Medicare-enrolled eligible clinicians. Such clinicians would ordinarily 
begin participating in MIPS in the subsequent year, but under our 
modified low-volume threshold, are more likely to be excluded for a 
second year. The low-volume threshold exclusion may apply if, for 
example, such eligible clinician became a new Medicare-enrolled 
eligible clinician during the last 4 months of the calendar year and 
did not exceed the low-volume threshold of billed Medicare Part B 
allowed charges. Since the initial eligibility determination period 
consists of the last 4 months of the calendar year 2 years prior to the 
performance period

[[Page 77070]]

and the first 8 months of the calendar year prior to the performance 
period, these new Medicare-enrolled eligible clinicians could be 
identified as having a low-volume status if the analysis reflects 
billed Medicare Part B allowed charges less than $30,000 or the 
provided care for 100 or fewer Part B-enrolled Medicare beneficiaries. 
As noted above, we will not change the low-volume status of any 
individual MIPS eligible clinician or group identified as not exceeding 
the low-volume threshold during the first eligibility determination 
analysis based on the second eligibility determination analysis.
d. Group Reporting
(1) Background
    As noted in section II.E.1.e. of the proposed rule (81 FR 28176), 
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 gives 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 proposed requirements for groups. For purposes of 
section 1848(q)(1)(D) of the Act, at Sec.  414.1310(e)(1) we proposed 
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.2.b. of the proposed rule).
    To have its performance assessed as a group, at Sec.  
414.1310(e)(2), we proposed 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 proposed 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 proposed that a group 
electing 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 solicited public comments on the proposal regarding how 
groups will be assessed under MIPS.
    The following is a summary of the comments we received regarding 
our proposed requirements for groups, including: Individual MIPS 
eligible clinicians would 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; a group must meet the definition of a 
group at all times during the performance period for the MIPS payment 
year; individual MIPS eligible clinicians within a group must aggregate 
their performance data across the TIN in order for their performance to 
be assessed as a group; and a group that elects to have its performance 
assessed as a group would be assessed as a group across all four MIPS 
performance categories.
    Comment: The majority of commenters were supportive of the proposed 
group requirements. In particular, several commenters supported our 
proposal to allow MIPS eligible clinicians to report across the four 
performance categories at an individual or group level. The commenters 
also expressed support for the way in which we would assess group 
performance.
    Response: We appreciate the support from commenters.
    Comment: One commenter supported CMS' recognition that MIPS 
eligible clinicians may practice in multiple settings and proposal to 
allow such MIPS eligible clinicians to be measured as individuals or 
through a group's performance.
    Response: We appreciate the support from the commenter.
    Comment: A few commenters recommended that CMS consider allowing 
for greater flexibility in the reporting requirements and allow MIPS 
eligible clinicians to participate either individually or as a group 
for each of the four performance categories, as it may be reasonable to 
report individually for some categories and as a group for other 
categories. One commenter indicated that reporting for the advancing 
care information measures via a group would be a helpful option, but 
there are hurdles clinicians and health IT vendors and developers may 
need to overcome during the first 2 years to do so.
    Response: We appreciate the feedback from the commenters. While we 
want to ensure that there is as much flexibility as possible within the 
MIPS program, we believe it is important that MIPS eligible clinicians 
choose how they will participate in MIPS as a whole, either as an 
individual or as a group. Whether MIPS eligible clinicians participate 
in MIPS as an individual or group, it is critical for us to assess the 
performance of individual MIPS eligible clinicians or groups across the 
four performance categories collectively as either an individual or 
group in order for the final score to reflect performance at a true 
individual or group level and to ensure the comparability of data. 
Section II.E.5.g.(5)(c) of this final rule with comment period 
describes group reporting requirements pertaining to the advancing care 
information performance category.
    Comment: A few commenters indicated that group reporting can be 
challenging if the group includes part-time clinicians.
    Response: We recognize that group-level reporting offers different 
advantages and disadvantages to different practices and therefore, it 
may not be the best option for all MIPS eligible clinicians who are 
part of a particular group. Depending on the composition of a group, 
which may include part-time clinicians, some groups may find meeting 
the MIPS requirements to be less burdensome if they report at the 
individual level rather than at the group level. Also, we note that 
some part-time clinicians may be excluded from MIPS participation at 
the individual level if they do not exceed the low-volume threshold 
(section II.E.3.c. of this final rule with comment period describes the 
low-volume threshold exclusion).
    Comment: One commenter requested clarification regarding whether or 
not clinicians excluded from MIPS would also be excluded from group-
level reporting.
    Response: With clinician practices having the option to report at 
the individual (TIN/NPI) or group level (TIN), we elaborate on how a 
MIPS group's (TIN) performance is assessed and scored at the group 
level and how the MIPS payment adjustment is applied at the group level 
when a group includes clinicians who are excluded from MIPS at the 
individual level. We note that there are three types of MIPS 
exclusions: New Medicare-enrolled eligible clinicians, QPs and Partial 
QPs

[[Page 77071]]

who do not report on applicable MIPS measures and activities, and 
eligible clinicians who do not exceed the low-volume threshold (see 
section II.E.3. of this final rule with comment period), which 
determine when an eligible clinician is not considered a MIPS eligible 
clinician and thus, not required to participate in MIPS. The two types 
of exclusions pertaining to new Medicare-enrolled eligible clinicians, 
and QPs and Partial QPs who do not report on applicable MIPS measures 
and activities are determined at the individual (NPI) level while the 
low-volume threshold exclusion is determined at the individual (TIN/
NPI) level for individual reporting and at the group (TIN) level for 
group reporting.
    A group electing to submit data at the group level would have its 
performance assessed and scored across the TIN, which could include 
items and services furnished by individual NPIs within the TIN who are 
not required to participate in MIPS. For example, excluded eligible 
clinicians (new Medicare-enrolled, QPs, or Partial QPs who do not 
report on applicable MIPS measures and activities, and do not exceed 
the low-volume threshold) are part of the group, and therefore, would 
be considered in the group's score. However, the MIPS payment 
adjustment would apply differently at the group level in relation to 
each exclusion circumstance. For example, groups reporting at the group 
level that include new Medicare-enrolled eligible clinicians, or QPs or 
Partial QPs would have the MIPS payment adjustment only apply to the 
Medicare Part B allowed charges pertaining to the group's MIPS eligible 
clinicians and the MIPS payment adjustment would not apply to such 
clinicians excluded from MIPS based on these two types of exclusions. 
We reiterate that any individual (NPI) excluded from MIPS because they 
are identified as new Medicare-enrolled, QP, or Partial QP would not 
receive a MIPS payment adjustment, regardless of their MIPS 
participation.
    We note that the low-volume threshold is different from the other 
two exclusions in that it is not determined solely based on the 
individual NPI status, it is based on both the TIN/NPI (to determine an 
exclusion at the individual level) and TIN (to determine an exclusion 
at the group level) status. In regard to group-level reporting, the 
group, as a whole, is assessed to determine if the group (TIN) exceeds 
the low-volume threshold. Thus, eligible clinicians (TIN/NPI) who do 
not exceed the low-volume threshold at the individual reporting level 
and would otherwise be excluded from MIPS participation at the 
individual level, would be required to participate in MIPS at the group 
level if such eligible clinicians are part of a group reporting at the 
group level that exceeds the low-volume threshold.
    We considered aligning how the MIPS exclusions would be applied at 
the group level for each of the three exclusion circumstances. We 
recognize that alignment would provide a uniform application across the 
three exclusions and offer simplicity, but we also believe it is 
critical to ensure that there are opportunities encouraging 
coordination, teamwork, and shared responsibility within groups. In 
order to encourage coordination, teamwork, and shared responsibility at 
the group level, we will assess the low-volume threshold so that all 
clinicians within the group have the same status: All clinicians 
collectively exceed the low-volume threshold or they do not exceed the 
low-volume threshold.
    In addition, we recognize that individual clinicians who do not 
meet the definition of a MIPS eligible clinician during the first 2 
years of MIPS such as physical and occupational therapists, clinical 
social workers, and others are not MIPS eligible. Thus, such clinicians 
are not required to participate in MIPS, but may voluntarily report 
measures and activities for MIPS. For those clinicians not MIPS 
eligible who voluntarily report for MIPS, they would not receive a MIPS 
payment adjustment. Accordingly, groups reporting at the group level 
may voluntarily include such eligible clinicians in its aggregated data 
that would be reported for measure and activities under MIPS. For 
groups reporting at the group level that voluntarily include eligible 
clinicians who do not meet the definition of a MIPS eligible clinician, 
they would have their performance assessed and scored across the TIN, 
but those clinicians would not receive a MIPS payment adjustment, 
regardless of their MIPS voluntary participation. We further note that 
these clinicians who are not eligible for MIPS, but volunteer to 
report, would not receive a MIPS payment adjustment.
    We are finalizing our proposals regarding group requirements; 
however, we welcome additional comment on: How we are applying the 
application of group-related policies pertaining to group-level 
performance assessment and scoring and the MIPS payment adjustment to 
groups with eligible clinicians excluded from MIPS based on the three 
exclusions or not MIPS eligible for the first 2 years of MIPS; the 
advantages and disadvantages of how we are applying the application of 
group-related policies when groups include eligible clinicians excluded 
from the requirement to participate in MIPS at the individual level; 
and alternative approaches that could be considered.
    Comment: One commenter expressed concerns that group reporting 
benchmarks and comparison groups have not yet been identified.
    Response: All MIPS eligible clinicians, regardless of specialty, 
geographic location, or whether they report as an individual or group, 
who submit data using the same submission mechanism would be included 
in the same benchmark. We refer readers to sections II.E.6.a.(2)(a) and 
II.E.6.a.(3)(a) of this final rule with comment period for further 
discussion of policies regarding quality measure and cost measure 
benchmarks under MIPS.
    Comment: One commenter requested clarification regarding group 
reporting for organizations with multiple practices/specialties.
    Response: As proposed, group reporting would occur and be 
aggregated at the TIN level. No distinct reporting occurs at the 
specialty or practice site level.
    Comment: One commenter requested clarification on what can be 
expected under MIPS by small practices for which measures are not 
applicable.
    Response: In section II.E.6.b.(2)(b) of this final rule with 
comment period, we describe our scoring methodology that is applied 
when there are a few or no applicable measures under the quality 
performance category for MIPS eligible clinicians or groups to report.
    Comment: One commenter recommended that CMS focus regulations on 
large systems and practices and have fewer regulations for small 
practices.
    Response: We believe that it is essential for our requirements 
pertaining to group-level reporting should be applicable to all groups 
regardless of size, geographic location, composition, or other 
differentiating factors. However, we believe that there are 
circumstances in which our policies should consider how different types 
of groups would be affected. In this final rule with comment period, we 
establish an exclusion for individual MIPS eligible clinicians and 
groups who do not exceed a low-volume threshold pertaining to a dollar 
value of Medicare Part B allowed charges or a Part B-enrolled 
beneficiary count. Also, we finalize our proposal relating to MIPS 
eligible clinicians practicing RHCs and FQHCs, in which services 
rendered by an eligible clinician that are payable under the RHC or 
FQHC methodology

[[Page 77072]]

would not be subject to the MIPS payments adjustments.
    After consideration of the public comments we received, we are 
finalizing a modification to the following proposed policy:
     Individual MIPS eligible clinicians who choose to report 
as a group will have their performance assessed as part of a single TIN 
associated with two or more eligible clinicians (including at least one 
MIPS eligible clinician), as identified by a NPI, that have their 
Medicare billing rights reassigned to the TIN (Sec.  414.1310(e)(1)).
    In addition, we are finalizing the following policies:
     A group must meet the definition of a group at all times 
during the performance period for the MIPS payment year in order to 
have its performance to be assessed as a group (Sec.  414.1310(e)(2)).
     Eligible clinicians and MIPS eligible clinicians within a 
group must aggregate their performance data across the TIN in order for 
their performance to be assessed as a group (Sec.  414.1310(e)(3)).
     A group that elects to have its performance assessed as a 
group will be assessed as a group across all four MIPS performance 
categories (Sec.  414.1310(e)(4)).
(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. To address this issue, we proposed to eliminate a registration 
process for groups submitting data using third party entities. When 
groups submit data utilizing third party entities, such as a qualified 
registry, QCDR, or EHR, 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 are 
submitted.
    At Sec.  414.1310(e)(5), we proposed that a group must adhere to an 
election process established and required by CMS, as described in this 
section. We did 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 the 
proposed rule. For all other data submission mechanisms, 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 proposed 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 the proposed rule.
    The following is a summary of the comments we received regarding 
our proposal that requires a group participating via the CMS Web 
Interface or electing to administer the CAHPS for MIPS survey to adhere 
to an election process established and required by CMS.
    Comment: Several commenters expressed support for CMS's effort to 
ease the registration burden by not requiring registration or an 
election process for groups other than those electing to use the CMS 
Web Interface or CAHPS for MIPS survey for reporting of the quality 
performance category.
    Response: We appreciate the support from commenters regarding our 
proposal.
    Comment: One commenter expressed concern that clinicians who 
attempt to use the CMS Web Interface will not know if they have 
patients who satisfy reporting requirements until they attempt to 
submit their data. The commenter did not support the registration 
process required in order to select the use of the CMS Web Interface as 
a submission mechanism. The commenter asked whether clinicians will be 
able to elect other options once registration for the CMS Web Interface 
closes.
    Response: Similar to the process that has occurred in past years 
under the PQRS program, we intend to provide the beneficiary sample to 
the groups that have registered to participate via the CMS Web 
Interface approximately 1 month prior to the start of the submission 
period. The submission period for the CMS Web Interface will occur 
during an 8-week period following the close of the performance period 
that will begin no earlier than January 1 and end no later than March 
31 (the specific start and end dates for the CMS Web Interface 
submission period will be published on the CMS Web site). This is the 
earliest the sample is available due to the timing required to 
establish and maintain an effective sample size.
    We encourage groups to review the measure specifications for each 
data submission mechanism and select the data submission mechanism that 
applies best to the group prior to registering to participate via the 
CMS Web Interface. We want to note that groups can determine if they 
would have Medicare beneficiaries to report data on behalf of for the 
CMS Web Interface measures. Groups that register to use the CMS Web 
Interface prior to the registration deadline (June 30) can cancel their 
registration or change their selection to report at an individual or 
group level only during the timeframe before the close of registration.
    After consideration of the public comments we received, we are 
finalizing the following policy:
     A group must adhere to an election process established and 
required by CMS (Sec.  414.1310(e)(5)), which includes:
    ++ Groups will not be required 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 CAHPS for MIPS survey for the quality 
performance category. For all other data submission methods, groups 
must work with appropriate third party entities as necessary 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, such groups 
must register by June 30 of the applicable performance period (that is, 
June 30, 2017, for performance periods occurring in 2017).
    Additionally, for operational purposes, we are considering the 
establishment of a voluntary registration process, if technically 
feasible, for groups that intend to submit data on performance measures 
via a qualified registry, QCDR, or EHR, which will enable such groups 
to specify whether or not they intend to participate as a group and 
which submission

[[Page 77073]]

mechanism (qualified registry, QCDR, or EHR) they plan to use for 
reporting data, and provide other applicable information pertaining to 
the TIN/NPIs. In order for groups to know which requirements apply to 
their group for data submission purposes in advance of the performance 
period or submission period, we want to establish a mechanism that 
would allow us to identify the data submission mechanism a group 
intends to use and notify groups of the applicable requirements they 
would need to meet for the performance year, if technically feasible. 
We believe it is essential for groups to be aware of their applicable 
requirements in advance and as a result, the only means that would 
allow us to inform groups is dependent on us receiving such information 
from groups through a voluntary registration process; otherwise, it is 
impossible to contact groups without knowing who they are or inform 
groups of applicable requirements without knowing whether or not a 
group intends to report at the group level and the data submission 
mechanism a group is planning to utilize. For groups that would not 
voluntarily register, we would only be able to identify such groups 
after the close of the submission period when data has been submitted. 
To address this operational facet, we are considering the establishment 
of a voluntary registration process similar to PQRS in that groups 
would make an election of a data submission mechanism; however, based 
on feedback we have received over the years from PQRS participants, the 
voluntary registration process under MIPS would not restrict group 
participation to the selected options, including individual- or group-
level reporting or a selected data submission mechanism, made by groups 
during the voluntary registration process; groups would have the 
flexibility to modify how they participate in MIPS.
    With the optional participation in a voluntary registration 
process, the assessment of a group's performance would not be impacted 
by whether or not a group elects to participate in voluntary 
registration. We note that if a group voluntarily registers, 
information provided by the group would be used to proactively inform 
MIPS eligible clinicians about the timeframe they would need to submit 
data, which would be provided to the group during the performance 
period. We intend to use the voluntary registration process as a means 
to provide additional educational materials that are targeted and 
tailored to such groups; and if technically feasible, provide such 
groups with access to additional toolkits. We believe it is important 
for groups to have such information in advance in order to prepare for 
the submission of data. Also, we note that the voluntary registration 
process differs from the registration process required for groups 
electing to submit data via the CMS Web Interface, such that groups 
registering on a voluntary basis would be able to opt out of group-
level reporting and/or modify their associated settings such as the 
chosen submission mechanism at any time. The participation of a group 
in MIPS via a data submission mechanism other than the CMS Web 
Interface or a group electing to administer the CAHPS for MIPS survey 
would not be contingent upon engagement in the voluntary registration 
process. Whether or not a group elects to participate in voluntary 
registration, a group must meet all of the requirements pertaining to 
groups. We intend to issue further information regarding the voluntary 
registration process for groups in subregulatory guidance.
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 the proposed rule, we proposed 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 CY 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

[[Page 77074]]

cumbersome and a burden for groups to pursue participation in a virtual 
group. Implementation of a web-based registration system for CY 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 CY 2018 performance period, and we intend to 
address all of the requirements pertaining to virtual groups in future 
rulemaking. We requested comments on factors we should consider 
regarding the establishment and implementation of virtual groups.
    The following is a summary of the comments we received regarding 
our intention to implement virtual groups for the CY 2018 performance 
period and factors we should consider regarding the establishment and 
implementation of virtual groups.
    Comment: Many commenters supported the development of virtual 
groups. Some commenters noted that virtual groups are needed because 
some patients require multidisciplinary care in and out of a hospital 
and practice.
    Response: We appreciate the support from commenters.
    Comment: Several commenters supported CMS' decision not to 
implement virtual groups in year 1 in order to allow for the successful 
technological infrastructure development and implementation of virtual 
groups, but requested that CMS outline the criteria and requirements 
regarding the execution of virtual groups as soon as possible. Several 
commenters recommended that CMS use year 1 to develop the much-needed 
guidance and assistance that outlines the steps groups would need to 
take in forming virtual groups, such as drafting written agreements and 
developing additional skills and tools.
    Response: We appreciate the support from commenters regarding the 
delay in the implementation of virtual groups. We intend to utilize 
this time to work with the stakeholder community to further advance the 
framework for virtual groups.
    Comment: Multiple commenters expressed concern that virtual groups 
would not be implemented in year 1 and requested that CMS 
operationalize the virtual group option immediately. A few commenters 
indicated that the delay would impact small and solo practices and 
rural clinicians. Some commenters requested that in the absence of the 
virtual group option, small and solo practices and rural clinicians 
should be eligible for positive payment adjustments, but exempt from 
any negative payment adjustment. The commenters stated that exempting 
these physicians from negative payment adjustments would better 
incentivize the pursuit of quality and performance improvement among 
solo and small practices. A few commenters recommended that all 
practices of 9 or fewer physicians be exempt from MIPS or APM 
requirements until the virtual group option has been tested and is 
fully operational. One commenter suggested that as an alternative to 
delaying the implementation of virtual groups, CMS should allow virtual 
groups to report performance data on behalf of small practices and 
HPSAs for the CY 2017 performance period.
    Response: As noted in the proposed rule, we identified significant 
barriers regarding the development of a technological infrastructure 
required for successful implementation and operationalization of the 
provisions pertaining to virtual groups. As a result, we believe that 
it would be technically infeasible to make a successful system to 
support the implementation of virtual groups for year 1. Also, we note 
that clinicians who are considered MIPS eligible clinicians are 
required to participate in MIPS unless they are eligible for one of the 
exclusions established in this final rule with comment period (see 
section II.E.3. of this final rule with comment period); thus, a MIPS 
eligible clinician participating in MIPS either as an individual or 
group will be subject to a payment adjustment whether it is positive, 
neutral, or negative. The Act does not provide discretion to only apply 
a payment adjustment when a MIPS eligible clinician receives a positive 
payment adjustment. In regard to the request to allow virtual groups to 
have an alternative function for year 1, we intend to implement virtual 
groups in a manner consistent with the statute.
    Comment: A few commenters recommended that CMS redirect funds from 
the $500 million set aside for bonus payments to top performers toward 
financing a ``safe harbor'' for solo and small practices and rural 
providers.
    Response: This is not permissible by statute, as the $500 million 
is available only for MIPS eligible clinicians with a final score at or 
above the additional performance threshold.
    Comment: Several commenters identified several factors CMS should 
consider as it develops further policies relating to virtual groups, 
including the following: Ensuring that virtual groups have shared 
accountability for performance improvement; limiting the submission 
mechanisms to those that require clinicians in the virtual group to 
collaborate on ongoing quality analysis and improvement; maintaining 
flexibility for factors being considered for virtual groups; 
implementing a virtual group pilot to be run prior to 2018 
implementation; and hosting listening sessions to receive input and 
feedback on this option with specialty societies and other 
stakeholders. Several commenters requested that CMS avoid placing 
arbitrary limits on minimum or maximum size, geography proximity, or 
specialty of virtual groups, but allow virtual groups to determine 
group size, geographic affiliations, and group composition. One 
commenter encouraged CMS to explore broad options for virtual groups 
outside the norm of TIN/NPI grouping. However, a few commenters 
recommended that virtual groups be limited to practices of same or 
similar specialties or clinical standards. Another commenter requested 
more detail on the implementation of virtual groups.
    A few commenters recommended the following minimum standards for 
members of a virtual group: Have mutual interest in quality 
improvement; care for similar populations; and be responsible for the 
impact of their decisions on the whole group. A few commenters 
suggested that virtual groups should not have their performance ratings 
compared to other virtual groups, but instead, virtual groups should 
have their performance ratings compared to their annual performance 
rating during the initial implementation of virtual groups given that 
each virtual group's clinicians and beneficiaries may have varying risk 
preventing a direct comparison.
    Response: We appreciate the suggestions from the commenters and as 
a result of the recommendations, we are interested in obtaining further 
input from stakeholders regarding the types of provisions and elements 
that should be considered as we develop requirements applicable to 
virtual groups. Therefore, we are seeking additional comment on the 
following issues for future consideration: The advantages and 
disadvantages of establishing minimum standards, similar to those 
suggested by commenters as noted above; the types of standards could be 
established for members of a virtual group; the factors would need to 
be considered in establishing a set of standards; the advantages and 
disadvantages of requiring members of a virtual group to adhere to 
minimum standards; the types of factors or parameters could be 
considered in developing a virtual group framework to ensure that 
virtual groups would be able to effectively use

[[Page 77075]]

their data for meaningful analytics; the advantages and disadvantages 
of forming a virtual group pilot in preparation for the development and 
implementation of virtual groups; the framework elements could be 
included to form a virtual group pilot.
    As we develop requirements applicable to virtual groups, we will 
also consider the ways in which virtual groups will each have unique 
characteristic compositions and varying patient populations and how the 
performance of virtual groups will be assessed, scored, and compared. 
We are committed to pursuing the active engagement of the stakeholders 
throughout the process of establishing and implementing virtual groups.
    Comment: Several commenters recognized the potential value of 
virtual groups to ease the burden of reporting under MIPS. Commenters 
recommended that CMS expand virtual groups to promote the adoption of 
activities that enhance care coordination and improve quality outcomes 
that are often out of reach for small practices due to limited 
resources; encourage virtual groups to establish shared clinical 
guidelines, promote clinician responsibility, and have the ability to 
track, analyze, and report performance results; and promote 
information-sharing and collaboration among its clinicians.
    Response: We appreciate the suggestions from the commenters and as 
a result of the recommendations, we are interested in obtaining further 
input from stakeholders regarding the technical and operational 
elements and data analytics/metrics that should be considered as we 
develop requirements applicable to virtual groups. Therefore, we are 
seeking additional comment on the following issues for future 
consideration: The types of requirements that could be established for 
virtual groups to promote and enhance the coordination of care and 
improve the quality of care and health outcomes; and the parameters 
(for example, shared patient population), if any, could be established 
to ensure virtual groups have the flexibility to form any composition 
of virtual group permissible under the Act while accounting for virtual 
groups reporting on measures across the four performance categories 
that are collectively applicable to a virtual group given that the 
composition of virtual groups could have many differing forms. We 
believe that each MIPS eligible clinician who is part of a virtual 
group has a shared responsibility in the performance of the virtual 
group and the formation of a virtual group provides an opportunity for 
MIPS eligible clinicians to share and potentially streamline best 
practices.
    Comment: One commenter requested clarification on what constitutes 
a virtual group and how virtual groups will be formed. The commenter 
recommended that performance for individual MIPS eligible clinicians in 
virtual groups should be based on specialty-specific measures. The 
commenter also recommended that, when assessing performance, CMS should 
develop sufficient risk adjustment mechanisms that ensure MIPS eligible 
clinicians are only scored on the components of care they have control 
over, and CMS should develop robust and appropriate attribution 
methods. Another commenter recommended that CMS require virtual groups 
to demonstrate a reliable mechanism for establishing patient 
attribution as well as the ability to report throughout the performance 
period.
    Response: We will consider these suggestions as we develop 
requirements applicable to virtual groups in future rulemaking. In 
regard to the commenter's request for clarification regarding what 
constitutes a virtual group and how they are formed, we note that 
section 1848(q)(5)(I) of the Act 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.
    Comment: One commenter suggested that virtual groups could be 
organized similarly to the current PQRS GPRO, in which virtual groups 
would have the flexibility to select both quality and resources use 
measures once they are further developed.
    Response: We want to clarify that there is no virtual group 
reporting or similar option under PQRS. We note that virtual groups are 
not a data submission mechanism. MIPS eligible clinicians would have 
the option to participate in MIPS as individual MIPS eligible 
clinicians, groups, or, following implementation, virtual groups.
    Comment: One commenter recommended the use of third-party 
certifications to assist with emerging virtual groups. The commenter 
also suggested that CMS provide bonus points for clinicians that 
register as virtual groups, similar to electronic reporting of quality 
measures.
    Response: We will consider these suggestions as we develop 
requirements for virtual groups in future rulemaking.
    Comment: A few commenters encouraged CMS to assess many of the 
virtual group challenges associated with EHR technology. One commenter 
stated that most small independent clinician offices do not use the 
same EHR technology as their neighbors, and virtual groups would create 
reporting and measurement challenges, especially with respect to the 
advancing care information performance category; the commenter 
suggested that CMS provide attestation as an option.
    Another commenter indicated that the implementation of virtual 
groups could be unsuccessful based on the following factors: There is 
no necessary consistency in the nomenclature and methods used by 
different health IT vendors and developers, which would prevent 
prospective virtual group members from correctly understanding the 
degree and nature of the differences in approaches regarding data 
collection and submission; any vendor-related issues would be combined 
in unpredictable ways within virtual groups, causing the datasets to 
not correspond categorically and having inconsistent properties among 
the datasets; there is the prospect of a mismatch of properties for 
virtual group members on assessed measures, where neither excellence 
nor laggardly work would be clearly visible; and there is a risk of a 
practice joining a virtual group with ``free riders,'' which would 
result in a churning of membership and a serious loss of year-to-year 
comparison capabilities. In order to address such issues, the commenter 
recommended that CMS develop a system that includes the capability for 
clinicians and groups to participate in a service similar to online 
dating service applications that would allow clinicians and groups to 
use self-identifying descriptors to select their true peers within 
similar CEHRT.
    A few commenters requested clarification regarding the approved 
methods for submitting and aggregating disparate clinician data for 
virtual groups, and whether or not new clinicians should be included in 
virtual groups if they have not been part of the original TIN 
throughout the reporting year.
    Response: We thank the commenters for providing suggestions and 
identifying potential health IT challenges virtual groups may encounter 
regarding the reporting and submission of data. As a result of the 
recommendations and identification of potential barriers, we are 
interested in

[[Page 77076]]

obtaining further input from stakeholders on these issues as we 
establish provisions pertaining to virtual groups and build a 
technological infrastructure for the operationalization of virtual 
groups. Therefore, we are seeking comment on the following issues for 
future consideration: The factors virtual groups would need to consider 
and address in order for the reporting and submission of data to be 
streamlined in a manner that allows for categorization of datasets and 
comparison capabilities; the factors an individual clinician or small 
practice who are part of a virtual group would need to consider in 
order for their CEHRT to have interoperability with other CEHRT if part 
of a virtual group; the advantages and disadvantages of having members 
of a virtual group use one form of CEHRT; the potential barriers that 
may make it difficult for virtual groups to be prepared to have a 
collective, streamlined system to capture measure data; and the 
timeframe virtual groups would need in order to build a system or 
coordinate a systematic infrastructure that allows for a collective, 
streamlined capturing of measure data.
    Comment: One commenter suggested having Virtual Integrated Clinical 
Networks (VICN) as an alternative type of delivery system within the 
Quality Payment Program. The commenter further indicated that the 
development of VICNs can lead to better patient care and lower costs by 
including only physicians and other clinicians who commit to value-
based care at the outset. The commenter noted that in order to 
participate, clinicians would have to agree to work and practice in a 
value-based way, with transparency of patient satisfaction, clinical 
outcomes, and cost results.
    Response: We will consider the suggestion as we develop the 
framework and requirements for virtual groups.
    Comment: One commenter suggested that CMS change the name of 
virtual groups to virtual network since a group includes coordination 
of a wide range of physician and related ancillary services under one 
roof that is seamless to patients while the term ``network'' implies 
more of an alignment of multiple group practices and clinicians 
operating across the medical community for purposes of reporting in 
MIPS.
    Response: We will consider the suggestion as we establish the 
branding for virtual groups.
    Comment: Multiple commenters did not support virtual groups being 
limited to groups consisting of not more than 10 MIPS eligible 
clinicians to form a virtual group with at least one other MIPS 
eligible clinician or group of not more than 10 MIPS eligible 
clinicians.
    Response: With regard to commenters not supporting the composition 
limit of virtual groups, we note that section 1848(q)(5)(I) of the Act 
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. Thus, we do not have the authority to modify this statutory 
provision.
    Comment: A few commenters requested that CMS work with clinician 
communities as it establishes the framework for the virtual group 
option. Commenters recommended that CMS protect against antitrust 
issues that may arise regarding physician collaboration to recognize 
economies of scale. One commenter indicated that accreditation entities 
have experience with the Federal Trade Commission (FTC) rules related 
to clinically integrated networks formed to improve the quality and 
efficiency of care delivered to patients and that publicly vetted 
accreditation standards could guide the development of virtual groups 
in a manner that incentivizes sustainable growth as integrated networks 
capable of long-term success under value-based reimbursement.
    Response: We will consider the recommendations provided as we 
develop requirements pertaining to virtual groups.
    Comment: One commenter recommended that in future rulemaking, CMS 
create a unique identifier for virtual groups, allow multiple TINs and 
split TINs, avoid thresholds based on the number of patients treated, 
avoid restricting the number of participants in virtual groups, and 
avoid limitations on the number of virtual groups. Another commenter 
suggested that virtual groups should be reporting data at either the 
TIN level, NPI/TIN level, or APM level.
    Response: We appreciate the recommendations from the commenters and 
as a result of the suggestions, we are interested in obtaining further 
input from stakeholders regarding a group identifier for virtual 
groups. Therefore, we are seeking additional comment for future 
consideration on the following: The advantages and disadvantages of 
creating a new identifier for virtual groups; and the potential options 
for establishing an identifier for virtual groups. We intend to explore 
this issue.
    We thank the commenters for their input regarding our intention to 
implement virtual groups for the CY 2018 performance period and factors 
we should consider regarding the establishment and implementation of 
virtual groups. We intend to explore the types of requirements 
pertaining to virtual groups, including, but not limited to, defining a 
group identifier for virtual groups, establishing the reporting 
requirements for virtual groups, identifying the submission mechanisms 
available for virtual group participation, and establishing 
methodologies for how virtual group performance will be assessed and 
scored. In addition, during the CY 2017 performance period, we will be 
convening a user group of stakeholders to receive further input on the 
factors CMS should consider in establishing the requirements for 
virtual groups and identify mechanisms for the implementation of 
virtual groups in future years.
(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 proposed 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 
proposed 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 will address all 
elements relating to the election process and outline the criteria and 
requirements regarding the formation of virtual groups. We solicited 
public comments on this proposal.
    The following is summary of the comments we received regarding our 
proposals that apply to virtual groups, including: The establishment of 
an election process that would end on June 30 of a calendar year 
preceding the applicable performance period; the requirement of 
individual MIPS eligible clinicians and groups electing to be a virtual 
group to register in order to submit reportable data; and the 
assessment of virtual groups across all four MIPS performance 
categories.
    Comment: A few commenters requested that CMS reconsider the 
deadline by which virtual groups would be required to make an election 
to participate in MIPS. One commenter recommended that the deadline 
should be 90 days before the performance period as opposed to 6 months.

[[Page 77077]]

    Response: We will consider the recommendations as we establish the 
election process for virtual groups.
    Comment: One commenter indicated that a registration process for 
the virtual group option would be an unnecessary burden and recommended 
that registration by virtual groups should only be required if the 
group participates in MIPS via the CMS Web Interface. Another commenter 
expressed concern that without a manageable registration system for 
virtual groups, there would be too many loopholes, which would add 
confusion to the program.
    Response: We appreciate the commenters providing recommendations 
and we will consider the recommendations as we establish the virtual 
group registration process.
    After consideration of the public comments we received, and with 
the delay of virtual group implementation, we are not finalizing our 
proposal to establish a virtual group election process that would end 
on June 30 for the CY 2017 performance period; the proposed requirement 
of individual MIPS eligible clinicians and groups electing to be a 
virtual group to register in order to submit reportable data; or the 
proposed assessment of virtual groups across all four MIPS performance 
categories.
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 clinicians seeking to participate. 
This means that we must balance potential impacts of changes to systems 
and technical requirements to successfully synchronize reporting, as 
noted in the discussion regarding the definition of a MIPS eligible 
clinician in the proposed rule (81 FR 28173). We must take operational 
feasibility, systems impacts, and education and outreach on 
participation 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 cost 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 MIPS 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 MIPS payment adjustment. For MIPS, 
we proposed 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. We proposed that if we determined 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 in the calendar 
year immediately following the performance period.
    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 in this 
section, if we determined 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. As an alternative to our 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 
solicited comments on both approaches.
    Given the need to collect and process information, we proposed 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 CY 2017, that is, January 1, 2017 through 
December 31, 2017. We proposed to use the 2017 performance year for the 
2019 MIPS 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 groups 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 family leave, or has an illness), we proposed 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

[[Page 77078]]

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 proposed this approach 
to incentivize accountability for all performance during the 
performance period. We also believe these policies would help minimize 
the impact of partial year data. First, MIPS eligible clinicians with 
volume below the low-volume threshold would be excluded from any MIPS 
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 final 
rule with comment period for more information on scoring.
    To potentially refine this proposal in future years, we solicited 
comments on methods to accurately identify MIPS eligible clinicians 
with less than a 12-month reporting period, notwithstanding common and 
expected absences due to illness, vacation, or holiday leave. Reliable 
identification of these MIPS eligible clinicians would allow us to 
analyze the characteristics of MIPS eligible clinicians' patient 
population and better understand how a reduced reporting period impacts 
performance.
    We also solicited 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 clinicians and confirm 
there are data issues that led to invalid performance calculations, 
then we could score the MIPS eligible clinician with a final score 
equal to the performance threshold, which would result in a zero MIPS 
payment adjustment. We note this approach would not assess a MIPS 
eligible clinicians' performance for partial-year performance data. We 
do 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 solicited comment on reasonable thresholds for considering 
performance that is 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 solicited comment on how to account for MIPS eligible 
clinicians with extended leave that may affect measure sample size.
    We solicited comments on these proposals and approaches. The 
following is summary of the comments we received regarding our 
proposals for the MIPS performance period.
    Comment: Numerous commenters believed that the first MIPS 
performance period should be delayed or treated as a transition year. 
The commenters stated that the proposed timeline for implementation was 
too compressed, unrealistic, and aggressive. They cited numerous 
educational and readiness factors for the recommended delay including: 
Time needed for stakeholders to digest the final rule with comment 
period and engage in further education and to make the necessary 
modifications to their practices, not overly burden their systems with 
such a short implementation time, and time needed to establish the 
administrative and technological tools necessary to meet the reporting 
requirements. The commenters suggested numerous alternative start dates 
to allow what the commenters believed would be sufficient time for MIPS 
eligible clinicians to prepare for reporting, ranging from a 2-year 
delay in implementation, using CY 2018 as the initial assessment period 
for MIPS, a start date no less than 15 months between the adoption of 
the final rule with comment period and its implementation, a start date 
no earlier than July 1, 2017, and lastly a start date of April 1, 2017.
    Response: We appreciate the suggestions and have examined the 
issues raised closely. We agree with the commenters that to ensure a 
successful implementation of the MIPS, providing MIPS eligible 
clinicians' additional time to prepare their practices for reporting 
under MIPS is needed. Therefore, we have decided to finalize a 
modification of our proposal for the performance period for the 
transition year of MIPS to provide flexibility to MIPS eligible 
clinicians as they familiarize themselves with MIPS requirements in 
2017 while maintaining reliability. Therefore, we are finalizing at 
Sec.  414.1320(a)(1) that for purposes of the 2019 MIPS payment year, 
the performance period for all performance categories and submission 
mechanisms except for the cost performance category and data for the 
quality performance category reported through the CMS Web Interface, 
for the CAHPS for MIPS survey, and for the all-cause hospital 
readmission measure, is a minimum of a continuous 90-day period within 
CY 2017, up to and including the full CY 2017 (January 1, 2017 through 
December 31, 2017). Thus, MIPS eligible clinicians will only need to 
report for a minimum of a continuous 90-day period within CY 2017, for 
the majority of the submission mechanisms. This 90-day period can occur 
anytime within CY 2017, so long as the 90-day period begins on or after 
January 1, 2017, and ends on or before December 31, 2017. We note that 
the continuous 90-day period is a minimum; MIPS eligible clinicians may 
elect to report data on more than a continuous 90-day period, including 
a period of up to the full 12 months of 2017. For groups that elect to 
utilize the CMS Web Interface or report the CAHPS for MIPS survey, we 
note that these submission mechanisms utilize certain assignment and 
sampling methodologies that are based on a 12-month performance period. 
In addition, administrative claims-based measures (this includes all of 
the cost measures and the all-cause hospital readmission measure), are 
based on attributed population using the 12-month period. Additionally, 
we are finalizing at Sec.  414.1320(a)(2) that for purposes of the 2019 
MIPS payment year, for data reported through the CMS Web Interface or 
the CAHPS for MIPS survey and administrative claims-based cost and 
quality measures, the performance period under MIPS is CY 2017 (January 
1, 2017 through December 31, 2017). Please note that, unless otherwise 
stated, any reference in this final rule with comment period to the 
``CY 2017 performance period'' is intended to be an inclusive reference 
to all performance periods occurring during CY 2017. More details on 
these submission mechanisms are covered in section II.E.5.a.2. of this 
final rule with comment period.
    We believe the flexibilities we are providing in our modified 
proposal discussed above will provide time for stakeholders to engage 
in further education about the new requirements and make the necessary 
modifications to their practices to accommodate reporting under the 
MIPS. We note that the continuous 90-day period of time required for 
reporting can occur at any point within the CY 2017 performance period, 
up until and including October 2, 2017, which is the last date that the 
continuous 90-day period of time required for reporting can begin and 
end within the CY 2017 performance period.
    For the second year under the MIPS, we are finalizing our proposal 
to require reporting and performance assessment

[[Page 77079]]

for the full CY performance period for purposes of the quality and cost 
performance categories. Specifically, we are finalizing at Sec.  
414.1320(b)(1) that for the 2020 MIPS adjustment, for purposes of the 
quality and cost performance categories, the performance period is CY 
2018 (January 1, 2018 through December 31, 2018). We do believe, 
however, that for the improvement activities and advancing care 
information performance categories, utilizing a continuous 90-day 
period that occurs during the 12-month MIPS performance period will 
assist MIPS eligible clinicians as they continue to familiarize 
themselves with the requirements under the MIPS. Additionally, to allow 
MIPS eligible clinicians and groups adequate time to transition to 
technology certified to the 2015 Edition for use in CY 2018, we believe 
it is appropriate to allow reporting on any continuous 90-day period 
that occurs during the 12-month MIPS performance period for the 
advancing care information performance category in CY 2018. 
Specifically, for the improvement activities and advancing care 
information performance categories, we are finalizing at Sec.  
414.1320(b)(2) that the performance period under MIPS is a minimum of a 
continuous 90-day period within CY 2018, up to and including the full 
CY 2018 (January 1, 2018 through December 31, 2018).
    Comment: Other commenters suggested making 2018 the first 
performance period for the first payment year of 2019. They stated that 
MIPS eligible clinicians could receive more timely feedback on their 
performance and still have the opportunity to make improvements in the 
second half of 2017 before the first performance period would begin.
    Response: It is not technically feasible to establish the first 
performance period in 2018 and begin applying MIPS payment adjustments 
in 2019. Some of the factors involved include: Allowing for a data 
submission period that occurs after the close of the performance 
period, running our calculation and scoring engines to calculate 
performance category scores and final score, allowing for a targeted 
review period, establishing and maintaining budget neutrality and 
issuance of each MIPS eligible clinician's specific MIPS payment 
adjustment. Based on our experience under the PQRS, VM, and Medicare 
EHR Incentive Program for Eligible Professionals, all of these 
activities on average take upwards of 9-12 months. We will continue to 
examine these operational processes to add efficiencies and reduce this 
timeframe in future years.
    Comment: Other commenters noted that MIPS eligible clinicians 
ideally require 18 to 24 months' time to adequately identify, adopt, 
and apply measures to established workflows for consistent data 
capture. The commenters also noted that most MIPS eligible clinicians 
are not yet comfortable with ICD-10 and added that there are 1491 new 
ICD-10 CM codes becoming effective in October 2016, and that MIPS 
eligible clinicians would not have sufficient time to refine processes 
within the proposed timeline (that is, by January 1, 2017).
    Response: We are finalizing a modified CY 2017 performance period, 
as discussed above. We believe this will allow MIPS eligible clinicians 
to adequately identify, adopt, and apply measures to establish 
workflows for consistent data capture as they familiarize themselves 
with MIPS requirements in 2017. We appreciate the concern raised by the 
commenters on the introduction of the new ICD-10 codes. However, we 
note that there are numerous resources available to assist commenters 
on incorporating these codes into their workflows at https://www.cms.gov/medicare/Coding/ICD10/index.html.
    Comment: Another commenter requested more time for clinicians and 
payers other than Medicare to make adjustments to programs and amend 
large numbers of significant risk[hyphen]based contracts between states 
and health plans, and between health plans and their network delivery 
system individual practice associations (IPAs), groups, and clinicians. 
The commenter stated that this would allow time for significant 
contract and subcontract amendments for other payers, and system 
changes for metrics, claims, and benefit systems.
    Response: We believe the flexibilities we are providing in the 
first performance period, as discussed in this final rule with comment 
period, will allow MIPS eligible clinicians and third party 
intermediaries the time needed to update their systems to meet program 
requirements and amend any agreements as necessary.
    Comment: Some commenters were concerned that setting the 
performance period too soon would not give third party intermediaries, 
such as EHR vendors, qualified registries, health IT vendors, and 
others the time needed to update their systems to meet program 
requirements. The commenters recommended setting the performance period 
later to allow these third party intermediaries time to validate new 
data entry and testing tools and overhaul their systems to comply with 
2015 edition certification requirements. Another commenter believed the 
proposed policies would often require the use of multiple database 
systems that could not be accomplished in the time required.
    Response: We agree with the commenters that ensuring that third 
party intermediaries have sufficient time to update their technologies 
and systems will be a key component of ensuring that MIPS eligible 
clinicians are ready to meet program requirements. We believe the 
flexibilities we are providing in the first performance period, as 
discussed in this final rule with comment period, will allow third 
party intermediaries the time needed to update their systems to support 
MIPS eligible clinician participation. We note that there are no new 
certification requirements required for the Quality Payment Program and 
many health IT vendors have already begun work toward the 2015 Edition 
certification criteria which were finalized in October 2015. We believe 
that the flexibility offered and the lead time to required use of 
technology certified to the 2015 Edition, will mitigate these concern; 
however, we intend to monitor health IT development progress, adoption 
and implementation, and the readiness of QCDRs, health IT vendors, and 
other third parties supporting MIPS eligible clinician participation.
    Comment: Another commenter believed a later start date would 
provide CMS with more time to address several issues that were absent 
from the proposed rule, including the development of virtual groups, 
improved risk-adjustment and attribution methods, further refinement of 
episode-based resource measures and measurement tools and enhanced data 
feedback to participants. One commenter stated that they believed that 
the government programs that regulate and support MIPS have yet to be 
designed, tested, and implemented. The commenter stated they do not 
have MIPS performance thresholds or measure benchmark data and 
therefore cannot prepare their office to streamline the new processes 
and report appropriately in 2017.
    Response: We respectfully disagree with the commenter and intend to 
address further refinements to the MIPS program in future years. We 
appreciate the commenter's desire to delay the start of the MIPS until 
we are able to have full implementation of these factors. However, as 
we have noted in other sections within this final rule with comment 
period we intend to implement these provisions when technically 
feasible, as in the case of

[[Page 77080]]

virtual groups, and when available, as in the case of improved risk-
adjustment and attribution methods as well as additional episode-based 
resource measures. Additionally, as noted in section II.E.10. of this 
final rule with comment period, we intend to provide feedback to 
participants as required by statute, and we will enhance these feedback 
efforts over time. Lastly, as indicated in section II.E.6.a. of this 
final rule with comment period, due to the additional factors we are 
incorporating to simplify our scoring methodology, we have published 
the MIPS performance threshold in this final rule with comment period, 
and we will publish the measure benchmarks where available prior to the 
beginning of the performance period.
    Comment: Several commenters recommended that the first performance 
period occur later than January 1, 2017 based on commenters' analysis 
of the MACRA statute. Some commenters believe a delayed start date of 
July 1, 2017 would better match Congressional intent that the 
performance period be as close to the MIPS payment adjustment period as 
possible, while still allowing for the related MIPS payment adjustments 
to take place in 2019. The commenters further recommended that CMS use 
the time between the publication of the final rule with comment period 
and a delayed performance period start date to test and refine the 
performance feedback mechanisms for the Quality Payment Program. The 
commenters stated that by including the ``as close as possible'' 
language in section 1848(q)(4) of the Act, the Congress sought to urge 
CMS to select a performance period that will close the gap on CMS's 
practice of setting a 2-year look-back period for Medicare quality 
programs.
    Response: We appreciate the commenters concerns about Congressional 
intent for having a performance period as close as possible to the 
related MIPS payment adjustments. However, we believe our proposal is 
consistent with section 1848(q)(4) of the Act, as a performance period 
that occurs 2 years prior to the payment year is as close to the 
payment year as is currently possible. As noted above, from our 
experiences under the PQRS, VM, and Medicare EHR Incentive Program for 
Eligible Professionals, it takes approximately 9-12 months to perform 
the operational processes to produce a comprehensive and accurate list 
of MIPS eligible clinicians to receive a MIPS payment adjustment. We 
will continue to assess this timeframe for efficiencies in the future.
    Comment: Some commenters noted that section 1848(s) of the Act, as 
added by section 102 of MACRA, requires a quality measure development 
plan with annual progress reports, the first of which must be issued by 
May 1, 2017. The commenters stated that by starting the Quality Payment 
Program on January 1, 2017, before the first annual progress report is 
finalized, CMS will not have finalized key program requirements before 
it begins MIPS.
    Response: We note that the commenters are referring to 2 separate 
requirements under section 1848(s) of the Act. The quality measure 
development plan, known as the CMS Quality Measure Development Plan 
(MDP), was finalized and posted on May 2, 2016, which is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf and 
required to be updated as appropriate. In addition, the MDP Annual 
Report, which is to report on progress in developing measures, is 
required to be posted annually beginning not later than May 1, 2017. We 
intend to post the initial MDP Annual Report on May 1, 2017. While 
these statutory requirements are mandatory and support the development 
of the MIPS program, they are not prerequisites for the implementation 
of the MIPS program.
    Comment: Several commenters stated that the performance period was 
too early and suggested that CMS create an initial transitional 
performance period or phase-in period for the MIPS program. These 
commenters recommended numerous modifications and advantages as part of 
the transitional or phase-in period including: Phasing in some of the 
performance requirements such as requiring fewer quality measures and/
or improvement activities in the transition year, creation of gradual 
performance targets which would allow sufficient time for participants 
to adapt to data collection and reporting prior to increasing 
performance standards, and phasing in the MIPS adjustment amounts such 
as applying a maximum MIPS payment adjustment of 2 percent in the 
transition year of the program, or applying negative MIPS adjustments 
only to groups of MIPS eligible clinicians above a certain size. These 
commenters noted the advantages of a transitional or phase-in period 
include allowing CMS to offset its concerns around calculation of 
outcome and claims-based measures, the feasibility of using different 
reporting mechanisms, meeting statutory deadlines, postponing changes 
to the advancing care information performance category and the 
capability of CMS' internal processes.
    The commenters suggested various dates for the transitional or 
phase-in period such as: January 1, 2017 through June 30, 2017, July 1, 
2017 through December 31, 2017, allowing MIPS eligible clinicians to 
select a 6-month performance period or allowing MIPS eligible 
clinicians to use the full calendar year with an optional look-back to 
January 1 in 2017. The commenters requested that CMS provide technical 
assistance and a submission verification process during the transition 
period.
    Response: We agree with the commenters that there are numerous 
advantages to having a transitional or phase-in period for the 
transition year. As indicated previously in this section of this final 
rule with comment period, we have modified the performance period for 
the transition year to occur for a minimum of one continuous 90-day 
period up to a full calendar year within CY 2017 for all data in a 
given performance category and submission mechanism. We believe that 
this modified performance period as well as the modifications we are 
making to our scoring methodology as reflected in section II.E.6. of 
this final rule with comment period address a number of the concerns 
the commenters have raised. Lastly, we note that section 1848(q)(6) of 
the Act requires us to apply the MIPS adjustment based on a linear 
sliding scale and an adjustment factor of an applicable percent, which 
the statute defines as 4 percent for 2019. We do not have the 
discretion to apply a smaller adjustment factor to MIPS eligible 
clinicians such as only 2 percent.
    Comment: Multiple commenters recommended that 2017 be utilized for 
reporting purposes only and not payment purposes. Their recommendations 
ranged from having 2017 function as a straightforward reporting year 
only, such as an ``implementation and benchmarking'' year which would 
still allow CMS to collect data, but would not be used for financial 
impacts in 2019. Other suggestions included utilizing 2017 as a beta 
test year for MIPS eligible clinicians, plan capabilities and system 
preparedness. The commenters believed that a staged approach to MACRA 
implementation would provide for more coordinated change within the 
delivery system for patients, which must remain a focus for all as we 
continue embracing the Triple Aim of improving the patient experience 
of care (including quality

[[Page 77081]]

and satisfaction); improving the health of populations; and reducing 
the per capita cost of health care. More information regarding the 
Triple Aim may be found at http://www.hhs.gov/about/strategic-plan/strategic-goal-1/.
    Response: We would like to explain that MIPS is a program where 
payment adjustments must be applied based on each MIPS eligible 
clinician's total performance on measures and activities. As such, we 
are not able to apply MIPS payment adjustments based on reporting 
alone. Additionally, as we have discussed above, we have made 
modifications to the performance period for the transition year of 
MIPS, as well as to the scoring methodology, as discussed in section 
II.E.6. of this final rule with comment period to allow MIPS eligible 
clinicians the opportunity to gain experience under the program without 
negative payment consequences.
    Comment: Other commenters urged changes to MIPS to provide 
flexibility for small practices. The commenters suggested a voluntary 
phase-in for small practices over a several-year period. Alternatively, 
the commenters suggested that CMS should not penalize very small 
practices (for example, five or fewer MIPS eligible clinicians) for a 
specified period of time, allowing them to implement and learn about 
MIPS reporting. Another commenter suggested that for the transition 
year of MIPS, CMS could permit small practices to be credited with full 
participation in MIPS based on a single quarter of successfully 
submitted 2017 data and permit larger practices to submit two quarters 
of data.
    Response: We have provided considerable flexibility for small 
practices throughout our MIPS proposals and this final rule with 
comment period. Specifically, we believe our modified low-volume 
threshold policy, as discussed in section II.E.3.c. of this final rule 
with comment period, will provide small groups considerable flexibility 
that will address the commenters' concerns.
    Comment: Some commenters were concerned with CMS statements from 
the proposed rule--specifically, that MIPS eligible clinicians do not 
have to begin reporting at the start of the performance period, 
suggesting that MIPS eligible clinicians will have more time to collect 
data, change workflows, and implement required MIPS and APM changes--
create confusion as many of the MIPS program's quality measures require 
actions to be taken at the point of care and cannot be completed at a 
later date.
    Response: Our comments from the proposed rule accurately reflected 
our proposed policies. We regret any confusion created by statements in 
the proposals. The commenters are correct that many quality measures 
are required to be reported for every encounter. It is also correct, 
however, that other quality measures do not require reporting of every 
encounter (that is, NQF 0043: Pneumonia Vaccination Status for Older 
Adults). In general, the performance period is a window of time to 
report measures and, depending on the measure, MIPS eligible clinicians 
may need to report for just one quarter and the specified number of 
encounters for a given measure, or may need multiple encounters in 
multiple quarters for other measures
    Comment: Some commenters stated that the proposal interrupts their 
current short-term course of action of meeting Meaningful Use in 2016 
and requested that we utilize 2017 as a preparation year to implement, 
adopt, measure, monitor, and manage new measures and boost performance 
on measures that previously had low thresholds for which MIPS eligible 
clinicians have to maximize performance.
    Response: We note that for those MIPS eligible clinicians who have 
previously participated in the EHR Incentive Program, the measures and 
objectives that are required under the advancing care information 
performance category are a reduction in the number and types of 
measures as previously required. More information on the advancing care 
information performance category can be found in section II.E.5.g. of 
this final rule with comment period.
    Comment: There were various comments regarding the duration of the 
MIPS performance period. Many commenters supported the 12-month 
performance period and requested that CMS stick to that timeline. The 
commenters stated that if timelines must be changed, CMS should do so 
before the performance period begins. Several commenters supported the 
performance period of one full year versus 90 days. They believed this 
would lead to consistent and high-quality data submission. Another 
commenter generally supported the proposed performance period but 
cautioned CMS that any shortened performance periods could burden 
certain MIPS eligible clinicians whose practices vary in volume based 
on factors such as their geographies, specialties, and nature of the 
patients they treat that are outside of their control. Other commenters 
believed CMS should not delay the Quality Payment Program 
implementation or finalize an abbreviated performance period in the 
transition year. These commenters suggested that CMS act immediately on 
the premise that implementation for 2017 should begin now with clear 
education and guidance in order to ensure successful transitions to the 
new Quality Payment Program.
    Response: We appreciate the commenters' support. We believe that 
measuring performance on a 12-month period is the most accurate and 
reliable method for measuring a MIPS eligible clinician's performance. 
We note that we are modifying our proposal to require reporting for a 
minimum continuous 90-day period of time within the CY 2017 performance 
period for the majority of available submission mechanisms for all data 
in a given performance category and submission mechanism. However, we 
strongly encourage all MIPS eligible clinicians to submit data for up 
to the full calendar year if feasible for their practice. We anticipate 
that MIPS eligible clinicians who are able to submit a more robust data 
set, such as data on a 12-month period, will have the benefit of having 
their full population of patients measured, which will assist these 
MIPS eligible clinicians on their quality improvement goals.
    Comment: Some commenters believed MACRA's four MIPS performance 
categories are adding complexity to the delivery of patient-centered 
care and do not increase the time medical clinicians spend with 
patients. Specifically, the commenters believed that there is not much 
of a difference between PQRS/MU and the new ``quality'' and ``advancing 
care information'' performance categories. The commenters added that 
the improvement activities performance category appears complicated and 
the cost performance category is intensive. The commenters proposed a 
solution that measurable elements be for a 90-day period during the 
calendar year so that measuring tools will not need to be in place at 
all times, resulting in less disruption and a greater focus on 
patients.
    Response: Our intention in creating MIPS is to provide a more 
comprehensive and simplified system that provides value. The commenter 
is correct that we maintained many elements of the PQRS and EHR 
Incentive Program that we found through experience to be meaningful to 
clinicians. The requirements for the cost and improvement activities 
performance categories are described in sections II.E.5.e. and 
II.E.5.f., respectively, of this final rule with comment period. We 
believe these performance categories to be very low in burden. In 
addition, as

[[Page 77082]]

described in section II.E.5.e of this final rule with comment period, 
the cost performance category will account for 0 percent of the final 
score in 2019 and we are redistributing the final score weight from 
cost performance category to the quality performance category. Lastly, 
as noted above, we are allowing MIPS eligible clinicians to report on 
quality, improvement activities, and advancing care information 
performance category information for a minimum of a continuous 90-day 
period during the CY 2017 performance period for the majority of 
available submission mechanisms for all data in a given performance 
category and submission mechanism. In addition, the cost performance 
category will be calculated based on the performance period using 
administrative claims data. As a result, individual MIPS eligible 
clinicians and groups will not be required to submit any additional 
information for the cost performance category.
    Comment: Another commenter believed a full year of quality 
reporting is necessary to ensure data reliability for small practices 
but encouraged CMS to finalize a 90-day performance period for the 
improvement activities and advancing care information performance 
categories. The commenter believed CMS could finalize a shorter 
performance period for quality reporting in the future if 2015 data is 
modeled to show sufficient reliability under a shorter performance 
period.
    Response: We agree with the commenter and believe that measuring 
performance on a 12-month period is the most accurate method for 
measuring a clinician's performance. However, for the transition year 
of MIPS, we are providing flexibility while maintaining reliability and 
finalizing a modified performance period, as discussed above, so that 
MIPS eligible clinicians may familiarize themselves with MIPS 
requirements.
    Comment: Several commenters requested that CMS define the 
performance period as less than a full year. The suggestions of the 
start date were varied including: A suggested start date of July 1, 
2017, which would allow MIPS eligible clinicians enough time to review 
and select appropriate measures; a 9-month performance period of April 
1 through December 31, 2017; a 90 day period from January 1st through 
March 31st of each year because the commenter believed that this 
shorter time frame would not differ significantly from a full-year 
assessment period; and a period occurring from January 15 through April 
15 so that reports could be compiled and tested prior to submission. 
These commenters cited various concerns, including that full calendar 
year reporting would be a significant departure from current reporting 
requirements under the EHR Incentive Program and that it would not 
allow for full validation and testing of EHR-generated data following 
software upgrades or measurement specification changes. Other 
commenters were concerned that the proposal to use a full calendar year 
for the performance period could create administrative burden for 
practices and limit innovation without improving the validity of the 
data. The commenters recommended that in future years, CMS take 
advantage of the flexibility granted under the MACRA statute to allow 
MIPS eligible clinicians to select a shorter performance period for 
either the MIPS program or APM incentive payments. Another commenter 
believed that CMS should permit MIPS eligible clinicians to select a 
shorter performance period if they believe it is more appropriate for 
their practice.
    Response: We do understand and appreciate the concerns raised by 
commenters that the performance period for the transition year of the 
program may be a shorter length than 12 months. For the transition year 
of MIPS, we are providing flexibility while maintaining reliability and 
finalizing a modified performance period, as discussed above, so that 
MIPS eligible clinicians may familiarize themselves with MIPS 
requirements.
    Comment: A few commenters noted that measures for the cost 
performance category may need to be calculated over a longer period of 
time in order to ensure their reliability and applicability to 
practices, and recommended that if CMS shortens the initial MIPS 
performance period, CMS should make a distinction between performance 
periods for performance categories where data submission is required 
versus those where CMS calculates measures using administrative claims 
data. The commenters suggested that CMS should conduct detailed 
analysis of VM data to determine the extent to which including data for 
a year rather than 6 or 9 months improves reliability and expands 
applicability of the measures.
    Response: We appreciate the commenters' suggestions. We have not 
done an analysis to look at reliability of the measures using a 6-month 
or 9-month performance period. We will consider this approach for 
future rulemaking.
    Comment: Another commenter recommended that CMS should also reduce 
the case minimums for measures as MIPS eligible clinicians will not 
have sufficient time to see the same number of patients during a 
shortened performance period.
    Response: We refer the commenter to section II.E.6.a.(2) of this 
final rule with comment period where we discuss the quality scoring 
proposals and the case minimum requirements.
    Comment: Other commenters recommended a 90-day performance period 
for 2017 for private specialty practices, as well as a 90-day 
performance period for any reporting year that the practice is required 
to upgrade their version of CEHRT. For example, the commenters noted 
that in mid-2017, many MIPS eligible clinicians will be upgrading from 
EHR technology certified to the 2014 Edition to EHR technology 
certified to the 2015 Edition. The commenters stated that this can 
often cause data integrity issues and would continuously place the 
practice on a split CEHRT any year that this type of upgrade occurs. 
They suggested a 90-day performance period during the upgrade year 
would allow a practice to upgrade and attest to the most recent version 
and standards.
    Response: We are modifying our proposal to allow reporting for a 
minimum of a continuous 90-day period of time within the CY 2017 
performance period for the majority of available submission mechanisms 
for all data in a given performance category and submission mechanism. 
Additionally, we understand the commenters' concerns and rationale for 
requesting a 90-day performance period. We note that for the first 
performance period in 2017, we will accept a minimum of 90 days of data 
within CY 2017, though we greatly encourage MIPS eligible clinicians to 
meet the full year performance period. In order to allow MIPS eligible 
clinicians and groups adequate time to transition to technology 
certified to the 2015 Edition for use in CY 2018, we believe it is 
appropriate to also allow a performance period of continuous 90-day 
period within the CY for the advancing care information performance 
category in CY 2018.
    Comment: Another commenter requested that CMS offer advance notice 
appropriate to the size of the change (for example, transitioning to 
new editions of CEHRTs might require years of notice, whereas annually 
updated benchmarks might require only a few months). The commenter 
requested that the proposed policies not be implemented until at least 
6 months after the final rule with comment period is published.
    Response: We will provide as much advance notice as is necessary 
when

[[Page 77083]]

making changes to the MIPS program. We recognize that all parties 
involved in the MIPS program require advance notice to make adjustments 
to accommodate changes.
    Comment: Some commenters suggested that CMS shorten the performance 
period to 9 months of the calendar year, followed by 3 months of data 
analysis to calculate the scores and MIPS payment adjustments. The 
rationale for this recommendation included allowing for a number of 
program improvements, including reducing administrative burden in MIPS, 
aligning the performance period across categories, shrinking the 2-year 
lag period between performance and payment, and increased relevance and 
timeliness of feedback. The commenters also stated that this would give 
opportunity to set benchmarks based on more current data. Based on one 
commenter's polling of its members, 92 percent preferred a performance 
period of any 90 consecutive days compared to the proposed performance 
period.
    Response: We considered utilizing a 9-month performance period as 
the commenter recommended, however we did not utilize this option since 
this would still require a ``2-year lag'' to account for the post 
submission processes of calculating the MIPS eligible clinician's final 
score, establishing budget neutrality and issuing the payment 
adjustment factors and allowing for a targeted review period to occur 
prior to the application of the MIPS payment adjustment to MIPS 
eligible clinicians claims. As stated above, we are modifying our 
proposal and finalizing that MIPS eligible clinicians will only need to 
report for a minimum of a continuous 90-day period in 2017, for the 
majority of the data submission mechanisms. We believe this flexibility 
will allow for a number of program improvements, including reducing 
administrative burden in MIPS for the transition year and will align 
across the quality, advancing care information, and improvement 
activities performance categories. In addition, we will continue 
working with stakeholders to improve feedback provisions under MIPS and 
to shorten the ``2-year lag'' that the commenter describes.
    Comment: One commenter stated that they recognized a shorter 
performance period may present challenges for CMS systems and 
processes; therefore, they urged CMS to work with MIPS eligible 
clinicians to develop options and a specific plan to provide 
accommodations where possible.
    Response: We appreciate the comment and will continue to work 
closely with stakeholders throughout the Quality Payment Program.
    Comment: Other commenters believed a shorter performance period 
would eliminate the participation burden and confusion for MIPS 
eligible clinicians who may switch practices mid-year and have to track 
and report data for multiple TIN/NPI combinations under the proposed 
full calendar year performance period.
    Response: We agree with the commenter that the shortened minimum 
continuous 90-day period of time will assist in decreasing 
participation burden. We note that the modified performance period will 
not eliminate the need for tracking multiple TIN/NPIs depending upon 
the specific circumstances of the MIPS eligible clinician, but we agree 
with the commenter that it will mitigate this issue.
    Comment: A few commenters recommended a 6-month performance period 
for MIPS with an optional look-back period for registries to increase 
sample size, validity and reliability and an extension of data 
submissions for QCDRs to April 31 following the performance period, or 
4 months after the performance period to allow for the capture and 
analytics required for the use of risk-adjusted outcomes data.
    Response: Our modified proposal of a continuous 90-day period 
within the CY 2017 performance period for all data in a given 
performance category and submission mechanism is a minimum period and 
we strongly encourage all MIPS eligible clinicians to report on data 
for a full year where possible for their practice. We believe this 
policy will address the commenters' concerns while maintaining 
reliability. Our policies regarding the performance period are 
described in more detail in section II.E.4. of this final rule with 
comment period. We note that it is not clear how a longer data 
submission timeframe will help with the capture of risk-adjusted data 
elements used in outcomes measures. In most, if not all, instances, any 
co-morbidities affecting the outcome for a patient would be known 
before or at the time the care is rendered.
    Comment: One commenter suggested that if CMS rejects changing the 
initial performance period for 2017 to 90 days, it should implement 
preliminary and f-Final performance periods, with analysis periods 
(from January to March) and implementation periods (from April to May), 
to allow MIPS eligible clinicians to evaluate their performance with 
the various MIPS requirements from August to September, followed by a 
final performance period from October to December.
    Response: We thank the commenter for their feedback. As discussed 
above, we are modifying our proposal to allow reporting for a minimum 
of a continuous 90-day period within the CY 2017 performance period for 
the majority of available submission mechanisms for all data in a given 
performance category and submission mechanism.
    Comment: Many commenters stated that CMS must work to reduce the 2-
year gap between the performance period and the payment year because it 
is burdensome, is not meaningful nor actionable as MIPS eligible 
clinicians will not know what they must adjust to meet benchmarks, and 
it hinders timely data reporting and feedback. One commenter 
acknowledged the operational difficulty associated with having 
performance periods close to MIPS payment adjustment periods, but 
requested that CMS work to shorten the look back period between 
performance assessment and adjustment.
    Response: We agree with commenters that improved feedback 
mechanisms are always important, and we will continue working with 
stakeholders to provide timely and better feedback under MIPS and to 
shorten the ``2-year gap'' that the commenter describes.
    Comment: There were various suggestions on the most appropriate 
time gap between the performance period and the payment year. Several 
commenters suggested that a 1-year gap would be more appropriate and 
others proposed a 6-month time gap. Another commenter believed, that 
the time lag of essentially 2 years between the performance period and 
the payment year severely disadvantages MIPS eligible clinicians 
falling below the top tier performance threshold and inflates the 
rating of competing MIPS eligible clinicians, who can rest on the 
laurels of their prior performance years. Further, the commenter noted 
that if a MIPS eligible clinician had an unsatisfactory performance 
rating, (for example, from data collected in January of 2016), and took 
corrective action to earn a higher rating, the efforts of that 
corrective action would not be available to the public for a minimum of 
2 years. A few commenters believed CMS should increase the relevance 
and timeliness of data, which could be provided on a quarterly basis.
    Response: We appreciate the commenters' feedback. We agree with the 
commenters that a delay between the performance period and the MIPS 
payment adjustment year impacts the clinicians' ability to make timely

[[Page 77084]]

improvements within their practice. For the initial years of MIPS, we 
do anticipate that this gap between the performance period and the 
payment adjustment year will continue to occur to allow time for 
submission and calculation of data, issuance of feedback, a targeted 
review period, calculation of final scores, and application of 
clinician-specific MIPS adjustments in time for the payment year.
    Comment: Other commenters believed CMS should use language 
clarifying that the MIPS performance period begins on January 1, 2017. 
The commenters suggested linking the language for the performance year 
with the adjustment year in some way (for example, ``MIPS 2017/19'', 
``2017 performance period (2019)'').
    Response: We will ensure that all communications clearly indicate 
the link between the performance period and the MIPS payment adjustment 
year.
    Comment: A few commenters expressed support for CMS' proposal of a 
90-day claims data run-out. Another commenter stated that if the 
proposed window is not feasible, the commenter supported a 60-day 
window.
    Response: We appreciate the commenter's feedback. Based on further 
analyses of Medicare Part B claims for 2014, we have determined that 
there is only a 0.5 percent difference in claims processing 
completeness when using 90 days rather than 60 days. Therefore, we are 
finalizing our alternative proposal at Sec.  414.1325(f)(2) that the 
submission deadline for Medicare Part B claims, must be on claims with 
dates of service during the performance period that must be processed 
no later than 60 days following the close of the performance period.
    Comment: Another commenter requested more information regarding how 
MIPS eligible clinicians participating for part of the performance 
period will be assessed against MIPS eligible clinicians participating 
for the full performance period. The commenter cautioned against 
penalizing MIPS eligible clinicians not practicing for reasons beyond 
their control, such as for health reasons. Other commenters expressed 
concern that MIPS eligible clinicians could attempt to game the system 
with extended leave. Other commenters supported the expectations for 
reporting when MIPS eligible clinicians have a break in their practice, 
and one commenter expressed concern about MIPS eligible clinicians who 
change groups because doing so may negatively impact group performance. 
The commenters believed a policy for exceptions may mitigate the 
problem and provide consistency. Another commenter stated that MIPS 
eligible clinicians with less than 12 months of performance data should 
be assessed on the period of time for which they do report.
    Response: As discussed in this final rule with comment period, we 
are modifying our proposal to allow reporting for a minimum of a 
continuous 90-day period within the CY 2017 performance period for the 
majority of available submission mechanisms for all data in a given 
performance category and submission mechanism. We would like to note 
that we are finalizing that individual MIPS eligible clinician or 
groups who report less than 12 months of data (due to family leave, 
etc.) would be required to report all performance data available from 
the performance period. For example, for the performance period in 
2017, MIPS eligible clinicians who have less than 90 days' worth of 
data would be required to submit all performance data that they have 
available. We are finalizing this proposal with modification to apply 
to any applicable performance period (for example, to any 90-day 
period). Based on the Medicare Part B data available to us, we do not 
intend to make any scoring adjustments based on the duration of the 
performance period. We recognize that a longer (that is, 12-month) 
performance period provides greater assurance of reliability with 
respect to the submitted data and therefore strongly encourage all MIPS 
eligible clinicians who have the ability to submit data for a period 
greater than 90 days, to do so.
    Comment: A few commenters supported the proposed performance 
period, but requested that CMS increase its outreach to MIPS eligible 
clinicians who have not successfully reported under PQRS in the past to 
help them to achieve the reporting standard during this time. A few 
commenters stated that going forward CMS should ensure that the 
timeframes for annual MACRA regulations, subregulatory guidance and 
other agency communications are sufficient to allow MIPS eligible 
clinicians and health plans to act on the information in advance of the 
applicable performance years. For purposes of publishing the list of 
APMs, Medical Home Models, MIPS APMs, Advanced APMs, and eventually 
other-payer APMs, the commenter believed that CMS should start the 
process at least 15 months in advance of the applicable performance 
year, and finalize the list at least 9 months in advance of the 
applicable performance year.
    Response: We appreciate the support. We have multiple mechanisms we 
have employed to reach out to all MIPS eligible clinicians to provide 
support. We will make every effort to ensure the timeframes for agency 
communications are sufficient to allow MIPS eligible clinicians and 
health plans to act on the information in advance of the applicable 
performance period. Please refer to section II.F.4. of this final rule 
with comment period for further information on how we will make clear 
the status of any APM upon its first public announcement.
    Comment: Other commenters urged CMS to communicate submission 
problems to both vendors and practices as soon as possible to allow for 
alternative submission mechanisms and to encourage vendors to be open 
about their ability to meet data submission standards.
    Response: We make every effort to communicate submission problems 
to stakeholders through multiple communication channels including 
health IT vendors, specialty societies, registries, and MIPS eligible 
clinicians as soon as possible and will continue to do so in the 
future.
    Comment: One commenter supported using claims paid within 60 days 
after the performance period.
    Response: We agree and appreciate the commenters support. We are 
finalizing our proposal to use claims that are processed within 60 
days, after the end of the performance period for purposes of assessing 
performance and computing the MIPS payment adjustment.
    After consideration of the comments we received regarding the MIPS 
performance period, we are finalizing a modification of our proposal of 
a 12-month performance period that occurs 2 years prior to the 
applicable payment year. For the transition year of MIPS, we believe it 
is important that we provide flexibility to MIPS eligible clinicians as 
they familiarize themselves with MIPS requirements while maintaining 
reliability. Therefore, we are finalizing at Sec.  414.1320(a)(1) that 
for purposes of the 2019 MIPS payment year, for all performance 
categories and submission mechanisms except for the cost performance 
category and data for the quality performance category reported through 
the CMS Web Interface, for the CAHPS for MIPS survey, and for the all-
cause hospital readmission measure, the performance period under MIPS 
is a minimum of a continuous 90-day period within CY 2017, up to and 
including the full CY (January 1, 2017 through December 31, 2017). 
Thus, MIPS eligible clinicians will only need to report for a minimum 
of a continuous 90-day period within CY 2017, for the majority of the

[[Page 77085]]

submission mechanisms. This 90-day period can occur anytime within CY 
2017, so long as the 90-day period begins on or after January 1, 2017, 
and ends on or before December 31, 2017. Additionally, for further 
flexibility and ease of reporting this 90-day period can differ across 
performance categories. For example, a MIPS eligible clinician may 
utilize a 90-day period that spans from June 1, 2017-August 30, 2017 
for the improvement activities performance category and could use a 
different 90-day period for the quality performance category, such as 
August 15, 2017-November 13, 2017. The continuous 90-day period is a 
minimum; MIPS eligible clinicians may elect to report data on more than 
a continuous 90-day period, including a period of up to the full 12 
months of 2017. We note there are special circumstances in which MIPS 
eligible clinicians may submit data for a period of less than 90 days 
and avoid a negative MIPS payment adjustment. For example, in some 
circumstances, MIPS eligible clinicians may meet data completeness 
criteria for certain quality measures in less than the 90-day period. 
Also, in instances where MIPS eligible clinicians do not meet the data 
completeness criteria for quality measures, we will provide partial 
credit for these measures as discussed in section II.E.6. of this final 
rule with comment period.
    For groups that elect to utilize the CMS Web Interface or report 
the CAHPS for MIPS survey, we note that these submission mechanisms 
utilize certain assignment and sampling methodologies that are based on 
a 12-month period. In addition, administrative claims-based measures 
(this includes all of the cost measures and the all-cause readmission 
measure) are based on attributed population using the 12-month 
performance period. Accordingly, we are finalizing at Sec.  
414.1320(a)(2) that for purposes of the 2019 MIPS payment year, for 
data reported through the CMS Web Interface or the CAHPS for MIPS 
survey and administrative claims-based cost and quality measures, the 
performance period under MIPS is CY 2017 (January 1, 2017 through 
December 31, 2017). Please note that, unless otherwise stated, any 
reference in this final rule with comment period to the ``CY 2017 
performance period'' is intended to be an inclusive reference to all 
performance periods occurring during CY 2017.
    Additionally, we are finalizing at Sec.  414.1320(b)(1) that for 
purposes of the 2020 MIPS payment year, the performance period for the 
quality and cost performance categories is CY 2018 (January 1, 2018 
through December 31, 2018). For the improvement activities and 
advancing care information performance categories, we are finalizing 
the same approach for the 2020 MIPS payment year that we will have in 
place for the transition year of MIPS. Specifically, we are finalizing 
at Sec.  414.1320(b)(2) that for purposes of the 2020 MIPS payment 
year, the performance period for the improvement activities and 
advancing care information performance categories is a minimum of a 
continuous 90-day period within CY 2018, up to and including the full 
CY 2018 (January 1, 2018 through December 31, 2018).
    We are also finalizing a modification to our proposal, which was to 
use claims run-out data 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. Specifically, we are finalizing at Sec.  414.1325(f)(2) to 
use claims with dates of service during the performance period that 
must be processed no later than 60 days following the close of the 
performance period for purposes of assessing performance and computing 
the MIPS payment adjustment.
    Lastly, we are finalizing our proposal that individual MIPS 
eligible clinicians or groups who report less than 12 months of data 
(due to family leave, etc.) would be required to report all performance 
data available from the applicable performance period (for example, to 
any 90-day period).
5. MIPS Performance 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 
final score under the MIPS: Quality; cost; improvement activities; 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 cost 
performance category as the measurement of cost 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 cost 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. In the 
proposed rule, we solicited 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 improvement activities 
performance category as improvement activities 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 improvement activities 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

[[Page 77086]]

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 improvement 
activities.
    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 the proposed rule (81 FR 28173), 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.
    We did not request comments on this section, but we did receive a 
few comments which are summarized below.
    Comment: Some commenters requested that MIPS begin in its most 
basic structure involving as few measures as possible due to the fact 
that the practices have little or no experience in these processes and 
very limited staff, particularly in smaller practices. Another 
commenter recommended that CMS reduce the number of MIPS measures 
across the four performance categories. The commenter expressed concern 
that the implementation time will be slow due to developing 
relationships with data submission vendors which will lead to practices 
being overwhelmed by the number of measures.
    Some commenters suggested that instead of focusing on four 
performance categories simultaneously, CMS should focus on 
interoperability and making that functionality fully workable before 
moving on to the next step.
    One commenter was very concerned that the cumulative effect of four 
sets of largely separate measures and activities, scoring 
methodologies, and reporting requirements could result in more 
administrative work for practices, not less, and encouraged CMS to 
consider additional ways to reduce the MIPS reporting burden for all 
practices such as reducing the number of required measures or 
activities in each MIPS performance category, lowering measure 
thresholds, establishing consistent definitions (such as for ``small 
practices'') across categories, and providing more opportunities for 
``partial credit.'' Other commenters urged CMS to take every possible 
step to dramatically simplify provisions and requirements, and to 
revise and develop practice-focused communications to reduce any 
remaining perceived complexity.
    Another commenter agreed with the level of flexibility CMS has 
proposed for MIPS eligible clinicians by allowing them to choose the 
specific quality performance measures most applicable to their practice 
and stated that CMS should design the requirements within the 
performance categories to work in concert with each other to ensure 
meaningful quality measurement. Some commenters asked if there will be 
interoperability between the four MIPS performance categories.
    Response: As discussed in section II.E.5.b.(3) of this final rule 
with comment period, we have decreased the data submission criteria for 
the quality performance category to a level that reduces burden while 
still maintaining meaningful measurements at this time. We will 
continue to assess this approach to improve on this aspect in the 
future. We appreciate the commenters' request for simplicity and the 
need for clear communications. We will continue to look for ways to 
simplify the MIPS program in the future and will work to ensure clear 
communications with the MIPS eligible clinician community on all of the 
MIPS provisions. We note that the definition of a small practice is the 
same across all four performance categories and is consistent with the 
statute. We have codified the definition of a small practice for MIPS 
at Sec.  414.1305 as practices consisting of 15 or fewer clinicians and 
solo practitioners.
    Further, we are required by statute to utilize the four performance 
categories to determine the final score. We appreciate the support and 
agree that the goal of the MIPS program is that the four performance 
categories should work in concert with one another. In addition, as 
discussed in section II.E.5. of this final rule with comment period, we 
have modified our policies to have the four performance categories work 
more in concert with one another.
    Comment: One commenter requested that CMS simplify the MIPS to the 
extent practicable by further limiting the number of measures 
reportable under each performance category and refraining from 
introducing any new and previously untested measures (for example, 
population-based quality measures).
    Response: In any quality measurement program, we must balance the 
data collection burden that we must impose on MIPS eligible clinicians 
with the resulting quality performance data that we will receive. We 
believe that without sufficiently robust performance data, we cannot 
accurately measure quality performance. Therefore, we believe that we 
have appropriately struck a balance between requiring sufficient 
quality measure data from MIPS eligible clinicians and ensuring robust 
quality measurement at this time. Regarding the global and population-
based measures, we refer the reader to section II.E.5.b.(6) of this 
final rule with comment period.
    Comment: One commenter stated that CMS appears to view the four 
MIPS categories as separate but should treat them holistically. The 
commenter suggested unifying definitions across all MIPS categories, 
such as the proposed definition of a ``small practice'' as consisting 
of 15 or fewer clinicians.
    Response: We are required by statute to utilize the four 
performance categories to determine the final score. As the program 
evolves we believe the performance categories will become more 
streamlined and integrated. The definition of a small practice is the 
same across all four performance categories and is consistent with the 
statute. We have codified the definition of a small practice for MIPS 
at Sec.  414.1305 as practices consisting of 15 or fewer clinicians and 
solo practitioners.
    Comment: Some commenters suggested combining the improvement 
activities and advancing care information performance categories.
    Response: Each of these performance categories is statutorily 
mandated, and we believe each has a distinct role in the MIPS program.
    Comment: Another commenter stated that data and reporting 
requirements should generally be efficient, strong,

[[Page 77087]]

and actionable for the purposes of quality improvement, payment, 
consumer decision-making, and any other areas where they can be useful. 
Another commenter generally recommended that quality measures in the 
MIPS program be meaningful, that innovative science should be 
accommodated when achieving quality aims in areas without measures or 
therapies, and incentives surrounding cost should reward high-value 
care, not simply low cost.
    Response: We appreciate the commenters' support.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
(2) Submission Mechanisms
    We proposed 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, improvement activities and advancing care 
information performance categories. We did not propose at Sec.  
414.1325(f) any data submission requirements for the cost performance 
category and for certain quality measures used to assess performance on 
the quality performance category and for certain activities in the 
improvement activities performance category. For the cost performance 
category, we proposed that each individual MIPS eligible clinician's 
and group's cost 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 cost performance category. In addition, we would be using 
administrative claims data to calculate performance on a subset of the 
MIPS quality measures and the improvement activities performance 
category, if technically feasible. For this subset of quality measures 
and improvement activities, 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 cost measures and quality measures, if data are 
available. We proposed multiple data submission mechanisms for MIPS as 
outlined in Tables 1 and 2 in the proposed rule (81 FR 28182) and the 
final policies identified in Tables 3 and 4 in this final rule with 
comment period, 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.

     Table 1--Proposed Data Submission Mechanisms for MIPS Eligible
              Clinicians Reporting Individually as TIN/NPI
------------------------------------------------------------------------
  Performance category/submission   Individual reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  Claims.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    Administrative claims (no submission
                                     required).
Cost..............................  Administrative claims (no submission
                                     required).
Advancing Care Information........  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
Improvement Activities............  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    Administrative claims (if
                                     technically feasible, no submission
                                     required).
------------------------------------------------------------------------


         Table 2--Proposed Data Submission Mechanisms for Groups
------------------------------------------------------------------------
  Performance category/submission      Group Reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  QCDR.
                                    Qualified registry.
                                    EHR.
                                    CMS Web Interface (groups of 25 or
                                     more).
                                    CMS-approved survey vendor for CAHPS
                                     for MIPS (must be reported in
                                     conjunction with another data
                                     submission mechanism.)
                                    and
                                    Administrative claims (no submission
                                     required).
Cost..............................  Administrative claims (no submission
                                     required).
Advancing Care Information........  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    CMS Web Interface (groups of 25 or
                                     more).

[[Page 77088]]

 
Improvement Activities............  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    CMS Web Interface (groups of 25 or
                                     more).
                                    Administrative claims (if
                                     technically feasible, no submission
                                     required).
------------------------------------------------------------------------

    We proposed 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 
performance category. For example, a MIPS eligible clinician could use 
one submission mechanism for sending quality measures and another for 
sending improvement activities 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 believe the proposal to allow 
multiple mechanisms, while restricting the number of mechanisms per 
performance category, offers flexibility without adding undue 
complexity.
    For individual MIPS eligible clinicians, we proposed at Sec.  
414.1325(b), that an individual MIPS eligible clinician may choose to 
submit their quality, improvement activities, and advancing care 
information performance category data using qualified registry, QCDR, 
or EHR submission mechanisms. Furthermore, we proposed 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, improvement activities, and advancing 
care information. In the proposed rule (81 FR 28280), we expanded third 
party intermediaries' capabilities by allowing them to submit data and 
activities for quality, improvement activities, and advancing care 
information performance categories. Additionally, we proposed 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 improvement activities and advancing care information performance 
category data through attestation.
    For groups that are not reporting through the APM scoring standard, 
we proposed at Sec.  414.1325(c) that these groups may choose to submit 
their MIPS quality, improvement activities, and advancing care 
performance category information data using qualified registry, QCDR, 
EHR, or CMS Web Interface (for groups of 25+ MIPS eligible clinicians) 
submission mechanisms. Furthermore, we proposed 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, improvement 
activities, and advancing care information. Additionally, we proposed 
that groups may elect to submit their improvement activities 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 the proposed rule 
(81 FR 28234), which describes how certain APM Entities submit data to 
MIPS, including separate approaches to the quality and cost performance 
categories for APMs.
    We proposed one exception to the requirement for one reporting 
mechanism per performance category. Groups that elect to include CAHPS 
for MIPS survey 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 proposed to allow MIPS eligible clinicians and groups to 
submit data for different performance categories via multiple 
submission mechanisms, we encouraged MIPS eligible clinicians to submit 
MIPS information for the improvement activities 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, improvement activities, and 
advancing care information performance category information. However, 
we were concerned that not all third party entities would be able to 
implement the changes necessary to support reporting on all performance 
categories in the transition year. We solicited 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 noted at (81 FR 28181), we proposed that MIPS eligible 
clinicians may report measures and activities using different 
submission methods for each performance category if they choose for 
reporting data for the CY 2017 performance period. As we gain 
experience under MIPS, we anticipate that in future years it may be 
beneficial for, and reduce burden on MIPS eligible clinicians and 
groups, 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 does submit data via multiple submission 
mechanisms (for example, registry and QCDR), we would score all the 
measures in each submission mechanism and use the highest performance 
score for the MIPS eligible clinician or group as described at (81 FR 
28247). However, we would not be blending measure results across 
submission mechanisms. We encourage MIPS eligible clinicians to report 
data for a given performance category using a single data 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 final score 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 the proposed rule used the term CEHRT and certified health IT 
in different contexts. For an explanation of these terms and contextual 
use within

[[Page 77089]]

the proposed rule, we refer readers to the proposed rule (81 FR 28256).
    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, CMS Web 
Interface, or CEHRT submission mechanisms see the proposed rule (81 FR 
28247). By promoting the 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 improvement activities 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 final 
score.
    We requested comments on these proposals.
    The following is summary of the comments we received on our 
proposals regarding MIPS data submission mechanisms.
    Comment: Several commenters expressed concern that, by providing 
too many data submission mechanisms and reporting flexibility to MIPS 
eligible clinicians, CMS would be allowing MIPS eligible clinicians to 
report on arbitrary quality metrics or metrics on which those MIPS 
eligible clinicians are performing well versus metrics that reflect 
areas of needed improvement. The commenters recommended that CMS ensure 
high standard final scoring, promote transparency, and enable 
meaningful comparisons of the clinicians' performance for specific 
services.
    Response: We believe allowing multiple data submission mechanisms 
is beneficial to the MIPS eligible clinicians as they may choose 
whichever data submission mechanism works best for their practice. We 
have provided many data submission options to allow the utmost 
flexibility for the MIPS eligible clinician. Based on our experience 
with existing quality reporting programs such as PQRS, we do not 
believe multiple data submission mechanisms will encourage MIPS 
eligible clinicians to report on arbitrary quality metrics or metrics 
on which those MIPS eligible clinicians are performing well versus 
metrics that reflect areas of needed improvement. We will monitor 
measure selection and performance through varying data submission 
mechanisms as we implement the program. However, we agree with 
commenters that measuring meaningful quality measures and encouraging 
improvement in the quality of care are important goals of the MIPS 
program. As such, we will monitor whether data submission mechanisms 
are allowing MIPS eligible clinicians to focus only on metrics where 
they are already performing well and will address any modifications 
needed to our policies based on these monitoring efforts in future 
rulemaking.
    Comment: Another commenter supported the requirement to use only 
one submission mechanism per performance category. Other commenters 
appreciated that CMS is allowing MIPS eligible clinicians to choose 
data submission options that vary by performance category.
    Response: We agree with the commenters and appreciate the support. 
We are finalizing the policy as proposed of requiring MIPS eligible 
clinicians to submit all performance category data for a specific 
performance category via the same data submission mechanism. In 
addition, we are finalizing the policy to allow MIPS eligible 
clinicians to submit data using differing submission mechanisms across 
different performance categories. We refer readers to section 
II.E.5.a.(2) of this final rule with comment period where we discuss 
our approach for the rare 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), and how we score those MIPS 
eligible clinicians. We further note that in that section we are 
seeking comment for further consideration on different approaches for 
addressing this scenario.
    Comment: Another commenter sought clarification as to whether MIPS 
eligible clinicians may use more than one data submission method per 
performance category. The commenter recommended the use of multiple 
data submission methods across performance categories because there are 
currently significant issues with extracting clinical data from EHRs to 
provide to a third party for calculation. The commenter believed that 
requiring a single submission method may force MIPS eligible clinicians 
to submit inaccurate data that does not reflect actual performance.
    Response: As noted in this final rule with comment period, MIPS 
eligible clinicians will have the flexibility to choose different 
submission mechanisms across different performance categories for 
example, utilizing a registry to submit data for quality and CEHRT for 
the advancing care information performance category. MIPS eligible 
clinicians will need to choose however, one submission mechanism per 
performance category, except for MIPS eligible clinicians who elect to 
report the CAHPS for MIPS survey, which must be reported via a CMS-
approved survey vendor in conjunction with another submission mechanism 
for all other quality measures. As discussed in this section of this 
final rule with comment period, we are finalizing policy that allows 
MIPS eligible clinicians to choose to report for a minimum of as few as 
90 consecutive days within CY 2017 for the majority of submission 
mechanisms. We believe this allows for adequate time for those MIPS 
eligible clinicians who are not already successfully reporting quality 
measures meaningful to their practice via CEHRT under the EHR Incentive 
Program and/or PQRS to evaluate their options and select the measures 
and a reporting mechanism that will work best for their practice. We 
will be providing subregulatory guidance for MIPS eligible clinicians 
who encounter issues with extracting clinical data from EHRs.
    Comment: A few commenters recommended that CMS reduce complexity by 
reducing the number of available reporting methods as health IT reduces 
the need to retain claims and registry-based reporting in the program. 
Other commenters supported the use of electronic data reporting 
mechanisms noted that due to the complexity of the MIPS, they were 
concerned that using claims data submission for quality measures may 
place MIPS eligible clinicians at a disadvantage due to the significant 
lag between performance feedback and the performance period.
    Response: We appreciate the commenters' feedback. We agree that the 
usage of health IT in the future will reduce our reliance on non-IT 
methods of reporting such as claims. We do believe, however, that we 
cannot eliminate submission mechanisms such as claims until broader 
adoption of health IT and registries occurs. Therefore, we do intend to 
finalize both the claims and registry submission mechanisms. We also 
refer readers to section II.E.8.a. for final polices regarding 
performance feedback.

[[Page 77090]]

    Comment: Some commenters expressed appreciation for our proposal to 
continue claims-based reporting for the quality performance category 
because this is the most convenient method for hospitals-based 
clinicians. The commenters explained that hospital-based MIPS eligible 
clinicians must use the EHRs of the hospitals in which they practice, 
which may limit the capabilities of these EHRs for reporting measures. 
Other commenters requested that CMS ensure that the option for claims 
reporting was available to all MIPS eligible clinicians, noting that 
there was only one anesthesia-related quality measure available for 
reporting via registry. Under such circumstances, the commenters asked 
CMS to ensure that MIPS did not impose excessive time and cost burdens 
on MIPS eligible clinicians by forcing them to use a different 
submission mechanism. Another commenter noted that the preservation of 
the claims-based reporting option will help those emergency medicine 
practices that have relied on this reporting option in the past make 
the transition to the new MIPS requirements. The commenter noted the 
additional administrative burden associated with registry reporting, 
including registration fees.
    Response: We appreciate the commenters' support. We do note that we 
intend to reduce the number of claims-based measures in the future as 
more measures are available through health IT mechanisms such as 
registries, QCDRs, and health IT vendors, but we understand that many 
MIPS eligible clinicians still submit these types of measures. We 
believe claims-based measures are a necessary option to minimize 
reporting burden for MIPS eligible clinicians at this time. We intend 
to work with MIPS eligible clinicians and other stakeholders to 
continue improving available measures and reporting methods for MIPS. 
In addition, we are finalizing policies that offer MIPS eligible 
clinicians substantial flexibility and sustain proven pathways for 
successful participation. Those MIPS eligible clinicians who are not 
already successfully reporting quality measures meaningful to their 
practice via one of these pathways will need to evaluate the options 
available to them and choose which available reporting mechanism and 
measures they believe will work best for their practice.
    Comment: A few commenters recommended that more quality measures be 
made available for reporting via claims or EHRs noting that there were 
more quality measures available for reporting by registry compared with 
EHRs or claims. The commenters stated that this will push clinicians to 
sign up with registries, undercuts fully using EHRs, and only services 
the interests of organizations who manage registries.
    Response: We appreciate the commenters' concern and are working 
with measure developers to develop more measures that are 
electronically based. We refer the commenter to the Measure Development 
Plan for more information https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf.
    Additionally, in section II.E.9.(b). of this final rule with 
comment period, we have expanded health IT vendors' opportunities by 
allowing health IT vendors to submit data on measures, activities, or 
objectives for any of the following MIPS performance categories: (i) 
Quality; (ii) improvement activities; or (iii) advancing care 
information. In addition, the health IT vendor submitting data on 
behalf of a MIPS eligible clinician or group would be required to 
obtain data from the MIPS eligible clinician's certified EHR 
technology. However, the health IT vendor would be able to submit the 
same information the qualified registry is able to. Therefore, we do 
not believe there is a disparity between health IT vendors and 
qualified registry's quality data submission capabilities.
    Comment: Other commenters stated that the use of CEHRT in all areas 
of the MIPS program should be required rather than just encouraged. The 
commenters stated that the use of CEHRT is required for participation 
in the Meaningful Use EHR Incentive Programs, is vitally important for 
ensuring successful interoperability, and is already part of the 
definition of a Meaningful EHR User for MIPS.
    Response: We do not believe it is appropriate to require CEHRT in 
all areas of the MIPS program as many MIPS eligible clinicians may not 
have had past experience relevant to the performance categories and use 
of EHR technology because they were not previously eligible to 
participate in the Medicare EHR Incentive Program. The restructuring of 
program requirements described in this final rule with comment period 
are geared toward increasing participation and EHR adoption. We believe 
this is the most effective way to encourage the adoption of CEHRT, and 
introduce new MIPS eligible clinicians to the use of certified EHR 
technology and health IT overall. As discussed in section 
II.E.6.a.(2)(f) of this final rule with comment period, 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, CMS Web Interface, or CEHRT submission 
mechanisms. By promoting use of CEHRT through various submission 
mechanisms, we believe MIPS eligible clinicians have flexibility in 
implementing electronic reporting in a manner which best suits their 
practice.
    Comment: One commenter requested information on how non-Medicare 
payers would route claims data to CMS for purposes of considering cost 
performance category data.
    Response: All measures used under the cost performance category 
would be derived from Medicare administrative claims data submitted for 
billing on Part B claims by MIPS eligible clinicians and as a result, 
participation would not require use of a separate data submission 
mechanism. Please note that the cost performance category is being 
reweighted to zero for the transition year of MIPS. Refer to section 
II.E.5.e. of this final rule with comment for more information on the 
cost performance category.
    Comment: Other commenters requested clarification on the difference 
between ``claims'' and ``administrative claims'' as reporting methods, 
citing slides 24 and 39 of the May 10th Quality Payment Program 
presentation, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Quality-Payment-Program.html. The commenters were 
confused because ``claims'' was listed as a method of reporting but it 
was stated that ``administrative claims'' will not require submission.
    Response: The ``claims'' submission mechanism refers to those 
quality measures as described in section II.E.5.b.(6). of this final 
rule with comment period. The claims submission mechanism requires MIPS 
eligible clinicians to append certain billing codes to denominator 
eligible claims to indicate to us the required quality action or 
exclusion occurred. Conversely, the administrative claims submission 
mechanism refers to those measures described in section II.E.5.b. for 
the quality performance category and section II.E.5.e. for the cost 
performance category of this final rule with comment period. 
Administrative claims submissions require no separate data submission 
to CMS. Rather, we calculate these measures based on data available 
from MIPS eligible clinicians' billings on Medicare Part B claims.

[[Page 77091]]

    Comment: Other commenters stated that some of the measures and 
activities, such as the CAHPS for MIPS survey, were dependent on third 
party intermediaries, over which practices have little control. The 
commenters recommended that CMS reduce requirements that are outside of 
the practice's control.
    Response: We believe the MIPS program has a broad span of measures 
and activities from which to choose. There are many measures and 
activities that are not dependent on a third party intermediary. We 
encourage MIPS eligible clinicians to report the measures and 
activities that are most meaningful to their practice.
    Comment: Another commenter stated that if CMS were to require 
vendors to have the capability to submit data for all performance 
categories, a vendor would need adequate time to implement any required 
changes going forward, would need CMS to produce implementation guides 
for 2017 reporting as soon as possible with the capability to ask CMS 
clarifying questions, and would need a testing tool no later than the 
3rd quarter. Several commenters did not support the proposed 
requirement that vendors have the capability to submit data for all 
MIPS performance categories. The commenters stated many product 
developers and product or service vendors have developed solutions 
tailored to specific areas of healthcare quality and performance 
improvement. The commenters stated that given the breadth of the 
proposed MIPS requirements, CMS should not require health IT companies 
to have the capability to submit information for all four MIPS 
performance categories because this task may be outside of their 
organizational and client priorities. Another commenter stated that 
while they appreciate CMS' attempts to reduce administrative burden 
they have a concern that third party entities will not be able to 
implement the necessary changes to support reporting on all performance 
categories in the transition year. In addition, the commenter was 
concerned that the additional cost of creating this functionality will 
be passed on to MIPS eligible clinicians in the form of higher fees for 
using those products and services. The commenter urged CMS to work with 
health IT developers, vendors, and other data intermediaries to ensure 
that data products and services evolve as CMS's policies evolve and to 
ensure adequate advanced notice of upcoming changes so that MIPS 
eligible clinicians will not be penalized for failing to report data 
the third party intermediary's technology was not updated to collect.
    Response: We would like to explain that we are not finalizing a 
requirement that a third party intermediary submitting data on behalf 
of a MIPS eligible clinician or group must become qualified to submit 
data for multiple MIPS performance categories, nor are we finalizing a 
certification requirement for submission of data. We are instead 
finalizing specific requirements for QCDRs related to quality data 
submission, and for a health IT vendor or other authorized third party 
intermediary that is submitting data for any or all of the MIPS 
performance categories on behalf of an MIPS eligible clinician or group 
must meet the form and manner requirements for each submission method. 
We direct readers to section II.E.9.b. of this final rule with comment 
period for further discussion of health IT vendor and other authorized 
third party intermediaries. We direct readers to section II.E.9.a. of 
this final rule with comment period for further discussion of 
submission requirements for QCDRs.
    Comment: Another commenter stated that the CMS Web Interface should 
have fewer down times during the first quarter submission period, 
following the performance period, to compensate for MIPS eligible 
clinicians' need to submit their files.
    Response: We intend to make every effort to keep the CMS Web 
Interface from having down times during the first quarter submission 
period. In some instances, down times are required to account for 
necessary system maintenance within CMS. When these down times do 
occur, we make every effort to ensure that the down times do not occur 
near final submission deadlines and to notify all groups and impacted 
parties well in advance so they can account for these down times during 
the data submission period.
    Comment: One commenter encouraged utilizing EHRs and claims to 
collect quality measure data whenever possible.
    Response: We agree with utilizing EHR whenever possible and 
encourage the use of EHR to collect data whenever possible. However, we 
intend to reduce the number of claims-based measures that in future 
years, but we note that many MIPS eligible clinicians still submit 
these types of measures. We believe claims-based measures are a 
necessary option to minimize reporting burden for MIPS eligible 
clinicians. We intend to work with MIPS eligible clinicians and other 
stakeholders to continue improving available measures and reporting 
methods for MIPS.
    Comment: One commenter expressed concern that multi-specialty 
groups reporting through a QCDR would face challenges if multiple 
specialties wanted to report non-MIPS measures. This commenter believed 
this would require reporting via two different submission mechanisms.
    Response: QCDRs are able to report both non-MIPS measures and MIPS 
measures. They are provided a great deal of flexibility and should be 
able to report for multiple specialties.
    Comment: Another commenter requested clarity regarding the 
submission mechanisms for a group. The commenter sought flexibility to 
use the most appropriate submission mechanism for each of the 
performance categories. Another commenter suggested continuing 2017 
reporting via CMS Web Interface for groups. The commenter stated that 
at a minimum, the CMS Web Interface reporting and EHR direct reporting 
should be maintained.
    Response: Please refer to the final submission mechanisms in Tables 
3 and 4 of this final rule with comment period for the available 
submission mechanisms for all MIPS eligible clinicians.
    Comment: Another commenter expressed concern that CMS proposed to 
allow measures which are available to report via EHR technology to be 
reported via a QCDR, because the commenter believed this would result 
in unnecessary burden as practices would be required to seek another 
data submission vendor beyond their EHR vendor. The commenter 
recommended that CMS allow MIPS eligible clinicians to report quality 
measures and improvement activities using their certified EHR 
technology.
    Response: MIPS eligible clinicians will have the flexibility to 
submit their quality measures and improvement activities using their 
certified EHR technology. The health IT vendor would need to meet the 
requirements as described in section II.E.9.b. of this final rule with 
comment period to offer this flexibility to their clients.
    Comment: A few commenters agreed with the proposal to allow third 
party submission entities, such as QCDRs and qualified registries, to 
submit data for the performance categories of quality, advancing care 
information, and improvement activities. The commenters believed that 
allowing MIPS eligible clinicians to use a single, third party data 
submission method reduces the administrative burden on MIPS eligible 
clinicians, facilitates consolidation and standardization of data from 
disparate EHRs and other systems, and enables the third parties to 
provide timely, actionable feedback to

[[Page 77092]]

MIPS eligible clinicians on opportunities for improvement in quality 
and value. Other commenters agreed with the proposals that encourage 
the use of QCDRs because QCDRs are able to quickly implement new 
quality measures to assist MIPS eligible clinicians with accurately 
measuring, reporting, and taking action on data most meaningful to 
their practices. Another commenter stated that vendors and QCDRs should 
have the capability to submit data for all MIPS performance categories. 
The commenter believed that working through a single vendor is the only 
way to provide a full picture of overall performance.
    Response: We thank the commenters for their support.
    Comment: A few commenters expressed support for the Quality Payment 
Program's approach of streamlining the PQRS, VM, and EHR Incentive 
Program into MIPS and encouraged CMS to continue to allow existing data 
reporting tools to report MIPS quality data. Hospitals have already 
made significant investments in existing reporting tools. Other 
commenters supported the option to use a single reporting mechanism 
under MIPS. The commenters considered this a positive development, and 
one that would be attractive to many groups and hospitals. Some 
commenters noted that CMS offers significant flexibility across 
performance category reporting options, and supported the proposal to 
accept data submissions from multiple mechanisms. The commenters urged 
CMS to retain this flexibility in future years and to hold QCDR and 
other vendors accountable for offering MIPS reporting capabilities 
across all performance categories. One commenter was pleased that CMS 
is allowing flexibility in measure selection and reporting via any 
reporting mechanism, and report as an individual or a group. Another 
commenter supported the proposal allowing MIPS eligible clinicians who 
are in a group to report on MIPS either as part of the group or 
individually. This flexibility would allow low performing groups the 
opportunity to reap the benefits of their higher performance. Other 
commenters were very supportive of the use of bonus points in the 
quality performance category to encourage the use of CEHRT and 
electronic reporting of CQMs.
    Response: We thank the commenters for their support on the various 
approaches. We would like to explain that groups must report either 
entirely as a group or entirely as individuals; groups may not have 
only some individual reporting. Groups must decide to report as a group 
across all four performance categories.
    Comment: Another commenter recommended that CMS adopt a clear, 
straightforward, and prospective process for practices to determine 
whether a MIPS performance category applies to their particular 
specialty and subspecialty.
    Response: We agree with the commenter and are working to establish 
educational tools and materials that will clearly indicate to MIPS 
eligible clinicians their requirements based on their specialty or 
practice type.
    Comment: One commenter urged CMS to offer a quality and cost 
performance category measure reporting option in which hospital-based 
MIPS eligible clinicians can use the hospital's measure performance 
under CMS hospital quality programs for purposes of MIPS.
    Response: We appreciate the feedback and will take it into 
consideration for future rulemaking. We also note that in the Appendix 
in Table C of this final rule with comment period we have created a 
specialty-specific measure set for hospitalists.
    Comment: Another commenter recommended that CMS and HRSA 
collaborate to develop a data submission mechanism that would allow 
MIPS eligible clinicians practicing in FQHCs to submit quality data one 
time for both MIPS and Uniform Data System (UDS).
    Response: We intend to address this option in the future through 
separate notice-and-comment rulemaking.
    Comment: Some commenters supported the proposed data submission 
mechanisms and the proposal that MIPS eligible clinicians and groups 
must use the same mechanism to report for a given performance category 
with the exception of those reporting the CAHPS for MIPS survey.
    Response: We thank the commenters for their support.
    Comment: Other commenters agreed with the proposal to maintain a 
manual attestation portal option for some of the performance 
categories. The commenters believed that this option provided MIPS 
eligible clinicians with an option of consolidating and submitting data 
on their own, which for some may reduce their overall cost to 
participate. The commenters recommended that this option remain in 
place for the future, but that if CMS decided to remove it, they 
provide EHR vendors at least 18 months' notice to develop and deploy 
data submission mechanisms.
    Response: We appreciate the support and will take the feedback into 
consideration in the future.
    Comment: Another commenter encouraged CMS to ensure that the 
reporting requirements for MIPS are aligned with each of the American 
Board of Medical Specialties (ABMS) Member Board's requirements for 
Maintenance of Certification, particularly activities required to 
fulfill Part IV: Improvement in Medical Practice.
    Response: We align our quality efforts where possible. We intend to 
continue to receive input from stakeholders, including ABMS, in the 
future.
    Comment: One commenter suggested that CMS ensure that the MIPS 
reporting process is simple to understand, conducive to automated 
reporting and clinically relevant.
    Response: We believe we have made the reporting process as flexible 
and simple as possible for the MIPS program at this time. We have 
provided several data submission mechanisms, activities, and measures 
for MIPS eligible clinicians to choose from. We intend to continue to 
work to improve the program in the future as we gain experience under 
the Quality Payment Program.
    Comment: Another commenter was appreciative that CMS outlined a 
data validation and auditing process in the proposed rule. The 
commenter requested more details about implementation, including CMS' 
timeline for providing performance reports to MIPS eligible clinicians.
    Response: We thank the commenters for their support. We refer 
readers to section II.E.8.e. for information on data validation and 
section II.E.8.a. for information on performance feedback of this final 
rule with comment period.
    Comment: A few commenters urged CMS to integrate patient and family 
caregiver perspectives as part of Quality Payment Program development. 
The commenters noted that value and quality are often perceived through 
``effectiveness'' and ``cost'' whereas the patient typically 
prioritizes outcomes beyond clinical measures.
    Response: We agree that the patient and family caregiver 
perspective is important, but note that we would expect patients and 
caregivers to prioritize successful health outcomes. We are finalizing 
the policy that the CAHPS for MIPS survey would count as a patient 
experience measure which is a type of high priority measure. In 
addition, a MIPS eligible clinician may be awarded points under the 
improvement activities performance category as the CAHPS for MIPS 
survey is included in the Patient Safety and Practice Assessment 
subcategory.

[[Page 77093]]

    Comment: One commenter expressed concern that no measures exist 
that are useful to MIPS eligible clinicians working in multiple 
settings with diverse patient populations.
    Response: We believe the MIPS program has a broad span of measures 
and activities from which to choose. There are many measures and 
activities that are applicable to multiple treatment facility types and 
diverse patient populations. We encourage MIPS eligible clinicians to 
report the measures and activities that are most meaningful to their 
practice.
    Comment: One commenter stated that CMS should clarify the reporting 
options for nephrologists who practice in multiple settings. The 
commenter urged CMS to provide illustrative examples of options for 
nephrologists based on actual sample clinical practices.
    Response: The final data submission options for all MIPS eligible 
clinicians are outlined in this final rule with comment period in 
Tables 3 and 4. We intend to provide further subregulatory guidance and 
training opportunities for all MIPS eligible clinicians in the future. 
In addition, the MIPS eligible clinician may reach out to the Quality 
Payment Program Service Center with any questions.
    Comment: Other commenters recommended that CMS not amend the 
technical specifications for eCQMs until MIPS eligible clinicians are 
required to transition to 2015 Edition CEHRT to report data for MIPS. 
In addition, the commenters requested that CMS maintain the eMeasure 
versions issued with the EHR Incentive Program Stage 2 final rule until 
that transition point. The commenters noted that by delaying any 
changes to eCQM measures until 2018, CMS will give the health IT 
industry and MIPS eligible clinicians the necessary time to adapt to 
new reporting demands and respond appropriately to new specifications.
    Response: We understand the concerns of needing necessary time to 
adapt to new reporting requirements. Therefore, we did not make major 
amendments to the technical standards for eCQMs. We have updated 
measure specification for various eCQMs to align with current clinical 
guidelines. However, this alignment should not impact technical 
standards and certification requirements. We plan to update the EHR 
community to allow necessary time for implementers to adapt any new 
standards required to report eCQMs in the future.
    Comment: One commenter recommended that technologies such as the 
CMS Web Interface be available for submission of all data, not just the 
quality performance category.
    Response: We appreciate the feedback and note that we are expanding 
the ability of the CMS Web Interface to be used for submissions on 
improvement activities, advancing care information, and quality 
performance categories.
    Comment: Another commenter stated that the avenue for reporting 
different measures requires careful consideration because there are 
appropriate avenues of reporting depending upon different measure 
types. The commenter stated that this should be taken into 
consideration during measure development.
    Response: We appreciate the feedback and will take this suggestion 
into consideration in the future.
    Comment: One commenter supported allowing groups to utilize a 
CMS[hyphen]approved survey vendor for CAHPS for MIPS survey data 
collection in conjunction with another data submission mechanism. 
Another commenter proposed expanding the survey option in the future to 
include a CMS[hyphen]approved survey vendor for CAHPS for MIPS survey 
data collection for MIPS eligible clinicians reporting individually.
    Response: We would like to note that when a MIPS eligible clinician 
utilizes the CAHPS for MIPS survey they must also utilize another data 
submission mechanism in conjunction with it. We will take the 
suggestion of expanding the survey option to individuals in the future.
    Comment: One commenter believed that CMS could simplify MIPS 
reporting by streamlining the number of submission methods and focusing 
on the options that are most appropriate for each performance category. 
The commenter recommended the following options: (1) Quality: EHR 
Direct, QCDR, Qualified Registry, CMS Web Interface, remove Claims; (2) 
Cost: Claims; (3) Improvement Activities: Attestation, Claims, EHR 
Direct, QCDR, qualified registry, and CMS Web Interface; (4) Advancing 
care information: Attestation, EHR Direct, remove QCDR, remove 
qualified registry, and remove CMS Web Interface.
    Response: We appreciate the feedback as we are striving to balance 
simplicity with flexibility. We believe that by having numerous data 
submission mechanisms available for selection it reduces burden to MIPS 
eligible clinicians. The data submission options for all MIPS eligible 
clinicians are outlined in this final rule with comment period in 
Tables 3 and 4.
    Comment: Some commenters opposed the lack of transparency of the 
claims-based quality and cost performance category measures. The 
commenters recommended that CMS make the claims-based attribution of 
patients and diagnoses fully transparent to MIPS eligible clinicians 
and beneficiaries. They suggested CMS modify them so they accurately 
reflect each MIPS eligible clinician's contribution to quality and 
resource utilization.
    Response: We appreciate the feedback and will take the suggestions 
into consideration in the future. We would like to note that 
information regarding claims-based quality and cost performance 
category measures can be found in the Appendix of this final rule with 
comment period under Table A through Table G under the ``data 
submission method'' tab. In addition, claims-based quality measures 
information may be found at QualityPaymentProgram.cms.gov.
    Comment: Another commenter recommended that CMS consider allowing 
MIPS eligible clinicians to report across multiple QCDRs because 
allowing MIPS eligible clinicians to report through multiple QCDRs 
would permit the specificity of reporting required for diverse 
specialties, but without increasing the IT integration burden on MIPS 
eligible clinicians who might already be reporting through these 
registries.
    Response: Many QCDRs charge their participants for collecting and 
reporting data. Not only might this increase the cost to MIPS eligible 
clinicians, but it would make the calculation of the quality score that 
much more cumbersome and prone to error. Errors that could occur 
include incorrect submission of TIN or NPI information, incomplete data 
for one or more measures, etc. We note, however, that MIPS eligible 
clinicians do have the flexibility to submit data using different 
submission mechanisms across the different performance categories. For 
example, one QCDR could report the advancing care information 
performance category for a particular MIPS eligible clinician, and that 
MIPS eligible clinician could use another QCDR to report the quality 
performance category.
    Comment: One commenter requested that CMS clearly state the 
reporting requirements for each reporting mechanism for quality. The 
commenter noted that MIPS eligible clinicians who elect to submit four 
eCQMs will submit that data through a QCDR, qualified registry, or EHR 
with the QRDA standard that is certified, and then be restricted on 
their ability to use the attestation mechanism for the remaining two 
quality measures if they elect to submit non-eCQMs that do not require

[[Page 77094]]

certification. The commenter agreed that not all submitted measures 
need to be eCQMs, but believed CMS needed to provide greater clarity on 
handling such a scenario and wanted CMS to consider the submission 
mechanism's ability to submit data using a single standard.
    Response: The quality data submission criteria is described in 
section II.E.5.a.(2) of this final rule with comment period. We would 
like to explain that attestation is not a submission mechanism allowed 
for the quality performance category, rather only for the improvement 
activities and advancing care information performance categories. 
Additionally, we are finalizing our policy that MIPS eligible 
clinicians would need to submit data for a given performance category 
only one submission mechanism. We refer readers to section II.E.5.a.(2) 
of this final rule with comment period where we discuss our approach 
for the rare 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), and how we score those MIPS eligible clinicians. We 
further note that in that section we are seeking comment for further 
consideration on different approaches for addressing this scenario.
    Comment: Some commenters agreed with the proposal of using 
submission methods already available in the current PQRS program 
because this allows QCDRs to focus on the creation of measures and 
adapting to final MIPS rule rather than on the submission process 
itself.
    Response: We appreciate the commenters' support.
    Comment: Several commenters noted they support the CMS goals of 
patient-centered health care, and the aim of the MIPS program for 
evidence-based and outcome-driven quality performance reporting. These 
commenters appreciated that the flexibility allowed in the MIPS 
program, including the variety of reporting options, is intended to 
meet the needs of the wide variety of MIPS eligible clinicians. The 
commenters believed, however, that the variety of reporting options can 
easily create confusion due to the increased number of choices and 
methods. Such confusion will be challenging in general, but could be 
especially problematic for 2017, given the short time to prepare. One 
commenter suggested that technical requirements for reporting options 
should be incorporated into CEHRT, and not added through subregulatory 
guidance. Another commenter stated that there are too many reporting 
options, and the number of options should be reduced.
    Response: We appreciate the commenters' support. We have provided 
several data submission mechanisms to allow flexibility for the MIPS 
eligible clinician. It is important to note that substantive aspects of 
technical requirements for reporting options incorporated into CEHRT 
have been addressed in section II.E.g. of this final rule with comment 
period. However, we intend to issue subregulatory guidance regarding 
further details on the form and manner of EHR submission.
    Comment: One commenter recommended CMS allow each specialty group 
within a multi-specialty practice to report its own group data file. 
The commenter suggested that if this cannot be done under a single TIN, 
then CMS should explicitly encourage multi-specialty practices that 
wish to report specialty-specific measure sets and improvement 
activities at the group level to register each specialty group under a 
different TIN for identification purposes. The commenter recognized 
that there may be operational challenges to implementing this 
recommendation and is willing to work with CMS and its vendors to 
develop the framework for the efficient collection and calculation of 
multiple data files for a single MIPS performance category from a 
group.
    Response: We appreciate the commenters' recommendation and will 
take it into consideration in future rulemaking. We refer readers to 
section II.E.1.e. of this final rule with comment period for more 
information on groups.
    After consideration of the comments on our proposals regarding the 
MIPS data submission mechanisms, we are modifying the data submission 
mechanisms at Sec.  414.1325. We will not be finalizing the data 
submission mechanism of administrative claims for the improvement 
activities performance category, as it is not technically feasible at 
this time. All other data submission mechanisms will be finalized as 
proposed. Specifically, we are finalizing at Sec.  414.1325(a) that 
MIPS eligible clinicians and groups must submit measures, objectives, 
and activities for the quality, improvement activities, and advancing 
care information performance categories.
    Refer to Tables 3 and 4 of this final rule with comment period for 
the finalized data submission mechanisms. Table 3 contains a summary of 
the data submission mechanisms for individual MIPS eligible clinicians 
that we are finalizing at Sec.  414.1325(b) and (e). Table 4 contains a 
summary of the data submission mechanisms for groups that are not 
reporting through an APM that we are finalizing at Sec.  414.1325(c) 
and Sec.  414.1325(e). Furthermore, we are finalizing our proposal at 
Sec.  414.1325(d) that except for groups that elect to report the CAHPS 
for MIPS survey, 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. In addition, we are 
finalizing at Sec.  414.1305 the following definitions as proposed: (1) 
Attestation means a secure mechanism, specified by CMS, with respect to 
a particular performance period, whereby a MIPS eligible clinician or 
group may submit the required data for the advancing care information 
or the improvement activities performance categories of MIPS in a 
manner specified by CMS; (2) CMS-approved survey vendor means a survey 
vendor that is approved by CMS for a particular performance period to 
administer the CAHPS for MIPS survey and to transmit survey measures 
data to CMS; and (3) CMS Web Interface means a web product developed by 
CMS that is used by groups that have elected to utilize the CMS Web 
Interface to submit data on the MIPS measures and activities.

    Table 3--Data Submission Mechanisms for MIPS Eligible Clinicians
                    Reporting Individually as TIN/NPI
------------------------------------------------------------------------
   Performance  category/ submission        Individual reporting data
         combinations  accepted               submission mechanisms
------------------------------------------------------------------------
Quality................................  Claims.
                                         QCDR.
                                         Qualified registry.
                                         EHR.
Cost...................................  Administrative claims (no
                                          submission required).
Advancing Care Information.............  Attestation.
                                         QCDR.
                                         Qualified registry.
                                         EHR.
Improvement Activities.................  Attestation.
                                         QCDR.
                                         Qualified registry.
                                         EHR.
------------------------------------------------------------------------


[[Page 77095]]


             TABLE 4--Data Submission Mechanisms for Groups
------------------------------------------------------------------------
   Performance  category/ submission           Group reporting data
         combinations  accepted               submission mechanisms
------------------------------------------------------------------------
Quality................................  QCDR.
                                         Qualified registry.
                                         EHR.
                                         CMS Web Interface (groups of 25
                                          or more).
                                         CMS-approved survey vendor for
                                          CAHPS for MIPS (must be
                                          reported in conjunction with
                                          another data submission
                                          mechanism.).
                                         and
                                         Administrative claims (For all-
                                          cause hospital readmission
                                          measure--no submission
                                          required).
Cost...................................  Administrative claims (no
                                          submission required).
Advancing Care Information.............  Attestation.
                                         QCDR.
                                         Qualified registry.
                                         EHR.
                                         CMS Web Interface (groups of 25
                                          or more).
Improvement Activities.................  Attestation.
                                         QCDR.
                                         Qualified registry.
                                         EHR.
                                         CMS Web Interface (groups of 25
                                          or more).
------------------------------------------------------------------------

(3) Submission Deadlines
    For the submission mechanisms described in the proposed rule (81 FR 
28181), we proposed a submission deadline whereby all associated data 
for all performance categories must be submitted. In establishing the 
submission deadlines, we took 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 MIPS 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 the proposed 
rule (81 FR 28179), the MIPS performance period for payments adjusted 
in 2019 is CY 2017 (January 1 through December 31).
    Based on the factors noted, we proposed at Sec.  414.1325(e) that 
the data submission deadline for the qualified 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 EPs and group practices under PQRS. We were 
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 requested comments on these items.
    We further proposed 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 8-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 requested comments on these proposals.
    The following is a summary of the comments we received on our 
proposals regarding MIPS submission deadlines.
    Comment: One commenter requested clarity on the first reporting 
deadline.
    Response: The first proposed submission deadline for the qualified 
registry, QCDR, EHR, and attestation submission mechanisms is from 
January 2nd, 2018 through March 31st, 2018. For the CMS Web Interface 
submission mechanism, the first proposed submission deadline will occur 
during an 8-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, January 16 through March 13, 2018). The specific 
deadline during this timeframe will be published on the CMS Web site.
    Comment: Several commenters supported the data submission deadline 
of March 31 of the year following the performance period. The 
commenters also suggested that more frequent submissions could be 
useful but only if data are easy to submit. Another commenter 
recommended that CMS not make more frequent data submission a 
requirement, but allow for reporters to submit data on a more frequent 
basis if they so choose. The commenter saw benefit to more frequent 
data submission, but stated that there are some concerns CMS should 
consider. For example, they noted that monthly submission would not 
work well with the advancing care information performance category 
requirement that requires reporting patients' choosing to view their 
patient portal, as patients would have to visit the portal during the 
month after their appointment in order for the portal visit to count 
towards the measure.
    Response: We appreciate the commenters' support. We intend to 
explore the capability of more frequent data submission to the MIPS 
program. As a starting point we intend to allow for optional, early 
data submissions for the qualified registry, QCDR, EHR, and attestation 
submission mechanisms. Specifically, we would allow submissions to 
begin earlier than January 2, 2018 for those individual MIPS eligible 
clinicians and groups who would like to optionally submit data early to 
us, if technically feasible. If it is not technically feasible to allow 
the submission period to begin prior to January 2 following the close 
of the performance period, the submission period will occur from 
January 2 through March 31 following the close of the performance 
period. Please note that the final deadline for these submission 
mechanisms will remain March 31, 2018. Additional details related to 
the technical feasibility of early data submissions will be made 
available at QualityPaymentProgram.cms.gov.
    Comment: Some commenters were concerned about timelines for the 
PQRS, VM, and Medicare EHR Incentive Program for EPs. The commenters 
believed it was unfair to expect MIPS eligible clinicians and groups to 
complete full calendar year reporting in 2016 for EHR Incentive Program 
and PQRS and then completely switch to a new program while still 
completing attestations for 2016 programs.

[[Page 77096]]

    Response: We understand the commenters' concerns and therefore have 
modified our proposed policy to allow more flexibility and time for 
MIPS eligible clinicians to transition to CEHRT and familiarize 
themselves with MIPS requirements. As discussed in section II.E.5.b.(3) 
of this final rule with comment period, we are finalizing the policy 
that MIPS clinicians will only need to report for a minimum of a 
continuous 90-day period within CY 2017, for the majority of the 
submission mechanisms for all data in a given performance category and 
submission mechanism, to qualify for an upward adjustment for the 
transition year.
    Comment: Another commenter called for the elimination of reporting 
electronically to data registries unless the registries have been 
empirically demonstrated to improve care and reduce cost in practice.
    Response: We appreciate the comment regarding the function of a 
qualified registry to improve care and reduce cost in practice. We 
agree that registries are a tool to drive value in clinical practice. 
For MIPS, a qualified registry or QCDR is required to provide 
attestation statements from the MIPS eligible clinicians during the 
data submission period that all of the data (quality measures, 
improvement activities, and advancing care information measures and 
activities, if applicable) and results are accurate and complete.
    Comment: Another commenter believed that limiting performance 
category data submission to one mechanism per performance category will 
limit innovation and disincentivize reporting the highest quality data 
available. The commenter believed that if MIPS eligible clinicians 
could report some of the required quality measures through a QCDR, they 
should be allowed to do so. Other commenters supported CMS' proposal to 
retain reporting mechanisms available in PQRS but opposed the proposal 
to allow only one submission mechanism per performance category, 
especially for the quality performance category. The commenters stated 
that some MIPS eligible clinicians may need to report through multiple 
mechanisms, such as MIPS eligible clinicians reporting a proposed 
specialty-specific measure set containing measures requiring differing 
submission mechanisms. A few commenters requested that CMS reconsider 
its proposal that all quality measures used by CMS must be submitted 
from the same reporting method because there are limits in the 
applicable reporting methods for certain measures, with some specialty-
specific measure sets having very few EHR-enabled measures. These 
commenters believed the MIPS eligible clinicians should be able to use 
multiple reporting options. Another commenter urged CMS to limit the 
number of measure data reporting options so hospitals, health systems, 
and national stewards can accurately assess and benchmark performance 
over time. Another commenter recommended that for at least the first 3 
to 5 years of the program, the submission mechanism flexibility to 
report measures using a variety of mechanisms remain in place.
    Response: MIPS eligible clinicians may choose whichever data 
submission mechanisms works best for their practice. We have provided 
many data submission options to allow the utmost flexibility for the 
MIPS eligible clinician. We believe the proposal to allow multiple 
mechanisms, while restricting the number of mechanisms per performance 
category, offers flexibility without adding undue complexity. We 
discuss our policies related to multiple methods of reporting within a 
performance category in section II.E.5.a. of this final rule with 
comment period. We would also like to note that in section II.E.6.a. of 
this final rule with comment period we are seeking comment for further 
consideration on additional flexibilities that should be offered for 
MIPS eligible clinicians in this situation.
    In addition, we do not believe that allowing these various 
submission mechanisms impacts the ability to create reliable and 
accurate measure benchmarks. We discuss our policies related to measure 
benchmarks in more detail in section II.E.6.e. of this final rule with 
comment period.
    Comment: One commenter recommended that CMS require Medicare Part B 
claims to be submitted, rather than processed, within 90 days of the 
close of the applicable performance period, as MIPS eligible clinicians 
have no control over how quickly claims are processed and should not be 
held responsible for delays. Another commenter recommended that the 
submission time period be extended to 12 weeks, as more data will be 
required to be submitted than historically during that time period. 
Other commenters expressed concern with CMS' proposed submission 
deadline and requested a minimum 90-day submission period as MIPS 
eligible clinicians employed by health systems may not have access to 
December data until February and cumulative data even later. The 
commenters further believed that submission periods should be 
standardized regardless of submission mechanism and suggest a 
submission period from January 1 through March 31. A few commenters 
agreed with the proposed 90-day submission period policy for submittal 
of data via the claims mechanism and noted that the prior deadline was 
often too challenging for MIPS eligible clinicians to meet.
    Response: In establishing the submission deadlines, we took 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 Program. Our experience has shown that allowing 
for the submission of data after the close of the performance period 
provides either the MIPS 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. We do note, 
however, that as indicated previously in this final rule with comment 
period, we would allow submissions to begin earlier than January 2, 
2018 for those individual MIPS eligible clinicians and groups who would 
like to optionally submit data early to us, provided that it is 
technically feasible. If it is not technically feasible, individual 
MIPS eligible clinicians and groups will still be able to submit data 
during the normal data submission period. Please note that the final 
deadline for all submission mechanisms will remain at March 31, 2018. 
However, for the Medicare Part B claims submission mechanism, we 
believe the best approach for the data submission deadline is to 
require Medicare Part B claims to be processed no later than 60 days 
following the close of the performance period.
    Comment: Another commenter stated that despite MIPS data submission 
via the CMS Web Interface, the process of data verification prior to 
submission is still manual and labor-intensive. The commenter 
encouraged CMS to explore methods for allowing test submissions 
(whether throughout the performance period or during the submission 
window) to uncover any possible submission errors; this would provide 
an opportunity for CMS to give feedback to MIPS eligible clinicians and 
third party intermediaries in advance of the submission deadline.
    Response: We appreciate the feedback and would like to note as 
indicated previously in this final rule with comment period, we would 
allow submissions to begin earlier than January 2, 2018 for those 
individual MIPS eligible clinicians and groups who would like to 
optionally submit data

[[Page 77097]]

early to us, if technically feasible. If it is not technically feasible 
to allow the submission period to begin prior to January 2 following 
the close of the performance period, the submission period will occur 
from January 2 through March 31 following the close of the performance 
period. Please note that the final deadline for these submission 
mechanisms will remain March 31, 2018.
    Comment: We received comments on our request for 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. A few commenters opposed shorter 
reporting timeframes for MIPS eligible clinicians using the CMS Web 
Interface or other reporting mechanisms. The commenters recommended, in 
general, quarterly or semi-annual data submission periods with a 
minimum report of at least once annually, and subsequently a quarterly 
report by CMS detailing MIPS eligible clinicians' progress. The 
commenters recommended a real-time tool for MIPS eligible clinicians to 
be able to track their MIPS progress. Another commenter stated that 
MIPS reporting deadlines should be no earlier than 2 months following 
the notification of QP status. Other commenters stated that bi-annual 
and quarterly submission period requirements would be advantageous only 
if CMS intended to provide timely MIPS eligible clinician feedback on a 
quarterly basis. They stated that if quarterly reporting were to be 
required, EHR vendors would need to have upfront notice regarding 
changes in measures in order to prepare. One commenter expressed that 
clinicians must know the standards by which they will be measured in 
advance of the performance period and require 3 months after the 
performance period to scrub data before submitting. The commenter 
stated that quarterly data submission would be too burdensome.
    Response: We appreciate the feedback and agree with the commenter 
that we want to strike the right balance on allowing for more frequent 
submissions which would allow us to issue more frequent performance 
feedback, while ensuring that the process that is developed is not 
overly burdensome. Therefore, as indicated previously in this final 
rule with comment period, we would allow submissions to begin earlier 
than January 2, 2018 for those individual MIPS eligible clinicians and 
groups who would like to optionally submit data early to us, if 
technically feasible. If it is not technically feasible to allow the 
submission period to begin prior to January 2 following the close of 
the performance period, the submission period will occur from January 2 
through March 31 following the close of the performance period. Please 
note that the final deadline for these submission mechanisms will 
remain March 31, 2018.
    After consideration of the comments received on the proposals 
regarding MIPS submission deadlines, we are finalizing the submission 
deadlines as proposed with one modification. Specifically, we are 
finalizing at Sec.  414.1325(f) the data submission deadline for the 
qualified registry, QCDR, EHR, and attestation submission mechanisms as 
March 31 following the close of the performance period. The submission 
period will begin prior to January 2 following the close of the 
performance period, if technically feasible. For example, for the first 
MIPS performance period, the data submission period will occur prior to 
January 2, 2018, through March 31, 2018, if technically feasible. If it 
is not technically feasible to allow the submission period to begin 
prior to January 2 following the close of the performance period, the 
submission period will occur from January 2 through March 31 following 
the close of the performance period. In any case, the final deadline 
will remain March 31, 2018.
    We further finalize at Sec.  414.1325(f)(2) that for the Medicare 
Part B claims submission mechanism, the submission deadline must be on 
claims with dates of service during the performance period that must be 
processed no later than 60 days following the close of the performance 
period. Lastly, for the CMS Web Interface submission mechanism, we are 
finalizing at Sec.  414.1325(f)(3) the submission deadline must be an 
8-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.
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 populations 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 (ED) to a primary care physician office, health care 
providers on both sides of the transition 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 cost measures that are related to one another and will 
be engaged in improvement activities that directly help them improve in 
both specialty-specific clinical practice and more holistic areas (for 
example, patient experience, prevention, population health). The cost 
performance category will provide clinicians with information needed to 
delivery efficient, effective, and high-value care. 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 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

[[Page 77098]]

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 final score 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 final score, 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 
final score 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 
requirements for satisfactory reporting and satisfactory participation 
to earn payment incentives or to avoid a PQRS 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 
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 proposed that it would not have a ``satisfactory reporting'' 
requirement. However, 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 the proposed rule (81 FR 28184), 
we proposed the minimum data submission criteria and data completeness 
standard for the MIPS quality performance category for the submission 
mechanisms that were discussed in the proposed rule (81 FR 28181), as 
well as benchmarks against which eligible clinicians' performance would 
be assessed. The scoring methodology discussed in the proposed rule (81 
FR 28220) would adjust the quality performance category scores based on 
whether or not an individual MIPS eligible clinician or group met these 
criteria and how their performance compared against the benchmarks.
    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 requested 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 MIPS and APMs RFI comments, and based on our 
desire to simplify the MIPS reporting system and make the measurement 
more meaningful, we proposed 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 proposed 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 also proposed to use all-payer data where possible.
    As beneficiary health is always our top priority, we proposed 
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 proposed 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,

[[Page 77099]]

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 encourage MIPS eligible clinicians to select 
measures that cross multiple domains. In addition, we believe the MIPS 
program overall, with the focus on cost, improvement activities, and 
advancing care information performance categories, will naturally cover 
many elements in the NQS.
(2) Contribution to the Final Score
    For the 2019 MIPS adjustment year, the quality performance category 
will account for 50 percent of the final score, 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 final score 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 final score 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 cost performance 
category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of 
the Act requires that, for the transition year for which MIPS applies 
to payments, not more than 10 percent of the of final score shall be 
based on performance to the cost 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 final score shall be based on performance to the cost performance 
category. We proposed at Sec.  414.1330 for payment years 2019 and 
2020, 50 percent and 45 percent, respectively, of the MIPS final score 
would be based on performance on the quality performance category. For 
the third and future years, 30 percent of the MIPS final score would 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.
    The following is summary of the comments we received regarding our 
general strategy and the quality performance category contribution to 
the final score.
    Comment: Numerous commenters supported the focus on quality in the 
proposed rule and our proposal that, for payment year 2019, 50 percent 
of the final score would be based on performance on quality measures.
    Response: We thank the commenters for their support.
    Comment: Other commenters were concerned with the quality 
performance category's final score weights decreasing to 30 percent for 
payment years 2021 and beyond, as some eligible clinicians will not be 
eligible to participate in MIPS and receive a MIPS adjustment until 
payment year 2021. The commenters believed this would be a disadvantage 
with the cost performance category final score weight increasing. The 
commenters noted that increasing penalties under MIPS would also place 
such clinicians in an unfair position. The commenters requested that 
CMS make appropriate considerations for such MIPS eligible clinicians.
    Response: We appreciate the concerns raised that MIPS eligible 
clinicians who are not initially eligible to participate in MIPS and 
receive MIPS adjustments until payment year 2021 might have a different 
starting point than those MIPS eligible clinicians who begin 
participating in CY 2017. We note that those MIPS eligible clinicians 
who are not initially eligible to participate in MIPS and receive MIPS 
adjustments, do have the option to volunteer to report. By volunteering 
to report, these eligible clinicians will gain experience with the MIPS 
scoring system prior to being required to do so. We will, however, take 
the commenter's recommendation into consideration for future 
rulemaking.
    Comment: Another commenter requested that when the time comes to 
include rehabilitation therapists in MIPS program, they be granted the 
same stepped-down percentage of scoring for quality and stepped-up 
percentage of scoring for cost that are in place for those MIPS 
eligible clinicians participating in MIPS program in the first 2 years. 
Such an approach would give those MIPS eligible clinicians the same 
time and consideration doctors of medicine or osteopathy, doctors of 
dental surgery or dental medicine, physician assistants, nurse 
practitioners, clinical nurse specialists, and certified registered 
nurse anesthetists will receive during their transition to MIPS 
program.
    Response: We would like to explain that in the first 2 years of the 
MIPS program, the quality weight will be higher and the cost weight 
will be lower. In addition, we note that those MIPS eligible clinicians 
who are not initially eligible to participate in MIPS in 2017 for the 
2019 MIPS payment year, do have the option to voluntarily report. By 
volunteering to report, these eligible clinicians will gain experience 
with the MIPS scoring system prior to being required to do so. We thank 
the commenter for their feedback and will take their comments into 
consideration in future rulemaking.
    Comment: One commenter supported CMS' proposal to incentivize MIPS 
eligible clinicians to use CEHRT for end-to-end electronic reporting.
    Response: We thank the commenter for their support.
    Comment: One commenter stated they were concerned about how 
different evaluation criteria have been weighed in the MIPS program. 
They believed there was an arbitrary nature and bias in the weighting 
for MIPS which they stated cannot be corrected through a change in 
weighting. The commenter provided an example of the scoring system 
including bonus points, which they believed results in an inaccurate 
view of real outcomes.
    Response: We do not believe that the evaluation criteria we have 
developed and proposed for MIPS are arbitrary or biased. Moreover, as 
we explained in the proposed rule (81 FR 28255), bonus points are 
intended to recognize quality measurement priorities. We believe that 
recognition is necessary to focus quality improvement efforts on 
specific CMS goals.
    Comment: Another commenter suggested for the quality performance 
measures that CMS adopt standards and mapping tools by ensuring that 
eCQM calculations are accurate. In addition, the commenter stated CMS 
should adopt standards to ensure different EHRs are accurately and 
uniformly capturing eCQMs. Another commenter recommended that CMS 
ensure that the eCQMs in the quality performance category align with 
measures used by

[[Page 77100]]

other payers and accrediting and certification programs (for example, 
NCQA), noting that if the specifications do not align, the commenter 
believed that shared data will not help streamline the reporting 
processes.
    Response: We thank the commenters and agree that adopting standards 
to accurately and uniformly capture eCQMs is essential. We currently 
use the Health Level Seven (HL7) standard Health Quality Measures 
Format (HQMF) for electronically documenting eCQM content as well as 
the Quality Data Model (QDM) for measure logic. We will continue to 
ensure industry standards are used and refined in order best capture 
eCQM data.
    Comment: One commenter recommended that CMS consider merging the 
quality and cost performance categories as a ratio of quality and cost.
    Response: We do not believe we have the statutory authority to 
merge the quality and cost performance categories. MACRA specified the 
four performance categories we are required to incorporate into the 
MIPS program.
    After consideration of the comments received regarding our general 
strategy and the quality performance category contribution to the final 
score and the additional factors described in section II.E.5.b. of this 
final rule with comment period, we are not finalizing this policy as 
proposed. Rather, as discussed in section II.E.5.e. of this final rule 
with comment period, the cost performance category will account for 0 
percent of the final score in 2019, 10 percent of the final score in 
2020, and 30 percent of the final score in 2021 and future MIPS payment 
years, as required by statute. In accordance with section 
1848(q)(2)(E)(i)(I)(bb) of the Act, we are redistributing the final 
score weight from cost performance category to the quality performance 
category. Therefore, we are finalizing at Sec.  414.1330(b) for MIPS 
payment years 2019 and 2020, 60 percent and 50 percent, respectively, 
of the MIPS final score will be based on performance on the quality 
performance category. For the third and future years, 30 percent of the 
MIPS final score will be based on performance on the quality 
performance category.
(3) Quality Data Submission Criteria
(a) Submission Criteria
    The following are the proposed criteria for the various proposed 
MIPS data submission mechanisms described in the proposed rule (81 FR 
28181) for the quality performance category.
(i) Submission Criteria for Quality Measures Excluding CMS Web 
Interface and CAHPS for MIPS
    We proposed 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 
proposed 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 of the Appendix in this final rule with comment period and including 
at least one outcome measure. If an applicable outcome measure is not 
available, we proposed 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 
proposed the MIPS eligible clinician or group would be required to 
report on each measure that is applicable.
    MIPS eligible clinicians and groups would select their measures 
from either the list of all MIPS measures in Table A of the Appendix in 
this final rule with comment period, or a set of specialty-specific 
measure set in Table E of the Appendix in this final rule with comment 
period. We noted 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 of the Appendix in 
this final rule with comment period, are the same measures that are 
within Table A of the Appendix in this final rule with comment period, 
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 requested comments on the measures proposed under each 
of the specialty-specific measure sets. Specifically, we solicited 
comments on whether or not the measures proposed for inclusion in the 
specialty-specific measure sets are appropriate for the designated 
specialty or subspecialty and whether there are additional proposed 
measures that should be included in a particular specialty-specific 
measure set.
    Furthermore, in the proposed rule we noted that there were some 
special scenarios for those MIPS eligible clinicians who selected their 
measures from a specialty-specific measure set at either the specialty 
or subspecialty level (Table E of the Appendix in this final rule with 
comment period). We provided the following example in the proposed 
rule, where some of the specialty-specific measure sets have fewer 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, at 
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 of the Appendix in 
this final rule with comment period. In other scenarios, the specialty-
specific measure sets may have six or more measures, and 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

[[Page 77101]]

six measures must be a cross-cutting measure which is defined in Table 
C of the Appendix in this final rule with comment period.
    As noted above, the submission criteria is provided 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. We proposed that 
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 solicited 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 solicited comment on whether we should only 
consider reporting up to six measures at the higher overall specialty 
level to satisfy the submission criteria. We noted 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 proposed 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 of the Appendix in this final rule with comment 
period. We further note that measure types listed as an ``intermediate 
outcome'' are considered outcome measures for the purposes of scoring 
(see 81 FR 28247).
    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 of the Appendix in this final rule with comment period and one high 
priority measure (outcome, appropriate use, patient safety, efficiency, 
patient experience, and care 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 of 
the Appendix in this final rule with comment period or a set of 
specialty-specific measure set in Table E of the Appendix in this final 
rule with comment period.
    As discussed in the proposed rule (81 FR 28173), MIPS eligible 
clinicians who are non-patient facing MIPS eligible clinicians would 
not be required to report any cross-cutting measures. For further 
details on non-patient facing MIPS eligible clinician discussions, we 
refer readers to section II.E.1.b. of this final rule with comment 
period.
    In addition, in the proposed rule (81 FR 28187) we discussed our 
intention 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 (81 FR 28254), 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 proposed 
to no longer require reporting across multiple NQS domains. We believed 
these proposals were the best approach for the quality performance 
category because they decrease 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 solicited 
comments on what specific measures of over or under use should be 
included as appropriate use measures.
    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. Under the Improving 
Medicare Post-Acute Transformation (IMPACT) Act of 2014, the Office of 
ASPE has been conducting studies on the issue of risk adjustment for 
sociodemographic factors on quality measures and cost, as well as other 
strategies for including SDS evaluation in CMS programs. We will 
closely examine the ASPE studies when they are available and 
incorporate findings as feasible and appropriate through future 
rulemaking. We look forward to working with stakeholders in this 
process. In

[[Page 77102]]

addition, we solicited 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 proposed 
to score MIPS eligible clinicians in this scenario is discussed in the 
proposed rule (81 FR 28187). We also solicited comment on whether these 
proposals sufficiently encourage clinicians and measure developers to 
move away from clinical process measures and towards outcome measures 
and measures that reflect other NQS domains. We requested comments on 
these proposals.
    The following is summary of the comments we received regarding our 
proposal on submission criteria for quality measures excluding CMS Web 
Interface and CAHPS for MIPS.
    Comment: Many commenters expressed support for lowering the 
reporting threshold from nine to six quality measures, including one 
cross-cutting and one outcome measure, and no longer requiring that 
MIPS eligible clinicians report on measures that span three NQS 
domains.
    Response: We thank the commenters for their support.
    Comment: Another commenter appreciated the decreased requirement 
relative to PQRS of reporting on six quality measures for MIPS; 
however, the commenter was disappointed about our proposal to maintain 
an absolute minimum number of measures that MIPS eligible clinicians 
are required to report. The commenter believed that the current quality 
measures list is insufficient to cover all practice types. The 
commenter stated that the challenge of participating would only be 
exacerbated by imposition of a minimum number of measures. The 
commenter appreciated the lack of penalty if a MIPS eligible clinician 
is unable to report on the minimum requirement when they do not have 
applicable measures. A few commenters noted that emergency clinicians 
who report via claims cannot report on six measures. They stated that 
it was not clear from proposal whether these MIPS eligible clinicians 
would still be able to qualify for the full potential score available 
under the scoring methodology. Another commenter requested CMS provide 
special consideration be given to clinicians practicing at urgent care 
centers, including reducing the required number of quality measures to 
report on from six to four.
    Response: We would like to note that MIPS eligible clinicians with 
fewer than six applicable measures are not required to report six 
measures, and must only report those measures that are applicable. 
While claims-based reporting is one submission mechanism available, 
emergency clinicians also have the option to use the other submission 
mechanisms available to satisfy the requirements. We further note that 
we have revised the emergency medicine specialty-specific measure set 
whereby the set now includes 17 measures with 11 of them reportable via 
claims. Emergency medicine clinicians will be able to report measures 
to earn the full potential score.
    Comment: Some commenters disagreed with our proposed measure 
threshold of six measures, and recommended maintaining the PQRS 
threshold of reported measures at nine. These commenters were concerned 
that lowering the threshold of reported measures (from nine to six) 
sends the wrong signal about the importance of quality measures within 
MIPS. The commenters believed MIPS eligible clinicians might pick and 
choose measures that they perform well on, providing a less 
comprehensive picture of quality of care. Instead, the commenters 
stated CMS should establish mandatory core sets of measures by 
specialty/subspecialty groups to signal areas where MIPS eligible 
clinicians should focus their attention and increase comparability 
across MIPS eligible clinicians. Other commenters believed a core set 
of measures would create unequal performance by groups of different 
sizes and specialties, allowing single specialty groups to report only 
measures specific to their practice. The commenters recommended that 
CMS establish benchmarks for a set of core quality measures.
    Conversely, other commenters disagreed with our proposed measure 
threshold of six measures, and recommended that the measure threshold 
be lowered. Recommendations ranged from four measures, three measures 
or one to two measures. These commenters indicated that a reduced 
threshold would allow MIPS eligible clinicians to choose a few measures 
that will have a high impact on care improvements. Additionally, 
commenters were concerned that the threshold of six may burden 
practices that are struggling to find relevant measures and jeopardize 
their ability to achieve the maximum number of points under the quality 
performance category. The commenters stated that fewer required 
measures will reduce administrative burden, better reflect the 
conditions and realities of medical practice, allow MIPS eligible 
clinicians time to focus on quality improvement, and lead to more 
accurate measurement and a better snapshot of quality. Some commenters 
requested that CMS, the Department of Health (DOH), The Joint 
Commission (TJC), and Det Norske Veritas (DNV) join forces to focus on 
meaningful improvement.
    Response: We do not believe the thresholds for quality measurement 
should be lowered further. In any quality measurement program, we must 
balance the data collection burden that we must impose on MIPS eligible 
clinicians with the resulting quality performance data that we will 
receive. We believe that without sufficiently robust performance data, 
we cannot accurately measure quality performance. Therefore, we believe 
that we have appropriately struck a balance between requiring 
sufficient quality measure data from clinicians and ensuring robust 
quality measurement at this time. We want to emphasize that we are 
committed to working with stakeholders to improve our quality programs 
including MIPS. An integral part of these programs are quality measures 
that reflect the scope and variety of the many types of clinical 
practice. It is important that we offer enough quality measures that 
assess the various practice types and that clinicians report sufficient 
measures to allow a reasonable comparison of their quality performance.
    We do note that for the initial performance period under the MIPS 
many flexibilities have been implemented, including a modified scoring 
approach which ensures that MIPS eligible clinicians who prefer to only 
submit data on one or two measures can avoid a negative MIPS 
adjustment. Furthermore, our modified scoring approach incentivizes 
high performers who have a robust data set available. We refer readers 
to section II.E.6. of this final rule with comment period for more 
details on the scoring approach.
    Comment: Another commenter referenced our proposal, which stated 
that ``if fewer than six measures apply to the individual MIPS eligible 
clinician or group, then the MIPS eligible clinician or group would be 
required to report on each measure that is applicable,'' and mentioned 
that this statement seemed to provide no penalty. The commenter 
requested clarification on this language to ensure that groups would 
not be penalized for submitting

[[Page 77103]]

fewer than six measures. Another commenter requested clarification on 
how CMS proposes to define ``applicable.'' One commenter suggested that 
MIPS eligible clinicians should have the opportunity to pre-certify 
with CMS that fewer than six measures are available to them prior to 
the beginning of the performance period.
    Response: While we expect this to occur in only rare circumstances, 
we would like to confirm the commenter's understanding. If fewer than 
six measures apply to the MIPS eligible clinician or group, the MIPS 
eligible clinician or group would be required to report on each 
applicable measure. Additionally, groups that report on a specialty-
specific measure set that has fewer than six measures would only need 
to report the measures within that specialty-specific measure set. 
Generally, we define ``applicable'' to mean measures relevant to a 
particular MIPS eligible clinician's services or care rendered. The 
MIPS eligible clinician should be able to review the measure 
specifications to see if their services fall into the denominator of 
the measure. For example, if a MIPS eligible clinician who is an 
interventional radiologist decides to submit data via a specialty-
specific measure set by selecting the interventional radiology 
specialty-specific measure sets, this MIPS eligible clinician would not 
have six measures applicable to them. Therefore, the MIPS eligible 
clinician would submit data on all of the measures defined within the 
specialty-specific measure set. MIPS eligible clinicians who do not 
have six individual measures available to them should select their 
appropriate specialty-specific measure set, because that pre-defines 
which measures are applicable to their specialty and provides certain 
assurances to them. For the majority of MIPS eligible clinicians 
choosing the specialty-specific measure sets provides a means to select 
applicable measures and, if the set includes less than 6 measures, this 
also assures that there is no need to report any additional measures. 
Furthermore, we will apply a clinical relation test to the quality data 
submissions to determine if the MIPS eligible clinician could have 
reported other measures. For more information on the clinical relation 
test, see section II.E.6.a.(2) of this final rule with comment period, 
where we discuss our validation process. Lastly, we are working to 
provide additional toolkits and educational materials to MIPS eligible 
clinicians prior to the performance period that will ease the burden on 
identification of which measures are applicable to MIPS eligible 
clinicians. If the MIPS eligible clinician required assistance, they 
may contact the Quality Payment Program Service Center.
    Comment: Another commenter requested that CMS add a requirement 
that MIPS-eligible clinicians report at least six measures, including 
one cross-cutting measure (if patient-facing), at least one outcome 
measure, and at least one high-priority measure. The commenter was 
concerned that high-priority measures may not be reported if they are a 
substitute for outcome measures.
    Response: We agree with the commenter that we want to maintain an 
emphasis on both outcome and high priority measures within the MIPS. We 
will take this comment into consideration for future rulemaking.
    Comment: Numerous commenters supported the proposal to encourage 
reporting of outcome measures over clinical process measures. One 
commenter noted that significant work remains to ensure measurement 
efforts across the health care system are focused on the most important 
quality issues, while other commenters recommended that future quality 
metrics emphasize patient care and health outcomes.
    Response: We thank the commenters for their support. We intend to 
finalize our proposal that one of the six measures a MIPS eligible 
clinicians must report on is an outcome measure.
    Comment: One commenter recommended that patient experience and 
patient satisfaction should not be categorized as quality metrics since 
these measures and surveys include factors outside the control of the 
clinician. The commenter stated that patient satisfaction, while 
important, does not always correlate with better clinical outcomes and 
may even conflict with clinically indicated treatments. In addition, 
another commenter expressed concern that the emphasis on patient 
opinions and their care experiences drives up cost.
    Response: We do believe it is important to assess patient 
experience of care, as it represents items such as communication and 
family engagement, which are important factors of the health care 
experience and these are measures that are important to patients and 
families. While patient experience may not always be directly related 
to health outcomes, there is evidence of a correlation between higher 
scores on patient experience surveys and better health outcomes. Please 
refer to http://www.ahrq.gov/cahps/consumer-reporting/research/index.html for more information on AHRQ studies pertaining to patient 
experience survey and better health outcomes.
    Comment: A few commenters supported the proposed reduction in 
burden in the MIPS quality performance category, but noted that MIPS 
eligible clinician specialties lacking validated outcome measures or 
``high priority'' measures are likely to be at a disadvantage under 
this performance category because the quality performance category 
lacks sufficient specialty-specific quality measures. The commenters 
recommended that CMS work with specialty societies and measure 
development bodies to increase the availability of specialty-specific 
quality measure sets. Another commenter supported the reduced number of 
quality measures required for reporting, but recommended that specialty 
MIPS eligible clinicians not be required to report a cross-cutting 
measure. Some commenters supported CMS's proposal to allow the 
reporting of specialty and subspecialty specific measure sets to meet 
the submission criteria for the quality performance category, even if 
it would mean a MIPS eligible clinician or group would report on fewer 
than six measures.
    Response: We thank the commenters for their feedback. We believe 
that all MIPS eligible clinicians regardless of their specialty have a 
high priority measure available. Therefore, we intend to finalize that 
if a MIPS eligible clinician does not have an outcome measure 
available, they are required to report on a high priority measure.
    Comment: Several commenters recommended eliminating the proposed 
requirement that an outcome measure and a cross-cutting measure be 
reported in the quality performance category. One commenter believed 
this proposal may disadvantage small or rural practices and posed 
challenges for QCDRs. The commenter noted that some approved QCDRs do 
not incorporate value codes in their data collection process, and many 
specialized QCDRs may not capture the data needed to report cross-
cutting measures. The commenter believed the requirement for reporting 
on cross cutting measures also makes the 90 percent reporting threshold 
for QCDRs nearly impossible to meet. Another commenter stated that, 
until more valid and reliable outcome measures are developed, CMS 
should keep flexibility of measures throughout and lift the 
requirements that certain types of measures be reported, such as 
outcomes-based or cross-cutting measures. Other commenters recommended 
that specialty-specific measure sets lacking outcome measures be 
clearly marked as such and also

[[Page 77104]]

contain notations as to which measures would qualify as high-priority 
alternatives. Several commenters recommended CMS provide bonus points 
for these measures rather than require all participants to report on 
them, and that CMS not require use of any specific measure types in the 
initial years of the program.
    Response: We appreciate the comments and have examined the policies 
very carefully. We have modified our proposal for the transition year 
of MIPS and are finalizing that for the applicable performance period, 
the MIPS eligible clinician or group would report at least six measures 
including at least one outcome measure. If an applicable outcome 
measure is not available, 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 the MIPS 
eligible clinician or group would be required to report on each measure 
that is applicable. We note that generally, we define ``applicable'' to 
mean measures relevant to a particular MIPS eligible clinician's 
services or care rendered.
    We are not finalizing the requirement that one of the measures must 
be a cross-cutting measure. Although we still believe that the concept 
of having a common set of measures available to clinicians that they 
can draw from is important we understand that not all of these measures 
are the most meaningful to clinicians and their scope of practice. We 
do strongly recommend however that where appropriate, clinicians 
continue to perform and submit data on these measures to CMS. Lastly, 
while we recognize that there are limitations in the current set of 
available outcome measures, we believe that a strong emphasis on 
outcome-based measurement is critical to improving the quality of care. 
Due to these limitations in the available outcome measure set, we are 
finalizing that MIPS eligible clinician may select another high 
priority measure if an outcome is not available.
    Comment: A few commenters recommended that CMS provide a ``safe 
harbor'' for reporting on new quality measures with innovative 
approaches and improvement by allowing entities to register ``test 
measures'' which would not be scored on but would count as a subset of 
the six quality measures with a participation credit. In addition, the 
commenters stated that CMS should provide a transitional period during 
the first half of 2017 in which MIPS eligible clinicians can receive 
written confirmation from CMS that their intended measures meet the 
requirements. The commenter expressed concern that CMS needs to provide 
specifications and a scoring methodology for the population health 
measures to improve transparency.
    Response: As noted in other sections of this final rule with 
comment period, we are providing a transitional year for the first 
performance period under the MIPS. We also note that commenters 
successfully reporting an appropriate specialty-specific measure set 
for a sufficient portion of their beneficiary population will have met 
all minimum reporting requirements for the quality category. We 
appreciate the commenter's feedback and will incorporate their 
suggestion as we develop toolkits and educational materials. We refer 
the commenter to section II.E.5.b.(6) and II.E.6. of this final rule 
with comment period for information on population health measures and 
the MIPS scoring methodology respectively.
    Comment: Another commenter urged CMS to pursue the following 
policies in the quality performance category: The commenter urged CMS 
to reconsider its proposal to require reporting on a minimum of six 
measures, if six measures apply. Instead, CMS should encourage the use 
of non-MIPS measures associated with a QCDR and/or allow MIPS eligible 
clinicians to select measures that directly relate to their clinical 
specialty and outcomes for their patients; and CMS should carefully 
monitor modifications to the cross-cutting measures list and ensure 
that at least one cross-cutting measure remains on this list for each 
category of MIPS eligible clinicians to allow them to remain compliant 
with the proposed requirements. Alternately, CMS could develop an 
option similar to the outcomes measures reporting requirement that 
would allow the MIPS eligible clinician to report a different type of 
measure, such as a high priority measure, if a cross-cutting measure 
does not apply.
    Response: We thank the commenter for their feedback and will take 
these recommendations into consideration for future rulemaking. We 
would like to note that there are already a number of outcome and 
specialty-specific measure sets available for reporting. In addition, 
the cross-cutting measure requirement is not being finalized.
    Comment: One commenter recommended that CMS develop a pilot 
program/test within the first MIPS implementation year that identifies 
a core measure set that allows direct comparison among MIPS eligible 
clinician performance where commonly applicable metrics allow for such 
a measure set for specific MIPS eligible clinician specialties. The 
commenter supported the general flexibility of quality reporting, but 
was concerned that the existing proposal may not foster true 
comparisons and performance could vary based on the measures selected 
to report rather than differences in quality performance. Another 
commenter encouraged CMS to identify a strategy to assess the most 
appropriate number of measures and distribution of metrics that MIPS 
eligible clinicians should be required to report. The commenter 
believed these analyses would provide necessary information for CMS to 
make evidence-based decisions with regard to changes to the quality 
measures reporting requirements to ensure an accurate account of the 
quality of care individual patients are receiving.
    Response: The majority of the quality measures that are being 
included in the MIPS program have already been utilized in PQRS for 
many years. In addition, we have created specialty-specific measure 
sets that may be utilized by specialist. We do not believe we need a 
pilot program as these measures have already been tested. The quality 
measures go through a rigorous evaluation process prior to being 
accepted in the MIPS program. With respect to the ideal number of 
measures that should be required per the commenter's suggestion above, 
we believe that our final submission requirements of six measures is 
the appropriate number based on our experience under the PQRS, VM and 
Medicare EHR Incentive Programs. We will however take the commenter's 
suggestion into consideration for future analyses and rulemaking.
    Comment: A few commenters were concerned that using self-reported 
measures and tying payment to self-reported quality measures will give 
MIPS eligible clinicians an incentive to select and report measures on 
which they perform well, especially when they have a large number of 
measures from which to choose. The commenters were also concerned that 
MIPS eligible clinicians are not likely to select certain high priority 
measures because of unfavorable results, such as overuse measures (for 
example, imaging for low-back pain) or because of the effort required 
to collect the measure (for example, the CAHPS for MIPS survey). The 
commenters stated self-reporting would tend to produce compressed 
ranges for measures that are scored in

[[Page 77105]]

MIPS, which they believed would mean MIPS eligible clinicians would 
receive different incentive payments based on very small gradations in 
performance.
    Other commenters expressed concern that the ability of MIPS 
eligible clinicians to select their own measures could result in the 
reliance on low-bar measures that do not drive value-based care. The 
commenters recommended that CMS encourage MIPS eligible clinicians to 
report both an outcome and a high priority measures representative of 
their patient populations. Another commenter stated CMS should finalize 
requirements that provide more explicit standards around the type and 
caliber of measures that MIPS eligible clinicians and groups must 
report. The commenter encouraged CMS to utilize variations in weighting 
and scoring of measures to incentivize greater reporting on clinical 
and patient-reported outcomes measures. The commenter supported the 
inclusion of patient-reported outcomes and patient experience measures 
in MIPS.
    Other commenters recommended re-evaluation of the quality measures 
required by MIPS. The commenters stated that under the proposed rule, 
MIPS eligible clinicians participating in MIPS would choose six quality 
measures to report, one of which must be an outcome measure, and 
another a cross-cutting measure. The commenters recognized that CMS 
proposed this approach to reduce administrative burden and allow 
clinicians the flexibility to choose appropriate measures; however, was 
concerned that this approach may not meaningfully advance the quality 
of care provided to Medicare beneficiaries. The commenters stated given 
the financial incentive, the commenter would expect that MIPS eligible 
clinicians will select those measures on which they are already high-
performing and on which they believe they can be at the top of the 
curve. Thus, they will focus more effort on the few areas that are 
existing strengths, and have limited incentive to drive improvement in 
a broad set of areas. The commenter recommended that CMS leverage the 
work of the Core Quality Measure Collaborative--which brought together 
stakeholders from America's Health Insurance Plans (AHIP), CMS and the 
National Quality Forum (NQF), as well as national physician 
organizations, employers and consumers--and select core sets of 
measures for each specialty to report. The commenters also proposed 
bonus points for clinicians who choose to report innovative, outcome-
based measures in addition to the core set.
    Response: We agree with the commenters that there are certain 
challenges in using self-reported measures rather than a core or common 
measure set that all clinicians would be required to submit. We also 
appreciate the emphasis placed on outcome measurement. We do however 
believe that there are certain challenges in creating a core or common 
measure set for clinicians, as compared to other settings, due to the 
various practice and specialty types that clinicians may practice 
under. However, we have included the measures in the core measure sets 
that were developed by the Core Quality Measure Collaborative in the 
MIPS measure set and several of the specialty-specific measure sets. 
Lastly, we note that as indicated in other sections of this rule the 
first performance period of MIPS is a transitional year. We will take 
these comments into consideration for future rulemaking and will 
continue to monitor whether clinicians select only low-bar measures or 
measures on which their performance is already high. We will address 
any changes to policies based on these monitoring activities through 
future rulemaking.
    Comment: A few commenters recommended that CMS remove the 
requirement that specialists reporting under the specialty-specific 
measure set report a cross-cutting measure because they believed that 
the list of cross-cutting measures was not truly applicable to all 
specialties. For example, the commenters stated that emergency medicine 
MIPS eligible clinicians have only one proposed cross-cutting measure 
that is somewhat relevant: PQRS #3 1 7: High Blood Pressure Screening 
and Follow-Up. The commenters stated that the measure is problematic 
for emergency medicine because follow-up is required for any patient 
outside of the ``normal'' range. While the measure does include 
exclusion for patients in ``emergent or urgent situations where time is 
of the essence and to delay treatment would jeopardize the patient's 
health status,'' the commenters noted that a substantial number of ED 
patients are inadvertently included in the universe addressed by this 
measure, requiring burdensome documentation, follow-up, and even 
unnecessary downstream medical care.
    Response: We appreciate the comments and have examined the policies 
very carefully. As discussed above, we have modified our proposal for 
the transition year of MIPS. We are not requiring a cross-cutting 
measure but rather are finalizing that for the applicable performance 
period, the MIPS eligible clinician or group would report at least six 
measures including at least one outcome measure. If an applicable 
outcome measure is not available, 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 the MIPS eligible clinician or group would be required to 
report on each measure that is applicable or may report more measures 
that are applicable. We note that generally, we define ``applicable'' 
to mean measures relevant to a particular MIPS eligible clinician's 
services or care rendered.
    Comment: Some commenters urged CMS to take advantage of promoting a 
new set of cross-cutting quality measures--including measures generally 
applicable to patients with rare, chronic, and multiple chronic 
conditions--that would incorporate a patient-centered perspective, 
adding a critical patient voice to quality measurement.
    Response: We appreciate the suggestion and will take into 
consideration in the future.
    Comment: Other commenters supported the reporting criteria for 
cross-cutting measures and outcome measures. The commenters hoped that 
CMS would work with specialties that do not fall under the American 
Board of Medical Specialties' board certification to develop specialty-
specific measure sets for clinicians such as physical therapists, as 
this may help clinicians who are less familiar with the program report 
successfully. Additionally, the commenters supported the flexibility of 
reporting either the specialty-specific measure set or the six 
measures.
    Response: We appreciate the commenters' support. We welcome 
suggestions for additional specialty-specific measure sets in the 
future.
    Comment: Another commenter urged CMS to use the recommendations of 
the National Academy of Medicine's (NAM) 2015 Vital Signs report, 
available at http://www.nationalacademies.org/hmd/Reports/2015/Vital-Signs-Core-Metrics.aspx, to identify the highest priority measures for 
development and implementation in the MIPS program.
    Response: When we identified high priority measures, we sought 
feedback from numerous stakeholders and we encourage commenters to 
submit any specific suggestions for future consideration. We will take 
this specific suggestion into consideration for future rulemaking.

[[Page 77106]]

    Comment: A few commenters recommended that CMS provide 
clarification on how proposed specialty-specific measure sets will be 
scored, given many have less than the required number of measures and 
do not include a required outcome or high priority measure. The 
commenters were also concerned that many sets may not be applicable for 
sub-specialists, and many specialties do not have a proposed specialty-
specific measure set. In addition, the commenters stated that the 
number of applicable measures in a specialty-specific measure set may 
be reduced based on the proposed submission mechanism. For example, the 
commenters sought clarification as to whether an urologist who reports 
the one eCQM in the set (PQRS 50: Urinary Incontinence: Assessment of 
Presence or Absence Plan of Care for Urinary Incontinence in Women) is 
only accountable for the one eCQM and not accountable for reporting on 
an outcome or high priority measure.
    Response: We would like to explain that if fewer than six measures 
apply to the MIPS eligible clinician or group, the MIPS eligible 
clinician or group would be required to report on each applicable 
measure or may report more measures that are applicable. We note that 
generally, we define ``applicable'' to mean measures relevant to a 
particular MIPS eligible clinician's services or care rendered. 
Additionally, groups that report on a specialty-specific measure set 
that has fewer than six measures would only need to report the measures 
within that specialty-specific measure set. Please see section II.E.6. 
of this final rule with comment period for more on scoring. Finally, we 
would like to explain that if an MIPS eligible clinician or group 
reports via a data submission method that only has one applicable 
measure reportable via that method, the MIPS eligible clinician or 
group is only responsible for the measure that is applicable via that 
method. Alternatively, if an MIPS eligible clinician or group reports 
via a data submission method that does not have any measures reportable 
via that method, the MIPS eligible clinician or group must choose a 
data submission method that has one or more applicable measures. Given 
the potential for gaming in this situation, we will monitor whether 
MIPS eligible clinicians appear to be actively selecting submission 
mechanisms and measures sets with few applicable measures; we will 
address any changes to policies based on these monitoring activities 
through future rulemaking. We will also seek to expand the availability 
of measures available for reporting via all submission methods to the 
extent feasible.
    Comment: Some commenters recommended that CMS include in the 
specialty-specific measure sets those cross[hyphen]cutting measures 
that are most applicable to the specialty, rather than maintaining a 
separate list of cross-cutting measures and requiring MIPS eligible 
clinicians to refer to two lists. The commenters recommended that a 
geriatric measure set be created that will encourage geriatrician 
reporting and measures directly associated with improvements in care 
for the elderly.
    Response: We agree with the commenter and although we are not 
finalizing the requirement that MIPS eligible clinicians must report on 
a cross-cutting measure, we do still believe these measures add value. 
Therefore, we have incorporated the appropriate cross-cutting measures 
into the specialty-specific measure sets located in Table E of the 
Appendix in this final rule with comment period.
    Comment: Another commenter noted that there may be MIPS eligible 
clinicians whose services overlap in one or more specialty areas, and 
that flexibility is therefore necessary, yet believed that, in order 
for payers and patients to have a clear comparison, the ability to 
distinguish clinicians on like metrics is critical. Thus, with regard 
to specialty-specific measure sets, the commenter recommended that MIPS 
eligible clinicians be required to select a minimum number of quality 
measures from within their appropriate specialty-specific measure set. 
The commenter recommended that CMS continue to explore specialty-
specific measure sets for additional specialty and subspecialty areas 
in order to enhance and refine meaningful comparisons over time.
    Response: If a clinician has a specialty set, by submitting all of 
the measures in that set (which may be fewer than six), they will 
potentially achieve a maximum quality score, depending on their 
performance. If the measure set has fewer than six measures, and the 
clinician reports all the measures in that set, there is not a 
requirement for further reporting. We thank the commenters for the 
suggestion and intend to work with the specialty societies to further 
develop specialty measure sets, specifically those that would be 
applicable for subspecialists.
    Comment: Some commenters urged CMS to hold all MIPS eligible 
clinician types to the six measure requirement, suggesting that a sub-
specialty could select from the broader specialty list to reach six 
measures, or if necessary, report cross-cutting measure to achieve six 
measures if they have insufficient specialty-specific measures sets 
available to them.
    Response: We appreciate the commenters' suggestion and agree that 
it is important for clinicians to submit a sufficient number of 
measures. However, we are concerned that some subspecialists do not 
currently have a sufficient number of applicable measures to reach our 
6 measure requirement; we are working with specialty societies to 
ensure that all specialists soon have access to a sufficient number of 
measures. To assure that these subspecialists report a sufficient 
number of measures in the interim period, we are finalizing our 
proposal to allow subspecialists to submit a specialty-specific measure 
set fully in lieu of meeting the six measure minimum requirement.
    Comment: One commenter urged CMS to be more transparent on how 
designations used for high priority are determined. The commenter 
stated that since bonus points are factored into the determination of a 
domain or a measure's priority, it is vital that CMS considered 
recommendations from measure stewards and QCDR entities for this 
determination.
    Response: We define high priority measures as outcome, patient 
experience, patient safety, care coordination, cost, and appropriate 
use. These measures are designated and identified in rulemaking, based 
on their NQF designation or if the measures are not NQF endorsed, based 
on their NQS domain designation or measure description as defined by 
the measure owners, stewards and clinical experts. We welcome 
commenters' feedback on high priority measure determinations in the 
future.
    Comment: Some commenters stated that measures applicability should 
be determined by analyzing the MIPS eligible clinician's claims, not 
just their specialty designation.
    Response: We agree and intend to determine measure applicability 
based on claims data whenever possible. Absent claims data we would use 
other identifying factors such as specialty designation. Generally, we 
define ``applicable'' to mean measures relevant to a particular MIPS 
eligible clinician's services or care rendered. When we initially 
proposed the specialty-specific measure sets we factored into 
consideration both of the elements the commenter suggested.
    Comment: A few commenters encouraged CMS to emphasize that 
specialty-specific measures sets are intended as a helpful tool as 
opposed to a required set of submissions. The

[[Page 77107]]

commenters believed it is simpler for all MIPS eligible clinicians to 
report on six measures when they have eligible patients within the 
denominators of the approved measures so that everyone meets the same 
standards. Another commenter recommended that specialists and sub-
specialists be required to meet the same program expectations including 
reporting on six measures. The commenter stated that if six measures 
are not available in the sub-specialty list, the MIPS eligible 
clinicians would need to report at the higher specialty level or cross-
cutting measure until they reach a total of six measures. If CMS allows 
a lower number of quality measures for a particular specialty group in 
MIPS, the lower number of measures for reporting should be available to 
all MIPS eligible clinicians. If specialists and sub-specialists do not 
report on six measures, the commenter recommended that they should 
receive a score of zero for measures not reported.
    Response: We agree with the commenters that specialty-specific 
measure sets are intended to be helpful to MIPS eligible clinicians 
under the MIPS program. While it may be simpler to require the same six 
measures of all MIPS eligible clinicians, we do not believe it is 
appropriate to hold MIPS eligible clinicians accountable for measures 
that are not within the scope of their practice. The specialty-specific 
measure sets includes measures from the comprehensive list of MIPS 
quality measures available (Reference Table A). Measures within the 
specialty-specific measure set should be more relevant for the 
specialists and should be easier to identify and report. If a MIPS 
eligible clinician does not believe the measures within a specialty-
specific measure set are relevant for their practice, they can choose 
any six measures within the comprehensive quality measure list. If a 
specialty measure set is further broken out by sub-specialty exists, we 
would recommend that the MIPS eligible clinician should submit measures 
within the sub-specialty set. We have made every effort to ensure the 
sub-specialty set includes the relevant measures for the particular 
sub-specialty.
    Comment: Another commenter approved of the proposed specialty-
specific measures for the MIPS quality category and encouraged the 
creation of more specialty-specific measure sets. The commenter stated 
that currently, many specialty-specific measure sets have fewer than 
six measures, and many also do not have any outcome based measures. In 
addition, some of the specialty-specific measure sets have few or no 
EHR submission-eligible measures. The commenter urged CMS to prioritize 
e-specified measures currently listed as registry-only to enable 
clinicians to make maximum use of their CEHRT for reporting. The 
commenter also requested that CMS clarify MIPS eligible clinicians' 
obligations for quality measure reporting when no single reporting 
method will meet the reporting requirements even though the full 
specialty-specific measure set would do so.
    Response: We thank the commenter for their support of specialty-
specific measure sets. It is our intent to adopt more specialty-
specific measure sets over time, especially as new measures become 
available. Although some of the specialty-specific measure sets do not 
all have six measures they all contain an outcome or other high 
priority measure. When a MIPS eligible clinician chooses to report a 
specialty-specific measure set they are only required to report what is 
in the set and what is reportable through the selected data submission 
mechanism. We note, in rare 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 claims), we would score all the options 
(such as scoring the quality performance category with data from a 
registry, and also scoring the quality performance category with data 
from claims) and use the highest performance category score for the 
MIPS eligible clinician final score. We would not however, combine the 
submission mechanisms to calculate an aggregated performance category 
score. We refer readers to section II.E.6. of this final rule with 
comment period for more information on scoring. Lastly, we agree with 
the commenter that eCQMs are a priority, and we intend to continue 
adopting additional measures of this type on the future. We intend to 
continue leveraging MIPS eligible clinicians' use of CEHRT for quality 
reporting requirements to the greatest extent possible.
    Comment: A few commenters supported CMS' focus on outcome measures, 
and specifically supported CMS' proposal to require MIPS eligible 
clinicians to report on at least one outcome measure and to allow MIPS 
eligible clinicians to earn two additional points for each additional 
outcome measure reported because the commenters stated that outcome 
measures provide more meaning and value for Medicare beneficiaries and 
are critical for delivering high quality care. Several other commenters 
commended CMS' plan to increase the requirements for reporting outcome 
measures over the next several years through future rulemaking, as more 
outcome measures become available. The commenter recommended that CMS 
consider accelerating the implementation of additional outcome or high 
quality measures, and expressed support for additional bonus points 
awarded to MIPS eligible clinicians for reporting additional outcome or 
high quality measures. One commenter agreed that outcome measures 
should be emphasized in the future, as these are the true indicators of 
healthcare services reflected directly on a patient's health status. 
Another commenter recommended that CMS develop of both clinical 
outcomes (for example, survival for patients with cancer and other life 
threatening conditions) and patient-reported outcome measures (for 
example, quality of life, functional status, and patient experience) to 
support this aim.
    Response: We thank the commenters and agree; we believe outcome 
measures are critical to quality improvement. We will take the 
commenters' suggestions into consideration for future rulemaking.
    Comment: Other commenters stated that if quality is based on good 
outcomes, MIPS eligible clinicians may deter treating the sickest 
patients since it will negatively impact their numbers, thereby 
resulting in sick patients not receiving timely and proper treatment 
and increasing national medical expenditures.
    Response: We have confidence in the clinician community and its 
commitment to their patients' overall wellbeing. To date, there is no 
evidence from the PQRS, VM, or Medicare EHR Incentive Program for EPs 
that clinicians have been deterred from seeing all types of patients 
seeking their care. We also note that many outcomes measures are risk-
adjusted to account for beneficiary severity prior to treatment. We do 
recognize this issue is a concern for some stakeholders and will 
monitor MIPS eligible clinicians' performance under the MIPS for this 
unintended consequence.
    Comment: A few commenters recommended that CMS set limits on some 
of the measures that may be reported by multiple MIPS eligible 
clinicians with respect to one patient. For example, many beneficiaries 
will see multiple MIPS eligible clinicians. Hypothetically, the 
commenters believed it would not be appropriate for the body mass index 
(BMI) measure to be reported by a patient's primary care

[[Page 77108]]

physician, cardiologist, endocrinologist, ophthalmologist, and 
rheumatologist in the same year.
    Response: We thank the commenters for the suggestion and will take 
it into consideration in the future.
    Comment: Another commenter opposed CMS' overall policy to attempt 
to assess patient experience and satisfaction under the quality 
performance category of MIPS with outcomes-based measures. The 
commenter stated that these measures and surveys include factors that 
may be outside the control of the MIPS eligible clinician, such as 
hospital nursing and staff behavior and performance and wait times in a 
hospital setting due to inadequate staffing levels and physical plant 
design. Also, patient satisfaction, while important, does not always 
correlate with better clinical outcomes and may even conflict with 
clinically indicated treatments. Another commenter believed patients 
should be asked to report outcomes across a continuum of care domains 
including treatment benefit, side effects, symptom management, care 
coordination, shared decision-making, advanced care planning, and 
affordability.
    Response: We respectfully disagree and believe that outcomes-based 
measures and high priority measures are critical to measuring health 
care quality. We thank the commenter also for their thoughts on patient 
satisfaction surveys, but we believe it is appropriate to measure and 
incentivize directly MIPS eligible clinicians' performance on patient 
experience surveys which uniquely present patients the opportunity to 
assess the care that they received. There is evidence that performance 
on patient experience surveys is positively correlated with better 
patient outcomes. We intend to continue working with stakeholders to 
improve available measures.
    Comment: Other commenters stated the measures in the physical 
medicine specialty-specific measure set are all process measures and 
that the only way one can report on six out of seven measures is via a 
registry. Although the measures could be applicable to some Physical 
Medicine and Rehabilitation (PM&R) physicians, the commenters believed 
they are not applicable to all PM&R MIPS eligible clinicians. The 
commenters urged CMS to remove the specialty-specific measure set and 
work with American Academy of Physical Medicine and Rehabilitation 
(AAPM&R) on identifying better measurements for their specialty.
    Response: If MIPS eligible clinicians find that the measures within 
a specialty-specific measure set are not applicable to their practice, 
they may report any of the measures that are available under the MIPS 
program. We believe that the physical medicine specialty-specific 
measure set is applicable to PM&R MIPS eligible clinicians and that 
this policy appropriately accommodates those MIPS eligible clinicians 
that are unable to report the full specialty-specific measure set. 
Although all measures within the specialty-specific measure set may not 
be applicable to all PM&R clinicians, we believe that most PM&R 
clinicians will be able to report the measures within the set because 
they are relevant for most with the specialty. If an MIPS eligible 
clinician finds that they are unable to report the specialty-specific 
measure set, they are able to report any six measures from the larger 
quality measure set. We will continue to work with specialty societies 
to adjust the specialty-specific measure sets as more relevant measures 
become available. We also welcome specific feedback from MIPS eligible 
clinicians who are specialists on what quality measures would be most 
appropriate for their specialty-specific measure set.
    Comment: Another commenter supported the reporting of specialty-
specific measure sets as meeting the full requirements in the quality 
performance category because specialty MIPS eligible clinicians 
struggle to meet many other measures outside their domain and should 
not be penalized for not going outside their specialty by having to 
find additional measures to report that may not be appropriate for the 
care they provide.
    Response: We thank the commenter for their support. We note that 
the only additional measure that would be calculated as part of an MIPS 
eligible clinician's quality score is the population-based measure 
which does not require any data submission, reflected in Table B of the 
Appendix in this final rule with comment period, which only applies to 
groups of 16 or greater. For more information on this measure we refer 
readers to the Global and Population-Based Measures section below.
    Comment: Several commenters suggested that quality measurement and 
reporting must measure things that are clinically meaningful and should 
emphasize outcomes over process measures. The commenters added that 
quality measurement should also incorporate patient experience measures 
and patient-reported outcomes measures (PROMs), and quality measures 
should be disaggregated by race/ethnicity, gender, gender identity, 
sexual orientation, age, and disability status. Another commenter 
recommended that patient-reported outcome measures (PROMs) be given 
greater weight in the MIPS program. Other commenters encouraged the 
inclusion of medication adherence measures beyond those currently 
included under the quality performance category.
    Response: We agree with commenters that quality measurement must 
capture clinically-meaningful topics. We further agree that patient-
reported measures are important and we have included a number of PROMs 
in MIPS. We intend to expand their portfolio in the future. We will 
consider the commenter's suggestions on quality measure demographics 
and medication adherence measures, particularly in the context of risk-
adjustment, and increased weighting in the future.
    Comment: A few commenters recommended that CMS provide an incentive 
to MIPS eligible clinicians to submit eCQMs and not deter MIPS eligible 
clinicians from using CEHRT for eCQMs. The commenters recommended that 
CMS provide an exemption on reporting a cross-cutting ensure for MIPS 
eligible clinicians who use CEHRT/health IT vendors to report eCQMs for 
the quality performance category.
    Response: We thank the commenters for these suggestions. We refer 
the commenter to section II.E.6. of this final rule with comment period 
where we describe our policies for bonus points available for using 
CEHRT in a data submission pathway that to report patient demographic 
and clinical data electronically from end to end. An exemption on 
reporting a cross-cutting measure is not necessary considering our 
decision not to finalize a requirement to report a cross-cutting 
measure.
    Comment: One commenter urged CMS to maintain greater control of the 
reporting under Quality Payment Program and to provide more thoroughly 
defined measurements. They also urged CMS to incorporate more reporting 
requirements that would assess the actual and overall quality of care 
being provided to beneficiaries.
    Response: We thank the commenter for the feedback. We have 
structured the MIPS program to rely on the MIPS eligible clinician's 
choice of specialty, which remains in the clinician's control, and 
which we expect reflects the services that they provide, as well as the 
quality measures that those MIPS eligible clinicians select. The 
quality measures go through a rigorous review process to assure they 
are thoroughly defined measurements as discussed in section II.E.5.c. 
of this final rule with

[[Page 77109]]

comment period. We believe the MIPS program is designed to assess 
actual and overall quality of care being provided to the beneficiaries.
    Comment: Other commenters stated their small staff does not have 
time to spend on reporting quality metrics.
    Response: It has been our intention to adopt measures that are as 
minimally burdensome as possible. We have also adopted several other 
policies for smaller practices in order to ensure that MIPS does not 
impose significant burdens on them. We encourage the commenters to 
contact the Quality Payment Program Service Center for assistance 
reporting applicable measures.
    Comment: One commenter believed that some flexibility in reporting 
requirements under quality would be helpful, especially for small 
practices, but encouraged CMS to balance the need for flexibility 
against the need for consistent reporting across MIPS eligible 
clinicians. Another commenter stated that CMS should allow small 
practices to report a smaller number of quality measures, at least for 
the initial few years.
    Response: We thank the commenter. We have attempted to be flexible 
with the measures that we have adopted under MIPS. It has been our 
intention to adopt measures that are as minimally burdensome as 
possible. We have also adopted several other policies for smaller 
practices in order to ensure that MIPS does not impose significant 
burdens on them.
    Comment: Another commenter supported narrowing the requirements for 
improving quality measurement and reporting for MIPS based on data 
collected as a natural part of clinical workflow using health 
information technology.
    Response: We will take this comment into account in the future. We 
believe that electronic quality measurement is an important facet of 
quality programs more generally.
    Comment: One commenter supported allowing flexibility for MIPS 
eligible clinicians to choose measures that are relevant to their type 
of care.
    Response: We thank the commenter and agree.
    Comment: Other commenters encouraged CMS and Health Resources and 
Services Administration (HRSA) to align the quality measurement 
sections of MIPS and the Uniform Data System so that FQHCs can submit 
one set of quality data one time for both purposes.
    Response: We thank the commenters for their suggestion and will 
examine this option for future rulemaking. Please refer to section 
II.E.1.d. of this final rule with comment period for more information 
regarding FQHCs.
    Comment: Some commenters requested that CMS clarify the proposal to 
eliminate the need to track and report duplicative quality measures by 
modifying its proposal to require that if quality is reported in a 
manner acceptable under MIPS or an APM, it would not need to be 
reported under the Medicaid EHR Incentive Program. The commenters were 
concerned the programs could potentially cause the same conflict CMS 
specifically noted MIPS and APMs were intended to correct.
    Response: We thank the commenters and have worked to eliminate 
duplicative measures between MIPS and other programs where possible. We 
intend to continue to align MIPS and the Medicaid EHR Incentive Program 
to the greatest extent possible. As we have noted in section II.E.5.g. 
of this final rule with comment period, the requirements for the 
Medicaid EHR Incentive Program for EPs were not impacted by the MACRA. 
There is a requirement to submit CQMs to the state as part of a 
successful attestation for the Medicaid EHR Incentive Program. While 
the MIPS objectives for the advancing care information performance 
category are aligned to some extent with the Stage 3 objectives in the 
Medicaid EHR Incentive Program, they are two distinct programs, and 
reporting will stay separate.
    Comment: Another commenter stated that while the quality section 
discusses outcome measures, much of the measures are traditional, 
clinic based process measures. The commenter was unclear how such 
measures will drive transformation.
    Response: We currently have approximately 64 outcome measures 
available from which MIPS eligible clinicians may choose. We do agree 
that more work needs to occur on outcome measure development to impact 
the quality of care provided. As additional outcome measures are 
developed, we will incorporate these for future rulemaking.
    Comment: One commenter agreed that moving to more ``high value'' 
measures or ``measures that matter'' is important. However, the 
commenter recommended that neurologists be able to select measures that 
have the greatest value in driving improvement for their patients. The 
commenter stated that measures considered ``high value'' may differ by 
specialty or patient population.
    Response: We appreciate the commenters support. We recommend that 
all MIPS eligible clinicians select measures that have the greatest 
value in driving improvement for their patients.
    Comment: Another commenter suggested that MIPS eligible clinicians 
who report different quality measures from the prior year should be 
requested to provide the rationale for the change. The commenter 
suggested that CMS request the MIPS eligible clinician report data for 
the same categories as the prior year to preclude the chance that a 
MIPS eligible clinician may be seeking to find loopholes and flaws in 
the system.
    Response: We appreciate the suggestion and will take it into 
consideration for future years of the program. We will also monitor 
whether clinicians appear to be switching measures to improve their 
scores, rather than due to changing medical goals or patient 
populations. We will report back on the results of our monitoring in 
future rulemaking.
    Comment: A few commenters requested that MIPS eligible clinicians 
reporting quality using third party submission mechanisms not certified 
to all available measures only be required to report from the list of 
measures to which the system is certified. That is, receive an 
exemption from standard reporting requirements similar to the 
flexibility built in for others who lack reportable measures.
    Response: We respectfully disagree that an exemption is necessary 
in the circumstance the commenters describe. MIPS eligible clinicians 
choosing to report data via third party intermediary should select an 
entity from the list of qualified vendors that is able to report on the 
quality metrics that MIPS eligible clinician believes are most 
appropriate for their practice and that they wish to report to CMS.
    Comment: Some commenters encouraged CMS to further evaluate the use 
of more than one measure, which must be an outcome measure or a high 
priority measure, when more than one measure exists and each measures a 
distinct and different health outcome; and if an applicable outcome 
measure is not available, another high priority measure (appropriate 
use, patient safety, efficiency, patient experience, and care 
coordination measures) in lieu of an outcome measure should be 
considered. Thus, the commenters recommended that CMS consider the 
requirement of two (or more) outcome or high quality measures, as a 
component of the final score, when available.
    Response: Thank you for the feedback, and we will consider this in 
future rulemaking. We also want to refer this commenter to section 
II.E.6.a.(2) of this final rule with comment period

[[Page 77110]]

where we describe the bonus points available for high priority measures 
and section II.E.5.b.(3)(a) of this final rule with comment period 
where we describe our interest in increasing the emphasis on outcome 
measures moving forward.
    Comment: Other commenters urged CMS to continue to include process 
measures in quality reporting programs while testing relevant outcomes 
measures for future inclusion. Specifically, the commenters were 
concerned that a small number of orthopedic surgery outcomes measures 
currently exist and believed that more time is required to develop 
relevant outcomes measures before CMS emphasizes outcomes for specialty 
clinicians.
    Response: MIPS eligible clinicians are required to submit data on 
an outcome measure if available, but if not, another high priority 
measure may be selected. We agree with the commenter that additional 
outcome measure development needs to occur.
    Comment: A few commenters wanted to know if there would be any 
impacts (beyond loss of points) if a MIPS eligible clinician chooses to 
not report any outcome or high priority condition measures.
    Response: The commenters are correct that the only impacts for not 
submitting outcomes or high priority measures would be a loss of points 
under the quality performance category.
    Comment: Several commenters recommended that CMS reinstate measures 
group reporting as an option under MIPS. The commenters stated that by 
removing this option CMS has skewed reporting in favor of large group 
practices, the majority of whom report through the GPRO web-interface 
that allows for and requires reporting on a sampling of patients. One 
commenter noted that while measure groups are not the most popular 
reporting option in PQRS, MIPS eligible clinicians choosing this option 
have had a high success rate and that measures included in a measures 
group undergo a deliberate process that ensures a comprehensive picture 
of care is measured. One commenter indicated many oncology small 
practices use the measure group reporting mechanism which is less 
burdensome and a meaningful mechanism for quality reporting for these 
practices. Another commenter requested that small practices be able to 
continue reporting measures groups on 20 patients. Some commenters 
stated by doing away with the measures group quality reporting option, 
CMS has actually made this category more difficult for many clinicians 
to meet, particularly those in small practices. Another commenter 
requested CMS retain the asthma and sinusitis measure groups as 
currently included in PQRS.
    Response: We did not propose the measures group option under MIPS 
because, as commenters noted, very few clinicians utilized this option 
under PQRS. Under the MIPS, we substituted what we believe to be a more 
relevant selection of measures through specialty-specific measure sets. 
Adopting this policy also enables a more complete picture of quality 
for specialty practices. We do not believe the specialty-specific 
measure set will pose an undue burden on small practices, and may make 
it easier for eligible clinicians, including those in small practices, 
to easily identify quality measures to report to MIPS. We will continue 
to assess this policy for enhancements in future rulemaking.
    Comment: Other commenters stated the quality requirements are ill-
conceived and unworkable and the severity of illness calculations 
unfair (for example, if MIPS eligible clinicians do a good job 
preventing complications, they are punished with a low score).
    Response: We believe that the quality measures we are adopting for 
the MIPS program will appropriately incentivize high quality care, 
including care that prevents medical complications. However, we will 
monitor the MIPS program's effects on clinical practices carefully.
    Comment: Some commenters supported CMS' proposals to require MIPS 
eligible clinicians to report only six measures and to remove the NQS 
domain requirement for selecting measures as compared to the PQRS, but 
opposed CMS' proposed requirement that MIPS eligible clinicians report 
on outcomes and high priority measures. The commenters recommended that 
CMS incentivize outcomes based measures by assigning them more weight 
within MIPS. Additionally, the commenters were concerned that many 
specialties do not have access to outcome measures. The commenters 
opposed requiring patient experience and satisfaction measures for MIPS 
eligible clinicians, noting that evaluating patient experience is best 
done using confidential feedback to clinicians. The commenters would 
support CMS' use of the patient satisfaction surveys under the 
improvement activities performance category if performance was based 
only on administering a survey, evaluating results, and addressing the 
findings of the survey. The commenters encouraged CMS to give funding 
preference for development of measures to those specialties with 
limited measures. Another commenter recommended requiring the inclusion 
of patient centered measures that reflect the values and interests of 
patients, including patient reported outcome measures, patient 
experience of care, cross cutting measures, and clinical outcome 
measures.
    Response: We thank the commenters for their support. However, we do 
believe that outcome measures and high priority measures are critical 
to measuring health care quality, and are designated high priority for 
that reason. We thank the commenter also for their thoughts on patient 
satisfaction surveys, but we believe it is appropriate to measure and 
incentivize directly MIPS eligible clinicians' performance on patient 
experience surveys. We intend to continue working with stakeholders to 
improve available measures. We would like to explain for commenters 
that the CAHPS for MIPS survey is included under the quality 
performance category, as well as the improvement activities performance 
category as a high-weighted activity in the Patient Safety and Practice 
Assessment subcategory noted in Table H of the Appendix in this final 
rule with comment period.
    Comment: The commenters requested further clarification on the 
number of measures required when specialty-specific measure sets are 
used. For example, if a non-patient facing MIPS eligible clinician 
submits all measures from a specialty-specific measure set (in Table E 
of the Appendix), would they still be allowed to submit other measures 
applicable to their practice, such as cross-cutting measures? In a 
scenario where an MIPS eligible clinician submits all three available 
measures in a specialty-specific measure set and also submits one 
cross-cutting measure not listed in the a specialty-specific measure 
set (therefore submitting a total of four measures), will the MIPS 
eligible clinician be penalized for not submitting six total measures? 
The commenters requested that the final rule with comment period 
include specific requirements on the number of measures required for 
MIPS eligible clinicians who elect to submit measures from a specialty-
specific measure set.
    Response: We would like to explain that our final policy for 
quality performance category is for the applicable continuous 90-day 
performance period during the performance period, or longer if the MIPS 
eligible clinician chooses, the MIPS eligible clinician or group will 
report one specialty-specific measure set, or the measure set defined 
at the

[[Page 77111]]

subspecialty level, if applicable. If the measure set contains less 
than six measures, MIPS eligible clinicians will be required to report 
all available measures within the set. If the measure set contains six 
or more measures, MIPS eligible clinicians will be required to report 
at least six measures within the set. We note that generally, we define 
``applicable'' to mean measures relevant to a particular MIPS eligible 
clinician's services or care rendered.
    Regardless of the number of measures that are contained in the 
measure set, MIPS eligible clinicians reporting on a measure set will 
be required to report at least one outcome measure or, if no outcome 
measures are available in the measure set, report another high priority 
measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures) within the measure set in 
lieu of an outcome measure. For the commenter's specific questions, 
there is no penalty or harm in submitting more measures than required. 
Rather, this can benefit the clinician because if more measures than 
the six required are submitted, we would score all measures and use 
only those that have the highest performance, which can result in a 
MIPS eligible clinician receiving a higher score. Lastly, we note that 
since we are not finalizing the requirement of cross-cutting measures 
in the quality performance category, there is no difference in 
requirements for patient facing and non-patient facing clinicians in 
the quality performance category.
    Comment: One commenter supported the flexibility provided for non-
patient facing MIPS eligible clinicians; however, the commenter 
suggested that CMS continue to keep in mind that most measures across 
the MIPS components apply to patient-facing encounters. The commenter 
recommended that CMS work with medical specialty and subspecialty 
groups to determine how to best expand the availability of clinically 
relevant performance measures for non-patient facing MIPS clinicians, 
or ways to reweight MIPS scoring to provide these clinicians with 
credit for activities that more accurately align with their role in the 
treatment of a patient.
    Response: We appreciate the commenters' suggestions and will take 
them into consideration in future rulemaking. We would like to explain 
that we consistently work closely with specialty societies and intend 
to continue engaging with them on future MIPS policies.
    Comment: Several commenters supported the decision from CMS to 
reduce the number of mandatory quality measures for reporting from nine 
to six, and appreciated steps to clarify reporting requirements when 
fewer than six applicable measures are available. Some commenters 
believed that the best approach when directly applicable measures are 
not available is to minimize the number of measures required for 
reporting and focus instead on the measures that do apply to the 
clinician and patient. Additionally, these commenters stated there is 
value in the stratification of data across different identifiers, 
particularly for some gastrointestinal (GI) services with differential 
impacts across patient groups; however, the lack of existing data 
related to factors such as ethnicity and gender makes data 
stratification particularly difficult and often irrelevant. The 
commenters requested that CMS engage in an open dialogue once 
recommendations are received from the ASPE if they believe it necessary 
to move forward with proposals impacting GI care.
    Response: We appreciate the commenters support. We have an open 
dialogue and appreciate feedback from all federal agencies and 
stakeholders. We will closely examine the ASPE studies when they are 
available and incorporate findings as feasible and appropriate through 
future rulemaking. We look forward to working with stakeholders in this 
process.
    Comment: One commenter supported the goals for meaningful 
measurement but indicated that there are challenges to implementing 
policies to achieve them, including the proposed quality performance 
category which is overly complex, largely unattainable, lacks 
meaningful measures, lacks transparency and lacks appropriate risk-
adjustment. The commenter recommended further collaboration with 
specialty societies to create policies which will engage surgeons, 
including surgeons who were unable to successfully participate in PQRS.
    Response: We appreciate the comment. As stated above, we 
consistently work closely with specialty societies to solicit measures 
and we intend to continue engaging with them on future MIPS policies.
    Comment: Some commenters requested that CMS allow flexibility 
around outcome measure reporting requirements and allow suitable 
alternatives where necessary, as many stakeholders still face barriers 
in the development of and use of meaningful outcome measures. The 
commenters discouraged CMS from assigning extra weight to outcome 
measures, as there is no standard methodology for reporting and risk-
adjustment methodologies, which may unfairly disadvantage some MIPS 
eligible clinicians and advantage others. The commenters supported 
comprehensive measurement and consideration of measures in the IOM/NQS 
Quality Domains.
    Response: We appreciate the commenter's suggestions and will take 
them into consideration in the future. However, to address the 
commenter's concern regarding an unfair disadvantage for some eligible 
clinicians as it relates to the availability and reporting of outcome 
measures, we have provided flexibility of reporting for those eligible 
clinicians that do not have access to outcome measures by allowing 
eligible clinicians to report on high priority measures as well. Since 
high priority measures span all eligible clinician specialties, we do 
not believe some eligible clinicians will have an advantage of 
reporting over others.
    Comment: Another commenter asked CMS to clarify whether a measure 
type listed as an `intermediate outcome' would count equally as an 
`outcome' measure. Another commenter recommended that intermediate 
outcome measures should only be counted as outcome measures if there is 
a strong evidence base supporting the intermediate outcome as a valid 
predictor of outcomes that matter to patients.
    Response: We consider measures listed as an ``intermediate 
outcome'' measure to be outcome measures. In addition, it is important 
to note that if an applicable outcome measure is not available, a 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.
    Comment: Another commenter requested clarity on whether a clinician 
is evaluated on the same six quality measures as the group they report 
in. The commenter wanted to know what happens if one of those group 
measures is not applicable to the clinician.
    Response: MIPS eligible clinicians that report as part of a group 
are evaluated on the measures that are reported by the group, whether 
or not the group's measures are specifically applicable to the 
individual MIPS eligible clinician. In addition, MIPS eligible 
clinicians who form a group, but have elected to report as individuals, 
will each be evaluated only on the measures they themselves report.
    Comment: Some commenters were concerned about group reporting of 
quality measures in multispecialty practices. Thus, the commenters 
recommended that CMS allow MIPS

[[Page 77112]]

eligible clinicians in multi-specialty practices to report on measures 
that are meaningful to their specialty, and that each MIPS eligible 
clinician in a group be assessed individually, and all scores of the 
MIPS eligible clinicians reporting under the same TIN be aggregated to 
achieve one score for the entire practice.
    Response: We appreciate the commenter's suggestions. From the 
example provided, we would recommend that clinicians in this situation 
may find reporting as individual MIPS eligible clinicians favorable 
over reporting as a group. We will take these recommendations into 
consideration in for future rulemaking.
    Comment: One commenter recommended a cap of nine measures in the 
future if CMS believes that allowing more than the required six is 
needed.
    Response: We appreciate the commenter's suggestion. We will take 
this into consideration in the future.
    Comment: A few commenters applauded CMS's extensive efforts to 
include specialists in the quality component of MIPS. The commenters 
recommended that CMS determine which specialties do not have enough 
measures to select at least six that are not topped out and exempt 
those specialists from the quality category until enough measures 
become available. Some commenters were pleased that CMS recognized that 
very specialized MIPS eligible clinicians may not meet all six 
applicable measures.
    Response: We appreciate the commenters support. MIPS eligible 
clinicians who do not have enough measures to select at least six 
measures should choose all of the measures that do apply to their 
practice and report them. We will conduct a data validation process to 
determine whether MIPS eligible clinicians have reported all measures 
applicable to them if the MIPS eligible clinician does not report the 
minimum required 6 measures. As an alternative, the MIPS eligible 
clinician may choose a specialty-specific measure set. If the measure 
set contains fewer than six measures, MIPS eligible clinicians will be 
required to report all available measures within the set. If the 
measure set contains six or more measures, MIPS eligible clinicians 
will be required to report at least six measures within the set. 
Regardless of the number of measures that are contained in the measure 
set, MIPS eligible clinicians reporting on a measure set will be 
required to report at least one outcome measure or, if no outcome 
measures are available in the measure set, report another high priority 
measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures) within the measure set in 
lieu of an outcome measure. Generally, we define ``applicable'' to mean 
measures relevant to a particular MIPS eligible clinician's services or 
care rendered. MIPS eligible clinicians who do not have six individual 
measures available to them should select their appropriate specialty-
specific measure set, because that pre-defines which measures are 
applicable to their specialty and provides protections to them. For the 
majority of MIPS eligible clinicians choosing the specialty-specific 
measure sets provides protections to MIPS eligible clinicians because 
we have pre-determined which measures are most applicable, based on the 
MIPS eligible clinicians specialty.
    We do intend to provide toolkits and educational materials to MIPS 
eligible clinicians that will reduce the burden on determining which 
measures are applicable. We do not believe, however, that it is 
appropriate to exempt specialties from the quality performance category 
if they have fewer than six measures or topped out measures. Rather 
these specialties are still able to report on quality measures, just a 
lesser the number of measures. We refer the readers to section II.E.6. 
of this final rule with comment period for the discussion of authority 
under 1848(q)(5)(F) to reweight category weights when there are 
insufficient measures applicable and available.
    Comment: A few commenters requested clarification on whether the 
measures are separate for each individual performance category such as 
quality, and advancing care information or whether one measure can 
apply to more than one category.
    Response: Each measure and activity applies only for the 
performance category in which it is reported. However, some actions 
might contribute to separately specified activities, such as reporting 
a quality measure through a QCDR, which may make it easier for the MIPS 
eligible clinician to perform an improvement activity that also 
involves use of a QCDR. However, it is important to note that the CAHPS 
for MIPS survey receives credit in the quality and improvement 
activities performance categories. In addition, certain improvement 
activities may count for bonus points in the advancing care information 
performance category if the MIPS eligible clinician uses CEHRT.
    Comment: One commenter stated that while CMS has provided CPT codes 
for consideration for PQRS in the past, it has not provided the type of 
CPT codes to be used for MIPS assessment.
    Response: The CPT codes that have historically been available under 
the PQRS program will be made available for the MIPS as part of the 
detailed measure specifications which will be posted prior to the 
performance period at QualityPaymentProgram.cms.gov. More information 
on the detailed measure specifications is available in section 
II.E.5.c. of this final rule with comment period.
    Comment: The commenter requested clarification as to whether a MIPS 
eligible clinician is obligated to report on measures if the procedures 
are performed in a surgery center or hospital.
    Response: Yes, in the instances where those procedures or services 
are billed under Medicare Part B or another payer that would have 
services that fall under the measure's denominator, MIPS eligible 
clinicians are required to report on measures where denominator 
eligible patients are designated within the measure specification.
    Comment: One commenter stated that in addressing CMS' question of 
whether to require one cross-cutting measure and one outcome measure, 
or one cross-cutting measure and one high priority measure (which is 
inclusive of the outcome measures), the commenter recommended that CMS 
allow MIPS eligible clinicians to select one cross-cutting and one high 
priority measure. The commenter noted that this approach gives MIPS 
eligible clinicians more flexibility and gives CMS time to develop 
additional outcome measures to choose from.
    Response: We appreciate the comment. However, we believe it is 
important to include the requirement to report at least one outcome 
measure if it is available given the importance of outcome measures on 
assessing health care quality. As noted above, we are finalizing our 
proposal to require one outcome measure, or if an outcome measure is 
not available, another high priority measure. We are not finalizing our 
proposal to require one cross-cutting measure.
    Comment: Some commenters did not support CMS' proposal to require 
the reporting of outcome/high priority measures in order to achieve the 
maximum quality performance category points. The commenters recommended 
that instead, CMS reward high priority measures with bonus points, but 
cap the bonus points CMS Web Interface users can earn. The commenters 
recommended their approach because more large practices can use the CMS 
Web Interface option, which includes several high priority measures, 
and this could favor these MIPS eligible

[[Page 77113]]

clinicians over those in smaller practices. Another commenter expressed 
concern about CMS's requirement to report on high priority, including 
specific outcomes based, and cross-cutting measures, and stated that 
those standards are currently counterproductive due to inherent 
difficulty with tracking outcomes in cancer care, in part because 
meaningful outcomes often require years of follow-up, and because 
sample sizes of cancer patients may be very small at the clinician 
level. The commenter further noted that the vast majority of oncology 
measures existing today are process-based versus outcomes based, 
rendering an adjustment period for outcomes based measures in cancer 
care. The commenter recommended that CMS clearly state in the final 
rule with comment period that the outcomes measure reporting 
requirement does not apply to oncology clinicians until more meaningful 
quality measures are developed for oncology care.
    Response: We would like to explain that our proposals do include 
bonus points (subject to a cap) for reporting on high priority 
measures; we refer readers to section II.E.6.a.(2)(e) of this final 
rule with comment period. We believe that outcome measures and high 
priority measures are critical to measuring health care quality, and 
they are designated high priority for that reason. We intend to 
continue working with stakeholders to improve available measures.
    Comment: Other commenters believed that in order to allow and 
encourage MIPS eligible clinicians to report the highest quality data 
available, which includes outcomes measures in EHR and registry data, 
and support innovation, CMS should allow MIPS eligible clinicians to 
report at least one of the six required quality measures under MIPS 
through a QCDR. Some commenters strongly encouraged CMS to move toward 
a streamlined set of high priority measures that align incentives and 
actions of organizations across the health care system. The commenters 
also recommended that CMS give NQF-endorsed measures priority.
    Response: We thank the commenters for their feedback and intend to 
finalize our proposal that one of the six measures a MIPS eligible 
clinicians must report on is an outcome measure. We also understand the 
concerns that not all MIPS eligible clinicians may have a high priority 
measure available to them. However, we do believe that all MIPS 
eligible clinicians regardless of their specialty have a high priority 
measure available for reporting. Therefore, we intend to finalize that 
if a MIPS eligible clinician does not have an outcome measure 
available, they are required to report on a high priority measure. In 
addition, a QCDR is one of the data submission mechanisms available to 
a MIPS eligible clinician to report measures.
    Comment: A few commenters encouraged CMS to provide additional time 
for small or mid-sized practices to transition to CEHRT and QCDRs by 
ensuring that there are a sufficient number of measures available for 
claims-based reporting, particularly in the quality performance 
category, in the first several performance years under MIPS.
    Response: We appreciate the commenter's concerns, and while we do 
have the goal of ultimately moving away from the claims based 
submission mechanism, we do recognize that this mechanism must be 
maintained until electronic--based mechanisms of submission continue to 
develop and mature.
    Comment: One commenter wanted to ensure that the proposed reporting 
does not detract from the patient--clinician clinical visit because it 
is crucial for the patient-clinician relationship.
    Response: We agree that the patient--clinician encounter is 
paramount. Reporting can be captured through the EHR or through a 
registry at a later time.
    Comment: One commenter stated that the proposed guidelines cannot 
be applied to all of the specialties and sub-specialties uniformly.
    Response: We are assuming that the commenter is referring to the 
proposed data submission requirements for the quality performance 
category. We are providing flexibility on the submission mechanisms and 
selection of measures by MIPS eligible clinicians because we understand 
that varying specialties have differing quality measurement needs for 
their practices.
    Comment: Some commenters were concerned about lowering the 
threshold on measures and thought the measure criteria were 
insufficient. One commenter was also concerned that there was no 
requirement for reporting on a core set of measures for every primary 
care physician (PCP) and specialist.
    Response: We respectfully disagree with the commenter. Drawing from 
our experiences under the sunsetting programs, we believe that is more 
important to ensure that clinicians are measured on quality measures 
that are meaningful to their scope of practice as well as quality 
measures that emphasize outcome measurement or other high priority 
areas rather than a large quantity of measures.
    Comment: One commenter asked for clarification on whether six non-
MIPS measures (QCDR) can be selected by a MIPS eligible clinician and 
be used to meet the reporting criteria.
    Response: Yes, this is allowable for reporting using QCDRs as long 
as one of the selected measures is an outcome measure, or another high 
priority measure if an outcome is unavailable.
    Comment: Some commenters urged CMS to ensure the proposed 
validation process to review and validate a MIPS eligible clinician's 
inability to report on the quality performance category requirements--
similar to the Measure-Applicability Validation (MAV) process--is 
transparent. The commenters urged consultation with clinician 
stakeholders as CMS develops the new validation process, expressing 
concerns related to the MAV, including the lack of clarity in how the 
MAV actually functions. Another commenter recommended CMS develop a 
validation process that will review and validate a MIPS eligible 
clinician's or group's ability to report on a sufficient number of 
quality measures and a specialty-specific sample set--with a sufficient 
sample size--including both a cross-cutting and outcome measure. One 
commenter requested a timeframe for the validation process so they may 
prepare.
    Response: We agree with the commenters and intend to provide as 
much transparency into the data validation process for the quality 
performance category under MIPS as technically feasible. The validation 
process will be part of the quality performance category scoring 
calculations and not a separate process as the MAV was under PQRS. We 
refer readers to section II.E.6.a.(2) of this final rule with comment 
period for more information related to the quality performance scoring 
process. Lastly, we are working to provide additional toolkits and 
educational materials to MIPS eligible clinicians prior to the 
performance period that will ease the burden on identification of which 
measures are applicable to MIPS eligible clinicians. If the MIPS 
eligible clinician required assistance, they may contact the Quality 
Payment Program Service Center.
    Comment: Another commenter recommended delegating each medical 
specialty the task of choosing three highly desirable outcomes to focus 
on each year and rewarding those outcomes to promote quality in lieu of 
using 6-8 dimensions of meaningful use

[[Page 77114]]

performance combined with numerous quality indicators.
    Response: We agree with the commenter that focusing on outcomes and 
outcome measurement is important, as we have indicated in this final 
rule with comment period. We are however required by statute to measure 
MIPS eligible clinician's performance on four performance categories, 
which quality and advancing care information are a part of.
    Comment: One commenter stated that claims data is misleading and 
may corrupt attempts to analyze information with ``big data'' 
approaches, because a significant proportion of claims data only 
captures the first four codes that a clinician enters into the medical 
record. The commenter further noted that many clinicians documented 
numerous diagnoses into the medical record, unaware that some vendors 
only accept the first four diagnoses and that some EHR systems arrange 
diagnoses in alphabetical order despite how the clinician entered them. 
The commenter suggested CMS mandate no restriction on the number of 
diagnoses entered into the 1500 Health Insurance claim form--or at 
least mandate the National Uniform Claim Committee (NUCC) 
recommendation to expand the maximum amount of diagnoses from four to 
eight.
    Response: Although the commenter's recommendation is outside the 
scope of the proposed rule, we note that we do not believe that this 
approach compromises either data mining or claims processing.
    Comment: One commenter requested CMS provide guidance regarding the 
treatment of measures that assess services that are not Medicare 
reimbursable, such as postpartum contraception. The commenter 
recommended that CMS adopt the measures in the Medicaid Adult and Child 
Core Sets that have been specified and endorsed at the clinician level.
    Response: We agree that working to align MIPS quality measures with 
Medicaid is important and intend to develop a ``Medicaid measure set'' 
that will be based on the existing Medicaid Adult Core Set (https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Downloads/Medicaid-Adult-Core-Set-Manual.pdf). Further, we 
believe it is important to have MIPS quality measure alignment with 
private payers and have engaged a Core Quality Measure Collaborative 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Core-Measures.html) to develop measures to 
be used both by private payers and the MIPS program. Our strategic 
interest is a future state where measurement in multi-payer systems, 
Medicaid, and Medicare can be seamlessly integrated into CMS programs.
    After consideration of the comments regarding our proposal on 
submission criteria for quality measures excluding CMS Web Interface 
and CAHPS for MIPS, we are finalizing at Sec.  414.1335(a)(1) 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) are required to meet the following 
submission criteria. For the applicable period during the performance 
period as discussed in section II.E.5.b.(3) of this final rule with 
comment period, the MIPS eligible clinician or group will report at 
least six measures including at least one outcome measure. If an 
applicable outcome measure is not available, the MIPS eligible 
clinician or group will 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 the MIPS eligible clinician or group 
will be required to report on each measure that is applicable. We 
define ``applicable'' to mean measures relevant to a particular MIPS 
eligible clinician's services or care rendered.
    Alternatively, for the applicable performance period in 2017, the 
MIPS eligible clinician or group will report one specialty-specific 
measure set, or the measure set defined at the subspecialty level, if 
applicable. If the measure set contains fewer than six measures, MIPS 
eligible clinicians will be required to report all available measures 
within the set. If the measure set contains six or more measures, MIPS 
eligible clinicians will be required to report at least six measures 
within the set. Regardless of the number of measures that are contained 
in the measure set, MIPS eligible clinicians reporting on a measure set 
will be required to report at least one outcome measure or, if no 
outcome measures are available in the measure set, report another high 
priority measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures) within the measure set in 
lieu of an outcome measure. MIPS eligible clinicians may choose to 
report measures in addition to those contained in the specialty-
specific measure set will not be penalized for doing so, provided such 
MIPS eligible clinicians follow all requirements discussed here.
    In accordance with Sec.  414.1335(a)(1)(ii), MIPS eligible 
clinicians and groups will select their measures from either the list 
of all MIPS measures in Table A of the Appendix in this final rule with 
comment period, or a set of specialty-specific measure set in Table E 
of the Appendix in this final rule with comment period. 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 also are finalizing the definition of a high priority measure at 
Sec.  414.1305 means an outcome, appropriate use, patient safety, 
efficiency, patient experience, or care coordination quality measures. 
These measures are identified in Table A of the Appendix in this final 
rule with comment period.
    We are not finalizing our proposal to require MIPS eligible 
clinicians and groups to report a cross-cutting measure because we 
believe we should provide flexibility during the transition year of the 
program as MIPS eligible clinicians adjust to MIPS. However, we are 
seeking comments on adding a requirement to our modified proposal that 
patient-facing MIPS eligible clinicians would be required to report at 
least one cross-cutting measure in addition to the high priority 
measure requirement for further consideration for MIPS year 2 and 
beyond. We are interested in feedback on how we could construct a 
cross-cutting measure requirement that would be most meaningful to MIPS 
eligible clinicians from different specialties and that would have the 
greatest impact on improving the health of populations.
(ii) Submission Criteria for Quality Measures for Groups Reporting via 
the CMS Web Interface
    We proposed 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 proposed 
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

[[Page 77115]]

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 did 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 note 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 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 proposed 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 in the proposed rule (81 FR 28188) and total per capita cost 
for all attributed beneficiaries discussed in proposed rule (81 FR 
28188). As MIPS is a different program, we proposed 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 the proposed rule (81 FR 28188). We 
requested comments on these proposals.
    The following is summary of the comments we received regarding our 
proposal on submission criteria for quality measures for groups 
reporting via the CMS Web Interface.
    Comment: Some commenters supported the general direction and intent 
of the proposed quality performance category, and particularly 
supported CMS's alignment between the CMS Web Interface measure set and 
the quality measure reporting and performance requirements for the 
Medicare Share Savings Program Tier 1 organizations. Another commenter 
supported national alignment of quality measures.
    Response: We thank the commenters for their support.
    Comment: Another commenter stated that CMS should either remove or 
modify some of the quality measures used as part of CMS Web Interface, 
as existing criteria make them difficult to achieve for large group 
practices and may not reflect current recommendations. The commenter 
provided examples of three specific measures and why they present 
challenges to practice in the context of large groups using CMS Web 
Interface. For example, the commenter stated that the depression 
remission measure (MH-1) measures the number of patients with major 
depression, as defined as an initial PHQ-9 score > 9, who demonstrate 
remission at 12 months, as defined as a PHQ-9 score < 5. The 
requirement for PHQ-9 use for evaluating patients combined with a 
follow-up evaluation is problematic for many large group practices. The 
measure must be recorded for 248 patients, a very difficult bar for 
large multi-specialty group practices which refer patients for 
treatment and follow-up to psychiatrists if they have a PHQ of 9. The 
measure seems to be designed for group practices that do not have this 
type of referral pattern to psychiatrists.
    Another problematic example the commenter provided was the 
medication safety measure (CARE 3). The commenter stated that the score 
includes all medications the patient is taking, including over-the-
counter and herbal medications, and therefore relies on the patient 
recalling and accurately reporting this information. For each 
medication on the list, clinicians must include the dose, route (for 
example, by mouth or by injection), and frequency. This measure is 
difficult to meet, even if medication lists are substantially complete. 
According to the specifications, if a multi-vitamin is listed but ``by 
mouth'' is not recorded then the encounter(s) is scored as non-
performance. Finally, the commenter believed that the blood pressure 
measure must be updated to reflect recent national consensus about 
appropriate blood pressure measurements. The commenter stated that a 
national consensus has developed that blood pressure should vary by age 
and diagnosis. However, the measure requires a strict policy of 
controlling to less than 140/90 for hypertensive patients, regardless 
of age, and 120/80 for screening purposes. These levels are not 
consistent with current medical evidence or opinion such as those noted 
in the Eighth Joint National Committee.
    Response: We do not believe it appropriate to remove or modify 
measures, including the three mentioned by the commenter, used in the 
CMS Web Interface reporting. On the three specific measures the 
commenter listed, we have been working with the multi-stakeholder 
workgroup for the Core Measure Quality Collaborative (CQMC). These 
measures are included in the CQMC measure set for ACO and certified 
patient-centered medical homes. To align with the CQMC set, CMS has 
included these measures within the CMS Web Interface. We believe all 
measures within the CMS Web Interface are appropriate for the data 
submission method and level of reporting.
    Comment: A few commenters recommended, to ensure comparability 
across reporting mechanisms, that CMS should allow groups reporting 
through the CMS Web Interface to select which six quality measures will 
be used to calculate the quality performance score. Currently, the CMS 
Web Interface requires 18 measures, so if a group performs highly on 
some CMS Web Interface measures but not others, their overall quality 
score will be lowered.
    Response: We thank the commenters for this feedback, but we believe 
that requiring groups to report all measures included in the CMS Web 
Interface provides us a more complete picture of quality at a given 
group practice. All of the measures reported on the CMS Web Interface 
will be used to determine an overall quality performance category 
score.
    Comment: Other commenters expressed that CMS Web Interface 
reporting should be coupled with useful reports for MIPS eligible 
clinicians including timely and actionable claims data in order to make 
value-based decisions.
    Response: We do not believe it to be operationally feasible to 
provide claims data as part of a report for the transition year of the 
MIPS; however, we will work to provide as much information to MIPS 
eligible clinicians as possible and

[[Page 77116]]

will consider this request for future rulemaking.
    Comment: Some commenters suggested that CMS identify a minimum 
number of beneficiaries to report on through CMS Web Interface based on 
the number of MIPS eligible clinicians in the group.
    Response: We appreciate the comment, and in past years under the 
PQRS program there were different beneficiary sample sizes based on the 
size of the group, specifically a sample of 411 patients for groups 
100+ and a sample of 248 patients for groups 25-99. However after 
additional data analysis, we found that the differing sample sizes made 
no impact on the group's performance, so we modified the sample to 248 
patients in the CY 2015 final rule (79 FR 67789). We do not believe it 
reduces burden by issuing different sample sizes by groups. Rather, we 
believe that a larger sample size is more burdensome.
    Comment: Another commenter had concerns about the statistical 
accuracy of the requirement for reporting the first 248 patients. The 
commenter had particular concerns about regional and seasonal bias for 
larger groups because performance measures for large groups would be 
based on data from patients in the first few weeks of the year.
    Response: The methodology for sampling and assignment for the CMS 
Web Interface has been tested extensively, and we believe that the 
methodology appropriately controls for the biases the commenter 
suggests. However, we will monitor performance data reported via the 
CMS Web Interface.
    Comment: Some commenters recommended that in addition to the 
proposed CMS Web Interface used to submit quality measures, a 
transactional Electronic Data Interchange (EDI) capability be developed 
to achieve CMS' goal of permitting multiple methods for submission. The 
commenters believed multiple technologies have benefits in different 
situations for various stakeholders. The commenters also suggested that 
the CMS Web Interface should also become usable by Medicaid, other 
payers and purchasers on a voluntary basis.
    Response: We thank the commenters for these suggestions and will 
take them under consideration in the future as we continue implementing 
the MIPS program.
    Comment: Some commenters expressed concern with the proposal to 
limit reporting through the CAHPS for MIPS survey and the CMS Web 
Interface systems to groups of 25 clinicians or more. The commenters 
expressed that small practices would benefit greatly from the use of 
the CMS Web Interface, and limiting this option is a further burden 
upon solo and small practices who often do not have the resources to 
purchase more advanced health IT systems with more sophisticated 
reporting capabilities. The commenters recommended that CMS look at 
options that ensure solo and small practices have the same 
opportunities to succeed as larger groups. Another commenter proposed 
that CMS consider opening the CAHPS for MIPS survey reporting program 
to all patient-facing MIPS eligible clinicians with the exception of 
certain specialties such as psychiatry, addiction medicine, emergency 
medicine, critical care, and hospitalists.
    Response: The CAHPS for MIPS survey is available for all MIPS 
groups. The CMS Web Interface has been limited to groups of 25 or 
greater because smaller groups or individual MIPS eligible clinicians 
have not been able to meet the data submission requirements on the 
sample of the Medicare Part B patients we provide.
    Comment: One commenter recommended that a transactional Electronic 
Data Interchange (EDI) capability be developed so as to achieve CMS' 
goal of permitting multiple methods for submission. The commenter 
believed multiple technologies have benefits in different situations 
for various stakeholders and the industry should do the hard work now 
to support flexible technologies. The commenter also suggested that CMS 
Web Interface should also become usable by Medicaid, other payers and 
purchasers on a voluntary basis.
    Response: We appreciate the suggestions and will take them into 
consideration in future rulemaking.
    After consideration of the comments regarding our proposal on 
submission criteria for quality measures for groups reporting via the 
CMS Web Interface, we are finalizing the policies as proposed. 
Specifically, we are finalizing at Sec.  414.1335(a)(2) 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, 
the group will 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 or measure. If the sample of eligible assigned 
beneficiaries is less than 248, then the group will report on 100 
percent of assigned beneficiaries. A group will be required to report 
on at least one measure for which there is Medicare patient data. 
Groups reporting via the CMS Web Interface are required to report on 
all of the measures in the set. Any measures not reported will be 
considered zero performance for that measure in our scoring algorithm.
    We are finalizing our proposal 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 measure discussed in the 
proposed rule (81 FR 28188) and total per capita cost for all 
attributed beneficiaries discussed in the proposed rule (81 FR 28196). 
We are also finalizing our proposal 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 the proposed rule (81 FR 28196).
    (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 Agency for Health Care Research (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 proposed to allow registered groups to voluntarily elect to 
participate in the CAHPS for MIPS survey. Specifically, we proposed 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.

[[Page 77117]]

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 6-
month look-back period. In previous years the CAHPS for PQRS survey was 
administered from November to February of the reporting year. We 
proposed 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 therefore 
proposed a scoring incentive for those groups who report the CAHPS for 
MIPS survey. As described in the proposed rule (81 FR 28188), we 
proposed that groups electing to report the CAHPS for MIPS survey, 
would be required to register for the reporting of data. Because we 
believe assessing 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 the proposed rule (81 FR 28247), for further 
details. We solicited 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 
solicited comments on criteria that would ensure comparable samples and 
on these proposals.
    The following is a summary of the comments we received regarding 
our proposed performance criteria for quality measures for groups 
electing to report the CAHPS for MIPS survey.
    Comment: One commenter recommended that CMS should require MIPS 
eligible clinicians in groups to report a standard patient experience 
measure.
    Response: We are not requiring groups to report the CAHPS for MIPS 
survey for the transition year of MIPS. We are aware that requiring a 
standard patient experience measure, such as the CAHPS for MIPS survey, 
can be cost-prohibitive for small groups. However, we do believe 
patient experience measures are important and are providing bonus 
points for the CAHPS for MIPS survey, as discussed in section II.E.6. 
of this final rule with comment period.
    Comment: Some commenters requested clarification about whether the 
CAHPS for MIPS survey would be required for groups of 100+ MIPS 
eligible clinicians, as it was under PQRS. Some commenters opposed 
mandatory CAHPS for MIPS survey reporting under MIPS and recommended 
that CMS allow reporting on the CAHPS for MIPS survey to be voluntary. 
Another commenter opposed making the CAHPS for MIPS survey a 
requirement for large groups because it is a survey tool to measure 
outpatient practices and is not useful for many facility based 
practices. The commenter stated that there will be significant 
confusion as large groups try to determine which parts of the survey 
apply to them.
    Response: We would like to explain that the CAHPS for MIPS survey 
is optional for MIPS eligible clinician groups. We recognize that while 
the CAHPS for MIPS survey is a standard tool used for large 
organizations, we know that there are challenges with the CAHPS for 
MIPS survey for certain specialty clinicians and clinicians who work in 
certain settings.
    Comment: A few commenters urged CMS to include the CAHPS for MIPS 
survey, as well as other non-CAHPS experience of care and patient 
reported outcomes measures and surveys (including those that are 
offered by QCDRs), under the improvement activities performance 
category rather than the quality performance category. One commenter 
stated that the CAHPS for MIPS survey should be counted as a high 
weight improvement activities. This commenter stated that this would 
simplify the program and ensure that specialists have the same 
opportunity as primary care clinicians to earn the maximum number of 
points in the quality performance category. The commenter was concerned 
that if CMS does not revise this proposal, specialists will be at a 
disadvantage as the CAHPS for MIPS survey is less relevant for 
specialists, especially surgeons, anesthesiologists, pathologists and 
radiologists. If CMS moves forward with the proposed quality 
requirements and bonus points for reporting on a patient experience 
measure, the commenter requested that CMS clarify whether the CAHPS for 
MIPS survey would automatically provide two bonus points or would count 
as the one required high priority measure that all MIPS eligible 
clinicians must report before bonus points are counted. The commenters 
recommended ensuring specialists have the same opportunity as primary 
care practices. Other commenters urged CMS to work closely with the 
transplant community and the American College of Surgeons to adopt a 
patient experience of care measure that is relevant to all surgeons, 
including transplant surgeons, and that adequately takes into account 
the team-based nature of transplantation and other complex surgery.
    Response: We would like to explain for commenters that the CAHPS 
for MIPS survey is included under the quality performance category, as 
well as the improvement activities performance category as a high 
weighted activity in the Patient Safety and Practice Assessment 
subcategory noted in Table H of the Appendix in this final rule with 
comment period. In addition, the CAHPS for MIPS survey measures 
complement other measures of care quality by generating information 
about aspects of care quality for which patients are the best or only 
source of information, such as the degree to which care is respectful 
and responsive to their needs (for example, ``patient-centered''); 
therefore, these measures are well suited to the quality performance 
category. We do recognize that certain specialties such as surgeons, 
anesthesiologists, pathologists and radiologists that do not provide 
primary care services may not have patients to whom the CAHPS for MIPS 
survey could be issued and would therefore not be able to receive any 
bonus points for patient experience. However, these specialties do have 
the ability to earn bonus points for other high priority measures. We 
agree with the commenters that ensuring all specialties have the 
ability to earn full points for the quality performance category is 
important. We believe that we have constructed the quality category in 
a manner where this is true.

[[Page 77118]]

    Comment: Other commenters encouraged CMS to require for all MIPS 
eligible clinicians in groups to report the CAHPS for MIPS survey. One 
commenter suggested these CAHPS for MIPS survey measures transcend the 
core survey and include questions from the Cultural Competence 
supplement and the Health IT supplement. Another commenter was very 
concerned that the CAHPS for MIPS survey was optional under MIPS. They 
stated that the CAHPS for MIPS survey is the only standardized, 
validated tool available in the public domain to capture information 
about the experience of care from a patient's perspective. The 
commenter requested that CMS finalize this as a mandatory reporting 
requirement for groups of 100 or more. In addition, the commenter 
further requested that CMS consider developing an easier-to-administer 
version in the future. Another commenter stated that CMS should 
encourage the development and use of PROMs. Other commenters requested 
that CMS reconsider mandating the participation for practice groups of 
a certain size, such as 50 MIPS eligible clinicians.
    Response: We do not believe making the CAHPS for MIPS survey 
mandatory to be an appropriate policy at this time, but we will 
consider doing so for future MIPS performance years. Rather as we have 
indicated at the onset of this rule, we are removing as many barriers 
from participation as possible to encourage clinicians to participate 
in the MIPS. We are mindful of the reporting burden and expense 
associated with patient reported measures such as CAHPS for MIPS and do 
not want to add a cost or reporting burden to clinicians who prefer to 
choose other measures. We also believe that by providing bonus points 
for patient experience surveys, we believe that we are still able to 
emphasize that patient experience is an important component of quality 
measurement and improvement. We also appreciate the request to consider 
developing an easier to administer version and will take into 
consideration in the future.
    Comment: Other commenters urged CMS to continue exclusion of 
pathologists, as non-patient facing, from selection as ``focal 
providers'' about whom the CAHPS for MIPS survey asks.
    Response: We thank the commenters for their feedback on non-patient 
facing MIPS eligible clinicians and the CAHPS for MIPS survey. We agree 
that non-patient facing MIPS eligible clinicians should not be 
considered the clinician named in the survey who provided the 
beneficiary with the majority of the primary care services delivered by 
the group practice, that is, the ``focal provider'' for that survey.
    Comment: Several commenters supported CMS' proposal to no longer 
require that larger practices report on patient experience, explaining 
that, historically, this measure was not intended to target emergency 
clinicians, yet larger emergency practices were still required to go 
through the time and expense of contracting with a certified survey 
vendor before finding out whether they were exempt from the 
requirement. Another commenter supported voluntary reporting of the 
CAHPS for MIPS survey. The commenter stated the CAHPS for MIPS survey 
is too long and generates low response rates. The commenter urged CMS 
to work with MIPS eligible clinicians, AHRQ, CAHPS stewards, and other 
stakeholders to develop means for obtaining patient experience data. A 
few commenters stated that many MIPS eligible clinicians survey their 
patients' satisfaction in a variety of patient care areas, and these 
surveys are often electronic and allow timely submission of feedback 
that is valuable to the overall patient care experience. The commenters 
suggested that CMS consider allowing MIPS eligible clinicians to survey 
their patients through alternative surveys.
    Response: We thank the commenters for this feedback and acknowledge 
that there may be other potential survey methods. However, the CAHPS 
for MIPS survey is the only survey instrument with robust evidence 
support demonstrating a beneficial impact on quality. For a program of 
this scale that also has payment implications, we believe the CAHPS for 
MIPS survey is the most appropriate survey to utilize.
    Comment: Some commenters stated that small practices cannot afford 
to pay vendors to obtain the CAHPS for MIPS survey information for 
bonus points.
    Response: We would like to explain that the CAHPS for MIPS survey 
is optional for all MIPS eligible clinician groups, and that there are 
other ways to obtain bonus points, such as by reporting additional 
outcome measures.
    Comment: Other commenters encouraged CMS to invest resources in 
evolving CAHPS instruments--or creating new tools--to be more 
meaningful to consumers, more efficient and less costly to administer 
and collect, and better able to supply clinicians with real-time 
feedback for practice improvement. The commenters would like this to 
include continuing research and implementation efforts to combine 
patient experience survey scores with narrative questions.
    Response: We will take under advisement for future rulemaking.
    Comment: Another commenter supported the proposal to use all-payer 
data for quality measures and patient experience surveys. The commenter 
supported stratification by demographic characteristics to the degree 
that such stratification is feasible and appropriate and thinks CMS 
should make this data publicly available at the individual and practice 
level.
    Response: We thank the commenter for their support. We will take 
this recommendation into consideration for future rulemaking.
    Comment: A few commenters stated that the potential expansion of 
the CAHPS for MIPS survey to all-payer data should be optional, as this 
could make the survey more costly and lead to it being unaffordable to 
those who use it in its current form. Other commenters recommended that 
CMS expand the CAHPS for MIPS patient sample and survey process to 
include additional payers, in a process similar to that used by the 
HCAHPS, Hospice CAHPS, and the Outpatient and Ambulatory Surgery CAHPS 
surveys.
    Response: As we continue to evaluate the inclusion of all-payer 
data as part of the CAHPS for MIPS survey, we will consider the impact 
of implementation as well as viable options.
    Comment: One commenter was concerned about the patient satisfaction 
surveys, particularly in the context of team-based care delivery. The 
commenter noted that individual scoring of patient satisfaction is 
prone to misassignment of both good and bad quality. Another commenter 
expressed concern about the numerous patient surveys because, although 
patient feedback is important, this feedback must be balanced by 
acknowledging limitations to these surveys. The commenter mentioned 
that selection bias and survey fatigue may become a problem. Another 
commenter questioned whether the CAHPS for MIPS survey was an accurate 
reflection of the quality of care patients received, or whether it 
might be biased by superficial factors. The commenter also questioned 
the surveys statistical validity. The commenter encouraged CMS to 
explore alternative means of capturing patient experience, which is 
different from patient satisfaction.
    Response: The CAHPS for MIPS survey is optional for groups. 
However, because we believe assessing 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

[[Page 77119]]

measures). In addition, while patient experience may not always be 
associated with health outcomes, there is some evidence of a 
correlation between higher scores on patient experience surveys and 
better health outcomes. Please refer to http://www.ahrq.gov/cahps/consumer-reporting/research/index.html for more information on AHRQ 
studies pertaining to patient experience survey and better health 
outcomes.
    Comment: Another commenter stated that the CAHPS for MIPS survey 
should modify its wording to reflect that much work is done by a ``care 
team'' rather than a ``clinician.''
    Response: We thank the commenter for this feedback, which we will 
take into consideration for future rulemaking.
    Comment: Some commenters believed that the CAHPS for MIPS survey 
should count for three measures, including one cross-cutting and one 
patient experience measure, noting that in the past, CMS has counted 
the CAHPS for PQRS survey as three measures covering one NQS domain. 
Another commenter encouraged CMS to require that MIPS eligible 
clinicians reporting CAHPS still submit an outcome measure, if one is 
available.
    Response: We recognize that under the PQRS program, CAHPS surveys 
counted as three quality measures rather than one quality measure. To 
simplify our scoring and communications we are only counting the CAHPS 
for MIPS survey as one measure. We do note, however, that the CAHPS for 
MIPS survey would fulfill the requirement to report on a high priority 
measure, in those instances when MIPS eligible clinicians do not have 
an outcome measure available.
    Comment: Other commenters believed that the CAHPS for MIPS survey 
is not designed for and is inappropriate for skilled nursing facility 
based MIPS eligible clinicians because in many situations the source of 
the information is not reliable due to the mental status of the 
patients being surveyed. Therefore, the commenters opposed applying 
bonuses and/or mandatory requirements to use such surveys in the 
quality performance category of MIPS until such surveys are available 
for MIPS eligible clinicians practicing in all settings of care.
    Response: To ensure meaningful measurement of patient experiences, 
we plan to include the CAHPS for MIPS survey as one way to earn bonus 
points since we believe this survey is important and appropriate for 
the Quality Payment Program. However, we would like to explain that the 
CAHPS for MIPS survey is optional for all MIPS eligible clinician 
groups, and that there are other ways for skilled nursing facilities to 
obtain bonus points, such as by reporting additional outcome measures 
or other high priority measures. We encourage stakeholders who are 
concerned about a lack of high priority measures to consider 
development of these measures and submit them for future use within the 
program. In addition, our strategy for identifying and developing 
meaningful outcome measures are in the quality measure development 
plan, authorized by section 102 of the MACRA (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). The plan references 
how we plan to consider evidence-based research, risk adjustment, and 
other factors to develop better outcome measures.
    Comment: Some commenters urged CMS to work with other stakeholders 
to improve upon the CAHPS for MIPS survey and/or develop additional 
tools for measuring patient experience. The commenters also encouraged 
CMS to consider ways to make the CAHPS for MIPS survey easier for 
patients to complete, including different options for how it is 
administered and employing skip logic to reduce its redundancy, and to 
make it more meaningful to clinicians, such as by disaggregating by 
different types of patients. Other commenters recommended that CMS 
consider having MIPS eligible clinicians report the CAHPS for MIPS 
survey using an electronic administration of the instrument because 
such tools would be more efficient for administering the survey and 
would offer MIPS eligible clinicians real-time feedback for practice 
improvement. A few commenters recommended that CMS use short-form 
surveys, electronic administration, and alternative instrument as a 
means to reduce the burden of surveying while improving utility to 
patients and MIPS eligible clinicians.
    Response: We are exploring potential options available for the 
CAHPS for MIPS administration, including electronic modes of 
administration, for the future.
    Comment: One commenter requested that clinicians have the option to 
use other patient satisfaction surveys, such as the surgical CAHPS 
survey.
    Response: We thank the commenter for the suggestion and note that 
QCDRs would have the option to include the surgical CAHPS survey as one 
of their non-MIPS measures, if they so choose. We will however take 
this comment into consideration for future rulemaking.
    Comment: Another commenter recommended that CMS evaluate the CAHPS 
for MIPS survey and remove summary survey measures (SSMs) which make 
the survey less relevant for MIPS eligible clinicians and groups which 
are not delivering primary services, such as the ``Access to 
Specialists'' SSM, as the subsequent survey would be widely applicable 
to a large number of patient[hyphen]facing MIPS eligible clinicians.
    Response: We thank the commenter for the suggestion. We will 
continue to explore potential improvements to the CAHPS for MIPS survey 
in the future.
    Comment: Some commenters opposed implementing the changes to the 
Clinician and Group survey items that AHRQ has released as 
CG[hyphen]CAHPS 3.0, as a recent memorandum released by AHRQ indicates 
that the changes resulted in increased scores caused by the removal of 
low scoring questions and not an improvement in the experience of 
beneficiaries. A few commenters supported retaining lower performing 
CAHPS for MIPS questions as supplemental questions.
    Response: We appreciate the interest in retaining survey items that 
AHRQ has removed from version 3.0 of CG-CAHPS, and will take that 
interest into consideration as we finalize the survey implementation, 
scoring, and benchmarking procedures for CAHPS for MIPS. It is 
important to note that CAHPS for MIPS will include content in addition 
to CG-CAHPS core items, including but not limited to shared decision-
making, access to specialist care, and health promotion and education.
    Comment: Other commenters recommended that the CAHPS for MIPS 
surveys be conducted closer to the time of a patient-clinician 
encounter to improve recall.
    Response: We will consider the commenter's recommendations in 
future rulemaking.
    Comment: One commenter requested that CMS limit additional CAHPS 
for MIPS questions and that the CAHPS for MIPS survey either remain the 
same as for PQRS or that the questions remain stable for the first few 
program years.
    Response: For the transition year of MIPS, the CAHPS for MIPS 
survey will primarily be the same as the current CAHPS for PQRS survey; 
however, as noted the survey contains additional questions to meet 
CMS's program needs. We would like to note that there may be updates 
made in regards to those questions that meet CMS's information

[[Page 77120]]

and program needs. Further, we would like to note that in future years 
we do anticipate that we will revise the CAHPS for MIPS survey. We 
anticipate these revisions will not only improve the survey, but reduce 
burden.
    Comment: Another commenter requested clarification on how CMS can 
ensure the data are reliable to drive improvement when CAHPS for MIPS 
survey response rates are declining.
    Response: Response rates to CAHPS for PQRS (the precursor to CAHPS 
for MIPS) are comparable to those of other surveys of patient care 
experiences. Under CAHPS for MIPS, we will adjust reported scores for 
case mix, which allows the performance of groups to be compared against 
the same case mix of patients. Studies have not found evidence that 
response rates bias comparisons of case-mix adjusted patient experience 
scores.
    Comment: Some commenters recommended raising the threshold for the 
minimum number of patient CAHPS for MIPS survey responses to 30 to 
increase reliability.
    Response: We will consider the commenter's recommendations in 
future rulemaking.
    Comment: One commenter encouraged CMS to consider expanding the use 
of CAHPS for all clinicians as a tool in the quality measurement 
category of MIPS, with appropriate exclusions for rural and non-patient 
facing MIPS eligible clinicians. Additionally, the commenter encouraged 
CMS to expand the target population for such surveys to include the 
families of patients who have died, and to adapt questions from the 
hospice instrument so they can be used in CAHPS surveys of other 
settings to assess palliative care eligible clinicians and eligible 
clinicians who treat the patients facing the end of life in other 
settings other than hospice.
    Response: We appreciate the recommendation and will continue to 
look at ways to expand the CAHPS survey.
    After consideration of the comments regarding our proposed 
performance criteria for quality measures for groups electing to report 
the CAHPS for MIPS survey we are finalizing the policies as proposed. 
Specifically, we are finalizing at Sec.  414.1335(a)(3) 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, a group that wishes to voluntarily elect 
to participate in the CAHPS for MIPS survey measures must use a survey 
vendor that is approved by CMS for a particular performance period to 
transmit survey measures data to CMS. The CAHPS for MIPS survey counts 
for one measure towards the MIPS quality performance category and, as a 
patient experience measure, also fulfills the requirement to report at 
least one high priority measure in the absence of an applicable outcome 
measure. In addition, groups that elect this data submission mechanism 
must select an additional group data submission mechanism (that is, 
qualified registries, QCDRs, EHR etc.) in order to meet the data 
submission criteria for the MIPS quality performance category. The 
CAHPS for MIPS survey will count as one patient experience measure, and 
the group will 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. We will retain the survey administration period 
for the CAHPS for MIPS survey November to February. Groups that 
voluntarily elect to participate in the CAHPS for MIPS survey will bear 
the cost of contracting with a CMS-approved survey vendor to administer 
the CAHPS for MIPS survey on the group's behalf. Groups electing to 
report the CAHPS for MIPS survey will be required to register for the 
reporting of data. Only Medicare beneficiaries can be selected to 
participate in the CAHPS for MIPS survey.
(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 
proposed 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 proposed 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 proposed 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 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 welcomed 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 proposed 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

[[Page 77121]]

thresholds for future years of the program. We requested comments on 
this proposal.
    We were 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 solicited feedback data and 
circumstances where it would be appropriate to lower the data 
completeness criteria.
    The following is summary of the comments we received regarding our 
proposed data completeness criteria.
    Comment: The majority of commenters recommended that CMS reduce the 
quality reporting thresholds to 50 percent, and not proceed with the 
proposals to increase the threshold for successfully reporting a 
measure to 80 percent via claims, and 90 percent via EHR, clinical 
registry, QCDR, or CMS Web Interface. The commenters cited numerous 
concerns and justifications for a modified threshold including: The 50 
percent reporting rate allows those MIPS eligible clinicians just 
starting to report a quicker pathway to success and to gain familiarity 
with the program before such a high threshold is established, an 
advanced announcement of an increased threshold through future 
rulemaking provides those MIPS eligible clinicians already reporting 
sufficient time to implement changes to their practice to meet the 
higher threshold, and the proposed thresholds would present a 
significant administrative burden and make higher quality scores 
difficult to achieve. These commenters believed a majority of MIPS 
eligible clinicians would struggle to meet the proposed threshold of 90 
percent and that the threshold is unrealistic. Another commenter 
opposed CMS's proposal to increase the reporting thresholds because 
this leaves MIPS eligible clinicians and third party data submission 
vendors with very little room for expected error.
    Response: We thank the commenters for their detailed feedback. 
Based on the overwhelming feedback received, we do not intend to 
finalize the data completeness thresholds as proposed. The numerous 
details the commenters cited on the increased burden the data 
completeness thresholds will impose on MIPS eligible clinicians is not 
intended. We agree with the commenters that some of the unintended 
consequences of having a higher data completeness threshold may 
jeopardize the MIPS eligible clinician's ability to participate and 
perform well under the MIPS. We want to ensure that an appropriate yet 
achievable level of data completeness is applied to all MIPS eligible 
clinicians. Based on stakeholder feedback, for the transition year of 
MIPS, we will finalize a 50 percent data completeness threshold for 
claims, registry, QCDR, and EHR submission mechanisms. This threshold 
is consistent with the current PQRS program. Additionally, for the 
second year of MIPS, for performance periods occurring in 2018, we are 
finalizing a 60 percent data completeness threshold for claims, 
registry, QCDR, and EHR submission mechanisms. We believe it is 
important to incorporate higher thresholds in future years to ensure a 
more accurate assessment of a MIPS eligible clinician's performance on 
the quality measures and to avoid any selection bias. We also believe 
that we are providing ample notice to MIPS eligible clinicians so they 
can take the necessary steps to prepare for this higher threshold for 
MIPS payment year 2020. Lastly, we anticipate that, in the 2021 MIPS 
payment year and beyond, for performance periods occurring in 2019 
forward, as MIPS eligible clinicians gain experience with the MIPS we 
would further increase these thresholds over time.
    Comment: Another commenter cited specific concerns for QCDRs. The 
commenter believed the 50 percent threshold for QCDRs to report should 
be maintained for reporting and data completeness because of the 
proposed changes to QCDR functionality such as reporting additional 
performance categories and requiring MIPS eligible clinician feedback 
at least six times a year. Another commenter stated that the rule needs 
to maximize the role of QCDRs to ensure reporting and data submission 
are flexible, meaningful, and useful. The proposed QCDR requirement 
increasing from 50 to 90 percent will require reassuring MIPS eligible 
clinicians of the value of QCDR participation and reporting.
    Response: We appreciate the commenters concerns and as mentioned 
previously we are modifying the data completeness threshold for 
individual MIPS eligible clinicians and groups submitting data on 
quality measures using QCDRs. For the transition year, the MIPS 
eligible clinician will need to report on at least 50 percent of the 
MIPS eligible clinician or group's patients that meet the measure's 
denominator criteria, regardless of payer for the performance period. 
We do note that for the second year of MIPS, for performance periods 
occurring in 2018, we are increasing the data completeness threshold to 
60 percent. We also anticipate, that in the third and future years of 
MIPS, for performance periods occurring in 2019 and forward, as MIPS 
eligible clinicians gain experience with the MIPS we would further 
increase these thresholds over time. Lastly, we also want to refer the 
commenter to section II.E.9.a. of this final rule with comment period 
where we discuss the requirements to become a QCDR under the MIPS.
    Comment: Another commenter stated that setting a data completeness 
threshold of 80 or 90 percent is not achievable for practices, 
especially given struggles trying to meet the requirement for reporting 
measures for 50 percent of Medicare patients under PQRS. The commenter 
expressed disappointment that average reporting threshold rates from 
2014 PQRS Experience Report were not disclosed. The 80 or 90 percent 
requirement creates additional burden as well given inclusion of all-
payer data requirement. The commenter also believed that vendors will 
not be able to meet these more stringent requirements, especially for 
first performance period. The commenter urged CMS to reduce data 
completeness threshold to 50 percent of applicable Medicare Part B 
beneficiary encounters via claims and 50 percent for reporting via 
registry, EHR and QCDR.
    Response: As noted above, for the transition year of MIPS, we will 
finalize a 50 percent data completeness threshold for claims, registry, 
QCDR, and EHR submission mechanisms. This threshold is consistent with 
the current PQRS program. While we can appreciate the concern raised by 
the commenter related to vendors' readiness, we do not anticipate that 
vendors will have difficulty in meeting the original proposed data 
completeness threshold or the modified data completeness threshold we 
are finalizing here. Lastly, we will include the average reporting 
threshold rates for future years of the PQRS Experience Report, as 
technically feasible.
    Comment: Another commenter urged CMS to apply consistent data 
reporting requirements regardless of the method of data submission, as 
the commenter disagreed with different measure submission requirements 
for clinicians using a QCDR, qualified registry, or EHR. The commenter 
stated this consistency would allow for fair comparisons among 
clinicians.
    Response: We agree with the commenter and would like to explain 
that we did not propose different data completeness threshold nor are 
we finalizing different data completeness

[[Page 77122]]

thresholds across the QCDR, qualified registry, or EHR submission 
mechanisms.
    Comment: Another commenter stated it is necessary to maintain a 50 
percent threshold until a certain level of interoperability for data 
exchange across registries, EHRs and other data sources has been 
achieved. This commenter believed that claims reporting is the most 
burdensome for MIPS eligible clinicians as quality data codes (QDCs) 
will need to be attached for each applicable claim.
    Response: As noted above we are finalizing a 50 percent data 
completeness threshold for the transition year of MIPS. However, we do 
not agree that we can remain at a 50 percent threshold until 
interoperability is achieved. Rather we believe by providing ample 
notice to MIPS eligible clinicians and third party intermediaries, we 
can increase the thresholds over time. It is important to note that for 
the second year of MIPS, for performance periods occurring in 2018, we 
are increasing the data completeness threshold to 60 percent. We also 
anticipate, that for performance periods occurring in 2019 and forward, 
as MIPS eligible clinicians gain experience with the MIPS we would 
further increase these thresholds over time. Lastly, we recognize that 
the differing submission mechanisms have varying levels of burden on 
the MIPS eligible clinicians, which is why we believe that having 
multiple submission mechanisms as options is an important component as 
clinicians gain experience with the MIPS.
    Comment: Other commenters recommended a 50 percent threshold to 
ensure quality performance category scoring does not favor large 
practices. The commenters were concerned that CMS' proposed scoring 
favors large practices that submit data through the CMS Web Interface. 
The commenters noted that MIPS eligible clinicians using CMS Web 
Interface to submit data automatically achieve all of the requirements 
(plus bonus points) to potentially earn maximum points, and only need 
to report on a sampling of patients rather than the high percentage of 
patients needed for other data submission methods, and that this 
provides an advantage for these MIPS eligible clinicians over MIPS 
eligible clinicians in smaller practices.
    Response: While we do not agree that the MIPS quality scoring 
methodologies favor large practices that submit data using the CMS Web 
Interface, we can agree that small practices may require additional 
flexibilities under the MIPS. Therefore, as noted previously, we are 
finalizing flexibilities for smaller practices throughout this final 
rule with comment period, such as reduced improvement activities 
requirements.
    Comment: A few commenters indicated that the proposed thresholds 
would create an environment with little room for error, does not 
account for potential vendor, administrative or other problems, and 
will jeopardize MIPS eligible clinicians' success. These commenters 
noted that MIPS eligible clinicians may be deterred from reporting high 
priority and outcome measures and from reporting via electronic means 
due to the administrative burden posed by the high thresholds. The 
commenters stated that a 50 percent threshold still requires MIPS 
eligible clinicians to report on a majority of patients, and that this 
threshold does not encourage ``gaming'': Once MIPS eligible clinician 
workflows are in place, it is onerous to deviate from them simply to 
pick and choose which patients to include in which measure. The 
commenter stated that the higher threshold is especially burdensome for 
small practices without the resources to hire a full-time or part-time 
employee to collect and document such information.
    Response: We did not intend to increase the burden on MIPS eligible 
clinicians or deter MIPS eligible clinicians from submitting data on 
high priority measures. While we can agree with the commenters that 
modifying existing clinical workflows can be burdensome, we believe 
that once these workflows are established, performing the quality 
actions for the denominator eligible patients becomes part of the 
clinical workflow and is not unduly burdensome. For the transition year 
of MIPS, we will finalize a 50 percent data completeness threshold for 
claims, registry, QCDR, and EHR submission mechanisms. This threshold 
is consistent with the current PQRS program. Additionally, for the 
second year of MIPS, for performance periods occurring in 2018, we are 
finalizing a 60 percent data completeness threshold for claims, 
registry, QCDR, and EHR submission mechanisms. We believe it is 
important to incorporate higher thresholds in future years to ensure a 
more accurate assessment of a MIPS eligible clinician's performance on 
the quality measures and to avoid any selection bias. We also believe 
that we are providing ample notice to MIPS eligible clinicians so they 
can take the necessary steps to prepare for this higher threshold in 
the second year of the MIPS. We anticipate that, for performance 
periods occurring in 2019 and forward, as MIPS eligible clinicians gain 
experience with the MIPS we would further increase these thresholds 
over time.
    Comment: Another commenter stated the reporting requirement of at 
least 90 percent of all patients (not just Medicare) is not possible 
and that this is equivalent to requiring MIPS eligible clinicians to 
report on more than six individual quality measures and is a 
substantial change from the 20 patient requirement for measures groups 
under the current PQRS rule. The commenter's stated that their group 
performs thousands of general and vascular surgeries each year and that 
devoting the time and cost to review every hospital chart, operative 
note and call every patient at least once 30 days post operation simply 
is not possible. Another commenter stated that the data completeness 
criteria are onerous and require MIPS eligible clinicians to report on 
such a high percentage of their patients limits the types of measures 
physicians will be able to report (for example, MIPS eligible 
clinicians will prefer non-resource-intensive outcome measures).
    Response: We appreciate the commenters concerns and did not intend 
for the data completeness thresholds to limit the types of patients 
MIPS eligible clinicians would submit data on. We are finalizing a 50 
percent threshold for the transition year, and a 60 percent threshold 
for the second year of the MIPS, for performance periods occurring in 
2018. We do believe, however, it is important to incorporate higher 
thresholds in future years to ensure a more accurate assessment of a 
MIPS eligible clinician's performance on the quality measures and to 
avoid any selection bias. We also believe that we are providing ample 
notice to MIPS eligible clinicians so they can take the necessary steps 
to prepare for this higher threshold in the second year of the MIPS. We 
anticipate that, for performance periods occurring in 2019 and forward, 
as MIPS eligible clinicians gain experience with the MIPS we would 
further increase these thresholds over time. We will however monitor 
these policies to ensure that these data completeness thresholds do not 
become overly burdensome that they deter MIPS eligible clinicians from 
submitting data on their appropriate patient population.
    Comment: One commenter, a small mental health clinic, cited 
numerous reasons for concern including clients not tolerating 
significant time to ask assessment questions, difficulty in finding 
applicable measures, medical staff's limited time with clients, 
difficulty in getting measures from clients seen in their homes, 
clinical

[[Page 77123]]

inappropriateness of spending entire first or second appointments 
gathering PQRS measures, issues with PHQ9 score improvement, and other 
reporting requirements including California's Medi-Cal and Mental 
Health Service Act requirements. The commenter suggested the continued 
use of the 50 percent reporting requirement under PQRS.
    Response: We can appreciate the concerns raised by the commenter. 
We are continuing to use a 50 percent data completeness threshold 
similar to what was used under PQRS. We do note however that under MIPS 
the data completeness threshold applies for both Medicare and non-
Medicare patients.
    Comment: One commenter also requested that CMS release data 
demonstrating that raising the reporting rate is feasible for all MIPS 
eligible clinicians. This commenter noted the 2017 and 2018 PQRS and 
VBPM policies required 50 percent completeness and was a decrease from 
previous years, acknowledging feedback from clinicians. The commenter 
stated that issuing a drastic increase as clinicians shift to a new 
system will be problematic, and the commenter suggested remaining at 50 
percent for the first few years and consider phasing in increases if it 
is found that 50 percent is feasible.
    Response: We thank the commenters for their detailed feedback. 
Based on the overwhelming feedback received, we do not intend to 
finalize the data completeness thresholds as proposed. The numerous 
details the commenters cited on the increased burden the data 
completeness thresholds will impose on clinicians is not intended. We 
want to ensure that an appropriate yet achievable level of data 
completeness is applied to all MIPS eligible clinicians. Based on 
stakeholder feedback for the transition year of MIPS, we will finalize 
a 50 percent data completeness threshold for claims, registry, QCDR, 
and EHR submission mechanisms. This threshold is consistent with the 
current PQRS program. However, we continue to target a 90 percent 
reporting requirement as MIPS eligible clinicians gain experience with 
the MIPS we would further increase these thresholds over time.
    Comment: Another commenter agreed with the proposal to include at 
least 90 percent of patients regardless of payer to CMS in order to 
provide the most complete picture of the MIPS eligible clinician's 
quality, especially for specialists.
    Response: We thank the commenter for their support. However, based 
on stakeholder feedback, for the transition year of MIPS, we will 
finalize a 50 percent data completeness threshold for claims, registry, 
QCDR, and EHR submission mechanisms.
    Comment: A few commenters believed that a 100 percent review is not 
feasible because their practice performs 10,000 procedures annually. 
The commenters believed that review of 25-30 procedures is more 
practical.
    Response: Based on the overwhelming feedback received, we do not 
intend to finalize the data completeness thresholds as proposed. The 
numerous details the commenters cited on the increased burden the data 
completeness thresholds will impose on MIPS eligible clinicians is not 
intended. We want to ensure that an appropriate yet achievable level of 
data completeness is applied to all MIPS eligible clinicians. After 
consideration of stakeholder feedback, for the transition year of MIPS, 
we are modifying our proposal and will finalize a 50 percent data 
completeness threshold for claims, registry, QCDR, and EHR submission 
mechanisms.
    Comment: Other commenters requested that CMS consider using other 
reporting options that do not involve collecting data from a certain 
percentage of patients, such as requiring clinicians to report on a 
certain number of consecutive patients. The commenters believed the 
consecutive case approach could minimize the reporting burden while 
allowing for the collection of information to assess performance.
    Response: In the early years of PQRS we required EPs to report on a 
certain number of consecutive patients if the clinician was reporting a 
measures group. Our experience was that many EPs failed to meet the 
reporting requirements as they missed one or more patients in the 
consecutive sequence.
    Comment: A few commenters supported the proposal to give scores of 
zero if MIPS eligible clinicians can, but fail to, report on the 
minimum number of measures.
    Response: We thank the commenter for their support of our proposal.
    Comment: Another commenter supported CMS's proposal in the quality 
performance category to recognize a measure as being submitted and not 
assign a clinic zero points for a non-reported measure when a measure's 
reliability or validity may be compromised due to unforeseen 
circumstances, such as data collection problems. The commenter 
recommended that CMS notify affected MIPS eligible clinicians and 
groups by mail if in the future a data collection or vendor submission 
issue arises.
    Response: We intend to make every effort to notify affected MIPS 
eligible clinicians if data collection issues arise.
    Comment: Many commenters disagreed with the proposal to include 
all-payer data. . Several commenters believed that requiring MIPS 
eligible clinicians to report all-payer data goes beyond the scope of 
CMS's programmatic authority and need, violates clinicians' ethical 
duties to patient confidentiality, and violates patients' privacy 
rights.' Other commenters stated the federal government should not be 
able to access the medical information of patients who are not CMS 
beneficiaries. Another commenter believed that MIPS eligible clinicians 
may be discouraged from reporting through registries, QCDRs, and EHRs 
due to the requirement that they report on all of their patients 
regardless of payer. One commenter urged CMS to remove the requirement 
to report all patients when reporting via registry.
    Another commenter noted that MIPS eligible clinicians reporting 
outcomes should document all factors affecting outcomes, especially 
adversely affecting outcomes. The commenter stated that socioeconomic 
status, family support systems, cognitive dysfunction and mental health 
issues affect compliance and outcomes. Therefore, coding for some of 
these factors can be misleading, even if there are available options 
for diagnostic coding. The commenter noted that open access to all 
physician notes would jeopardize proper documentation of these issues. 
The commenter added that diagnostic coding must not inhibit 
documentation of issues and concerns for physicians, and that there 
must be proper acuity adjustment in measuring physician or team 
performance. The commenter suggested that all charts have certain areas 
of restricted protected access to allow documentation of such issues, 
and that this type of charting must be available to physicians who are 
not categorized as mental health professionals.
    Response: We have received numerous previous comments noting that 
it can be difficult for clinicians to separate Medicare beneficiaries 
from other patients, and our intention with seeking all-payer data is 
to make reporting easier for MIPS eligible clinicians. We note that 
section 1848(q)(5)(H) of the Act authorizes the Secretary to include, 
for purposes of the quality performance category, data submitted by 
MIPS eligible clinicians with respect to items and services furnished 
to individuals who are not Medicare beneficiaries. Furthermore, we 
believe that all-payer data makes it

[[Page 77124]]

easier for MIPS eligible clinicians to obtain a complete view of their 
quality performance without focusing on one subset or another of their 
patient populations. We do not believe that collection of this data 
constitutes a violation of patient privacy. We do not believe that the 
collection of all-payer data will decrease MIPS eligible clinicians' 
utilization of registries, QCDRs, and EHRs. It is important to note 
that MIPS eligible clinicians may elect to report information at the 
aggregate level which does not have any patient-identifiable 
information. We agree that documentation related to outcomes is 
challenging and we continue to work to identify the impact of socio-
demographic status on patient outcomes.
    Comment: Other commenters supported the proposal to use all-payer 
data for quality measures and also for patient experience surveys, 
recognizing that these data will create a more comprehensive picture of 
a MIPS eligible clinician's performance. Another commenter was 
supportive of the proposal to require MIPS eligible clinicians 
reporting quality data via qualified registries or EHR to report on 
both Medicare and non-Medicare patients. The commenter favored the 
proposal because it would be administratively easier and because 
quality of care affects all patients, not just those covered by 
Medicare.
    Response: We thank the commenters for the support.
    Comment: A few commenters recommended that CMS phase-in the 
requirement to include all-payer data for the QCDR, qualified registry, 
and EHR submission mechanisms and suggests that for year 1 of the 
program, requiring only Medicare data would be a more appropriate first 
step.
    Response: Third party intermediaries were required to utilize all 
payer data in PQRS. Therefore, we do not believe it should be a burden 
as they have already been meeting this requirement.
    Comment: Other commenters asked whether reporting all-payer data is 
optional year 1 of the program, whether there is a minimum percentage 
of Medicare Part B patients required, where the benchmarks will come 
from, and how it will be ensured that the benchmarks are comparable 
across the industry. Some commenters recommended that reporting on 
other payers be optional and that MIPS eligible clinicians not be 
penalized for activities related to payers other than Medicare. The 
commenters stated that the law does not require reporting data on other 
payers' patients. The commenters believed that reporting on all payers 
may skew data in favor of MIPS eligible clinicians with large private 
payer populations over physicians with large Medicare patient 
populations. A few commenters expressed concern that some practices 
will be required to submit data that represents all payers because 
Medicare populations are very different from those covered by other 
payers. This may create an inequitable assessment of quality 
performance.
    Response: We would like to explain that reporting all-payer data is 
not optional for the transition year of MIPS. 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 
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. In regards 
to the commenters concern that using all-payer data would create an 
inequitable assessment of the MIPS eligible clinicians' performance on 
quality, we respectfully disagree. Rather, we believe that utilizing 
all-payer data will provide a more complete picture of the MIPS 
eligible clinicians' performance.
    Comment: A few commenters suggested that rather than collecting 
data from all-payers for the quality performance category under MIPS, 
CMS should consider the federated data model, which would allow for 
different datasets to feed into a single virtual dataset that would 
organize the data. The commenters stated this would allow analysis and 
comparisons across datasets without structuring all of the source 
databases.
    Response: We thank the commenters for this feedback and will take 
into consideration for development in future rulemaking.
    Comment: Other commenters stated that the practice of medicine will 
be compromised by linking payment to collection of private patient data 
and making it available to CMS through electronic medical records.
    Response: We believe that MIPS eligible clinicians will continue to 
uphold the highest ethical standards of their professions and that 
medical practice will not be compromised by the MIPS program. 
Clinicians may elect to report information at the aggregate level which 
does not have any patient-identifiable information.
    Comment: Other commenters were very concerned that increasing the 
reporting threshold for quality data from 50 percent or more of 
Medicare patients to 90 percent or more of all patients regardless of 
payer is a major change that should be approached more gradually to 
give clinicians a chance to adapt. The commenters suggested a more 
gradual change, at least in the first few years, such as keeping the 
patient base and threshold as is (50 percent or more of the Medicare 
population) or even a smaller increase in threshold (maybe 60 or 75 
percent of patients) but only for Medicare beneficiaries rather than 
all payers. Another commenter requested reporting go from 50 to 75 
percent and be applied to Medicare patients only (as opposed to private 
insurance patients).
    Response: We are modifying our proposal and finalizing a 50 percent 
threshold for individual MIPS eligible clinicians or groups submitting 
data on quality measures using QCDRs, qualified registries, via EHR, or 
Medicare Part B claims. In addition, we are finalizing our approach of 
including 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 clinician's scope of practice 
and provides more access to data about specialties and subspecialties 
not currently captured in PQRS.
    Comment: Some commenters questioned CMS's ability to validate data 
completeness criteria for all-payer data under the quality performance 
category. They stated that because of this, all-payer completeness 
criteria function more like a request than a requirement. The 
commenters also requested information on what the auditing, 
notification, and appeal (targeted review) process will be specific to 
all-payer data completeness.
    Response: We recognize that our data completeness criteria are 
different since we are now requiring all-payer data. However, we do not 
currently have the optimal capability to validate data completeness for 
all-payer data. Please note validation of all-payer data will therefore 
continue to be reviewed based on the data submission mechanism used. 
For example, if the quality measure data is submitted directly from an 
EHR for an electronic Clinician Quality Measure (eCQM), we expect 
completeness from EHR reports will cover all of the patients that meet 
the inclusion criteria for the measure, to include all-payer data found 
within the

[[Page 77125]]

EHR data set for the population attributed to that measure. If the 
quality data is submitted via the CMS Web Interface, we will provide 
the sample of patients that must be reported on to CMS, though more may 
be included given the all-payer allowance under MIPS. For the 
transition year of MIPS we expect that MIPS eligible clinicians, and 
especially third party intermediaries, will comply fully with the 
requirements we are adopting.
    Comment: Another commenter was supportive of the proposal to 
require MIPS eligible clinicians reporting quality data via qualified 
registries or EHR to report on both Medicare and non-Medicare patients. 
The commenter favored the proposal because it would be administratively 
easier and because quality of care affects all patients, not just those 
covered by Medicare.
    Response: We thank the commenter for their support.
    Comment: Some commenters agreed that CMS should include all-payer 
data in order to push quality improvement throughout the entire health 
care system. The commenters were concerned, however, that including 
all-payer data, combined with the amount of flexibility some clinicians 
have in choosing which quality measures to report, may end up obscuring 
the quality of care actually received by Medicare beneficiaries. The 
commenters recommended CMS implement additional requirements or safe 
guards for the inclusion of all-payer data. The commenters also 
supported CMS raising the data completeness thresholds above what was 
required under PQRS and increasing these thresholds even higher in 
future years of MIPS. Some commenters recommended that CMS continue to 
encourage the creation of databases across the payer community but 
treat this as a long-term goal rather than yet another operational item 
with uncertain implications. Although commenters supported all-payer 
databases conceptually, they believed that operationally the United 
States is far from this reality.
    Response: We agree that there is potential for further quality 
improvement by utilizing all-payer data. We also believe the MIPS 
program's flexibility in measure selection is an asset. We will monitor 
the MIPS program's impacts on care quality carefully, particularly for 
Medicare beneficiaries.
    Comment: Some commenters suggested changing the 90 percent of 
patients' measures group reporting requirement to 25 patients per 
surgeon and suggested this will achieve statistical validity and is 
achievable level of data collection. The surgery measures groups as 
defined in the proposal would then provide the commenter's practice 
with highly valuable information that could benefit all patients as the 
MIPS eligible clinicians review ways to operate more safely, 
efficiently and at a lower cost. Another commenter recommended that CMS 
update patient sampling requirements over time.
    Response: We are modifying our proposal and finalizing a 50 percent 
threshold for the transition year of MIPS for individual MIPS eligible 
clinicians or groups submitting data on quality measures using QCDRs, 
qualified registries, via EHR, or Medicare Part B claims. In addition, 
we are finalizing our approach of including 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 clinician's scope of practice and provides more access to data 
about specialties and subspecialties not currently captured in PQRS. We 
have removed the measures groups referenced in the comment and replaced 
them with specialty-specific measure sets.
    Comment: A few commenters sought clarification on scoring when a 
MIPS eligible clinician fails to submit data for the required 80 or 90 
percent data completeness threshold; that is, where a MIPS eligible 
clinician reports on less than the 80 or 90 percent of patients but has 
a greater than zero performance rate.
    Response: We appreciate the commenter seeking clarification. As 
discussed, we are reducing the threshold for the data completeness 
requirement as outlined below for the transition year of MIPS. In 
addition, we proposed that measures that fell below the data 
completeness threshold to be assessed a zero; however, in alignment 
with the goal to provide as many flexibilities to MIPS eligible 
clinicians as possible, for the transition year, MIPS eligible 
clinicians whose measures fall below the data completeness threshold 
would receive 3 points for submitting the measure. We will revisit data 
completeness scoring policies through future rulemaking. It is 
important to note that we are also finalizing to ramp up the data 
completeness threshold to 60 percent for MIPS, for performance periods 
occurring in 2018, for data submitted on quality measures using QCDRs, 
qualified registries, via EHR, or Medicare Part B claims. In addition, 
these thresholds for data submitted on quality measures using QCDRs, 
qualified registries, via EHR, or Medicare Part B claims will increase 
for MIPS for performance periods occurring in 2019 and forward.
    As a result of the comments regarding our proposal on data 
completeness criteria we are not finalizing our policy as proposed. 
Rather we are finalizing at Sec.  414.1340 the data completeness 
criteria below for MIPS during the 2017 performance period.
     Individual MIPS eligible clinicians or groups submitting 
data on quality measures using QCDRs, qualified registries, or via EHR 
must report on at least 50 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 expect to receive quality data for both 
Medicare and non-Medicare patients. For the transition year, MIPS 
eligible clinicians whose measures fall below the data completeness 
threshold of 50 percent would receive 3 points for submitting the 
measure.
     Individual MIPS eligible clinicians submitting data on 
quality measures data using Medicare Part B claims, would report on at 
least 50 percent of the Medicare Part B patients seen during the 
performance period to which the measure applies. For the transition 
year, MIPS eligible clinicians whose measures fall below the data 
completeness threshold of 50 percent would receive 3 points for 
submitting the measure.
     Groups submitting quality measures data using the CMS Web 
Interface or a CMS-approved survey vendor to report the CAHPS for MIPS 
survey must meet the data submission requirements on the sample of the 
Medicare Part B patients CMS provides.
    We are also finalizing to ramp up the data completeness threshold 
to 60 percent for MIPS for performance periods occurring in 2018 for 
data submitted on quality measures using QCDRs, qualified registries, 
via EHR, or Medicare Part B claims. We note that these thresholds for 
data submitted on quality measures using QCDRs, qualified registries, 
via EHR, or Medicare Part B claims will increase for performance 
periods occurring in 2019 and onward. As noted in our proposal, we 
believe higher 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. In addition, we would like to 
align all the reporting mechanisms as closely as possible with 
achievable data completeness criteria.
    We are finalizing our approach of including all-payer data for the 
QCDR,

[[Page 77126]]

qualified registry, and EHR submission mechanisms because we believe 
this approach provides a more complete picture of each MIPS eligible 
clinician's scope of practice and provides more access to data about 
specialties and subspecialties not currently captured in PQRS. In 
addition, those clinicians who utilize a QCDR, qualified registry, or 
EHR submission must contain a minimum of one quality measure for at 
least one Medicare patient.
    We are not finalizing our proposal that MIPS eligible clinicians 
and groups who do not meet the proposed submission criteria noted below 
would fail the quality component of MIPS. Instead, those MIPS eligible 
clinicians who fall below the data completeness thresholds would have 
their specific measures that fall below the data completeness threshold 
not scored for the transition year of MIPS. The MIPS eligible 
clinicians would receive 3 points for measures that fall below the data 
completeness threshold.
(c) Summary of Data Submission Criteria
    Table 5 of the rule, reflects our final Quality Data Submission 
Criteria for MIPS:

 Table 5--Summary of Final Quality Data Submission Criteria for MIPS Payment Year 2019 via Part B Claims, QCDR,
                      Qualified Registry, EHR, CMS Web Interface, and CAHPS for MIPS Survey
----------------------------------------------------------------------------------------------------------------
                                                        Submission
       Performance period           Measure type        mechanism        Submission criteria   Data completeness
----------------------------------------------------------------------------------------------------------------
A minimum of one continuous 90-  Individual MIPS    Part B Claims....  Report at least six     50 percent of
 day period during CY2017.        eligible                              measures including      MIPS eligible
                                  clinicians.                           one outcome measure,    clinician's
                                                                        or if an outcome        Medicare Part B
                                                                        measure is not          patients for the
                                                                        available report        performance
                                                                        another high priority   period.
                                                                        measure; if less than
                                                                        six measures apply
                                                                        then 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 measures in
                                                                        Table E.
A minimum of one continuous 90-  Individual MIPS    QCDR Qualified     Report at least six     50 percent of
 day period during CY2017.        eligible           Registry EHR.      measures including      MIPS eligible
                                  clinicians or                         one outcome measure,    clinician's or
                                  Groups.                               or if an outcome        groups patients
                                                                        measure is not          across all
                                                                        available report        payers for the
                                                                        another high priority   performance
                                                                        measure; if less than   period.
                                                                        six measures apply
                                                                        then 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 measures in
                                                                        Table E.
Jan 1-Dec 31...................  Groups...........  CMS Web Interface  Report on all measures  Sampling
                                                                        included in the CMS     requirements for
                                                                        Web Interface; AND      their Medicare
                                                                        populate data fields    Part B patients.
                                                                        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.
Jan 1-Dec 31...................  Groups...........  CAHPS for MIPS     CMS-approved survey     Sampling
                                                     Survey.            vendor would have to    requirements for
                                                                        be paired with          their Medicare
                                                                        another reporting       Part B patients.
                                                                        mechanism to ensure
                                                                        the minimum number of
                                                                        measures are
                                                                        reported. CAHPS for
                                                                        MIPS Survey would
                                                                        fulfill the
                                                                        requirement for one
                                                                        patient experience
                                                                        measure towards the
                                                                        MIPS quality data
                                                                        submission criteria.
                                                                        CAHPS for MIPS Survey
                                                                        will only count for
                                                                        one measure.
----------------------------------------------------------------------------------------------------------------

(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 the proposed rule 
(81 FR 28247) to the discussion on how we address performance 
categories weighting for MIPS eligible clinicians for whom no measures 
exist in a given performance 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 improvement 
activities (new or from other payments systems) would be appropriate 
for these MIPS

[[Page 77127]]

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 improvement activities 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 improvement activities 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 improvement activities 
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 improvement activities performance category 
refer to the proposed rule (81 FR 28209). 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 
proposed 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).
     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 requested comments on these proposals.
    The following is summary of the comments we received regarding our 
proposals on the application of quality measures to non-patient facing 
MIPS eligible clinicians:
    Comment: Several commenters supported the proposed exemption from 
reporting a cross-cutting quality measure for non-patient facing MIPS 
eligible clinicians as these measures may not be reliable, 
developmentally feasible, or clinically relevant as well as the 
allowance for non-patient facing MIPS eligible clinicians to report on 
specialty-specific measure sets.
    Response: We agree, however, as we have noted earlier in this rule 
we do not intend to finalize the cross-cutting measure requirements for 
all MIPS eligible clinicians, including those that are determined to be 
non-patient facing MIPS eligible clinicians.
    Comment: Another commenter wanted more details on CMS's 
considerations for non-patient facing MIPS eligible clinicians under 
the quality performance category.
    Response: We thank the commenter for their question. As we are not 
finalizing our proposal for cross-cutting measures, we do not need to 
finalize our proposal for a separate designation for non-patient facing 
MIPS eligible clinicians at this time. We refer readers to section 
II.E.1.b. of this final rule with comment period for more information 
on non-patient facing MIPS eligible clinicians.
    Comment: Other commenters proposed that CMS remove the quality 
measure requirement related to patient outcomes for non-patient facing 
MIPS eligible clinicians.
    Response: We proposed to provide an exception for non-patient 
facing MIPS eligible clinicians from the requirement to report cross-
cutting measures, but we believe that outcome measures are of critical 
importance to quality measurement. Therefore, we do not believe an 
additional exception is appropriate.
    After consideration of the comments received regarding our 
proposals on application of the quality category to non-patient facing 
MIPS eligible clinicians we are not finalizing as proposed. As 
previously noted in this rule, we are not finalizing the criteria 
proposed at Sec.  414.1335 that MIPS eligible clinicians that are 
considered patient facing must report a cross-cutting measure. The only 
distinction within the quality performance for non-patient facing MIPS 
eligible clinicians as proposed at Sec.  414.1335 is that they were not 
required to report a cross-cutting measure. We are therefore finalizing 
at Sec.  414.1335 that non-patient facing MIPS eligible clinicians 
would be required to meet the otherwise applicable submission criteria 
that apply for all MIPS eligible clinicians for the quality performance 
category.
(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 cost 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 the transition year of MIPS because there are 
several operational considerations that must be addressed before this 
option can be implemented. We requested comment on the following 
issues: (1) whether we should attribute a facility's performance to a 
MIPS eligible clinician for purposes of the

[[Page 77128]]

quality and cost 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 cost performance categories; and (3) the specific 
measures and settings for which we can use the facility's quality and 
cost data as a proxy for the MIPS eligible clinician's quality and cost 
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 
solicited comments on these approaches.
    The following is summary of the comments we received regarding our 
approaches to application of additional system measures:
    Comment: The majority of commenters that discussed the potential 
use of facility performance supported our proposal to attribute a 
facility's performance to a MIPS eligible clinician for purposes of the 
quality and cost performance categories. Several commenters urged CMS 
to implement a CMS hospital quality program measure reporting option 
for hospital-based clinicians in the MIPS as soon as possible. Other 
commenters believed that using hospital measure performance in the MIPS 
would help clinicians and hospitals better align quality improvement 
goals and processes across the care continuum and reduce data 
collection burden. One commenter thought that attributing facility 
performance for the purposes of the quality and cost performance 
categories could encourage harmony between the performance agendas of 
clinicians and their facilities. Another commenter supported a 
streamlined measurement approach for MIPS reporting for hospital based 
clinicians and alignment of MIPS measures with hospital measures.
    One commenter believed that hospital quality reporting should 
substitute for MIPS quality reporting for hospital based clinicians. 
While another commenter specified that hospital measures should only be 
used for the quality performance category, not for the cost performance 
category. Another commenter strongly recommended CMS either allow 
hospital based clinicians to use hospital quality measures for MIPS 
reporting, or exempt hospital based clinicians from the quality 
performance category until there is substantial alignment of clinician 
and hospital measures. This commenter requested that such exemption be 
the same as the hospital based clinician exemption under the advancing 
care information performance category.
    Response: We agree that using hospital measure performance may 
promote more harmonized quality improvement efforts between hospital-
based clinicians and hospitals and promote care coordination across the 
care continuum. We are considering appropriate attribution policies for 
facility-based measures and will take commenter's suggestions into 
account in future rulemaking.
    Comment: Several commenters opposed using a facility's quality and 
cost performance as a proxy for MIPS eligible clinicians. A few 
commenters did not support inclusion of other system measures at this 
time and stated that this could potentially create an additional burden 
for vendors to provide additional reporting measures which they had not 
previously developed or mapped out workflows for. One commenter did not 
support attributing a facility's performance to a MIPS eligible 
clinician for the quality and cost performance categories, noting that 
facility-level performance would not be appropriate or representative 
of the MIPS eligible clinician's individual performance. One commenter 
expressed concern that this approach would potentially benefit MIPS 
eligible clinicians with lower individual performance and would be a 
detriment for those with higher performance, for whom being assessed 
based on facility performance could potentially lead to lower ratings. 
Another commenter expressed concern that MIPS eligible clinicians 
substituting their institution's performance for their own might give 
an unfair advantage to MIPS eligible clinicians from larger systems. 
This commenter also requested that CMS pilot system measures prior any 
implementation of facility performance attribution under MIPS.
    Another commenter opposed our proposed use of facility level 
measures for accountability at the individual level as facility 
performance as they believed it is not within the control of individual 
clinicians. Another commenter requested that facility-based MIPS 
eligible clinicians leverage continued expansion of specialty-specific 
measure sets through QCDRs and qualified registries instead of using 
facility-based scores. Another commenter noted that adding an 
additional group reporting option for facility-based MIPS eligible 
clinicians on top of the existing group reporting option is confusing. 
The commenter therefore recommended CMS remove this reporting option 
from the proposal. One commenter encouraged revisiting this proposal in 
future years.
    Response: The commenter is correct that many quality measures are 
not designed for team-based care in the inpatient setting, and we 
intend to examine how best to measure care provided by hospitalists and 
other team-based MIPS eligible clinicians in the future. We believe 
that facility-based quality measures have the potential to harmonize 
quality improvement efforts between hospital-based clinicians and 
hospitals, and promote care coordination across the care continuum. We 
agree that it is important to develop a thoughtful attribution policy 
that captures the eligible clinician's contribution and intend to 
develop appropriate attribution policies for facility-based measures.
    Comment: One commenter requested clarification on how CMS would 
expect reporting of facility-based measures to work under MIPS in 
instances where hospitals, their practices, and their EDs all use 
separate EHRs. This commenter also requested clarification on CEHRT/
certification requirements and what vendors would be required to do 
under such a scenario. Another commenter wanted to know whether MIPS 
eligible clinicians would be subject to a facility's performance score 
for quality and cost if facility-based measures were to be integrated 
into MIPS in future years. One commenter recommended CMS make 
additional information available regarding the use of facility measures 
for the cost performance category and publish information about the 
extent to which this option may improve participation by clinicians who 
are predicted to be unable to participate in the cost performance 
category of MIPS. Another commenter requested clarification on the 
specific MIPS eligible clinicians that would be considered facility-
based MIPS eligible clinicians.
    Response: We recognize that there are challenges associated with 
health information exchange within institutions and should we adopt 
policies for facility-based measures in future rulemaking, we would 
provide more information via subregulatory guidance. We believe that it 
is important to develop a thoughtful attribution policy that captures 
the MIPS eligible clinician's contribution and intend to develop 
appropriate attribution policies for facility-based measures.
    Comment: One commenter requested CMS develop MIPS participation 
options that apply to hospital's quality

[[Page 77129]]

and cost performance category measures to their employed clinicians and 
that CMS should seek input from hospitals, clinicians, and other 
stakeholders to establish processes and design implementation of this 
option. Another commenter recommended that prior to implementing any 
facility-level measures into the MIPS program, CMS should work with 
measure stewards and applicable specialties to ensure that measure 
specifications are appropriately aggregated to the clinician level and 
are reflective of those factors within the clinician's control.
    Response: We appreciate the suggestions and intend to work closely 
with stakeholders as we examine how best to measure care provided by 
hospitalists and other team-based MIPS eligible clinicians in the 
future. We believe that it is important to develop a thoughtful 
attribution policy that captures the MIPS eligible clinician's 
(including those employed by hospitals) contribution and intend to 
develop appropriate attribution policies for facility-based measures.
    Comment: One commenter suggested CMS use active membership on a 
hospital's medical staff or proof of an employment contract that is 
effective for the measurement period as evidence of an existing 
relationship between the clinician and a facility, which will be needed 
in order to verify a clinician's eligibility to use facility-based 
measures. However, several commenters believed that claims data 
elements could provide sufficient proof of such a relationship. Another 
commenter recommended CMS use specific claims data elements such as 
inpatient and hospital outpatient department place-of-service codes as 
evidence. One commenter suggested that CMS could consider adopting some 
of the following criteria: the facility-based MIPS eligible clinician 
or group is an employee of the facility; the facility-based MIPS 
eligible clinician or group is not an employee of the facility, but has 
a contract with the facility or the privileges needed to perform 
services at the facility; and the MIPS eligible clinician or group is 
an owner, co-owner, and/or investor of the facility and performs 
medical services in the facility.
    The same commenter proposed the following options for attribution: 
Option 1: The facility-based MIPS eligible clinician performed a 
plurality of his or her services at the facility in the performance 
period. This proposed method for attribution generally aligned with the 
Value-Based Payment Modifier two-step attribution methodology for 
purposes of MIPS quality and cost measurement proposed in other parts 
of the MACRA rule, which attributes a given patient to a clinician if 
the clinician has performed a plurality of the primary care services 
for a patient in the performance period. Option 2: The facility-based 
MIPS eligible clinician or group would have a payment amount threshold 
or patient count threshold at the facility that meets the payment 
amount threshold or patient count threshold finalized for purposes of 
eligibility to participate in an Advanced APM.
    Another commenter mentioned that in adopting additional system 
measures, CMS should ensure that attribution is appropriate and 
relevant to clinicians, to consider a methodology that enables 
proportional attribution that is as close a proxy for a group as 
possible, and to ensure that clinician performance is captured across 
settings.
    Response: We will continue to seek opportunities to improve our 
attribution process including the consideration of claims based codes 
with place-of-service modifiers among the array of options to best 
attribute eligible clinicians.
    Comment: The majority of commenters that supported the use of 
additional systems measures supported them only in cases where the 
facility-based clinician could elect use of the facility-based 
measures. They did not support automatic attribution of facility based 
measures. Some commenters believed that the MIPS eligible clinician 
should be able to elect to be attributed to the facility and also 
choose the appropriate facility through a registration process. One 
commenter noted that many MIPS eligible clinicians see patients at 
multiple facilities, and thus should be able to choose so which 
facility would most accurately align with their actual practice 
patterns.
    One commenter recommended CMS explore the possibility of allowing 
some clinicians to report their skilled nursing facility (SNF) scores 
as their MIPS scores. Another commenter urged as much flexibility as 
possible in the program and believed that SNF-based measurement should 
always be an optional approach, particularly for those who practice in 
a single facility. Another commenter recommended that quality and cost 
performance measures under MIPS always be attributed to the SNF TIN, as 
incentive payment adjustments would only be applicable at the facility 
TIN level. Furthermore, the commenter stated that the attribution to 
the SNF TIN would need to be automatic for clinicians working in 
facility-based outpatient environments. One commenter recommends self-
nomination at the TIN level because this would allow a group to attest 
that it is apprised of primarily hospital-based clinicians. This 
commenter noted that it would ensure that only the clinicians who wish 
to have this level of facility alignment are included in the program. 
It will also permit clinicians to select which hospitals are 
appropriate for alignment, allows for the inclusion of multiple 
hospitals, and would allow for the fact that many hospitalist groups 
practice in multiple locations. They also stated that this option would 
allow clinicians to align their performance on selected measures with 
their hospitals, which would support the drive towards team-based, 
coordinated care.
    One commenter noted the challenges faced by clinicians and groups 
that provide care across multiple facilities and recommended hospital-
level risk-adjusted outcome measurement that is attributable to the 
principal clinician or group responsible for the primary diagnosis. 
Another commenter stated that as an alternative to substituting 
facility measures under the MIPS program, facility-based clinicians 
ought to be given the option of being treated as participating in an 
Advanced APM.
    One commenter requested further clarification on the proxy scoring 
using facility's quality reporting. This commenter requested examples 
of proxy scoring, and wanted to see quality performance category 
scoring in practice before making a recommendation. Another commenter 
urged CMS to allow the use of PCHQR scores as a proxy for quality 
performance, for clinicians at PPS-exempt cancer hospitals. A couple of 
commenters urged CMS to make nearly all of the measures from CMS's 
hospital quality reporting and pay-for-performance programs available 
for use in hospital-based clinician reporting options. One commenter 
proposed the following criteria for evaluating measures: clinicians 
could use quality and cost measures for patient conditions and episode 
groups (currently under development) for which CMS has assigned them a 
clearly defined and clinically meaningful relationship under the 
patient relationship assignment methodology (currently under 
development). This commenter suggested that each evidence-based quality 
measure would be counter-balanced with an appropriate cost measure and 
that measures potentially could focus on patient safety, high quality 
care delivery, patient-centered care, communication, care coordination, 
and cost efficiency.
    Several commenters suggested measures to be adopted. One commenter 
suggested the following: PCP notification at admission, PCP

[[Page 77130]]

notification at discharge, percentage of beneficiaries with appointment 
with a PCP within 7 days, and percentage of beneficiaries with 
appointment with PCP within 30 days. This commenter believed that 
facility based MIPS eligible clinicians' play a valuable and 
underutilized role in care coordination and that Medicare stakeholders 
will benefit by MIPS eligible clinician inclusion versus exclusion. 
This commenter further recommended that facility based MIPS eligible 
clinicians have the ability to submit via institutional metrics and 
suggested PCP measures. Another commenter suggested several payment and 
costs measures such as: The Medicare Spending Per Beneficiary Measure; 
Pneumonia Payment per Episode of Care; the Cellulitis Clinical Episode-
based Payment Measure; the Kidney/UTI Clinical Episode-based Payment 
Measure; and the Gastrointestinal Hemorrhage Clinical Episode-based 
Payment Measure. Another commenter recommended the following measures: 
(1) Severe Sepsis and Sepsis Shock: Management Bundle; (2) HCAHPS 
(physician questions and 3-Item Care Transition Measure); (3) Hospital-
wide All-Cause Unplanned Readmission; (4) NHSN Measures (including 
CAUTI, CLABSI, CDI, And MRSA); (4) COPD Measures (COPD 30-Day Mortality 
Rate and COPD Readmission Rate); (5) Pneumonia Measures (Pneumonia 30-
Day Mortality Rate, Pneumonia 30-Day Readmission Rate, and Pneumonia 
Payment per Episode of care); (6) Heart Failure Measures (Heart Failure 
30-Day Mortality Rate, Heart Failure 30-Day Readmission Rate, Heart 
Failure Excess Days); (7) Payment Measures (MSPB); and (8) Chart 
Abstracted Clinical Measures (Influenza Immunization and Admit Decision 
Time to ED Departure Time for Admitted Patients).
    One commenter believed that clinicians who are MIPS eligible 
clinicians, and work primarily in either an outpatient or inpatient 
site--or both, as cancer care clinicians often do--should have the 
ability to choose the measures most relevant to them. A commenter 
recommended that MIPS eligible clinicians be able to align with 
hospitals, surgery centers, or other types of institutions to utilize 
patient experience survey metrics that are already collected as part of 
other quality reporting programs, in order to enable these metrics to 
be used as facility-based measures. Another commenter believed it was 
important for CMS to ensure that only visits, medications, tests, 
surgeries, and other components of maintenance for a disease that are 
ordered by a MIPS eligible clinician are attributed to the MIPS 
eligible clinician's quality and cost scores.
    One commenter urged CMS to enable a transplant surgeon and other 
members of the transplant team to elect to use their institution's 
performance rates under the outcomes requirements set forth at 42 CFR 
482.80(c) and 482.82(c) as a proxy for their quality performance 
category score. This commenter believed that a transplant surgeon or 
other MIPS eligible clinician or group's election to use their 
institutions performance data should not be automatic but the 
clinician's choice. Another commenter noted that a facility-based 
performance option would be beneficial to those clinicians involved in 
palliative care, and requested CMS allow for measures such as those 
used under the Hospice Quality Reporting Program to be considered 
facility-based measures under MIPS.
    Response: We would like to explain that under section 1848(q)(5)(H) 
of the Act we may include 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. 
We will take these suggestions into consideration as we move towards 
implementing these additional flexibilities in the future.
    We will take these comments into consideration in future 
rulemaking.
(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 the proposed rule (81 FR 28192). Population-
based measures are also used in the Medicare Shared Savings Program and 
for groups in the VM Program. For example, in 2015, clinicians were 
held accountable for a component of the 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 Program 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 four 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, ED 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 proposed to use the acute and 
chronic composite measures of AHRQ PQIs that meet a minimum sample size 
in the calculation of the quality measure domain for the MIPS total 
performance score; see Table B of the Appendix in this final rule with 
comment period. MIPS eligible clinicians would be evaluated on their 
performance on these measures in addition to the six required quality 
measures discussed previously and summarized in Table A of the Appendix 
in this final rule with comment period. 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 proposed to include the all-cause hospital 
readmissions (ACR) measure from the VM Program as we believe this 
measure also encourages care coordination. In

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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 
proposed to limit this measure to groups with 10 or more clinicians and 
to maintain the current VM Program requirement of 200 cases. Eligible 
clinicians in groups with 10 or more clinicians with sufficient cases 
would be evaluated on their performance on this measure in addition to 
the six required quality measures discussed previously and summarized 
in Table A of the Appendix of this final rule with comment period.
    Furthermore, the proposed claims-based population measures would 
rely on the same two-step attribution methodology that is currently 
used in the VM Program (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 be found at Sec.  425.20 and excludes claims for 
certain Skilled Nursing Facility (SNF) services that include the POS 31 
modifier). In the proposed rule (81 FR 28199), we proposed to exclude 
the POS 31 modifier from the definition of primary care services. As 
described in the proposed rule (81 FR 28199), the attribution would be 
modified slightly to account for the MIPS eligible clinician 
identifiers. We solicited comments on additional measures or measure 
topics for future years of MIPS and attribution methodology. We 
requested comments on these proposals.
    The following is summary of the comments we received regarding our 
proposal on global and population-based measures:
    Comment: Several commenters supported the importance of including 
sociodemographic factor risk adjustments in the quality and cost 
measures used to determine payments to MIPS eligible clinicians. One 
commenter stated that risk adjustment is a widely accepted approach to 
account for factors outside of the control of clinicians. Another 
commenter supported adjusting quality measures to reflect 
sociodemographic status (SDS), when appropriate, because measurement 
systems that do not incorporate such factors into evaluation can shift 
resources away from low-income communities through penalties. The 
commenter requested CMS adopt adjustments to quality measures that are 
affected by SDS, such as readmission within 30 days of discharge. 
Another commenter stated that sociodemographic issues, such as the 
inability to purchase medication and lack of family support, can 
increase cost related to future MIPS eligible clinician visits, and 
emergency room visits and readmissions. The commenter requested a level 
of protection for situations beyond a clinician's control that can play 
a major role in an individual's health outcome.
    A few commenters supported the inclusion of risk adjustment in 
measures and suggested that CMS examine ASPE's future recommendations. 
One commenter recommended that CMS examine ASPE's recommendations to 
consider other strategies as well such as stratification. Other 
commenters stated that the stakeholders affected by these decisions 
should have an opportunity to review the risk adjustment findings once 
issued by ASPE, and comment on how CMS proposes to incorporate the ASPE 
findings into its quality metrics.
    Several commenters urged CMS to work with the National Quality 
Forum (NQF) on how best to proceed with risk adjustment of quality and 
cost measures for sociodemographic status. One commenter recommended 
CMS adopt the NQF recommendation to consider risk adjustment for 
measures that have a conceptual relationship between sociodemographic 
factors and outcomes.
    Response: We appreciate the feedback on the role of socioeconomic 
status in quality measurement. We continue to evaluate the potential 
impact of social risk factors on measure performance. One of our core 
objectives is to improve beneficiary outcomes. We want to ensure that 
complex patients as well as those with social risk factors receive 
excellent care. While we believe the MIPS measures are valid and 
reliable, we will continue to investigate methods to ensure all 
clinicians are treated as fairly as possible within the program. Under 
the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014, 
ASPE has been conducting studies on the issue of risk adjustment for 
sociodemographic factors on quality measures and cost, as well as other 
strategies for including SDS evaluation in CMS programs. We will 
closely examine the ASPE studies when they are available and 
incorporate findings as feasible and appropriate through future 
rulemaking. We look forward to working with stakeholders in this 
process. We will also monitor outcomes of beneficiaries with social 
risk factors, as well as the performance of the MIPS eligible 
clinicians who care for them to assess for potential unintended 
consequences such as penalties for factors outside the control of 
clinicians.
    We additionally note that the National Quality Forum (NQF) is 
currently undertaking a 2-year trial period in which new measures and 
measures undergoing maintenance review will be assessed to determine if 
risk adjusting for sociodemographic factors is appropriate. This trial 
entails temporarily allowing inclusion of sociodemographic factors in 
the risk-adjustment approach for some performance measures. At the 
conclusion of the trial, NQF will issue recommendations on inclusion of 
sociodemographic factors in risk adjustment. We intend to continue 
engaging in the NQF process as we consider the appropriateness of 
adjusting for sociodemographic factors in our MIPS measures.
    Comment: Several commenters recommended that CMS develop the three 
population health measure benchmarks in the quality performance 
category by specialty and region to ensure more accurate, appropriate 
comparisons for the measures. The commenters noted this approach would 
help facilitate comparisons and improve the relevance of information 
for patients. The commenters stated the MACRA law does not preclude CMS 
from considering specialties that practice in settings such as nursing 
homes, assisted living, or home health and treating them in a different 
manner, but stated it is inappropriate to assume they can be compared 
to other internal medicine/family physicians that practice in the 
ambulatory settings. Other commenters supported the proposed three 
population-based measures that will be calculated using claims.
    Response: We appreciate the commenters' support. We continue to 
analyze the best means of assessing and comparing facility based 
clinicians in nursing homes, assisted living, or home health 
environments versus more routine ambulatory care settings. We will 
consider the feasibility of adopting disparate benchmarks for the 
population health measures and regional adjustments for the population 
health measures in the future. We appreciate the commenters support. 
However, as discussed in section II.E.5.b.(3) of this final rule with 
comment period, for the transition year the MIPS, we are not finalizing 
our proposal to require MIPS eligible clinicians and groups to report a 
cross-cutting measures because we believe we should provide flexibility 
for

[[Page 77132]]

MIPS eligible clinicians during the transition year to adjust to the 
program.
    Comment: Another commenter requested that CMS simplify the scoring 
methodology in the quality performance category by removing the 
``population health'' measures and avoiding creating different scoring 
subcategories--in particular creating subcategories for MIPS eligible 
clinicians in practices of 9 or fewer, which appears to create 
different definitions of ``small practices'' throughout the MIPS 
program. The commenter recommended that at a minimum, CMS should 
provide accommodations for MIPS eligible clinicians based on the 
statute's definition of a small practice--meaning 15 or fewer 
professionals.
    Response: We have examined the global and population-based measures 
closely and have decided to not finalize these measures as part of the 
quality performance category score. Specifically, we are not finalizing 
the acute and chronic composite measures of AHRQ PQIs. We will, 
however, calculate these measures for all MIPS eligible clinicians and 
provide feedback for informational purposes as part of the MIPS 
feedback.
    Comment: Some commenters believed that system level and population-
based measures should be applicable to MIPS eligible clinicians, such 
as pathologists, who typically furnish services that do not involve 
face-to-face interaction with patients. The commenters stated that 
activities such as blood utilization, infection control, and test 
utilization activities, including committee participation, should be 
credited to the whole group as pathology practices typically function 
as one unit with different members of the group having different roles. 
The commenters urged CMS to be flexible and not to focus exclusively on 
measures and activities that involve face-to-face encounters, as these 
would have an unfair and negative impact on the MIPS final scores of 
non-patient facing MIPS eligible clinician's specialties.
    Response: We agree that non-patient facing MIPS eligible clinicians 
need quality measures that are applicable to their practice. We 
encourage commenters to suggest specific additional measures that we 
should consider in the future.
    Comment: Other commenters believed the population-based measures 
would be difficult without prospective enrollment that informs MIPS 
eligible clinicians in advance of patients that are attributed to them.
    Response: We will make every effort to provide as much information 
as possible to MIPS eligible clinicians about the patients that will be 
attributed to them. However, we do not believe prospective enrollment 
to be feasible at this time.
    Comment: Several commenters recommended that CMS use its discretion 
to make proposed global and population-based measures optional under 
the improvement activities performance category, rather than including 
these VM Program measures into the MIPS quality performance category as 
population-based health measures: The acute composite, chronic 
composite, and ACR measure. The commenters were concerned that these 
measures are primarily intended to be used and reported at the 
metropolitan area or county level and have not been adequately tested, 
rigorously assessed for appropriate sample sizes, or risk adjusted for 
application at the clinician or group level. The commenters stated that 
the method by which reliability rates are arrived at must be 
transparent, and urged CMS to publicize the data supporting the 
proposal statement that based on the VM Program, the acute and chronic 
composites had an average reliability range of 0.64-0.79. The 
commenters recommended that if CMS moves forward with the three 
population health measures and does not make them optional, MIPS 
eligible clinician performance on any administrative claims measure 
should not be used for payment or be publicly reported unless they have 
a reliability of 0.80, which is generally considered by statisticians 
and researchers to be sufficiently reliable to make decisions about 
individuals based on their observed scores. The commenters recommended 
that in addition, the risk adjustment model should be developed, 
tested, and released for comment prior to implementation of the 
measures. Another commenter did not support the measures that are 
reliable with a minimum case size of 20 and with an average range of 
0.64 and 0.79 because the commenter stated that anything less than 0.9 
is unreliable. The commenter requested that CMS not implement this 
criterion until a risk adjustment can be implemented. Another commenter 
recommended CMS reconsider its use of a minimum sample size of 20 for 
calculating the cost measures, as extensive work has been done on both 
quality measures and cost measures pointing to the need of a sample 
size no smaller than 100 to achieve statistical stability.
    Response: We have examined the global and population-based measures 
closely and have decided to not finalize these measures as part of the 
quality performance category score. Specifically, we are not finalizing 
to use the acute and chronic composite measures of AHRQ PQIs. We agree 
with commenters that additional enhancements need to be made to these 
measures for inclusion of risk adjustment. We will, however, calculate 
these measures for all MIPS eligible clinicians and provide feedback 
for informational purposes as part of the MIPS feedback.
    Comment: One commenter opposed CMS' proposal to score population 
based measures during the transition year of MIPS. The commenter 
requested CMS phase-in population-based measures during the first 2 
years of MIPS as test measures with feedback (but not scored) so that 
MIPS eligible clinicians and CMS can learn how population level 
measures will impact the MIPS program.
    Response: We agree with the commenter that further testing and 
enhancements is required for some of these measures prior to inclusion 
in the MIPS for payment purposes. Therefore, we are no longer requiring 
two of the three population health measures and are only requiring the 
ACR measure for groups of more than 15 instead of our proposed approach 
of groups of 10 or more, assuming the case minimum of 200 cases has 
been met, as discussed in section II.E.6. of this final rule with 
comment period. If the case minimum of 200 cases has not been met, we 
will not score this measure. The MIPS eligible clinician will not 
receive a zero for this measure and this measure will not apply to the 
MIPS eligible clinician's quality performance category score. We will, 
however, calculate these measures for all MIPS eligible clinicians and 
provide feedback for informational purposes as part of the MIPS 
feedback.
    Comment: Another commenter recommended assessing the ACR measure 
over a longer time period as the comparable measure used for hospitals 
is found to be reliable and valid only when using a 3-year rolling 
average. The commenter appreciated that this measure is limited to 
groups with 10 or more MIPS eligible clinicians and requires 200 cases.
    Response: We believe that the measure's limitation to groups with 
16 or more MIPS eligible clinicians, as well as the requirement for at 
least 200 cases, ensures that the measure is sufficiently reliable for 
MIPS purposes. To explain, we will not apply the ACR to solo practices 
or small groups (groups of 15 or less). We will apply the ACR measure 
to groups of more than 15 who meet the case volume.
    Comment: Another commenter recommended that the population-based

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measures only be applied to MIPS groups.
    Response: We attempted to structure the MIPS program to be as 
inclusive as possible for quality measurement purposes. Our intention 
was to ensure that as many MIPS eligible clinicians as possible could 
report on as many measures as possible.
    Comment: Other commenters stated that MIPS is designed to determine 
aggregate population-based outcome measures across clinicians in a 
local area sharing the same hospitals and clinicians. The commenters 
proposed that CMS share with MIPS participants average MIPS final 
scores by clinician categories and cross reference comparative advanced 
APM performance.
    Response: We do not believe MIPS is designed to determine aggregate 
population-based outcome measures. However, we have discretion to 
pursue this approach if we deem appropriate. We will consider these 
suggestions as we develop appropriate feedback forms for MIPS eligible 
clinicians. Our intention is to provide as much information as possible 
to MIPS eligible clinicians to assist with quality improvement efforts.
    Comment: Other commenters disagreed with the proposed use of the 
30-day ACR measure because they believed that doing so will potentially 
penalize clinicians who care for the most complex patients and those of 
lowest SES. They also indicated that the measure is generally 
inappropriate given the lack of MIPS eligible clinician control over 
some of the factors that lead to readmission. Another commenter 
believed MIPS eligible clinicians are penalized for readmissions, but 
not rewarded for successfully keeping people out of the hospital 
completely. Other commenters expressed concern for the use of the ACR 
measure because there are a multitude of factors that contribute to 
readmission making it a difficult outcome to measure. The commenters 
believed that there needs to be more studies prior to using the measure 
at the MIPS eligible clinician level, including the impact on MIPS 
eligible clinicians who serve disadvantaged populations. In addition, 
the commenters believed that the measure requires risk-adjustment for 
SDS factors, community factors, and the plurality of care/care 
coordination. The commenters sought clarity on how the triggering of an 
index episode and attribution of ACR to any particular MIPS eligible 
clinician or group larger than 10 will be relevant. Other commenters 
opposed the ACR measure due to concern that it is not risk adjusted by 
severity level or tertiary care facility. The commenters were also 
concerned that MIPS eligible clinicians and hospitals are trimming back 
on SNF transfers to decrease bundled costs, increasing readmission 
rates. Some commenters recommended using National Committee for Quality 
Assurance's (NCQA's) ACR measure and not the ACR measure which is 
specified for hospitals. Other commenters urged CMS to reconsider 
requiring the use of the ACR measure, as they were concerned with the 
reliability and validity levels associated with applying the measure to 
a single clinician in a given year. They noted that the comparable 
measure for hospitals requires a 3-year rolling average to mitigate 
potential variability, and therefore, requested CMS explore assessing 
the measure over a longer time period.
    Response: We appreciate the commenters' concerns and suggestions. 
However, we have examined the ACR measures closely and have decided to 
finalize the ACR measure from the VM for groups with 16 or more 
eligible clinicians, as part of the quality performance category for 
the MIPS final score. Readmissions are a potential cause for patient 
harm, and we believe it necessary to incentivize their reduction. We 
believe measuring and holding MIPS eligible clinicians accountable for 
readmissions is important for quality improvement, particularly given 
the harm that patients face when readmitted. We hold hospitals and 
post-acute care facilities accountable for readmissions as well; 
holding all clinicians accountable for readmissions incentivizes better 
coordination of care across care settings and clinicians.
    We would like to explain that the all-cause hospital readmission 
measure from VM uses 1 year of inpatient claims to identify eligible 
admissions and readmissions, as well as up to 1 year prior of inpatient 
data to collect diagnoses for risk adjustment. The measure reports a 
single composite risk-standardized rate derived from the volume-
weighted results of hierarchical regression models for five specialty 
cohorts. Each specialty cohort model uses a fixed, common set of risk-
adjustment variables. It is important to note a couple features of the 
risk adjustment design developed for CMS by the Yale School of Medicine 
Center for Outcomes Research & Evaluation (CORE). First, the ACR 
measure involves estimating separate risk adjustment models for seven 
different cohorts of medical professionals (general medicine, surgery/
gynecology, cardiorespiratory, cardiovascular, neurology, oncology, and 
psychiatry because conditions typically cared for by the same team of 
clinicians are likely to reflect similar levels of readmission risk. 
The risk-adjusted readmission rates for each cohort that are then 
combined into a single adjusted rate. Second, for each cohort, the risk 
adjustment models control for age, principal diagnoses, and a broad 
range of comorbidities (identified from the patient's clinical history 
over the year preceding the index admission, not just at the time of 
the hospitalization). Please note that the measure has been included 
for the last several years in the Annual Quality Resource and Use 
Reports so clinician groups and clinicians can find out how they 
perform on the measure and use the data in the reports to improve their 
performance. We will not apply the readmission measure to solo 
practices or small groups (groups of 15 or less). We will apply the 
readmission measure to groups of more than 15 who meet the case volume 
of 200 cases. In addition, we continually reassess reliability and will 
monitor MIPS eligible clinicians' performance under the MIPS for 
unintended consequences.
    It is important to note that for the VM Program, an index episode 
for the readmission measure is triggered when a beneficiary who has 
been attributed to a TIN is hospitalized with an eligible hospital 
admission for the measure. Note that the index admission is not 
directly attributed to a TIN as in the case of an episode for the 
Medicare Spending per Beneficiary measure; rather, index admissions are 
tied to the beneficiaries attributed to the TIN per the two-step 
methodology. Regarding evidence for whether the measure incentivizes 
reductions in readmissions, we refer readers to The New England Journal 
of Medicine article available at http://www.nejm.org/doi/full/10.1056/NEJMsa1513024 which concluded that readmission trends are consistent 
with hospitals' responding to incentives to reduce readmissions, 
including the financial penalties for readmissions under the Affordable 
Care Act. With respect to SDS factors, we refer readers to our 
discussion above of the NQF's 2-year trial and ASPE's ongoing research. 
We will continue to assess the measure's results and will consider the 
commenter's feedback in the future.
    Comment: Another commenter believed that global outcome measures 
and population-based measures should not be included in the MIPS 
quality score until there is further understanding of the reliability 
of volume of measurement for 20 patients, assigning accountability to 
the MIPS

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eligible clinicians who have control, how conditions that are not 
treated by the surgeon will be included or excluded, how population-
based measures will be used at the MIPS eligible clinician level, the 
reliability and validity of measures if modified, the need for risk-
adjustment of the composite measures, if adjustments for safety data 
sheets will be considered and the potential unintended consequences for 
including resource utilization.
    Response: We advocate the continued implementation of population-
based measures and will continue to work with stakeholders to improve 
and expand them over time. We note that these measures have been used 
in other programs, such as the Medicare Shared Savings Program and for 
groups in the VM Program, and are aligned with the National Quality 
Strategy.
    Comment: Some commenters urged CMS to not maintain administrative 
claims-based measures, which were developed for use at the community or 
hospital level, and often result in significant attribution issues. The 
commenters stated these measures tend to have low statistical 
reliability when applied at the individual clinician level, and at 
times at the group level. They are also calculated with little 
transparency, which confuses and frustrates MIPS eligible clinicians. 
The commenters stated that scores on these particular measures do not 
provide actionable feedback to MIPS eligible clinicians on how they can 
improve.
    Response: We believe administrative claims-based measures are a 
necessary option to minimize reporting burden for MIPS eligible 
clinicians. The ACR measure has been used in both the Shared Savings 
Program and the VM Program for several years. We would like to note 
that at the minimum case sizes applied for the VM, average reliability 
for the ACSC composite measures exceed 0.40 even for TINs with one EP.
    We can understand why commenters see these measures as less 
transparent and actionable compared to the PQRS process measures. 
However, this is largely driven by risk adjustment and shrinkage (in 
the case of the ACR measure), both of which are attempts to protect 
clinicians from ``unfair'' outcomes, albeit at the cost of decreased 
transparency. In the context of the QRURs, we have provided 
supplementary tables to the QRUR containing patient level information 
on admissions, including reason for admission (principal diagnosis) and 
whether it was followed by an unplanned readmission, to support both 
more transparency as well as actionability. We intend to work with MIPS 
eligible clinicians and other stakeholders to continue improving 
available measures and reporting methods for MIPS.
    We continually reassess measures and this is why we have worked 
with measure owner and stakeholders to improve the risk adjustment 
methodology for these measures. In addition, we have used these 
measures under the VM Program and have provided feedback to groups and 
individual clinicians for the last several years. Further, we apply 
case minimums to ensure measures are reliable for groups and individual 
clinicians. The measures are outcome focused and are calculated on 
behalf of the clinician using Medicare claims and other administrative 
data. In addition, they are low burden with the goal for groups and 
individual clinicians to invest in care redesign activities to improve 
outcomes for patients where good ambulatory coordination reduces 
avoidable admissions.
    Comment: Another commenter had concerns about the proposal to 
include population health and prevention measures for all MIPS eligible 
clinicians, stating that some specialists and sub-specialists have no 
meaningful responsibility for population or preventive services.
    Response: We believe that all MIPS eligible clinicians, including 
specialists and subspecialists, have a meaningful responsibility to 
their communities, which is why we have focused on population health 
and prevention measures for all MIPS eligible clinicians. Individuals' 
health relates directly to population and community health, which is an 
important consideration for quality measurement generally and MIPS 
specifically. It is important to note that we are no longer requiring 
two of the three population health measures and are only requiring the 
ACR measure for groups of more than 15 instead of our proposed approach 
of groups of 10 or more, assuming the case minimum of 200 cases has 
been met, as discussed in section II.E.6. of this final rule with 
comment period. If the case minimum of 200 cases has not been met, we 
will not score this measure. Thus, the MIPS eligible clinician will not 
receive a zero for this measure, but rather this measure will not apply 
to the MIPS eligible clinician's quality performance category score. We 
believe the ACR measure for groups of more than 15 is appropriate and 
will provide meaningful measurement.
    Comment: Another commenter opposed using the same attribution 
method that was originally used for ACOs and is currently used for the 
VM Program for CMS' proposal to score MIPS eligible clinicians on two 
or three (depending on practice size) additional `global' or 
`population based' quality measures to be gathered from administrative 
claims data. The commenter believed these measures potentially hold 
MIPS eligible clinicians, especially specialists such as 
ophthalmologists, responsible for care they did not provide. The 
measures--acute and chronic care composites and ACR--focus on the 
delivery of primary care, which does not apply to ophthalmology or a 
variety of other specialties. Therefore, specialists should be exempt 
from these additional measures and evaluated only on the six measures 
they choose to report.
    Response: As noted above, the ACR and ACSC measures have been used 
in both the Shared Savings Program and the VM Program for several 
years. The ACR measure involves estimating separate risk adjustment 
models for seven different cohorts of medical professionals (general 
medicine, surgery/gynecology, cardiorespiratory, cardiovascular, 
neurology, oncology, and psychiatry) because conditions typically cared 
for by the same team of clinicians are likely to reflect similar levels 
of readmission risk. The measure reports a single composite risk-
standardized rate derived from the volume-weighted results of 
hierarchical regression models for five specialty cohorts. Each 
specialty cohort model uses a fixed, common set of risk-adjustment 
variables. We believe this measure is representative of most MIPS 
eligible clinicians.
    In addition, we have examined the global and population-based 
measures closely and have decided to not finalize two of these measures 
as part of the quality performance category score. Specifically, we are 
not finalizing use of the acute and chronic composite measures of AHRQ 
PQIs. We agree with commenters that additional enhancements need to be 
made to these measures for inclusion of risk adjustment. We will, 
however, calculate these measures for all MIPS eligible clinicians and 
provide feedback for informational purposes as part of the MIPS 
feedback.
    Comment: Other commenters requested that if the three claims-based 
measures were instead reported by a QCDR or quality registry and 
included total patient population, regardless of payer, the MIPS 
eligible clinicians' patient population would be better

[[Page 77135]]

represented and overall scores more accurate. The commenters also 
believed this would reduce administrative burden on CMS for the 
calculation of these metrics and beneficiary attribution. The 
commenters believed that since this is calculated by CMS and represents 
up to a third of the quality score, QCDRs and qualified registries 
would have limited ability to give MIPS eligible clinicians insight 
into their performances and provide benchmarking data back to MIPS 
eligible clinicians throughout the year, assisting with clinician's 
ability to judge how they are performing relative to other 
organizations within the registry. The commenters noted that QCDRs and 
qualified registries serve a critical component to MIPS eligible 
clinicians, allowing them to receive more timely feedback on their 
rates and how their rates compare to others using the same QCDR or 
qualified registry, so when up to a third of the quality score is based 
on data not calculated by the QCDR or qualified registry, it becomes 
challenging for that entity to provide meaningful feedback and 
benchmarking to the MIPS eligible clinicians on how they are performing 
in the overall quality category, which amounts to 50 percent of their 
MIPS final score.
    Response: We appreciate the suggestion but we believe it is 
important to use CMS claims data which we know to be valid and to 
calculate these measures in the way with which providers are familiar, 
at the outset of the MIPS program. We would consider future refinements 
to the measure, including exploring how a registry or QCDR might be 
able to participate in the claims-based measures' calculation.
    Comment: Some commenters supported the inclusion of ACR measure 
rates in the proposed global and population health measurement, and the 
use of telehealth to achieve goals.
    Response: We thank the commenters for their support. Regarding the 
commenters reference to telehealth, we note telehealth can help to 
support better health and care at the patient and population levels. As 
indicated in the Federal Health IT Strategic Plan 2015-2020 (Strategic 
Plan) which can be found at http://www.hhs.gov/about/news/2015/09/21/final-federal-health-it-strategic-plan-2015-2020-released.html#, 
telehealth can further the goals of: transforming health care delivery 
and community health; enhancing the nation's health IT infrastructure; 
and, advancing person-centered and self-managed health.
    Comment: Other commenters stated that population-based measures had 
low statistical reliability for practice groups smaller than hospitals. 
The commenters requested that specialists and small MIPS eligible 
clinicians be exempt from reporting population-based measures. Another 
commenter stated attributing population-based measure outcomes to 
specific MIPS eligible clinicians is inappropriate. Further, the 
commenter stated MIPS eligible clinicians should only be scored on 
measures they choose within the quality performance category. A few 
commenters requested that population-based measures be removed from 
quality reporting, because these measures were developed for use in the 
hospital setting and would be unreliable when applied at the individual 
MIPS eligible clinician's level. Another commenter stated that global 
and population-based measures (PQIs specifically) should not be used 
until they were appropriately risk adjusted for patient complexity and 
socio-demographic status.
    Response: We have examined the global and population-based measures 
closely and have decided to not finalize the acute and chronic 
composite measures of AHRQ PQI. Therefore, we are no longer requiring 
two of the three population health measures and are only requiring the 
ACR measure for groups of more than 15 instead of our proposed approach 
of groups of 10 or more, assuming the case minimum of 200 cases has 
been met, as discussed in section II.E.6. of this final rule with 
comment period. If the case minimum of 200 cases has not been met, we 
will not score this measure. Thus, the MIPS eligible clinician will not 
receive a zero for this measure, but rather this measure will not apply 
to the MIPS eligible clinician's quality performance category score. We 
believe the ACR measure for groups of more than 15 is appropriate and 
will provide meaningful measurement. Therefore, we respectfully 
disagree with the commenter's statement that MIPS eligible clinicians 
should only be scored on measures they choose within the quality 
performance category.
    Comment: Some commenters did not want CMS to use global and 
population-based measures for accountability. The commenters remarked 
that CMS has not provided enough evidence that these measures have any 
impact on quality. The commenters found global and population-based 
measures confusing and frustrating because MIPS eligible clinicians 
have no control over appropriate measures for accountability.
    Response: The purpose of the global and population-based measures 
is to encourage systemic health care improvements for the population 
being served by MIPS eligible clinicians. We note further that we have 
found the PQI measures to be reliable in the VM Program with a case 
count of at least 20. As we noted in our proposal, we intend to 
incorporate clinical risk adjustment for the PQI measures as soon as 
feasible.
    Comment: Other commenters supported the use of global and 
population-based measures, and supported CMS's inclusion of the acute 
and chronic composite measures and the ACR measure. A few commenters 
supported the proposal to use population-based measures from the acute 
and chronic composite measures and the ACR measure or AHRQ PQIs with a 
minimum case size of 20 and urged CMS to add a clinical risk adjustment 
as soon as feasible.
    Response: We thank the commenters for their support.
    Comment: A few commenters requested that the denominator for the 
quality performance category be adjusted as appropriate to reflect the 
inapplicability of the global and population-based measures to certain 
MIPS eligible clinician's practices (the commenter specifies that these 
measures are inappropriate for hospitalists). Another commenter 
requested population-based measures be removed from quality reporting, 
because these measures were developed for use in the hospital setting 
and would be unreliable when applied at the individual MIPS eligible 
clinicians' level. Other commenters stated that global and population-
based measures (PQIs specifically) should not be used until they were 
appropriately risk adjusted for patient complexity and socio 
demographic status.
    Response: We believe these measures are important for all MIPS 
eligible clinicians, because their purpose is to encourage systemic 
health care improvements for the population being served by MIPS 
eligible clinicians. We believe that hospitalists are fully capable of 
supporting that objective. Additionally, we are using the same two-step 
attribution methodology that we have adopted in the VM Program, and 
that methodology focuses on the delivery of primary care services both 
by MIPS eligible clinicians who work in primary care and by 
specialists.
    Comment: Some commenters expressed support for including more 
global, population-based measures that are not specialty-specific or 
limited to addressing specific conditions in the program, but noted 
that the level of accountability for population-based measures is best 
at the health system and community level--where the numbers are large 
enough--rather than at the MIPS eligible clinician level.

[[Page 77136]]

    Response: We thank the commenters for the feedback. We will take 
the suggestions into consideration in future rulemaking.
    Comment: Another commenter believed that the population-based 
measures included in the proposal were appropriate for population 
measurement, but could go further with respect to measuring outcomes. 
One commenter outlined necessary readmission scenarios to prevent graft 
rejection for transplant patients and urged CMS to remove the 
population-based measures, which indirectly include hospital 
readmissions, from consideration under the quality component of MIPS.
    Response: We believe the ACR measure for groups of more than 15 is 
appropriate and will provide meaningful measurement. Please refer to 
the discussion above regarding the ACR measure. In addition, we have 
examined the global and population-based measures closely and have 
decided to not finalize the acute and chronic composite measures of 
AHRQ PQIs.
    Comment: Several commenters recommended that CMS not require the 
submission of administrative claims-based population-based measures and 
stated that they tend to have low reliability at both the MIPS eligible 
clinicians individual and group levels. The commenters recommended that 
CMS make the measures optional in the improvement activities 
performance category or exempt small practices from the measures.
    Response: We believe that claims-based measures are sufficiently 
reliable for value-based purchasing programs, including MIPS. We note 
that the quality measures and improvement activities are not 
interchangeable. We will consider other measures that could potentially 
replace claims-based measures in the future. We note that the 
administrative claims-based population-based measures are calculated 
based on Part B claims, and are not separately submitted by MIPS 
eligible clinicians, so do not have administrative burden associated 
with them.
    Comment: Other commenters expressed concern that the proposal 
included administrative claims-based population-based measures that 
were previously part of the VM Program because these measures are 
specified for the inpatient and outpatient hospital setting and are 
less reliable when applied to individual MIPS eligible clinicians and 
groups. The commenters requested CMS decrease the threshold levels for 
quality reporting measures, expand exemptions, and develop payment 
modifier measures that have a higher reliability at the MIPS eligible 
clinician level. Another commenter had concerns about taking measures 
from other organizational settings (for example, hospitals) for MIPS as 
the underlying theory and concepts, technical definitions, and 
parameters of use might be different in different contexts.
    Response: We would like to explain that some measures are geared 
toward facilities and some are attributable to individuals. Please 
refer to the Table A of the Appendix in this final rule with comment 
period for the applicable measures. We have worked to adopt only MIPS 
eligible clinician individual or group-based measures in the MIPS 
program.
    Comment: Another commenter recommended aligning measures for 
hospitals and hospitalists and limiting those measures to the quality 
performance category. The commenter further recommended maintaining the 
voluntary application of hospital measures (specifically those that 
could reflect the influence of hospitalists) to MIPS eligible 
clinicians. Some commenters encouraged CMS to align quality measures 
with current hospital measures because hospital staff require time and 
effort to maintain and report MIPS and APM data due to small staffing 
levels. The commenters stated aligning hospital and MIPS eligible 
clinician measures would reduce potential for reporting error and allow 
them to pursue common goals to improve quality of care delivery. 
Another commenter recommended that hospital, ACO, and pay for 
performance data be used to measure MIPS performance.
    Response: We appreciate the commenter's feedback and will consider 
it in future years of the program.
    After consideration of the comments regarding our proposal on 
global and population-based measures we are not finalizing all of these 
measures as part of the quality score. Specifically, we are not 
finalizing our proposal to use the acute and chronic composite measures 
of AHRQ PQIs. We agree with commenters that additional enhancements, 
including the addition of risk adjustment, needed to be made to these 
measures prior to inclusion in MIPS. We will, however, calculate these 
measures for all MIPS eligible clinicians and provide feedback for 
informational purposes as part of the MIPS feedback.
    Lastly, we are finalizing the ACR measure from the VM Program as 
part of the quality measure domain for the MIPS total performance 
score. We are finalizing this measure with the following modifications 
as proposed. We will not apply the ACR measure to solo practices or 
small groups (groups of 15 or less). We will apply the ACR measure to 
groups of 16 or more who meet the case volume of 200 cases. A group 
would be scored on the ACR measure even if it did not submit any 
quality measures, if it submitted in other performance categories. 
Otherwise, then the group would not be scored on the readmission 
measure. In our transition year policies, the readmission measure alone 
would not produce a neutral to positive MIPS payment adjustment since 
in order to achieve a neutral to positive MIPS payment adjustment, a 
MIPS eligible clinician or group must submit information to one of the 
three performance categories as discussed in section II.E.7. of the 
final rule with comment period. In addition, the ACR measure in the 
MIPS transition year CY 2017 will be based on the performance period 
(January 1, 2017, through December 31, 2017). However, for MIPS 
eligible clinicians who do not meet the minimum case requirements the 
ACR measure is not applicable.
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

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inclusion in the MIPS annual list of quality measures. We rely on 
outside measure stewards and developers to maintain these measures. 
Therefore, we also proposed to give consideration to 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 transition year of MIPS, we proposed 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 could 
be found in Table A of the Appendix of the proposed rule: Proposed 
Individual Quality Measures Available for MIPS Reporting in 2017 (81 FR 
28399 through 28446). Also included in the Appendix in Table B of the 
proposed rule (81 FR 28447) was a list of proposed quality measures 
that do not require data submission, some of which were previously 
implemented in the VM (80 FR 71273-71300), that we proposed 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 also proposed measures that were not previously 
finalized for implementation in the PQRS program. These measures and 
their draft specifications are listed in Table D of the Appendix in the 
proposed rule (81 FR 28450 through 28460). The proposed specialty-
specific measure sets are listed in Table E of the Appendix in the 
proposed rule (81 FR 28460 through 28522). 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 clinicians and 
will help drive quality improvement for our beneficiaries. For future 
years, we solicited comment about the addition of a ``Medicaid measure 
set'' based on the Medicaid Adult Core Set (https://www.medicaid.gov/medicaid-chip-program-information/by-topics/quality-of-care/adult-health-care-quality-measures.html). We also sought to include measures 
that were part of the seven core measure sets that were developed by 
the Core Quality Measures Collaborative (CQMC). The CQMC is a 
collaborative of multiple stakeholders that is convened by America's 
Health Insurance Plans (AHIP) and co-led with CMS. The purpose of the 
collaborative is to align measures and develop consensus on core 
measure sets across public and private payers. Measures we proposed for 
removal can be found in Table F of the Appendix in the proposed rule 
(81 FR 28522 through 28531) and measures that will have substantive 
changes for the 2017 performance period can be found in Table G of the 
Appendix in the proposed rule (81 FR 28531 through 28569). In future 
years, the annual list of quality measures available for MIPS 
assessment will occur through rulemaking. We requested comment on these 
proposals. In particular, we solicited 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 (for example, process vs. outcome) than what was 
proposed.
    The following is a summary of the comments we received on our 
proposals regarding the Annual List of Quality Measures Available for 
MIPS Assessment.
    Comment: One commenter wanted to know via what mechanism 
stakeholders will be made aware of the public comment period and final 
measure publications associated with quality measure changes under MIPS 
(for example, the PFS rule) in advance of the proposed annual update, 
and if CMS plans to do measure updates specific to MIPS. Another 
commenter requested clarity on when the measures and measure sets will 
be released.
    Response: The final measure sets can be found in the Appendix of 
this final rule with comment period. We intend to make updates to the 
list of quality measures annually through future notice and comment 
rulemaking as necessary. At this time, we cannot provide more 
specificity on our rulemaking schedule, but intend to announce 
availability of the proposed and final measure sets through stakeholder 
outreach, listservs, online postings on qualitypaymentprogram.cms.gov, 
and other communication channels that we use to disseminate information 
to our stakeholders.
    Comment: One commenter asked that all measures be published in a 
sortable electronic format, such as MS Excel or a comma-delimited 
format compatible with Excel.
    Response: We intend to post the measures and their specifications 
on the Quality Payment Program Web site 
(qualitypaymentprogram.cms.gov). We are striving to design the Web site 
with user needs in mind so that users will have easy access to the 
information that they need.
    Comment: One commenter requested clarification on the methodology 
for publishing, reviewing, benchmarking, and giving feedback on 
measures.
    Response: As discussed in section II.E.5.c. of this final rule with 
comment period, we select measures through a pre-rulemaking process, 
which includes soliciting public comments, and adopt those measures 
through notice-and-comment rulemaking. We then collect measure data, 
establish performance benchmarks based on a prior period or the 
performance period, score MIPS eligible clinicians based on their 
performance relative to the benchmarks, and provide feedback to MIPS 
eligible clinicians on their performance. Also, as

[[Page 77138]]

discussed further in section II.E.10. of this final rule with comment 
period, we intend to publicly post performance information on the 
Physician Compare Web site.
    Comment: One commenter requested that any proposed introduction of 
additional inpatient or hospital measures be published in the same 
place that other MIPS quality measure proposed changes are published.
    Response: We agree with the commenter and will strive to ensure 
that all MIPS policy changes occur together. However, other rulemaking 
vehicles may be necessary for the Program's implementation in the 
future.
    Comment: One commenter did not support the Quality Payment Program, 
believing quality measures should be developed on a state level by the 
physicians in the state.
    Response: The Quality Payment Program is required by statute. In 
addition, we note that the vast majority of the measures that are being 
finalized were developed by the physician community.
    Comment: A few commenters cautiously supported the proposal that 
CMS release measures by November 1 the year in advance of the 
performance period, noting that ideally physicians would have more 
time. However, numerous commenters stated that November 1 is too late 
in the year for quality measures to be published in the Federal 
Register to be implemented by January 1 of the following year and 
encouraged CMS to publish the final list of approved measures earlier 
to allow clinicians and vendors sufficient time to prepare for the 
performance period. A few commenters specifically noted the need to 
give EHR software vendors adequate time to update their software and 
establish workflows to match measures. This process takes several 
months, and many vendors do not update their systems with new measures 
until June.
    Response: We understand the commenters' concern. As described 
above, the process for selecting MIPS quality measures entails multiple 
steps that begins with an annual call for measures and culminates with 
the publication of the annual list of quality measures in a final rule. 
While we strive to release the final list of quality measures as soon 
as feasible, we cannot do so until we have completed all of the 
requisite steps. With respect to commenters' statement that software 
developers need more adequate time to update their software to capture 
measures, we will work to assure that measures have been appropriately 
reviewed and release measures as early as possible. In future years, 
CMS will release specifications for eCQMs well in advance of November 1 
of the year preceding a given performance period. For example, for the 
2017 performance period, we released specifications for all eCQMs that 
may be considered for implementation into MIPS in April 2016. We are 
open to commenters' suggestions for other ways that we can streamline 
the measure selection process to enable us to release the annual list 
of quality measures and/or measure specifications sooner than November 
1st.
    Comment: A few commenters were concerned with CMS's plan to update 
quality measures on a yearly basis. The commenters recommended that 
measures be considered in ``test/pilot'' mode before they are included 
in CMS's quality programs and rigorously evaluated for validity and 
accuracy during the pilot period. Further, the commenters suggested 
that measures should be maintained for more than 1 year, to ensure the 
agency has a reasonable understanding of how clinicians have performed 
and improved over time, as well as to determine whether CMS's 
priorities have been reasonably met, with respect to included quality 
measures.
    Response: For measures that are NQF-endorsed, measures must be 
tested for reliability and validity. For measures that are not NQF-
endorsed, we consider whether and to what extent the measures have been 
tested for reliability and validity. We do not take the decision to 
remove a measure lightly and agree with the commenters that we should 
take into consideration how clinicians have performed and improved over 
time, among other factors, when deciding to remove a quality measure 
from the program.
    Comment: Several commenters recommended separate timelines for new 
measures as opposed to updated specifications and suggested that when 
changes to the list of MIPS quality measures are made, those changes 
should not be implemented until at least 18 months after they are 
announced and finalized. One commenter suggested that 12 months are 
needed for vendor implementation, and another 6 months allocated for 
real-world beta testing of measures to identify and resolve defects and 
inconsistencies in a measure update for implementation the following 
year. The commenter further requested a minimum of 6 months' notice 
prior to any reporting period for implementation of revised measures. 
Some commenters recommended more time, at least 6 months, to implement 
a new metric before being scored to allow time to work out reporting 
issues with vendors. Other commenters requested that specific measure 
definitions be published at least 120 days prior to the start of the 
reporting period.
    Response: We do not believe it is necessary to develop unique 
timelines for measures that we will consider for the program. Although 
we understand the commenters' point that new measures require 
additional consideration beyond simple changes to measure 
specifications, we believe we account for those considerations when 
developing our proposals and in consulting with the stakeholder 
community during the measure development process. We describe our 
process in detail in our Quality Measure Development Plan (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf).
    Comment: One commenter expressed discontent with measures 
specifications that change in mid-season. The commenter requested that 
the measures be accepted based on the new or the old specifications and 
that neither submission be scored.
    Response: We would like to note that measure specifications do not 
change during the performance period. Prior to the beginning of the 
performance period, measure specifications are shared, and only change 
for the next performance period or at another time indicated in 
rulemaking. We cannot accept multiple versions of quality measure data, 
so we can only accept one version of a measure's specifications during 
a performance period.
    Comment: One commenter requested that CMS quickly notify clinicians 
when measures are introduced and retired. Further, other commenters 
were concerned about the proposed changes in quality measures. The 
commenters stated that this will require more resources and time to 
sort through all the changes.
    Response: We agree and will make every possible effort to notify 
clinicians when we propose and adopt measures for MIPS, and will 
similarly notify clinicians as quickly as possible if and when we 
retire measures from the program, which is also done through 
rulemaking. Our intention is to keep clinicians as informed as possible 
about the quality criteria on which they will be measured, something we 
have done within the PQRS and other quality reporting programs.
    Comment: One commenter recommended that to avoid concerns regarding 
uneven opportunities for

[[Page 77139]]

clinicians, registries, and health IT vendors, CMS should require all 
measures planned for inclusion in its quality reporting programs to 
include specifications such that any organization that would want to 
use those measures may do so.
    Response: Measure specifications will be available on the Quality 
Payment Program Web site (qualitypaymentprogram.cms.gov). Additionally, 
to provide clarity to MIPS eligible clinicians when they select their 
quality measures we also will publish the numerical baseline period 
benchmarks prior to the performance period (or as close to the start of 
the performance period as possible) in the same location as the 
detailed measure specifications. These measure benchmarks will be 
published for those quality measures for which baseline period data is 
available. For more details on our quality performance category 
benchmarks, please refer to section II.E.6. of this final rule with 
comment period.
    Comment: One commenter recommended that CMS implement a review 
process when it considers measures for use at a different level than 
the measure's intended use (for example, the clinician level). The 
commenter recommended this process include, but not be limited to: 
Convening a technical expert panel and a public comment period, and a 
review of measure specifications to ensure measures are feasible and 
scientifically acceptable in all environments and at all intended 
levels of measurement.
    Response: As part of our measure selection process, stakeholders 
have multiple opportunities to review measure specifications and on 
whether or not they believe the measures are applicable to clinicians 
as well as feasible, scientifically acceptable, and reliable and valid 
at the clinician level. As we discussed in section II.E.5.c of this 
final rule with comment period, the annual Call for Measures process 
allows eligible clinician organizations and other relevant stakeholder 
organizations to identify and submit quality measures for 
consideration. Presumably, stakeholders would not submit measures for 
consideration unless they believe that the measure is applicable to 
clinicians and can be reliably and validly measured at the individual 
clinician level. The NQF convened Measure Application Partnership (MAP) 
provides an additional opportunity for stakeholders to provide input on 
whether or not they believe the measures are applicable to clinicians 
as well as feasible, scientifically acceptable, and reliable and valid 
at the clinician level. Furthermore, we must go through notice and 
comment rulemaking to establish the annual list of quality measures, 
which gives stakeholders an additional opportunity to review the 
measure specifications and provide input on whether or not they believe 
the measures are applicable to clinicians as well as feasible, 
scientifically acceptable, and reliable and valid at the clinician 
level. Additionally, we are required by statute to submit new measures 
to an applicable, specialty-appropriate peer-reviewed journal.
    Comment: Several commenters suggested providing a 3-year phase out 
period for measures being proposed for removal. CMS should provide 
measure owners with more detailed analysis on the use of their measures 
so that they can work to develop the next generation of measures and/or 
improve performance with measures.
    Response: We allow the public to comment on any proposals for 
measure removals, but we do not intend to adopt a general 3-year phase-
out policy at this time. We believe the MIPS program must be flexible 
enough to accommodate changes in clinical practice and evidence as they 
occur.
    Comment: A few commenters commended and supported CMS for its 
proposal to remove unneeded measures and reduce administrative burden 
while still providing meaningful rewards for high quality care provided 
by MIPS eligible clinicians in small practices. Commenters recommended 
that CMS remove topped out measures, duplicative measures, and measures 
of basic standards of care. Another commenter suggested that CMS 
establish a mechanism for expeditiously changing quality measures that 
are no longer consistent with published best practices. Further, 
another commenter noted that patients are better served when eligible 
clinicians are able to dedicate their time and effort to recording data 
that is pertinent and specific to patient issues and care, and thus, 
the commenter recommended that CMS remove irrelevant quality measures 
and redundant quality measures in order to align MIPS eligible 
clinicians with CMS' goal to improve reporting efficiency.
    Response: We intend to ensure that measures are not duplicative, 
and we believe that the need for some measures of basic care standards 
is still present given the clinical gaps evidenced by the performance 
rate. Measures must be removed through notice-and-comment rulemaking 
and are thus not expeditiously removed. Measures are reviewed in 
accordance with the removal criteria discussed in the proposed rule (81 
FR 28193) and a determination is made to retain or to propose for 
removal.
    Comment: A few commenters opposed removing measures as topped out, 
stating that high performance on a measure should be rewarded and 
incentivized. Other commenters recommended that CMS consider adopting 
new measures addressing similar concepts to ensure that there are no 
gaps in measurement in distinct disease areas before removing topped 
out measures.
    Response: We agree that we should not automatically remove measures 
that are topped out without considering other factors, such as whether 
or not removing the measure could lead to a worsening performance gap. 
We consider additional factors when removing measures on the basis of 
being ``topped out.'' For instance, if the variance of performance on 
the measure indicates that there is no identified clinical performance 
gap, this also impacts the decision to remove measures on the basis of 
being ``topped out.'' We will continue to look at topped out criteria 
in addition to performance gaps when selecting measures to remove. We 
recognize that topped out measures no longer provide information that 
permits the meaningful comparison of clinicians.
    Comment: One commenter did not support the selection of quality 
measures, as the commenter believed the quality measures are surrogates 
for measuring true value as a clinician and lack validity.
    Response: We believe quality measurement is critical to ensuring 
that Medicare beneficiaries and all patients receive the best care at 
the right time. We note further that we are required by statute to 
collect quality measures information, and we believe quality 
measurement is an opportunity for MIPS eligible clinicians to 
demonstrate the quality of care that they provide to their patients.
    Comment: One commenter proposed that instead of the list of self-
selected quality measures, CMS could establish a measure set that the 
agency could calculate on behalf of clinicians using administrative 
claims, QCDR data, and potentially other clinical data that clinicians 
report with their claims or through EHRs. These administrative claims-
based measures should include some measures that apply to a broad scope 
of clinicians, and also some overuse measures (for example, imaging for 
non-specific low back pain). Further, the commenter suggested that CMS 
also could include measures from other

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settings, such as inpatient hospitals, because some clinicians, such as 
hospitalists, may be best measured through hospital quality measures 
(for example, hospital readmissions). The commenter also suggested that 
through this approach CMS also would have more complete information to 
remove topped-out measures, and to prioritize measures based on 
performance gaps.
    Response: We note that we proposed three administrative claims-
based measures, and that we do accept information electronically and 
through QCDRs. We are researching the best way to attribute care to 
clinicians within facilities. We are also looking into the best method 
to identify topped-out measures and to quantify a decision to remove 
measures from the program. Finally, measures have been identified based 
on specialty.
    Comment: Numerous commenters disagreed with the elimination of 
measures group reporting and asked that CMS reconsider the removal of 
measures groups, in order to reduce reporting burden. Further, 
commenters noted that measures groups are designed to provide an 
overall picture of patient care for a particular condition or set of 
services and provide a valuable means of reporting on quality. Measure 
groups ensure that specialties, individual physicians, and small 
practices have access to meaningful measures that allow physicians to 
focus on procedures and conditions that represent a majority of his or 
her practice. Another commenter expressed belief that the removal of 
measure groups will skew quality reporting further in favor of large 
group practices because the CMS Web Interface allows for reporting on a 
sampling of patients.
    Response: We agree that there are measures to which specialists 
should have access to that are meaningful for their specialty, which is 
why we proposed replacing measure groups with specialty measure sets to 
ensure simplicity in reporting for specialists. We believe that the 
specialty measure sets are a more appropriate way for MIPS to 
incorporate measures relevant to specialists than measures groups. 
Further, we proposed specialty measures sets in an effort to align with 
the CQMC.
    Comment: One commenter agreed with efforts to streamline the 
process of reviewing and identifying applicable quality measures, and 
supported the inclusion of specialty measure sets in Table E of the 
Appendix in this final rule with comment period.
    Response: We appreciate the support.
    Comment: One commenter encouraged CMS to move rapidly to a core set 
of measures by specialty or subspecialty because the commenter believes 
an approach using high-value measures would enable direct comparison 
between similar clinicians, and would provide assurance that the 
comparison is based on a consistent and sufficiently comprehensive set 
of quality indicators. The commenter believed a core measure set should 
include measures of outcomes, appropriate use, patient safety, 
efficiency, patient experience, and care coordination.
    Response: We agree that a core set of measures by specialty would 
be optimal when comparing similar eligible clinicians and we did 
incorporate the measures that were included in the core sets developed 
by the CQMC. CMS will continue to evaluate a core set of measures by 
specialty to ensure each set is diverse and indicative of CMS 
priorities of quality care.
    Comment: One commenter recommended use of specialty- and 
subspecialty-specific core measure sets that would provide reliable 
comparative information about clinician performance than the 6 measure 
approach. The commenter believed that advancing the current state of 
performance measurement should be a top priority in MACRA 
implementation, and toward that end, the commenter supported using the 
improvement activities category to reward development of high-value 
measures, and in particular patient-reported outcomes.
    Response: We will consider any new measure sets in the future, and 
welcome commenters' and other stakeholders' feedback on what measure 
sets we should consider in the future for MIPS. We agree that advancing 
performance measurement should be a top priority for MIPS, and we thank 
the commenter for their support of improvement activities.
    Comment: One commenter recommended identifying quality measures 
that are specialty specific and germane to what is practiced. Another 
commenter recommended that CMS apply a standardized approach to ensure 
that measures included in the specialty measure sets are clinically 
relevant and aligned with updates occurring in the measure landscape.
    Response: We appreciate the comment and note that identification of 
quality measures that are germane to clinical practice is our intent. 
We are adopting quality measure sets that are specialty-specific and 
clinically relevant to that particular specialty.
    Comment: Several commenters supported the concept of measure sets, 
but had some concerns with the construction of the proposed measure 
sets. Some of the measures included in the specialty sets are not 
appropriate for some specialties or subspecialties. The commenters 
believed the proposed rule represents more of a primary care practice 
focus. Further, the commenters were concerned that reporting 
requirements may not always reflect real differences in specialized 
practices. Commenters suggested these issues reflect a need that all of 
the measure sets should be more closely vetted by clinicians from the 
specialty providing the service.
    Response: We worked with specialty societies to develop measure 
sets and will continue to work with specialty societies to further 
improve the existing specialty measure sets and also develop new 
specialty measure sets for more specialty types.
    Comment: Some commenters believed the quality measures are not 
relevant to certain specialties. Further, one commenter expressed 
concern about the proposed MIPS quality measures because the commenter 
believed the quality measures do not reflect the unique care provided 
by geriatricians for their elderly patients, but rather were developed 
for non-elderly patient care. The commenter believed this would 
unfairly disadvantage geriatricians who care for sicker, older 
patients; who are without the resources and technology incentives to 
develop new, more relevant measures, and frequently practice in 
settings that do not have health IT infrastructure.
    Response: We believe that the quality measures adopted under the 
Quality Payment Program are relevant to clinicians that offer services 
to Medicare beneficiaries, including elderly patients. We tried to 
align certain measures to specialty-specific services, and we welcome 
commenters' feedback on additional measures or specialties that we 
should consider in the future.
    Comment: A few commenters stated that not every physician and 
specialty fits CMS's measure molds and that there is a lack of 
specialty measure sets. Further, commenters suggested that CMS identify 
an external stakeholder entity to maintain the proposed specialty-
specific measure sets.
    Response: We have identified specialty sets based on the ABMS 
(American Board of Medical Specialties) list. Although we realize that 
all specialties or sub-specialties are not covered under these 
categories, we encourage clinicians to report measures that are most 
relevant to their practices, including those that are not within a 
specialty set.

[[Page 77141]]

    Comment: A few commenters stated that specialists with fewer 
options will be required to report on topped out measures which do not 
award full credit, resulting in a disadvantage. Another commenter was 
concerned that as groups choose the six quality measures on which they 
perform best, those popular measures will become inflated and quickly 
become ``topped out.'' Further, commenters stated that there is little 
value in reporting on measures already close to being ``topped out,'' 
just for the sake of reporting. One commenter suggested that CMS 
continue to develop more clinically relevant measures and remove those 
that have been topped out.
    Response: As measures become topped out, we will review each 
measure and make a determination to retain or remove the measure based 
on several factors including whether the measure is a policy priority 
and whether its removal could have unintended impact on quality 
performance. We refer the commenters to section II.E.6.a. of this final 
rule with comment period for additional details on our approach for 
identifying and scoring topped out measures.
    Comment: One commenter suggested that CMS carefully consider all of 
the specialties that will be engaged in the MIPS program in future 
years as measure requirements are expanded and to develop policies that 
provide flexibility for those physician types who may have limited 
outcomes measures to report. Another commenter recommended CMS ensure 
the availability of high priority MIPS quality measures for 
specialists. The commenter requested that CMS closely track whether the 
number of high priority MIPS measures available to specialists 
approximates the number available to primary care physicians. Should 
the measures available to specialists be considerably lower, they 
recommended that CMS expedite the creation of specialty specific high 
priority measures within its measure development process to assure 
parity in reporting opportunity across specialties.
    Response: We are aware of the limitations in the pool of measures, 
and we will continue to work with stakeholders to include more measures 
for specialties without adequate metrics.
    Comment: One commenter stated that it is difficult to evaluate the 
long-term negative impact the proposed rule may have because there was 
no information on how CMS intends to incorporate new measures into the 
quality category. Commenter encouraged information sharing on the 
intended process to evaluate newly proposed measures.
    Response: As part of the PQRS Call for Measures process, we have 
historically outlined the criteria that we will use to evaluate measure 
submissions. We anticipate continuing to do so for the annual MIPS Call 
for Measures process as well. To the extent measures that are submitted 
under the annual Call for Measures process meet these criteria, we 
would then propose to include them in the MIPS quality measure set 
through notice and comment rulemaking.
    Comment: A few commenters supported continued use of PQRS measures. 
In addition, one commenter acknowledged and expressed appreciation for 
CMS's addition of a comprehensive list of measures.
    Response: We thank the commenters for their support and believe 
that the continued use of PQRS measures will help ease the transition 
into MIPS for many MIPS eligible clinicians. Further, the statute 
provides that PQRS measures shall be included in the final measure list 
unless removed.
    Comment: Some commenters requested evidence based measures that are 
proven to improve quality of care, improve outcomes, and/or lower the 
cost of care. Further, they stressed that CMS must continue to improve 
measures for greater clinical relevance, clinical and patient centered 
measures, and avoid unintended consequences. A few commenters stated 
that the PQRS measures have no relevance or benefit to their practice. 
In addition, one commenter stated that the majority of PQRS measures do 
not show an evidence-based rationale or justify implementation.
    Response: We believe that the measures that we have adopted fulfill 
the goals the commenters suggest. We further believe that any metrics 
that capture activities beyond the clinician's control reflect systemic 
quality improvements to which MIPS eligible clinicians contribute. We 
note further that most measures that are being implemented have gone 
through consensus endorsement by a third-party reviewing organization 
(NQF) prior to their adoption. As part of this endorsement process, the 
measures are evaluated for validity, reliability, feasibility, 
unintentional consequences, and expected impact on clinician quality 
performance. Furthermore, MIPS eligible clinicians also have the option 
of working with QCDRs to submit measures that are not included in the 
MIPS measure set but that may be more appropriate for their practices.
    Comment: A few commenters expressed concern about the robustness of 
the proposed quality measures. The commenters thought that many of the 
measures lack demonstrated improvement in patient care, create 
administrative burden for the eligible clinician to track, and will not 
capture quality of care provided.
    Response: Most of the CMS measures are submitted by measure 
stewards and owners from the medical community. We continue to 
encourage stakeholders to submit measures for consideration during our 
annual call for measures. Further, we realize that measures are not the 
only indication of quality care. However, they are one objective way to 
assess quality of care patients receive. We believe this indicator will 
become more effective and reliable as the measure set is expanded and 
refined over the years.
    Comment: One commenter stated that none of the 465 options for 
reporting measures in the proposed rule are based on scientific method. 
They recommended that each of the 465 options should meet three 
criteria. First, it should be based on scientific method. Second, there 
should be a plan to review and act on the data that is reported to CMS 
on the measure. Third, the reporting of such quality measures should be 
an automated function of the electronic medical record system and not 
impair, slow down or distract physicians participating directly in 
patient care.
    Response: As stated previously, most of the proposed measures have 
been endorsed by the NQF. The endorsement process evaluates measures on 
scientific acceptability, among other criteria. Depending on the policy 
priority of the measure, CMS may include measures without NQF 
endorsement. All of our measures, regardless of endorsement status, are 
thoroughly reviewed, undergo rigorous analysis, presented for public 
comment, and have a strong scientific and clinical basis for inclusion.
    Comment: One commenter indicated that many proposed measures have 
not been tested, the proposed thresholds for reliability and validity 
are very low, and the proposed rule does not provide specific benchmark 
for measures. The commenter recommended extra time to test and 
implement measures across programs, with an emphasis on simplicity, 
transparency and appropriate risk-adjustment.
    Response: Most MIPS measures are NQF-endorsed, which means they 
have been evaluated for feasibility, reliability, and validity, or in 
the absence of NQF-endorsement, the measures are required to have an 
evidence-based focus. All of our measures, regardless of endorsement 
status, are thoroughly reviewed,

[[Page 77142]]

undergo rigorous analysis, presented for public comment, and have a 
strong scientific and clinical basis for inclusion. In addition, as 
discussed in section II.E.6. of this final rule with comment period, we 
intend to publish measure-specific benchmarks prior to the start of the 
performance period for all measures for which prior year data are 
available.
    Comment: One commenter recommended rigorous review and updating of 
quality measures, including addressing how measures are related to 
outcomes.
    Response: CMS does annual reviews of all measures to ensure they 
continue to be clinically relevant, appropriate, and evidence based. In 
the event that we determine that a measure no longer meets these 
criteria, then we may consider removing them from the MIPS quality 
measure set for future years through notice and comment rulemaking.
    Comment: One commenter asked CMS to offer time-limited adoption for 
any MIPS measures that are not fully tested and have not been through a 
rigorous vetting process, as this offers four benefits: MIPS eligible 
clinicians will have expedited access to a greater selection of 
measures; measure developers could have access to a larger data set for 
measure testing; we will gain earlier insight into appropriateness and 
relevance of such measures; and MIPS eligible clinicians will gain 
valuable experience with the measures before performance benchmarks are 
established.
    Response: We believe that we must ensure that all MIPS measures are 
clinically valid and tested prior to their use in a value-based 
purchasing program. All of our measures, are thoroughly reviewed, 
undergo rigorous analysis, presented for public comment, and have a 
strong scientific and clinical basis for inclusion including testing 
for validity, reliability, feasibility, unintentional consequences, and 
the expected impact on clinician quality performance.
    Comment: One commenter supported the Quality Payment Program 
rewarding MIPS eligible clinician performance as measured by quality 
metrics, but expressed concern that there are few outcomes measures, 
particularly regarding assessment of quality of care provided across 
settings and providers, linking clinical quality and efficiency to a 
team. The commenter recommended the Quality Payment Program develop and 
include quality measures that reflect performance of eligible 
clinicians as part of a team, perhaps through composite measure groups, 
which would take into account various components of quality that move 
toward the desired outcome. Alternatively, or in addition to such a 
measure, the commenter recommended that CMS work toward establishing 
clear associations between the clinician level measures in MIPS, 
facility level measures in the Hospital OQR and other provider level 
measures such as home health agency measures, so that all clinicians 
could see how one set of quality activities feeds into another, thus 
driving improvement across settings and providers for a given 
population.
    Response: We would encourage the commenter to submit measures for 
possible inclusion under MIPS through the Call for Measures process. 
Further, it may be advantageous for the commenter to report through a 
QCDR or report as a group. We are committed to developing outcome 
measures and intend to work with interested stakeholders through our 
Quality Measurement Development Plan which describes our approach.
    Comment: One commenter requested that the requirement for measures 
be reduced to encourage meaningful engagement and improvement in 
patient care. The current set of measures are not relevant to all 
clinicians, especially given the diversity of procedures, patient 
population and geographic location of clinicians. The commenter also 
believes that the quality measures do not align with the advancing care 
information, cost or improvement activities performance categories, and 
recommended alignment of quality and cost measures to provide 
information needed to increase value.
    Response: We have worked to adopt numerous measures that apply to 
as many clinicians as possible, and we have specified in other sections 
of this final rule with comment period how clinicians with few or no 
measures applicable to their practice will be scored under the program. 
We believe that the measures we are adopting will encourage meaningful 
engagement and quality improvement, and we do not agree that reducing 
the number of required measures will make those goals easier for 
physicians to pursue. However, following the principle that the MIPS 
performance categories should be aligned to enhance the program's 
ability to improve care and reduce participation burden, we will 
consider additional ways to align the quality and cost performance 
category measures in the future as well as ways to further quality 
improvement through the advancing care information and improvement 
activities performance categories.
    Comment: One commenter suggested limiting the available measures to 
three detailed measures per medical discipline. The commenter suggested 
that the criteria for choosing measures should be that they are related 
to a public health goal and will ensure that patients with a chronic or 
life-threatening condition are given a high level of care.
    Response: We believe that performance should be measured on 
measures that are most relevant and meaningful to clinicians. To that 
end, we need to balance parsimony with ensuring that there are relevant 
and meaningful measures available to the diverse array of MIPS eligible 
clinicians.
    Comment: One commenter expressed concern that there is a 30-month 
gap between the selection of quality measures and when they are used; 
commenter believes Core Quality Measure Collaborative (CQMC) core 
measure sets need immediate integration into the final rule with 
comment period.
    Response: Measures that are to be implemented in the program must 
undergo notice-and-comment rulemaking, as required by statute. Nearly 
all of the measures that are a part of the CQMC core measure sets are 
being finalized for implementation.
    Comment: Several commenters stated that all measures used must be 
clinically relevant, harmonized, and aligned among all public and 
private payers and minimally burdensome to report. The commenters 
stated the goal of such alignment would be to reduce measure 
duplication and improve harmonization and, ultimately, build a national 
quality strategy. Commenters recommended that CMS use measure sets 
developed by the multi-stakeholder Core Quality Measures Collaborative, 
as well as ensure that specialists are well represented in the effort 
to align quality measures.
    Response: Specialty societies are among the stakeholders that 
participate in the Core Measures Collaborative, and we will continue to 
work with specialists to align quality measures in the future. Further, 
nearly all of the measures that are a part of the CQMC core measure 
sets are being finalized for implementation.
    Comment: One commenter supported the consideration of Pioneer ACO 
required quality measures for use in MIPS. Another commenter requested 
we allow quality reporting measures to be differentiated between 
primary care and specialty physicians. For instance, we could use the 
same quality reporting

[[Page 77143]]

structure as the Pioneer ACO Model for MIPS, and allow flexibility in 
measures when considering reporting by an APM.
    Response: MIPS eligible clinicians have the opportunity to report 
by the CMS Web Interface if they are part of a group of at least 25 
MIPS eligible clinicians. Pioneer ACOs were also required to use the 
CMS Web Interface to submit their quality measures. In addition, many 
of the quality measures that are included in the CMS Web Interface are 
available for other data submission methods as well. Therefore, MIPS 
eligible clinicians could report these same measures through other data 
submission methods if they so choose or report measures from one of the 
specialty-specific measure sets. If a MIPS eligible clinician 
participates in an APM, then the APM Scoring Standard for MIPS Eligible 
Clinicians Participating in MIPS APMs applies. As discussed further in 
section II.E.5.h of this final rule with comment period, the APM 
Scoring Standard outlines how the MIPS quality performance category 
will be scored for MIPS eligible clinicians who are APM participants.
    Comment: A few commenters disagreed with being rated on things over 
which the commenters have no control (for example, A1c or Blood 
Pressure). Further, other commenters asked CMS to use quality metrics 
that captured activities under the physician's control and had been 
shown to improve quality of care, enhance access-to-care, and/or reduce 
the cost of care.
    Response: Clinicians have the option to report measures that are 
more relevant where they have control of the outcome and what is being 
reported. We further believe that clinicians have the opportunity to 
influence patients' actions and outcomes on their selected metrics, 
which reflect systemic quality improvements of which MIPS eligible 
clinicians are a part.
    Comment: One commenter requested patient acuity measures to modify 
the measures, which also alters clinician capability.
    Response: We believe that the commenter is referring to the need to 
risk adjust measures for patient acuity. We note that we allow for risk 
adjustment if the measures have risk adjusted variables and methodology 
included in their specifications.
    Comment: One commenter requested clear instructions from CMS as to 
how to choose quality measures since the concepts are extremely 
confusing. Another commenter sought clarification regarding the quality 
measures and submission of quality measures so that clinicians can 
submit the measures with highest performance. The commenter requested 
that CMS clearly define which measures are cross-cutting measures and 
which are outcomes measures.
    Response: We created the specialty sets to assist MIPS eligible 
clinicians with choosing quality measures that are most relevant to 
them. Other resources to help MIPS eligible clinicians choose their 
quality measures will also be available on the CMS Web site. In 
addition, we would encourage MIPS eligible clinicians to reach out to 
their specialty societies for further assistance. We would also like to 
note that the measure tables do indicate by use of a symbol which 
measures are outcomes. We are not finalizing the cross-cutting measure 
requirement.
    Comment: One commenter recommended adequately testing new eCQMs to 
confirm they are accurate, valid, efficiently gathered, reflects the 
care given, and successfully transports using the quality reporting 
document architecture format. Additionally, eCQMs should be endorsed by 
NQF and undergo an electronic specification testing process.
    Response: Thank you for your comments. We ensure that validity and 
feasibility testing are part of the eCQM development process prior to 
implementation. Although we strive to implement NQF-endorsed measures 
when available, we note that lack of NQF endorsement does not preclude 
us from implementing a measure that fulfills a gap in the measure set.
    Comment: A few commenters requested only non-substantive changes in 
eCQM measure sets and specifications, which do not require 
corresponding changes in clinician workflow, should be made through 
annual IPPS rulemaking while substantive changes (for example, a new 
CQM or a change in a current CQM that requires a workflow change) 
should be published in MIPS rulemaking and not go live until 18 months 
after publication.
    Response: We note that section 1848(q)(2)(D)(i)(II)(cc) of the Act 
requires the Secretary to update the final list of quality measures 
from the previous year (and publish such updated list in the Federal 
Register) annually by adding new quality measures and determining 
whether or not quality measures on the final list of quality measures 
that have gone through substantive changes should be included in the 
updated list. It is unclear why the commenters are suggesting that non-
substantive changes to MIPS eCQM measure sets and specifications should 
be made through the annual IPPS rulemaking vehicle since the IPPS 
proposed and final rules typically address policy changes for hospital 
clinicians. We would use rulemaking for the MIPS program in the future 
to address substantive changes to measures in the future.
    Comment: A few commenters supported the development of a robust de-
novo measure set of eCQMs for use by specialty MIPS eligible clinicians 
that are designed specifically to capture eCQM data as part of an EHR-
enabled care delivery for use in future iterations of the CMS Quality 
Payment Program. One commenter believed eCQMs should be developed for 
specialties to measure process improvement and improved outcomes where 
data is not available in a standardized format and no national standard 
has been codified.
    Response: We encourage stakeholders to submit new electronically-
specified specialty measures for consideration during the annual call 
for measures.
    Comment: Some commenters encouraged closer alignment between MACRA 
and EHR Incentive Program eCQM specifications and recommended using the 
same version specifications for the same performance year for MIPS and 
the EHR Incentive Program.
    Response: We appreciate the comments; however, we note that there 
is no overlap between the MIPS performance periods and the reporting 
period for the Medicare EHR Incentive Program for EPs. We note that a 
subset of the eCQMs previously finalized for use in the Medicare EHR 
Incentive Program for EPs are being finalized as quality measures for 
MIPS for the 2017 performance period.
    Comment: One commenter disagreed with the overall complexity of the 
quality performance category measures because the current available EHR 
software offerings do not easily automate the work of capturing 
measures.
    Response: We understand that not all quality measurement may yet be 
automated and share the concerns expressed. CMS and ONC also have 
received similar feedback in response to its CQM certification criteria 
within the ONC Health IT Certification Program.
    Based on this feedback, ONC has added a requirement to the 2015 
Edition ``CQM--record and export'' and ``CQM--import and calculate'' 
criteria that the export and import functions must be executable by a 
user at any time the user chooses and without subsequent developer 
assistance to operate. This is an example of one way ONC is 
incentivizing more automated quality measurement through regulatory 
requirements. In addition, CMS and

[[Page 77144]]

ONC will continue to work with health IT vendors and health IT product 
and service vendors, as well as the stakeholders involved in measure 
development to support the identification and capture of data elements, 
and to test and improve calculations and functionality to support 
clinicians and other health care providers engaged in quality reporting 
and quality improvement.
    Comment: One commenter wanted to know if CMS plans to continue 
adding and removing measures from the group of 64 e-measures, as these 
measures have not been modified for several years. They noted that 
adding new measures to this set will require much more than 2 months' 
notice in order for developers to implement them, especially given the 
90 percent data completeness criteria placed on EHRs.
    Response: We may propose to remove measures from the e-measures 
group if they meet our criteria for removal from the MIPS. We are 
lowering the data completeness criteria to 50 percent for the first 
MIPS performance period. As new eCQMs are developed and are ready for 
implementation, we will evaluate when they can be implemented into MIPS 
and will consider developer implementation timeframes as well.
    Comment: One commenter requested that CMS not significantly reduce 
the number of available eCQMs as many small practices adopted EHRs for 
their ability to capture and report quality data and lack sufficient 
resources to invest in another reporting tool.
    Response: We are revising the list of eCQMs for 2017 to reflect 
updated clinical standards and guidelines. A number of eCQMs have not 
been updated due to alignment with the EHR Incentive Program in the 
past. This has resulted in a number of measures no longer being 
clinically relevant. We believe the updated list, although smaller, is 
more reflective of current clinical guidelines.
    Comment: One commenter noted that CMS is proposing removal of 9 EHR 
measures, and that while removal may be warranted, in some cases the 
act of removal means that there are potential gaps for those who plan 
to report quality using eCQMs. The commenter therefore recommended CMS 
encourage measure developers to help fill these gaps.
    Response: We would encourage measure developers to continue to 
submit new electronically-specified measures for potential inclusion in 
MIPS through the Call for Measure process.
    Comment: One commenter wanted to know whether the number of 
measures will be expanded for electronic reporting or whether the 
additional measures are going to only be offered in Registry/QCDR 
reporting option.
    Response: In subsequent years, we expect more measures to be 
available by electronic reporting but that will depend partly on 
whether or not electronic measures are submitted via the annual Call 
for Measures process.
    Comment: One commenter supported the creation of a computer 
adaptive quality measure portfolio and believed measures should be an 
area of significant focus in the final rule with comment period, 
including portability.
    Response: We thank the commenter and agree that measures are an 
area of significant focus in this final rule with comment period. We 
look forward to learning more about private sector innovations in 
quality measurement in the future.
    Comment: A few commenters supported the option, but not the 
requirement, that physicians select facility-based measures that are 
aligned with physician's goals and have a direct bearing on the 
physicians' practice. A commenter noted the challenge of clinicians and 
groups which functions across multiple facilities and recommends 
hospital-level risk-adjusted outcome measurement attributable to the 
principal physician or group responsible for the primary diagnosis.
    Response: We thank the commenters for their support and the 
suggestion. We will consider proposing policies on this topic in the 
future.
    Comment: Some commenters supported the distinction between 
hospitalists and other hospital-based clinicians from community 
clinicians and recommended that CMS develop a methodology for the 
second year of MIPS that will give facility-based clinicians the choice 
to use their institution's performance rates as the MIPS quality score. 
Another commenter recommended evaluation of 20 existing measures that 
represent clinical areas of relevance to hospitalists and could be 
adapted for MIPS, and indicates that the commenter's organization is 
ready to work with CMS to develop facility-alignment options.
    Response: We will take this feedback into account in the future.
    Comment: One commenter stated that quality measures that apply to 
primary care physicians should not be the same measures applied to 
consulted physicians.
    Response: We would like to note that there is a wide variety of 
measures, and they do vary between those applicable to primary care 
physicians and to other physicians, and that all participants may 
select the measures that are most relevant to them to report.
    Comment: Several commenters requested that CMS accept Government 
Performance and Results Act (GPRA) measures that Tribes and Urban 
Indian health organizations are already required to report as quality 
measures to cut down on the reporting burden.
    Response: There are many GPRA measures that are similar to measures 
that already exist within the program. In addition, some GPRA measures 
are similar to measures that are part of a CQMC core measure set. We 
strive to lessen duplication of measures and to align with measures 
used by private payers to the extent practicable. If there are measures 
reportable within GPRA that are not duplicative of measures within 
MIPS, we recommend the commenters work with measure owners to submit 
these measures during our annual Call for Measures.
    Comment: One commenter recommended CMS provide options for 
specialties without a sufficient number of applicable measures such as: 
determining which quality measures are applicable to each MIPS eligible 
clinician and only holding them accountable for those measures; 
addressing measure validity concerns with non-MAP, non-NQF endorsed 
measures; establishing ``safe harbors'' for innovative approaches to 
quality measurement and improvement by allowing entities to register 
``test measures'' which clinicians would not be scored on but would 
count as a subset of the 6 quality measures with a participation 
credit; and allowing QCDRs flexibility to develop and maintain measures 
outside the CMS selection process.
    Response: We have intentionally not mandated that MIPS eligible 
clinicians report on a specific set of measures as clinicians have 
varying needs and specific areas of care. MIPS eligible clinicians 
should report the measures applicable to the service they provide. All 
measures, including those that are NQF endorsed, go through notice-and-
comment rulemaking. In regards to non-MAP and non-NQF endorsed 
measures, we would like to note that these measures were reviewed by 
the CQMC, an independent workgroup, which includes subject matter 
experts in the field. Further, we would like to note that over 90 
percent of the measures have gone through the MAP.
    Comment: Another commenter suggested that CMS require that 
outcomes-based measures constitute at least 50 percent of all quality 
measures and that CMS accelerate the development and adoption of such

[[Page 77145]]

clinical outcomes-based measures, including patient survival. Some 
commenters also suggested that CMS utilize measures that have already 
achieved the endorsement of multiple stakeholders and have been 
evaluated to ensure their rigor (for instance, through processes like 
the National Quality Forum (NQF) endorsement).
    Response: We encourage stakeholders to submit new specialty 
measures for consideration during the annual call for measures. We 
welcome specialty groups to submit measures for review to CMS that have 
received previous endorsement. Furthermore, we are committed to 
developing outcome measures and intend to work with interested 
stakeholders through our Quality Measurement Development Plan which 
describes our approach.
    Comment: One commenter stated that it is concerning that the 
proposed quality performance categories fail to explicitly mention 
health equity as a priority. A few commenters recommended stratified 
reporting on quality measures by race & ethnicity, especially quality 
measures related to known health disparities. One commenter 
specifically supported stratification by demographic data categories 
that are required for Office of National Coordinator (ONC) for Health 
Information Technology-certified electronic health records (EHRs). 
Stratification allows for the examination of any unintended 
consequences and impact of specific quality performance measures on 
safety net eligible clinicians and essential community clinicians for 
potential beneficiary/patient-based risk adjustment. Further, 
commenters stated that stand-alone health equity quality measures 
should be developed and incentivized with bonus points as high priority 
measures. Commenter recommended patient experience to be kept as a 
priority measure for a bonus point in the final rule with comment 
period.
    Response: We thank the commenter for this feedback on high-priority 
measures and bonus point awarded for them. It is our intent that 
measures actually examine quality for all patients, and some of our 
measures have been risk-adjusted and stratified. We look forward to 
continuing to work with stakeholders to identify appropriate measures 
of health equity.
    Comment: Several commenters supported adding the Medicaid Adult 
Core Set, which is particularly important for people dually enrolled in 
Medicare and Medicaid who have greater needs and higher costs.
    Response: We thank the commenters for their support, and would like 
to note that we are working to align the Medicaid core set with MIPS in 
future years.
    Comment: One commenter requested that CMS engage state Medicaid 
leaders to maximize measure alignment across Medicare and Medicaid, and 
articulate the functional intersection of various measure sets and 
measure set development work (Sec. Sec.  414.1330(a)(1) and 
414.1420(c)(2) and the Appendix in this final rule with comment 
period). The commenter specifically encouraged alignment efforts to 
focus on measures where there is a clear nexus between Medicare and 
Medicaid populations (Sec. Sec.  414.1330(a)(1) and 414.1420(c)(2) and 
Appendix in this final rule with comment period). With respect to 
specific measures, the commenter had a particular interest in MIPS 
measures that relate to the avoidance of long-term skilled care in the 
elderly and disabled. The commenter believed that this is an area of 
nexus between the two programs, as the majority of newly eligible 
elderly in nursing facilities were unknown to the Medicaid program in 
the timeframe immediately leading up to the long-term care stay. The 
commenter believed this is a high priority for state Medicaid leaders 
and federal partners to engage around quality measure alignment.
    Response: We intend to align quality measures among all CMS quality 
programs where possible, including Medicaid, and will take this comment 
into account in the future.
    Comment: One commenter suggested that CMS engage states to maximize 
measure alignment across Medicare and existing State common measure 
sets.
    Response: We work with regional health collaboratives and other 
stakeholders where possible, and we will consider how best to align 
with other measure sets in the future.
    Comment: A few commenters proposed that CMS align a set of quality 
measures to Medicare Advantage measures to be able to compare 
performance between APMs, FFS, and MAOs. Other commenters supported 
ensuring that quality measures are aligned across reporting programs, 
and build from the HVBP measures set when incorporating home health 
into quality reporting programs.
    Response: We will take these suggestions into account for future 
consideration.
    Comment: One commenter encouraged CMS to adopt measures in the 
quality performance category that align with existing initiatives 
focused on delivering care in a patient-centric manner. In particular, 
the commenter suggested that CMS make sure the quality measures align 
with the clinical quality improvement measures used in the Transforming 
Clinical Practice Initiative by the Practice Transformation Networks.
    Response: We purposely aligned the measures in the Transforming 
Clinical Practice Initiative with those used in CMS' quality reporting 
programs and value-based purchasing programs for clinicians and 
practices. We will continue to work on alignment across such programs 
as they evolve in the future.
    Comment: One commenter noted that CMS might also look to align with 
other measure sets that may be outside the health care sector such as 
with other local health assessment and community or state health 
improvement activities.
    Response: We work with regional health collaboratives and other 
stakeholders where possible, and we will consider how best to align 
with other measure sets in the future.
    Comment: One commenter believed that the Quality performance 
category should include a reasonable number of measures that truly 
capture variance in patient populations and that CMS should continue to 
review these measures on an annual basis to ensure that they are 
clinically relevant and address the needs of the general patient 
population.
    Response: It is within our process that we review the measures that 
we are adopting for clinical relevance on an annual basis, and we 
appreciate commenters' focus on ensuring that measures remain 
clinically relevant.
    Comment: One commenter did not believe current quality metrics 
reflect metrics that are meaningful to physicians or patients.
    Response: We respectfully disagree. Most of the current quality 
measures have been developed by clinician organizations that support 
the use of thoughtfully constructed quality metrics. We continue to 
welcome recommendations or submissions of new measures for 
consideration.
    Comment: One commenter noted that in order for small, private 
independent practices to demonstrate improved outcomes, the metrics 
system must be designed to account for their successes.
    Response: We are committed to developing outcome measures and 
intend to work with interested stakeholders following the approach 
outlined in our Quality Measurement Development Plan. While many 
existing outcome measures are focused on institution level improvement 
(such a tracking hospital readmissions), we believe there is an 
opportunity to develop clinician practice outcome

[[Page 77146]]

measures that are designed to reflect the quality of large group, small 
group, and individual practice types. We welcome submissions of new 
outcome measures for consideration.
    Comment: A few commenters suggested that CMS collect SES data for 
race, ethnicity, preferred language, sexual orientation, gender 
identity, disability status and social, psychological and behavioral 
health status, to stratify quality measures and aid in eliminating 
disparities. One commenter noted that use of 2014 and 2015 edition 
CEHRT would reduce burden on clinicians to collect this data.
    Response: The CMS Office of Minority Health (OMH) works to 
eliminate health disparities and improve the health of all minority 
populations, including racial and ethnic minorities, people with 
disabilities, members of the lesbian, gay, bisexual, and transgender 
(LGBT) community, and rural populations. In September 2015, CMS OMH 
released the Equity Plan for Improving Quality in Medicare (CMS Equity 
Plan), which provides an action-oriented, results-driven approach for 
advancing health equity by improving the quality of care provided to 
minority and other underserved Medicare beneficiaries.
    The CMS Equity Plan is based on a core set of quality improvement 
priorities that target the individual, interpersonal, organizational, 
community, and policy levels of the United States health system in 
order to achieve equity in Medicare quality. It includes six priorities 
that were developed with significant input and feedback from national 
and regional stakeholders and reflect our guiding framework of 
understanding and awareness, solutions, and actions. They provide an 
integrated approach to build health equity into existing and new 
efforts by CMS and stakeholders.
    Priority 1 of the CMS Equity Plan focuses on expanding the 
collection, reporting, and analysis of standardized demographic and 
language data across health care systems. Though research has 
identified evidence-based guidelines and practices for improving the 
collection of data on race, ethnicity, language, and disability status 
in health care settings, these guidelines are often not readily 
available to health care providers and staff. Preliminary research has 
been conducted to determine best practices for collecting sexual 
orientation and gender identity information in some populations, but 
currently there are no evidence-based guidelines to standardize this 
collection.
    We will facilitate quality improvement efforts by disseminating 
best practices for the collection, reporting, and analysis of 
standardized data on race, ethnicity, language, sexual orientation, 
gender identity, and disability status so that stakeholders are able to 
identify and address the specific needs of their target audience(s) and 
monitor health disparities.
    Comment: One commenter stated that quality measures vary between 
populations depending on practice location due to different outcomes. 
Different outcomes are due to nutrition, reliable transportation, drug 
addiction, safe living space, and more. Comparison between practices is 
difficult.
    Response: We understand the commenter's concern that any single 
measure cannot capture the unique circumstances of a clinician's 
community including some of the sociodemographic factors mentioned. Our 
aim, however, is to drive quality improvement in all communities and we 
believe thoughtfully constructed measures can help all clinician 
practice types improve. Further, we will continue to investigate 
methods to ensure all clinicians are treated as fairly as possible 
within the program and monitor for potential unintended consequences 
such as penalties for factors outside the control of clinicians.
    Comment: A few commenters suggested that CMS commit to measures for 
a set amount of time (for instance, 2-3 years) before making 
substantial changes. One commenter suggested that CMS adopt a broader 
policy of maintaining measures in MIPS for a minimum number of years 
(for example, at least 5 years) to limit scenarios where CMS does not 
have historical data on the same exact measure to set a benchmark or 
otherwise evaluate performance.
    Response: We understand the commenter's concern. However, we do not 
believe it appropriate to commit to maintaining the same measures in 
MIPS for a substantial period of time, because we are concerned about 
the possibility that the measures themselves or the underlying medical 
science may change. We believe MIPS must remain agile enough to ensure 
that the measures selected for the program reflect the best available 
science, and that may require dropping or changing measures so that 
they reflect the latest best practices. For example, when a gap in 
clinical care no longer exists, reporting the measure offers no benefit 
to the patient or clinician.
    Comment: One commenter encouraged CMS to indicate which measures 
would be on the quality measure list for more than 1 year to allow 
concentration of improvement efforts over a two to three-year period. 
The commenter indicated that uncertainty on which measures may be 
included on the list each year could negatively impact improvement 
programs in rural areas that have fewer patients and would require a 
longer time to determine if interventions are successful. Another 
commenter requested that CMS limit additions and modifications to 
quality measures, especially as MIPS eligible clinicians become 
accustomed to reporting, to allow eligible clinicians sufficient time 
to meet quality metrics.
    Response: We would like to note that CMS conducts annual reviews of 
all measures to ensure they are relevant, appropriate, and evidence 
based. Therefore there is potential for updates to the annual list of 
measures to be adopted on a yearly basis. We will make every effort to 
ensure that the measures we adopt for the MIPS program reflect the 
latest medical science, and we will also work to ensure that all 
physicians and MIPS eligible clinicians are fully aware of the measures 
that we have adopted.
    Comment: A few other commenters recommended testing and comment 
periods before new measures are added to assess for potential 
unintended effects associated with healthcare disparities, including a 
one-year transparency (report only) period before measures are phased 
into incentives, a requirement for NQF endorsement.
    Response: All of the measures selected for MIPS include routine 
maintenance and evaluation to assess performance and identify any 
unintended consequences. We have extensive measurement experience (such 
as in the PQRS) and do not believe we need to delay measure 
implementation to assess for unintended consequences. We further note 
that the NQF endorsement process is separate and apart from the MIPS 
measure selection process. We refer the commenter to NQF for their 
recommendations on enhancements to the endorsement process.
    Comment: One commenter was concerned about annual changes in the 
performance measurement category and ability to respond to the changes 
in an appropriate timeframe. Commenter proposed that a minimum of 9 
months, and ideally 12 months, be given to review changes to the 
performance categories each year.
    Response: We understand commenter's concern, but we do not believe 
this timeline to be operationally feasible given the Program's 
statutory deadlines. We note that stakeholders have the ability to 
begin reviewing

[[Page 77147]]

potential changes to the quality performance category and provide 
comment on the potential changes with the publication of the proposed 
rule each year.
    Comment: One commenter discussed how quality measures encourage 
shared decision making and patient centered care. They requested that 
CMS require both over treatment and under treatment of patient as 
specific quality measures in specific instances such as blood sugar and 
blood pressure.
    Response: We are looking at measures for appropriate use and are 
working with numerous stakeholders to identify more appropriate use 
measures.
    Comment: One commenter encouraged CMS to align quality measures of 
MIPS to Uniform Data System so FQHCs will be able to submit one set of 
quality data one time to both Uniform Data System and CMS.
    Response: We thank the commenter for this suggestion.
    Comment: One commenter was concerned that clinicians could select 
``low-bar'' quality measures, or measures that are not the best 
representation of clinicians' patient populations or the diseases they 
treat. Commenter requested that CMS monitor the selection of quality 
measures by clinicians.
    Response: We believe that MIPS eligible clinicians should have the 
ability to select measures that they believe are most relevant to their 
practice. Further, we would like to note that we conduct annual reviews 
of all measures to ensure they are relevant, appropriate, and evidence 
based.
    After consideration of the comments, correcting, and revising 
specific information, we are finalizing at Sec.  414.1330(a)(1) that 
for purposes of assessing performance of MIPS eligible clinicians on 
the quality performance category, CMS will use quality measures 
included in the MIPS final list of quality measures. Specifically, we 
are finalizing the Final Individual Quality Measures Available for MIPS 
Reporting in 2017 in Table A of the Appendix in this final rule with 
comment period. Included in Table B of the Appendix in this final rule 
with comment period is a final list of quality measures that do not 
require data submission. Newly proposed measures that we are finalizing 
are listed in Table D of the Appendix in this final rule with comment 
period. The final specialty-specific measure sets are listed in Table E 
of the Appendix in this final rule with comment period. Measures that 
we are finalizing for removal can be found in Table F of the Appendix 
and measures that will have substantive changes for the 2017 
performance period can be found in Table G of the Appendix in this 
final rule with comment period.
(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 proposed 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 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 proposed 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 utilization of 
healthcare resources.
     Measures that address a performance gap or measurement 
gap.
    We requested comment on these proposals.
    The following is summary of the comments we received regarding our 
proposal for the Call for Quality Measures.
    Comment: A few commenters supported the Call for Quality Measures 
approach to encouraging the development of quality measures and the 
list of considerations when submitting quality measures to MIPS. One 
commenter believed the criteria should also include: measures which 
span across the various phases of surgical care that align with the 
patient's clinical flow: measures based on validated clinical data; 
measures that can be risk-adjusted and include SDS factors, if 
applicable; and process measures used in conjunction with outcome 
measure to provide a more comprehensive picture of clinical workflow 
and help link to improvement activities.
    Response: We thank the commenter for their support and will 
consider including these additional factors for evaluating quality 
measures for potential inclusion in MIPS in the future. Further, we 
will consider additional measures covering the five phases of surgical 
care that the commenter specifies in the future. We have a rolling 
period for new measure suggestions, and we welcome commenters' 
nominations.
    Comment: One commenter recommended that the proposed rule quality 
measures emphasize patient experience, outcomes, shared decision 
making, care coordination, and other measures important to patients. 
One commenter believed the selection and development of measures should 
include patients, stakeholders, consumers and advocates. The commenter 
believes measures should be used to give feedback to clinicians and 
recommended the CAHPS for MIPS survey and clinical data registries be 
used to collect patient-reported data, and that individual clinician 
level data be collected on performance.
    Response: We agree that the selection and development of measures 
should include patients, consumers, and advocates. We have included 
patients, consumers, and advocates on the selection and development of 
measures to promote an objective and balanced approach to this process.
    Comment: One commenter recommended that CMS focus on

[[Page 77148]]

developing measures assessing physicians' communication with patients, 
care coordination, and efforts to fill practice gaps, because commenter 
believed these skills are more indicative of the care physicians 
provide than outcome measures.
    Response: We thank the commenter for this feedback. We have a 
process in place for nominating measures for inclusion in the MIPS 
program, including an annual call for measures and the Measures Under 
Consideration (MUC) list, and we welcome stakeholders' feedback into 
that process.
    Comment: One commenter supported the inclusion of robust quality 
measures. The commenter encouraged CMS to focus on including quality 
measures under MIPS that target shared decision making and health 
outcomes, including survival and quality of life. Commenter supported 
outcome measures, but noted in certain circumstances, where there is a 
well-defined link to outcomes, that process measure or intermediary 
outcome measures may be most appropriate.
    Response: Thank you for your comment. We agree that measures that 
target shared decision making and health outcomes should be included in 
MIPS.
    Comment: One commenter stated that CMS should promote the adoption 
of new quality measures that fill in measure gaps, accentuate the 
benefits of innovation, and keep pace with evolving standards of 
clinical care.
    Response: Thank you for your comment. We agree we plan to work with 
stakeholders on new measure development.
    Comment: Some commenters suggested that CMS carefully consider the 
selection of quality measures to ensure that they meaningfully assess 
quality of care for patients with diverse needs, particularly those 
patients with one or more chronic conditions.
    Response: CMS is aware of the need for measures that address 
diverse needs and encourages the development of these types of 
measures.
    Comment: One commenter believed that more patient safety measures 
should be included. The commenter recommended that a culture of patient 
safety be encouraged across healthcare organizations; that indicators 
of physical and emotional harms be used to measure workforce safety; 
that patient engagement be included as a measure of safety, beyond 
patient satisfaction; and that measures to track and monitor 
transparency, communication and resolution programs be added to the 
MIPS portion of the proposed rule.
    Response: We thank the commenter and agree that patient safety 
should be encouraged across healthcare organizations. We note that we 
consider patient safety measures to be high-priority measures.
    Comment: One commenter recommended quality measures be redefined. 
The commenter believed many are reporting burdens and are pedestrian 
from a quality standpoint and have little to do with physician work.
    Response: Our quality measures define a reference point for care 
that is expected in the delivery of care. CQMs are tools that help 
measure and track the quality of health care services provided by MIPS 
eligible clinicians within our health care system. Measuring and 
reporting these measures helps to ensure that our health care system is 
delivering effective, safe, efficient, patient-centered, equitable, and 
timely care. MIPS eligible clinicians are accountable for the care they 
provide to our beneficiaries.
    Comment: One commenter requested that when a MAV process is 
invoked, the number of measures which could have been reported is 
greater than the number of additional measures needed to satisfy the 
reporting requirement.
    Response: We did not propose a MAV process for the MIPS Program, 
but we did propose, and will be finalizing, a data validation process. 
This process will apply for claims and registry submissions to validate 
whether MIPS eligible clinicians have submitted all applicable measures 
when MIPS eligible clinicians submit fewer than six measures or do not 
submit the required outcome measure or other high priority measure if 
an outcome measure is not available, or submit less than the full set 
of measures in the MIPS eligible clinicians' applicable specialty set.
    Comment: One commenter suggested that CMS employ a more transparent 
approach to measure selection for the MIPS program, including a 
detailed rationale on why certain measures are not selected, providing 
feedback to MIPS eligible clinicians and provider organizations which 
have committed resources to improving measures.
    Response: While we understand commenter's concern, we believe we 
have been substantially transparent with the considerations we have 
taken into account when developing the proposed measure list for MIPS 
and have provided detailed rationale explaining the choices we have 
made. In the appendix of this final rule with comment period, we have 
provided a list of measures proposed for removal along with the 
rationale. We would also like to note that measures that appear on the 
MUC list are reviewed by the MAP and undergo detailed analyses, and we 
refer stakeholders to the MAP's report for feedback on those measures. 
We will continue working with stakeholders and measure developers to 
improve their measures.
    Comment: In an effort to increase transparency in the process, the 
commenter suggested that prior to the publication of the 
recommendations, CMS contact the measure developer to make sure CMS's 
conclusions are accurate and to ensure the developer does not have data 
to suggest otherwise.
    Response: We review measures annually with measure owners and 
stewards. Further, we provide feedback to measure developers on measure 
being submitted through the Call for Measures process. Stakeholders 
also have the opportunity to comment on new measures that are proposed 
in the annual notice and comment process.
    Comment: A few commenters suggested that CMS develop a plan to 
transition from the use of process measures to outcomes measures to 
allow MIPS eligible clinicians to adopt the most updated evidence-based 
standards care and to ensure that MIPS eligible clinicians are truly 
achieving the goals of value-based health care. One commenter 
acknowledged that there is a large body of evidence showing that 
process measures do not improve outcomes.
    Response: We aim to have the most current measure specifications 
updated annually. We also agree that outcome measures are more 
appropriate for assessing health outcomes and for accountability. We 
describe our measure development process in detail in our Quality 
Measure Development Plan (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). We look forward to working with 
stakeholders to develop a wide range of outcome measures.
    Comment: One commenter expressed concern that CMS' proposal is too 
focused on outcome measures while commenter believes the agency should 
also focus on establishing meaningful process measures tied to 
evidence-based outcomes. Another commenter noted that both outcome 
measures and high quality, evidence-based process measures that address 
gaps and variations in care have a role in improving care, and 
cautioned CMS against too much emphasis on outcomes without regard to 
evidence-based processes that underlie care.

[[Page 77149]]

    Response: Although process measures will continue to play an 
important role in quality measurement, we believe that they should be 
tied to evidence based outcomes. As noted, we have a measure 
development strategy that seeks to develop a wide range of outcome 
measures but our plan will also provide for the development of both 
process and structural measures that may be need to fill existing gaps 
in measurement. We encourage the submission of measures that address 
gaps in measurement, have significant variations in care, and also 
outcome measures, including patient reported outcome measures.
    Comment: Several commenters agreed that focusing more on the 
outcome of a clinical intervention than the process of care is better 
for patients and requested we adopted more outcome measures. Further, 
outcome measures would yield the most meaningful data for consumers and 
are true indicators of healthcare services.
    Response: We agree that outcome measures are important and will 
continue to emphasize the importance of outcomes measures in the 
future. We also agree that outcome measures are more appropriate for 
assessing health outcomes and for accountability. We describe our 
measure development process in detail in our Quality Measure 
Development Plan (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). We look forward to working with stakeholders to 
develop a wide range of outcome measures.
    Comment: One commenter requested the outcome measures represent 
clear care goals rather than intermediate process measures, thereby 
allowing clinicians' freedom to determine the best allocation of 
resources to improve clinical outcomes.
    Response: We have made available numerous measures to include those 
with intermediate outcomes. Although there are far fewer measures that 
have intermediate outcomes we also agree that we should consider both 
intermediate and long-term outcome measures for assessing overall 
health outcomes and for accountability. We describe our measure 
development process in detail in our Quality Measure Development Plan 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). We 
look forward to working with stakeholders to develop a wide range of 
outcome measures, including intermediate outcome measures.
    Comment: Another commenter noted that, within the set of quality 
measures that can be self-selected, 58 of the measures focus on 
outcomes and 192 focus on process, and that only 9 focus on efficiency. 
The commenter encouraged CMS to conduct additional research around 
efficiency measures that could be added to the overall menu of measures 
and, where available and clinically relevant to practice areas, MIPS 
eligible clinicians should be required to report on an efficiency 
measure. Some commenters believed that the relative imbalance of 
process measures over outcome measures can undermine CMS's efforts to 
encourage eligible clinicians to demonstrate actual improvements in a 
patient's health status.
    Response: We agree that there is a need for more outcome and 
efficiency measures and will strive to achieve a more balanced 
portfolio of measures in future years. As previously noted, we have a 
measure development strategy that seeks to develop a wide range of 
outcome measures but our plan will also provide for the development of 
both process and structural measures that may still be need to fill 
existing gaps in measurement. CMS encourages the submission of measures 
that address gaps in measurement and have significant variations in 
care. Outcome measures are a recognized gap in measurement, including 
patient reported outcome measures, and we look forward to working with 
stakeholders to develop a wide range of such measures.
    Comment: One commenter recommended that as CMS selects measures, it 
should include measures that capture variance across patient 
populations; should consider adopting more outcome measures; and should 
add measures related to coordination of care/exchange of information 
between specialists and PCPs in all specialty categories.
    Response: We agree with the commenter on the importance of these 
measures and have proposed these types of measures for the program. We 
would encourage the commenter to submit additional measures for 
possible inclusion in MIPS through the Call for Measure process. We are 
particularly interested in developing outcome measures for chronic 
conditions (such as diabetes care and hypertension management) which 
present a measurement challenge to capture the many factors that impact 
the care and outcomes of patients with chronic conditions.
    Comment: A few commenters agreed that outcome measures are very 
important, but cautioned CMS against simply increasing the number of 
such measures each year. Commenters also opposed the proposal to 
increase the required number of patient experience measures in future 
years because the physician lacks control over such measures. One 
commenter supported the inclusion of risk adjustment and stratification 
in measures and suggested that CMS examine ASPE's future 
recommendations.
    Response: We are aware of the need for measures that are adjusted 
for case-mix variation through risk adjustment and stratification 
techniques. As noted in this final rule with comment period, 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. 
Under the IMPACT Act, ASPE has been conducting studies on the issue of 
risk adjustment for sociodemographic factors on quality measures and 
cost, as well as other strategies for including SDS evaluation in CMS 
programs. We will review the report when issued by ASPE and will 
incorporate findings as appropriate and feasible through future 
rulemaking. With respect to patient experience measures, we believe 
that measures that assess issues that are important to patients are an 
integral feature of patient-centered care.
    Comment: One commenter requested that CMS continue to use both 
process and outcome measures moving forward as a ramp-up tactic for 
MIPS eligible clinicians new to reporting on quality measures. 
Additionally, some commenters expressed particular support for measures 
which track appropriate use. The commenters strongly believe that 
especially in advanced illness, individuals should only receive 
treatment that is aligned with their values and wishes but that many 
times, because of a lack of advance care planning, there is overuse and 
overtreatment at this time. Other commenters encouraged CMS to focus 
efforts on the development of underuse measures that can serve as a 
consumer protection for ensuring that eligible clinicians are not 
limiting access to needed care in order to reduce costs.
    Response: We agree with the importance of developing more measures 
of appropriate use and seek to have more of these measure types for a 
wider range of specialties, including geriatrics and palliative care.
    Comment: A few commenters suggested that CMS should focus on 
identifying and emphasizing measures that drive more robust outcomes. 
The

[[Page 77150]]

commenters stated there are too many measures from which to choose.
    Response: We appreciate the commenter's focus on the importance of 
patient outcome measurement. However, we believe there remains a role 
for process measures that are linked to specific health outcomes. We 
would encourage the commenter to submit potential new measures for 
inclusion in MIPS through the Call for Measures process.
    Comment: A few commenters suggested that CMS use the 
recommendations of the National Academy of Medicine's (NAM) 2015 Vital 
Signs report to identify the highest priority measures for development 
and implementation in the MIPS.
    Response: We have reviewed the recommendations of the National 
Academy of Medicine report and it informed our Quality Measure 
Development Plan (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf) which emphasizes the need for outcome measures over 
process measures. We will continue to use the report as a resource to 
inform future measurement policy development.
    Comment: Several commenters supported the development and 
strengthening of patient reported outcomes, PRO-based measures, and 
patient experience quality measures as a component of the MACRA 
proposed payment models. Further, commenters stated that patient-
generated data assesses issues that are important to patients and are a 
key element of patient-centered care, enabling shared decision-making 
and care planning, and ensuring that patients are receiving high-
quality health care services.
    Response: We agree that PROs are important. Currently we have a 
number of PRO measures and intend to expand their portfolio. We also 
believe the other measure domains are important in measuring other 
aspects of care.
    Comment: One commenter recommended that patient reported outcomes 
should have been given great weight, as well as continued solicitation 
of multi-stakeholder input on the available required measures through 
the NQF-convened MAP and updated patient sampling requirement over 
time. The commenter also recommended that all clinicians in groups of 
two or more should report a standard patient experience measure.
    Response: We agree that patient-reported outcomes are important 
quality measures. We note also that patient experience measures, while 
not required, are considered high-priority and are incentivized through 
the use of bonus points. However, patient-reported measurement 
generally requires a cost to clinician practices to conduct the survey 
and mandatory reporting of such measure may present a burden to many 
clinicians, especially those in small and solo practices. In future 
years, we will continue to seek methods of expanding reporting of these 
measures without unduly penalizing practices that cannot afford the 
measurement costs.
    Comment: One commenter believed that it is necessary to 
specifically call out and prioritize patient-reported outcomes (PROs) 
and PRO-based measures (PROMs).
    Response: We agree. We highlighted person and caregiver-centered 
experience and outcome measures in the proposed rule (81 FR 28194) and 
continue to believe that they appropriately emphasize the importance of 
collecting patient-reported data.
    Comment: One commenter recommended that CMS should encourage EHR 
developers to incorporate PROMs, as well as development and use of 
PROMs.
    Response: We agree that the inclusion of PROMs in health IT systems 
can help support quality improvement efforts at the provider level. As 
PROMs begin to be electronically specified and approved for IT 
development, testing and clinician use, we will work with ONC, health 
IT vendors, and stakeholders engaged in measure development to support 
the process of beginning to offer and support PROMs within certified 
health IT systems.
    Comment: One commenter recommended expediting the adoption of 
patient-reported outcome measures (PROMs) for all public reporting 
programs as well as condition-specific outcome sets that focus on the 
longitudinal outcomes and quality-of-life measures that are most 
important to patients.
    Response: We agree with the commenter that PROMs are an important 
aspect of assessing care quality, and we intend to continue working 
with stakeholders to encourage their use. We refer readers to section 
II.E.10. of this final rule with comment period for final policies 
regarding public reporting on Physician Compare.
    Comment: One commenter stated the quality metrics have nothing to 
do with patient outcomes and measure process instead of results. The 
commenter requested the metrics be shifted to clinical outcome 
measures, including patient reported outcomes.
    Response: We believe patient-reported outcomes are important as 
well, but we respectfully disagree with commenter's characterization of 
our measures.
    Comment: One commenter recommended that CMS consider measures that 
are validated and scientifically sound and to ensure measures address 
existing clinical relevance, given that the existing vehicles for 
measure inclusion has expanded to include qualified clinical data 
registries and specialty measure sets. The commenter also recommended 
that CMS consider working towards a set of core measures (similar to 
what was implemented through the Core Quality Measures Collaborative) 
that are most impactful to patient care. Further, they recommended that 
CMS consider the adoption of more outcome measures, specifically those 
using patient-reported outcomes.
    Response: We thank the commenter for this feedback and agree. Our 
intent is to include more outcomes measures in the MIPS Program as more 
become available over time, and we are working with measure 
collaboratives to include more measures and align them with other 
health care payers. We believe the specialty measure sets ensure that 
we have adopted measures of clinical relevance for specialists. We did 
propose adoption of the majority of measures that were part of the CQMC 
core measure sets into the MIPS program.
    Comment: One commenter recommended that CMS consider paring down 
from the list of over 250 quality measures from which a clinician may 
self-select for quality reporting, and instead focus on the creation of 
a smaller number of clinically relevant measures, particularly 
including additional patient outcome measures where available, and 
where there are separate and distinct outcomes measures. Additionally, 
as CMS embarks on future iterative changes to the Quality Payment 
Program, the commenter encouraged CMS to continue to rely on multi-
stakeholder and consensus driven feedback loops, such as Core Quality 
Measures Collaborative, to inform additional core measure sets, where 
such measure sets are useful and promote the appropriate comparisons.
    Response: We appreciate the commenters concerns and note that we 
intend to continue our work with the Core Quality Measures 
Collaborative. We did propose adoption of the majority of measures that 
were part of the CQMC core measure sets into the MIPS program. Further, 
to help clinicians successfully report, it is important that we provide 
as wide a range of measure options as possible that are germane to

[[Page 77151]]

the clinical practice of as many MIPS eligible clinicians as possible.
    Comment: One commenter expressed concern related to the self-
selection of quality measures. The commenter noted that they 
participated in the Core Quality Measures Collaborative (the 
``Collaborative'') to assist in the development of evidence-based 
measures and to help drive the health care system toward improved 
quality, decision making, and value-based payment and purchasing. The 
Collaborative recommended 58 MIPS quality measures. The commenter 
suggested that CMS consider making it mandatory for clinicians to 
report on those 58 measures when the measures are available within 
appropriate categories and when the measures are clinically relevant.
    Response: We have taken an approach to allow MIPS eligible 
clinicians select their own measures for reporting based on 
beneficiaries seen in their practices and the measures that are most 
relevant to their clinical practice. However, we have included the CQMC 
measures in the MIPS measure sets, including the specialty-specific 
measure sets, to encourage their adoption into clinical practice.
    Comment: A few commenters stated that CMS should ensure that 
ongoing quality measurement in the quality performance category 
encourages the appropriate use of imaging services that makes certain 
that Medicare patients receive accurate and timely diagnoses.
    Response: We are adopting a number of appropriate use measures that 
track both over- and under-use of medical services. We encourage 
stakeholders to submit additional measures on this topic, and will take 
those submissions into account in the future.
    Comment: One commenter expressed concern with the measures 
available to clinicians because many of the Core Quality Measures 
Collaborative measure sets were not included in the MIPS list and many 
of the MIPS measures are not NQF endorsed. Some commenters recommended 
that measures be approved by NQF before use in the program.
    Response: We believe including 17 Core Quality Measures 
Collaborative measures for the transition year is an excellent starting 
point to promote measurement alignment with private sector quality 
measurement leaders. While we encourage NQF-endorsement for measures, 
we do not require that all measures be endorsed by the NQF before use 
in the program, as requiring NQF endorsement would limit measures that 
currently fill performance gaps. We continue to encourage measure 
developers to submit their measures to NQF for endorsement.
    Comment: A few commenters supported CMS encouragement in the 
proposed rule of eliminating special restrictions as to the type and 
make-up of the organization developing quality measures. Commenters 
further supported the ability to submit measures regardless of whether 
such measures were previously published in a proposed rule or endorsed 
by NQF.
    Response: We would like to note that while we prefer NQF-
endorsement of measures for MIPS, we do not require that new measures 
for inclusion in MIPS be NQF-endorsed; however, in order for a measure 
to be finalized for MIPS it must be published in the Federal Register.
    Comment: A few commenters supported the proposed ``Call for Quality 
Measures.'' Further, one commenter suggested that CMS use this process 
to focus on specialty measures.
    Response: We note that although we also conducted an annual Call 
for Measures under PQRS, section 1848(2)(D)(ii) of the Act requires us 
to conduct a Call for Quality Measure for MIPS annually.
    Comment: One commenter supported allowing new quality measures to 
be submitted by specialty societies with supporting data from QCDRs.
    Response: We encourage specialty societies to continue to submit 
new measures for potential inclusion in the MIPS program.
    Comment: One commenter supported adoption of evidence-based 
measures through the ``Call for Quality Measures'' process. The 
commenter further suggested that CMS establish an interim process for 
adoption of subspecialty quality measure sets until quality measures 
can go through the ``Call for Quality Measures'' process so that CMS 
may be able to quickly assess the commenter's members on clinically 
meaningful measures.
    Response: We thank the commenter for the recommendation; however, 
we believe that the current process allows for careful review and 
scrutiny of the measures. We note that the Call for Quality Measures is 
open year-round, and that measures for inclusion in MIPS must go 
through notice-and-comment rulemaking.
    Comment: One commenter sought clarification regarding whether new-
process based measures will continue to be accepted.
    Response: While we will consider new process based measures, we 
would request that they be closely tied to an outcome and that there be 
demonstrable variation in performance.
    Comment: One commenter supported the flexibility CMS provided in 
the proposed rule for health care providers to select measures that 
make sense within their practice, as well as opening up the process for 
the annual submission of new measures, which will allow MIPS to evolve 
with the nation's dynamic health care system.
    Response: Thank you for the support.
    After consideration of the comments we are finalizing our proposal 
to continue the annual ``Call for Quality Measures'' under MIPS. 
Specifically, eligible clinician organizations and other relevant 
stakeholders may submit 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. 
We do encourage measure developers and stakeholders to submit measures 
for NQF-endorsement as this provides a scientifically rigorous review 
of measures by a multi-stakeholder group of experts. Furthermore, we 
are finalizing that stakeholders shall 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 utilization of 
healthcare resources.
     Measures that address a performance gap.
(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.

[[Page 77152]]

    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, utilization of 
healthcare resources 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 
proposed that we may consider the MAP's recommendations as part of the 
comprehensive assessment of each measure considered for inclusion under 
MIPS. Elements we proposed to consider in addition to those listed in 
the ``Call for Quality Measures'' section of this final rule with 
comment period 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 requested 
comment on these proposals.
    The following is summary of the comments we received regarding our 
proposal on requirements for selecting quality measures.
    Comment: A few commenters recommended that CMS continue to use the 
Measure Application Partnership (MAP) pre-rulemaking process in 
determining the final list of quality measures each year. One commenter 
supported elimination of the requirement for recommendation by the MAP 
for inclusion of MIPS quality measures and believed this could 
potentially speed the process for implementing measures into MIPS.
    Response: Prior to proposing new quality measures for 
implementation into MIPS for the 2017 performance period, we did 
consult the MAP for feedback. To view the MAP's recommendations on 
these measures, please refer to the report entitled, ``MAP 2016 
Considerations for Implementing Measures in Federal Programs: 
Clinicians.'' (http://www.qualityforum.org/Publications/2016/03/MAP_2016_Considerations_for_Implementing_Measures_in_Federal_Programs__Clinicians.aspx). We intend to continue to consult the MAP for feedback 
on proposed quality measures, but we retain the authority to propose 
measures that have not been supported by the MAP.
    Comment: Some commenters believed quality measures in MIPS should 
go through a multi-stakeholder evaluation process and that CMS should 
encourage the use of quality measures endorsed by the NQF.
    Response: Most measures are NQF endorsed or have gone through the 
pre-rulemaking process, but we retain the authority to adopt measures 
that are not so endorsed. All measures have gone through rulemaking and 
public comment process.
    Comment: One commenter had concerns with the performance measures 
currently used in PQRS, and therefore, recommended that any measures 
CMS proposes to use outside of the core set identified by the Core 
Quality Measures Collaborative be endorsed by the Measure Application 
Partnership (MAP).
    Response: We appreciate the comment to use measures identified by 
the CQMC, and while we intend to consult with MAP on measures for MIPS, 
we note that we have the authority to implement measures they have not 
reviewed.
    Comment: A few commenters recommended that quality measures should 
prioritize patient-reported outcomes and promote goal-concordant care, 
specifically that quality should be evaluated using a harmonized set of 
patient-reported outcomes and other appropriate measures that 
clinicians can reliably use to understand what matters to patients and 
families, achieve more goal-concordant care, and improve the patient 
and family experience and satisfaction. Another commenter suggested 
that CMS's proposed Quality Payment Program approach for considering 
value-based performance should expressly prioritize the patient and 
family voice and the constellation of what matters to them as key 
drivers of quality measures development and use.
    Response: We note that person and caregiver centered experience 
measures are considered high priority under MIPS. For this reason and 
the reasons cited by commenters, we encourage the development and 
submission of patent-

[[Page 77153]]

reported outcomes to the Call for Measures for the reasons cited by the 
commenters.
    Comment: One commenter recommended CMS include in the MIPS quality 
requirements measures outcomes that align with an individual's stated 
goals and values, commonly referred to as person-centered care, 
believing that performance measures that promote individuals 
articulating their goals and desired outcomes hold the system 
accountable for helping people achieve their goals and preferences. The 
commenter suggested that CMS reference the National Committee on 
Quality Assurance's work on long term services and supported measures 
and person centered outcomes using a standardized format to form a 
basis for building person centered metrics into MIPS and APMs.
    Response: We will take this into consideration for use in the 
future.
    Comment: A few commenters suggested making global and population-
based measures optional. Reclassifying these measures as ``population 
health measures'' under the quality category does not fix the inherent 
problems with these measures. Commenters suggested that CMS not include 
the three population health measures in the quality category.
    Response: We believe the population health measures are intended to 
incentivize quality improvement throughout the health care system, and 
we therefore believe that we have appropriately placed them under the 
Quality performance category. However, as discussed in section 
II.E.5.b. of this final rule with comment period, CMS will only 
finalize the all-cause readmission measure because the other population 
measures have not been fully tested with the new risk-adjusted 
methodology.
    Comment: One commenter expressed support for measures that address 
all six of the NQS domains. For the Patient Safety domain, commenter 
especially supported measures designed to reduce risk in the delivery 
of health care (for example, adverse events and complications from 
medication use). For the Communication and Care Coordination category, 
the commenter pointed out that for pharmacists, ensuring 
interoperability and bidirectional communication in this area is 
extremely critical.
    Response: We encourage MIPS eligible clinicians to select and 
report on measures that are applicable to their practices, regardless 
of their assigned domain, ultimately to improve the care of their 
beneficiaries.
    Comment: One commenter supported CMS aligning the MIPS quality 
measure domain of patient and caregiver experience with the National 
Quality Strategy's domain person and caregiver-centered experience and 
outcomes among the six required domains, believing it will improve 
patient centered care.
    Response: We appreciate the support. We support the measures in all 
domains, to include measures that embrace patient-centered care and 
involvement.
    After consideration of the comments, we are finalizing the 
requirements for the selection of the Annual MIPS Quality Measures. 
Specifically, we will categorize measures into the six NQS domains and 
we intend to place future MIPS quality measures within the NQF convened 
Measure Application Partnership's (MAP), as appropriate. We intend to 
consider the MAP's recommendations as part of the comprehensive 
assessment of each measure considered for inclusion under MIPS.
(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 with comment period are meaningful and comprehensive. We 
proposed 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 we do 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 Services Task Force (USPSTF) 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 timelines, establishing the proposed measure set for the 
year 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 requested comments on this proposal. 
Additionally, we solicited 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 solicited 
comment on the type of information that should be included in such 
notification.
    The following is summary of the comments we received regarding the 
submission of MIPS quality measures to a peer reviewed journal.
    Comment: One commenter supported the proposal that new measures 
must be submitted to peer reviewed journals.
    Response: We thank the commenter for their support.
    Comment: One commenter recommended that CMS use the Call for 
Quality Measures process as an opportunity to gather the information 
necessary to draft the journal articles required for quality measures 
implemented under MACRA. Commenter also recommended that any 
information required for journal article submission should align with 
the information required for the submission of the measure to CMS to 
reduce the workload of this new requirement on measure developers.
    Response: We appreciate the support and recommendation and intend 
to utilize the Call for Quality Measures process to gather information 
necessary to draft the journal articles.
    Comment: One commenter agreed that CMS should be responsible for 
submitting new measures for publication in applicable specialty-
appropriate, peer-reviewed journals before including such measures in 
the final list of measures annually. The commenter agreed the public 
requirement will help ensure measures are both meaningful and 
comprehensive, but requested that CMS ensure a more collaborative 
approach to the submission of measures to peer-reviewed journals. A few 
commenters requested that CMS allow measure developers the right to 
first submit measure sets to specialty specific, peer-reviewed journals 
of their choice. One commenter was concerned that there are 
difficulties with the timing and sequencing of submitting new measures 
in that, with the requirement to submit new measures for publication in 
applicable specialty appropriate peer reviewed journals before 
including such measure, many journals will be very

[[Page 77154]]

reluctant to publish measures that are already in the public domain, 
and the July 1 measure deadline provides a narrow window for 
publication. Another commenter noted that most peer-reviewed medical 
journals only contained ground-breaking research. Therefore, they would 
not be a good source of information about quality measurement and 
improvement. The commenter was concerned that this criterion for 
approving new quality measures would be a significant barrier.
    Response: We thank the commenters; however, we are required by 
statute to submit measures for publication in a peer-reviewed journal 
before including them in the final list of measures. Although we may 
collaborate with the measure owner to accurately capture the measure 
specifications, we cannot fulfill our statutory obligation by allowing 
the measure owner to submit the article. The statute 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. We would like to 
note, however, that this does not preclude a measure owner from 
independently submitting their measure for publication in a peer-
reviewed journal.
    Comment: One commenter recommended that CMS accept measures 
independently published in peer reviewed journals as well as measures 
submitted by CMS.
    Response: We appreciate the suggestion; however, we are required by 
statute to submit measures for publication in a peer-reviewed journal 
before including them in the final list of measures for MIPS.
    Comment: One commenter sought clarity on the process for submitting 
new measures for publication in specialty-appropriate, peer-reviewed 
journals prior to including measures in the final list, and suggested 
an abbreviated peer review process for publication to ensure there will 
not be slowdowns in the process of getting measures into the MIPS 
quality program.
    Response: It is our intent to illustrate this process via 
subregulatory guidance that will be posted on our Web site. Further, we 
would like to note that we only have an obligation to submit the 
measure for publication. If the submission is not accepted for 
publication, we will still have met the statute requirement. If the 
submission is accepted, which is our preference, we are not obligated 
to delay our rulemaking process until the date the journal chooses to 
publish the submission.
    Comment: One commenter believed that the proposed process requiring 
that HHS submit measures for publication in applicable specialty-
appropriate, peer-reviewed journals was highly duplicative of the work 
of measure developers; would infringe on measure ownership and 
copyright; and would ultimately limit the availability of and 
significantly delay the use of measures in MIPS. The commenter 
appreciated the exceptions to the rule for measures in QCDRs and those 
included in existing CMS programs, the commenter recommended this 
exclusion be extended to all measures published in a peer-review 
journal prior to their submission to CMS. The commenter believes that 
extending the exclusion would allow measure developers to maintain 
their ownership, copyright, prevent duplication, and ensure measures 
were not stagnated in the peer review and publication process.
    Response: The statute 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. Further, we would like to note that we only have an 
obligation to submit the measure; we do not have to wait for the 
measures to be published. Even if the article is not published, we will 
have met the requirements under section 1848(q)(2)(D)(iv) of the Act. 
We believe that the summary of proposed new quality measures will help 
increase awareness of quality measurement in the clinician community 
especially for clinicians or professional organizations that are not 
aware of the ability to provide public comment on proposed quality 
measures through the rulemaking process. We will only submit new 
measures in accordance with applicable ownership or copyright 
restrictions and cite the measure developer's contribution in the 
submission.
    Comment: One commenter recommended that new measures be posted to 
journals associated with the American Board of Medical Specialties 
(ABMS), related subspecialty journals or journals associated with the 
American College of that specialty and non-ABMS recognized clinical 
specialty journals that are trusted resources for specialists to ensure 
a wide range of readership and distribution.
    Response: We will take these recommendations into consideration for 
the future.
    Comment: Some commenters supported and appreciated the 
clarification that CMS will be submitting new measures for publication 
in applicable specialty appropriate, peer-reviewed journals before 
including such measures in the final list of measures annually. 
Commenters requested that CMS ensure a more collaborative approach to 
the submission of measures to peer-reviewed journals, possibly through 
societies that routinely publish guidelines in their peer-reviewed 
journals.
    Response: We appreciate the support. We will continue to seek input 
regarding our approach to the submission of measures from measure 
owners and specialty societies to improve the annual new measure 
submission process.
    Comment: One commenter recommended that CMS collaborate with a 
national, multi-stakeholder organization that can provide expertise on 
measurement science, quality improvement, and expertise on data 
submission mechanisms, such as clinical registries, to develop 
alternative approaches to the peer review process. Commenter expressed 
support for a process whereby new measures are subject to external 
expert review and recommended that such review occur in an expedient 
manner, and that results be made available and maintained as measures 
are updated.
    Response: Although we believe there is value in having external 
expert review of new measures, we note that we are required by statute 
to submit new measures to an applicable, specialty-appropriate peer-
reviewed journal.
    Comment: One commenter stated that until the USPSTF recommendation 
process is substantially reformed so that specialist physicians are 
consulted as part of its recommendation process, CMS should proceed 
with great caution before incorporating any future USPSTF 
recommendations into MIPS quality measures.
    Response: We are committed to engaging all stakeholders in our 
measure development and selection process. We note that the annual call 
for measures and the annual measure update provides for the 
participation of patient, eligible clinician, and clinician 
stakeholders, including specialists, and allows for a transparent and 
robust review of our quality measure development and selection process.
    Comment: One commenter recommended a quicker timeline for including 
quality measures after they had been published in a peer-reviewed 
journal; specifically, if a measure is already published in a peer-
reviewed

[[Page 77155]]

journal, the commenter recommended that the timeline for approval for 
MIPS be 6-12 months.
    Response: We appreciate the comments; however, new measures, even 
if they have been previously published, can only be included in MIPS 
through notice and comment rulemaking. Further, there is a statutory 
requirement that we publish the new measures not later than November 1 
prior to the first day of the applicable performance period for a given 
year.
    After consideration of the comments, we are finalizing our proposal 
to use the Call for Quality Measures process as a forum to gather the 
information necessary to draft the journal articles for submission from 
measure developers, measure owners and measure stewards since we do not 
always develop measures for the quality programs. Information from 
measure developers, measure owners and measure stewards shall 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 Services Task 
Force (USPSTF) recommendations; and how this measure would align with 
the CMS Quality Strategy. The submission of this information will not 
preclude us from conducting our own research using Medicare claims 
data, Medicare survey results, and other data sources that we possess. 
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.
(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 was finalized and posted on the CMS Web site on May 2, 
2016, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf.
(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 proposed 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 intermediaries' requirements can be found in 
section II.E.9 of the 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 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 in this final rule with 
comment period to the extent that such measures are appropriate for the 
specific QCDR and have been approved by CMS. We requested comment on 
these proposals.
    The following is a summary of the comments we received regarding 
our proposals on QCDR measures.
    Comment: One commenter supported CMS's proposed exception for QCDR 
measures.
    Response: We appreciate the support.
    Comment: Some commenters agreed that non-MIPS measures implemented 
in QCDRs should be analyzed for scientific rigor, technical 
feasibility, duplication to current MIPS measures, clinical performance 
gaps, as evidenced by background and literature review, and relevance 
to specialty practice quality improvement.
    Response: We appreciate the support.
    Comment: One commenter stated that quality measures developed by 
QCDRs should not be subject to an additional CMS verification process 
before they are used for MIPS reporting and that an additional process 
is problematic for specialty areas such as oncology where there are 
deficiencies in the quality measure set for these types of practices. 
The commenter further believed the additional verification and approval 
processes appear as micro-managing the QCDR-developed measures process 
which could undermine the goals of QCDR reporting and creates 
additional burden given mature QCDRs such as the Quality Oncology 
Practice Initiative have already undergone an extremely robust and 
evidenced-based process to ensure clinical validity and reliability. 
The commenter further stated that additional uncertainty, restraints 
and regulatory burden should not be placed on these QCDRs. The 
commenter did support focusing on evaluating the QCDR measure 
development methodology during the self-nomination process instead.
    Response: While we do not wish to add burden to QCDRs, we do need 
to maintain an appropriate standard for measures used in our program, 
especially since MIPS payment adjustments are based on the quality 
metrics.
    Comment: One commenter recommended that CMS publish the specific 
criteria that they plan to use in evaluating QCDR measures moving 
forward. Some commenters requested that if CMS decides to deny the use 
of a measure in a QCDR, that CMS provide the measure developer/steward/
owner with specific information on what criteria were not met that led 
to a

[[Page 77156]]

measure not being accepted for use and provide a process for immediate 
reconsideration when the issues have been addressed.
    Response: Criteria were already adopted under PQRS and proposed 
under MIPS (see 81 FR 28284) for non-MIPS measures. In the future, we 
may publish supplemental guidance. In addition, measures should be 
fully developed prior to submission, and we intend to provide necessary 
feedback in a timely fashion.
    Comment: A few commenters supported CMS's proposal for non-MIPS 
measures in QCDRs to go through a rigorous CMS approval process during 
the QCDR self-nomination period, and encouraged CMS to engage in a 
multi-stakeholder process as part of this approval process. One 
commenter recommended adopting an approval process for QCDR measures 
that would require them to be endorsed by the NQF.
    Response: We intend to take the multi-stakeholder process's views 
into account when adopting policies on this topic in the future. We 
retain the authority to adopt measures that have not been endorsed by 
NQF, and we do not believe it appropriate to commit to requiring 
endorsement.
    Comment: One commenter did not agree that CMS should support new 
measures developed by QCDRs.
    Response: We respectfully disagree because we believe that QCDRs 
offer MIPS eligible clinicians the opportunity to report on measures 
associated with their beneficiaries that otherwise they may not be able 
to report.
    Comment: A few commenters recommended that CMS encourage QCDRs to 
submit their measures for review by a consensus-based standards 
organization, like the NQF. One commenter suggested that CMS publish 
data for these measures to promote greater understanding of the use of 
QCDR measures and performance trends.
    Response: The QCDRs develop new measures and propose them for 
consideration into our programs. We review all proposed measures and 
consider them for inclusion based on policy principles described in our 
Quality Measure Development Plan (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). Although we do not require NQF 
endorsement for measure approval and acceptance, we expect all 
submitted measures to have had a rigorous evaluation including an 
assessment for feasibility, reliability, strong evidence basis, and 
validity. All of our measures, regardless of NQF endorsement status, 
are thoroughly reviewed, undergo rigorous analysis, presented for 
public comment, and have a strong scientific and clinical basis for 
inclusion. QCDR measures must be approved by us before they can be made 
available for use by MIPS eligible clinicians.
    Comment: One commenter approved of the use of QCDRs but is 
concerned that if QCDR measures are not part of the MIPS quality 
measure set and must undergo a thorough approval process by CMS, this 
will delay adoption of MIPS eligible measures and limit opportunities 
for transparency and stakeholder input to ensure measures are evidence-
based and clinically rigorous. The commenter suggested that subjecting 
these measures to a formal endorsement process, such as National 
Quality Forum (NQF) endorsement, could help ensure that QCDR measures 
enjoy broad, consensus-based support through a process of thorough 
review and public vetting.
    Response: We agree that ideally measures developed by QCDRs would 
be submitted to NQF for endorsement. However, we will not require NQF-
endorsement and will continue to review measures submitted by QCDRs 
prior to their implementation in the MIPS program. We believe that 
QCDRs allow specialty societies and others to develop more relevant 
measures for specialists that can be implemented more rapidly and 
efficiently.
    Comment: A few commenters expressed concern with CMS's 
``stringent'' approach to QCDR measures as they believe it may be too 
burdensome. Commenters stated that QCDR measures should continue to be 
developed by a multi-stakeholder processes by the relevant specialty 
societies and reviewed by CMS in the QCDR approval process, but they 
should not be required to undergo MAP and NQF processes that are too 
time consuming to allow such developments to keep pace with constantly 
changing CMS requirements.
    Response: We would like to note that QCDR measures are not required 
to undergo MAP and NQF processes.
    Comment: One commenter supported flexibility with regard to the 
measures that are available for reporting by physicians and also 
supported the statutory provision that does not require that QCDR 
developed measures to be NQF-endorsed.
    Response: We appreciate the comment and support.
    Comment: One commenter expressed concern with the need for CMS to 
encourage reporting of NQF measures. The commenter noted that obtaining 
NQF endorsement can be costly, time consuming and not the only way to 
ensure that measures are sound. The commenter expressed concern that 
the language will be interpreted as a requirement for NQF endorsement 
and encouraged CMS to reconsider the language. Another commenter 
opposed all measures being required to be endorsed by NQF for use in 
QCDRs because: requiring QCDR measures to go through NQF would go 
against CMS's goal of quickly iterating measures; the NQF process is 
cost and resource prohibitive for smaller specialties; such a revision 
would reduce the flexibility of QCDRs to offer specialty-specific 
reporting measures, which provide broader options that may be more 
meaningful to some practices than existing PQRS measures; and QCDRs 
provide a better picture of the overall quality of care provided, 
because QCDRs collect and report quality information on patients from 
all payers, not just Medicare patients.
    Response: We would like to note that NQF endorsement is not a 
requirement for QCDR or MIPS measures. However, we do encourage 
application for NQF endorsement because it provides a rigorous 
scientific and consensus based measures evaluation.
    Comment: One commenter expressed support for the use of quality 
measures that are used by QCDRs such as the Quality Oncology Practice 
Initiative (QOPI), which is designated as a QCDR and focuses 
specifically on measuring and assessing the quality of cancer care. 
However, the commenter expressed concern over the process for approval 
of QCDR measures, stating that CMS should not slow the continued use of 
existing, robust QCDR measures; decrease adoption of innovative, 
clinically relevant QCDR measures; or weaken the protections that 
exempt quality measures developed for use in a QCDR from many of the 
measure development process required for other MIPS measures.
    Response: We understand the commenters concern and will continue to 
review QCDR measures in a timely fashion. Further, we would like to 
note that the approval criteria are not changing.
    Comment: One commenter supported the CMS approach to non-MIPS 
measures used by QCDRs, including the caution about ``check box'' 
measures. Commenter expressed concern that the measurement of cancer 
care planning could become one such measure. Instead, the commenter 
suggested that care planning measures be developed as

[[Page 77157]]

patient engagement/experience measures.
    Response: We thank the commenter for the recommendation and will 
take under consideration for future years. We note that, consistent 
with clinicians submitting quality data through other reporting 
mechanisms, those submitting quality data through QCDRs must meet our 
requirements for one outcome measure, or, if one is not applicable, one 
high-priority measure.
    Comment: A few commenters recommended that CMS allow QCDRs to 
utilize measures from other QCDRs (with permission). One commenter 
further stated that CMS proposed that QCDR non-MIPS measures must go 
through a rigorous approval process and then be assigned a unique 
identifier that can only be used by the QCDR that proposed the measure. 
Commenters believe that prohibiting the sharing of non-MIPS quality 
measures between QCDRs would inhibit the efficient and cost-effective 
use and dissemination of such measures.
    Response: We allow a QCDR to use a measure with permission from the 
measure owner, which may be a QCDR in some instances. Further, if the 
QCDR would like the measure to be shared among other clinicians, they 
can submit the measure to be included in the Program, where it would 
not be limited to that specific QCDR. Any measure needs only a single 
submission for the measure approval process.
    Comment: One commenter recommended that CMS not require or restrict 
a QCDR from licensing its proprietary quality measures to other QCDRs 
after the QCDR-developed measures become available for MIPS reporting.
    Response: We do not restrict but in fact encourage the sharing of 
QCDR-developed quality measures with clinicians and also other QCDRs.
    Comment: One commenter requested that CMS clarify that the QCDR-
developed measures available for 2016 PQRS reporting would 
automatically qualify for 2017 MIPS quality reporting.
    Response: QCDR guidelines evolve over time as we continue to learn 
from implementation. We expect that measures in a QCDR 1 year would be 
expected to be retained for the next, however, we will review measures 
each year to ensure they are still relevant and meet scientific 
standards. Further, we would like to note that all QCDRs that were 
previously approved for PQRS will not be ``grandfathered'' as qualified 
under MIPS. Rather the QCDR must meet the requirements as described in 
section II.E.9.a. of this final rule with comment period.
    Comment: One commenter indicated that requiring data collection in 
2017 for measures not already included in a QCDR represents a myriad of 
technical challenges. QCDRs' development and modifications require 
partnering with a number of developers that program code and develop 
software updates to facilitate reporting. Software developer often 
require 9-12 months to update data elements. In addition, time is 
required to train practice staff on how to enter new data and integrate 
measures into the practice workflow.
    Response: We thank the commenter for the support of the QCDR 
program and understand the concern of the time involved in doing this 
work. We believe that QCDRs that implement and support non-MIPS 
measures are aware of the measure specifications in enough time to 
reliably work with developers to make system changes. Since these 
measures are owned by the QCDR or their partners, we believe they 
already know the changes needed prior to the submission of the measure 
for inclusion in the program.
    Comment: One commenter asked CMS to modify the QCDR self-nomination 
process to allow measures that have been approved in prior years a 
period of stability by automatic measure approval for a period of at 
least 3 years, which would allow physicians and developers a period of 
assured measure inclusion.
    Response: The QCDR measures are reviewed annually to ensure they 
are still appropriate for use in the program. We thank the commenter 
for the recommendation and will consider for future years.
    Comment: One commenter suggested that CMS streamline the process 
for measure inclusion into MIPS beyond the accommodations that have 
been made for QCDRs and recommended that CMS consider the development 
of an ``open source'' QCDR that would allow small specialty 
organizations the opportunity to take advantage of the benefits of 
QCDRs for measure development, thereby shortening the process for 
inclusion in MIPS.
    Response: It is not our intent to expand QCDR types at this time, 
but we will take this suggestion into consideration for future 
rulemaking.
    Comment: One commenter supported the inclusion of outcome measures 
and other high priority measures for QCDRs, as well as the optional 
reporting of cross cutting measures by those clinicians who find those 
measures relevant to their practice. However, the commenter did not 
support mandating cross cutting measures requirements, especially for 
QCDRs since it contradicts the intent of this submission mechanism, 
which is to give clinicians broad flexibility over determining which 
measures are most meaningful for their specialized practice.
    Response: CMS believes that there are basic standards that each 
physician, regardless of their specialty, can and should perform. 
Additionally, the MIPS program offers payment incentives and MIPS 
payment adjustments based on the value of care patients receive. Having 
across-cutting set of measures will allow for direct comparisons among 
participants. We would like to note, however, that as discussed in 
section II.E.5.b. of this final rule with comment period, we are not 
finalizing the cross-cutting measure requirement.
    Comment: One commenter requested that CMS compile the list of 
entities qualified to submit data as a QCDR, and that CMS accept the 
Indian Health Service (IHS) Resource and Patient Management System 
(RPMS) and other Tribal health information systems as a QCDR and work 
with IHS and Tribes to ensure health information systems are capable of 
meeting MIPS reporting requirements.
    Response: CMS posts a list of approved QCDRs on its Web site 
annually. Entities are required to self-nominate to participate in MIPS 
as a QCDR. Entities that meet the definition of a ``QCDR'' at Sec.  
414.1305 and meet the participation requirements outlined in section 
II.E.9 of this final rule with comment period will be approved as a 
QCDR.
    Comment: One commenter requested that CMS consider employing a MAV 
process for QCDRs or at minimum clarifying its intent for using such a 
process. The commenter stated that even in QCDRs certain clinicians do 
not have enough measures to report.
    Response: QCDRs are required to go through a rigorous approval 
process that requires both their MIPS and non-MIPS measures be 
submitted at time of self-nomination. Since QCDRs have the ability to 
have up to 30 non-MIPS measures approved for availability to the MIPS 
eligible clinicians we anticipate that very few MIPS eligible 
clinicians who utilize the QCDR mechanism would not have measures 
applicable to them.
    Comment: One commenter recommended that CMS not score non-MIPS QCDR 
measures in their first year as commenter does not believe they will 
have good benchmarking data.
    Response: The non-MIPS measures approved for use within QCDRs are 
required to have benchmarks when possible and appropriate.

[[Page 77158]]

    Comment: One commenter requested that CMS consider allowing QCDRs 
to determine the appropriate reporting sample (number or percentage) on 
a measure by measure basis.
    Response: We will consider this recommendation in future rulemaking 
as we review the impact of such a change. However, we believe that the 
reporting sample must be of sufficient size to meet our reliability 
standards.
    Comment: One commenter supported that the proposed rule established 
a quality measure review process for those measures that are not NQF-
endorsed or included on the final MIPS measure list to assess if the 
quality measures have an evidence-based focus, and are reliable and 
valid.
    Response: We appreciate the comment and support.
    Comment: One commenter did not support CMS's proposal to support 
new measures developed by QCDRs because the commenter believed quality 
measures should go through a rigid evaluation and review process. The 
commenter believed CMS should focus on streamlining quality reporting 
by gradually eliminating excessive measures.
    Response: We would like to note that all QCDR measures undergo a 
rigorous approval process before receiving approval.
    Comment: One commenter indicated that allowing for the inclusion of 
non-MIPS quality measures via QCDRs will introduce more inconsistency 
and burden and result in data that cannot be compared across states/
regions/providers, depending on their QCDR of origin.
    Response: Acceptance of non-MIPS QCDR measures is to support 
specialty groups' ability to report on measures most relevant to their 
practice. QCDRs operate on a large scale, many at a national level, and 
offer valid and reliable measure data.
    After consideration of the comments, we are finalizing at Sec.  
414.1330(a)(2) our proposal that for purposes of assessing performance 
of MIPS eligible clinicians on the quality performance category, CMS 
will use quality measures used by QCDRs. In the circumstances where a 
QCDR wants to use a non-MIPS measure for inclusion in the MIPS program 
for reporting, those measures will go through a CMS approval process 
during the QCDR self-nomination period. We also are finalizing our 
proposal 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.
(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 the proposed rule, we proposed 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.
    The following is a summary of the comments we received regarding 
our proposal on the Exception for Existing Quality Measures.
    Comment: Some commenters expressed preference for leveraging 
existing quality measures to ensure consistency of measurement.
    Response: The vast of majority of measures that we are finalizing 
for the MIPS quality performance category are existing PQRS measures.
    Comment: One commenter suggested that CMS conduct robust assessment 
of previously developed quality measures to ensure that the measures 
improve patient care and outcomes before introducing or maintaining 
those measures in the MIPS Program.
    Response: We routinely review all of our existing measures through 
a maintenance and evaluation process that assess for the clinical 
impact on quality and any unintended consequences. We are committed to 
utilizing measures that improve patient care and outcomes.
    After consideration of comments received from stakeholders on our 
proposals for exceptions to existing quality measures, we are 
finalizing our policies as proposed. While CMS has modified its 
performance period proposal as discussed in section II.E.4 of this 
final rule with comment period, this policy would not be affected since 
the minimum 90-day performance period would not begin any earlier that 
January 1, 2017.
(8) Consultation With Relevant Eligible Clinician Organizations and 
Other Relevant Stakeholders
    Section 1890A of the Act, as added by section 3014(b) of the 
Affordable Care Act, requires that the Secretary establish a pre-
rulemaking process under which certain steps occur for the selection of 
certain categories of quality and efficiency measures, one of which is 
that the entity with a contract with the Secretary under section 
1890(a) of the Act (that is, the NQF) 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.
    Although MIPS quality measures are not required to go through the 
pre-rulemaking process under section 1890A of the Act, we have found 
the

[[Page 77159]]

MAP's input valuable. The MAP process enables us to consult with 
relevant EP organizations and other stakeholders, including state and 
national medical societies, patient and consumer groups and purchasers, 
in finalizing the annual list of quality measures. In addition to the 
MAP's input this year, we also received input from the Core Quality 
Measure Collaborative on core quality measure sets. The Core Quality 
Measure Collaborative was organized by AHIP in coordination with CMS in 
2014. This multi-stakeholder workgroup has developed seven condition or 
setting-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 Quality 
Measure Collaborative and many of the remaining measures in the core 
sets were already in the PQRS program and have been proposed for MIPS 
for CY 2017.
    The following is a summary of the comments we received regarding 
consultation with relevant eligible clinician organizations and other 
relevant stakeholders.
    Comment: A few commenters applauded the work that went into 
establishing the measures that went in to MIPS. The commenters 
suggested CMS continue to work with all stakeholders to align quality 
measures with those used in the private sector.
    Response: We intend to continue to work with stakeholders to 
further align the MIPS quality measures with those used in the private 
sector.
    Comment: Several commenters encouraged CMS to engage as broad an 
array of stakeholder organizations as possible in the measure review 
and selection process, noting that physicians and healthcare facility 
stakeholders, relevant task forces, provider groups, including nurses, 
physician assistants, nurse practitioners, patients, and caregivers 
should be included. Further, the commenters requested CMS implement new 
opportunities for stakeholders to participate in the measure 
development process.
    Response: Part of the process for measure adoption is the public 
comment period, and we use the public comment period to enable all 
relevant stakeholders of all types, including the various stakeholders 
listed above, to provide feedback on measures that we have proposed for 
the Program.
    Comment: One commenter encouraged CMS to keep measure developers, 
clinicians, and stakeholders engaged in the quality measure development 
and selection process to ensure the implementation of clinically 
meaningful measures that are aligned across the MACRA Quality Payment 
Program performance pathways and other payer programs.
    Response: We will continue to keep measure developers, clinicians, 
and stakeholders engaged in the quality measure development and 
selection process as evidenced by the multiple opportunities to provide 
input to the measure development and selection process.
    Comment: A few commenters stated that CMS should work broadly with 
stakeholders, including patients and patient advocacy organizations to 
identify and address measures gaps. Further, these stakeholders could 
provide insight on patient experience and satisfaction measures, as 
well as measures of care planning and coordination. Increasingly, 
patient advocacy organizations are working to develop such measures 
based on their own registry data. Commenters encouraged CMS to commit 
to acting as a resource for those stakeholders that have less 
experience with the measures submission process, to encourage their 
participation in the process. Commenter also encouraged CMS to identify 
disease states for which commenters have articulated gaps in quality 
measures, and determine the feasibility of adopting measures based upon 
consensus-based clinical guidelines upon which CMS could solicit 
comments.
    Response: We appreciate the recommendations and will engage with 
all stakeholders, including patient and consumer organizations. We 
provide a wide array of support and information about our measure 
development process. Our Measure Development Plan for stakeholders' 
provides clear guidance on this process (available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf. We 
will take these suggestions into consideration in the future.
    Comment: One commenter suggested that CMS look to and work with 
International Consortium for Health Outcomes Measurement (ICHOM) to 
develop additional and needed outcome measures and references MEDPACs 
June 2014 report.
    Response: We will continue to collaborate with stakeholders that 
develop outcome measures for quality reporting.
    Comment: One commenter recommended that CMS collaborate with 
specialty societies, frontline clinicians, and EHR vendors in the 
development, testing, and implementation of measures with a focus on 
integrating the measurement of and reporting on performance with 
quality improvement and care delivery and on decreasing clinician 
burden.
    Response: We agree it is important to continuously enhance the 
integration of health IT support for quality measurement and 
improvement with safe, effective care delivery workflows that minimize 
burdens on the clinician, patient, and clinical relationship. We will 
take the commenter's recommendation into consideration as we develop, 
test, and implement new measures.
    Comment: One commenter recommended that CMS carefully review 
measure sets and defer to medical professional specialty society 
comments to ensure that measure sets are appropriately constructed. The 
commenter recommended that CMS obtain insight from clinicians who will 
be reporting these services to test the validity of the measure sets.
    Response: We will continue to work with specialty groups to improve 
the specialty measure sets in the future.
    Comment: Several commenters recommended that CMS use the core 
measure sets developed by the Core Quality Measures Collaborative 
because using these measure sets would ensure alignment, harmonization, 
and the avoidance of competing quality measures among payers.
    Response: Measures that are a part of the CQMC core measure sets 
have been proposed for implementation and CMS intends to continue its 
collaboration with the CQMC to ensure alignment and harmonization in 
quality measure reporting.
    Comment: One commenter recommended that CMS consider the 
recommendations made by the American College of Physicians (ACP) 
Performance Measurement Committee with regard to measure selection 
within MIPS.
    Response: The ACP, like all other professional societies, has the 
opportunity to comment and provide feedback on our measure selection, 
including their recommendations, through the notice and comment 
process.
    Comment: One commenter stated CMS has not adequately involved 
physicians in the measure development process.
    Response: All Technical expert panels (TEPs) for measures developed 
by CMS or a CMS contractor include a clinical expert. Additionally, the 
majority of measures in the program are not developed by CMS but by 
medical specialty societies.

[[Page 77160]]

    Comment: One commenter suggested that CMS account for the 
professional role of the Advanced Practice Registered Nurse (APRN) and 
all appropriate stakeholders who provide clinical services to 
beneficiaries when creating and evaluating quality measures. The 
commenter suggested that CMS ensure the committees and Technical Expert 
Panels tasked with developing quality measures include nurses.
    Response: We value the expertise of APRNs in providing patient care 
and we will consider their participation in the future.
    Comment: One commenter believed CMS should continue to work with 
stakeholders to make the process for selection of quality measures 
clear and well defined. The commenter encouraged CMS to focus on 
getting new, relevant measures into the program within a shorter 
timeframe. The commenter believed that a 2-year submission to 
implementation interval would hinder introduction of new measures into 
MIPS through the traditional approach. The commenter believed there 
will be growth in measures submitted to the program through QCDRs in 
the future.
    Response: We do not develop most of the measures, but rather 
measure stewards/owners submit their measures to CMS for consideration 
and implementation. We will work with measure developers and other 
stakeholders to continue to try and shorten the timeframe for measure 
development and implementation and to make the process as efficient as 
possible.
    Comment: One commenter requested that CMS promote and disseminate 
research on which process improvement measures have proven to be the 
most effective at improving clinical outcomes.
    Response: We will take this under consideration and will continue 
working with clinicians to promote best practices and the highest 
quality healthcare for clinicians and Medicare beneficiaries.
    Comment: One commenter believes we should consider how to work with 
measure developers to integrate patient preferences into measure 
design.
    Response: We agree with the commenter and believe the patient 
experience and incorporation of patient preferences are important 
components of healthcare quality.
    Comment: Commenters recommended that CMS consult with relevant 
eligible clinician organizations and other relevant stakeholders and 
reminded CMS that the MACRA statute does not require CMS to utilize the 
NQF MAP to provide guidance into the pre-rulemaking process on the 
selection of MIPS quality measures, but requires the Secretary to 
consult with relevant eligible clinician organizations, including state 
and national medical societies. To strengthen the pre-rulemaking 
process, commenters recommended that CMS address issues with the MAP 
around: voting options on individual measures; discussion and treatment 
of existing measures undergoing maintenance review; timelines for 
commenting on MAP recommendations; the make-up of the MAP coordinating 
committee and workgroups; and the sometimes inadequate notice for 
public comment (for example, agendas are often not available until 
close to the day of a MAP meeting). In addition, the commenters 
reminded CMS that requiring measure developers to propose measures to 
the MAP for use in CMS programs introduces another time-consuming step 
in the measure development cycle, and that MACRA provides CMS the 
flexibility in terms of how it uses the MAP.
    Response: We appreciate their feedback about the MAP, and the 
commenters correctly note that we retain the authority to adopt 
measures without MAP's recommendations. We will continue to work with 
the NQF on optimizing the MAP process and will take the commenters' 
recommendations into consideration in future rulemaking.
(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 
proposed 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 proposed to eliminate 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. 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 proposed to remove the above listed measures from the 
cross-cutting measure set, these measures were proposed to be available 
as individual quality measures available for MIPS reporting, some of 
which have proposed substantive changes.
    The following is a summary of the comments we received regarding 
our proposal on cross-cutting measures for 2017 and beyond.
    Comment: Some commenters supported the proposal to require 
reporting at least one cross-cutting measure, and suggested that CMS 
support the development of additional cross-cutting measures.
    Response: We appreciate the support; however, as discussed in 
section II.E.5.b. of this final rule with comment period, we are not 
finalizing the cross-cutting measure requirement in an effort

[[Page 77161]]

to reduce program complexity as part of the transition year of CY 2017.
    Comment: Several commenters requested that CMS provide a broader 
selection of cross-cutting measures to choose from. Further stating 
that the list is not robust enough to allow all clinicians to meet this 
requirement.
    Response: We appreciate the suggestion; however, as discussed in 
section II.E.5.b. of this final rule with comment period, we are not 
finalizing the cross-cutting measure requirement as part of the 
transition year of CY 2017.
    Comment: One commenter requested that all eligible clinicians must 
receive clear and timely notification of all cross-cutting and outcome 
measures before the start of the reporting period so that they can 
select and plan for a full year of quality improvement activities.
    Response: We appreciate the recommendation; however, as discussed 
in section II.E.5.b. of this final rule with comment period, we are not 
finalizing the cross-cutting measure requirement as part of the 
transition year of CY 2017.
    Comment: Numerous commenters did not agree with requiring all 
patient facing clinicians to report one cross-cutting measure. The 
commenters did not believe there were measures that are important or 
informative for some procedural or technical sub-specialties and that 
they are difficult to understand and implement. Further, one commenter 
believes that the cross-cutting measures appear to be measures that 
will be applicable for multiple clinicians types rather than 
cross[hyphen]sectional measures, or anything that would push for 
community collaboration.
    Response: We appreciate the feedback and would like to note that, 
as discussed in section II.E.5.b. of this final rule with comment 
period, we are not finalizing the cross-cutting measure requirement as 
part of the transition year of CY 2017.
    Comment: One commenter stated that Non-patient facing clinicians 
should be exempt from reporting a cross cutting measure.
    Response: We would like to note that non-patient facing clinicians 
would have been exempt from reporting a cross-cutting measure. Further, 
as discussed in section II.E.5.b of this final rule with comment 
period, we are not finalizing the cross-cutting measure requirement as 
part of the transition year of CY 2017.
    Comment: A few commenters recommended that CMS work with 
stakeholders to develop cross-cutting measures for non-patient facing 
MIPS eligible clinicians, as these MIPS eligible clinicians play an 
important role in ensuring safe, appropriate, high-quality care. The 
commenters supported allowing non-patient facing MIPS eligible 
clinicians to report through a QCDR that can report non-MIPS measures.
    Response: We appreciate the recommendation; however, as discussed 
in section II.E.5.b. of this final rule with comment period, we are not 
finalizing the cross-cutting measure requirement as part of the 
transition year of CY 2017.
    Comment: A few commenters objected to the requirement that 
clinicians report one cross-cutting measure chosen from a list of 
general quality measures because it is counter to the statute's intent 
to allow eligible clinicians who report via QCDR the flexibility to 
select measure that are most relevant to their practice. The commenters 
urged CMS to remove the requirement that physicians reporting the 
quality performance category via QCDR must report on one cross-cutting 
measure.
    Response: We appreciate the commenters' feedback; however, as 
discussed in section II.E.5.b. of this final rule with comment period, 
we are not finalizing the cross-cutting measure requirement as part of 
the transition year of CY 2017.
    Comment: Several commenters disagreed with our proposal to remove 
various measures from the cross-cutting measure set. We also received 
support for some of the measures we proposed to include, as well as 
comments on measures that commenters did not support. Additionally, we 
received several recommendations of additional quality measures for 
potential inclusion in the cross-cutting measure set.
    Response: We appreciate the commenters' feedback and would like to 
note that we are not finalizing the cross-cutting measure requirement 
as part of the transition year of CY 2017. We would also like to note 
that the measures that were proposed for the cross-cutting measure set 
are still listed as available measures under Table A of the appendix in 
this final rule with comment period.
    As a result of the comments, and based on our other finalized 
policies, we are not finalizing the set of cross-cutting measures as 
proposed to reduce the complexity of the program. Rather we are 
incorporating these measures within the MIPS individual (Table A) and 
specialty measure sets (Table E) within the appendix of this final rule 
with comment period. We continue to value the reporting of cross-
cutting measures to incentivize improvements in population health and 
in order to be better able to compare large numbers of physicians on 
core quality measures that are important to patients and the health of 
populations. We understand that many clinicians believe that cross-
cutting measures may not apply to them. We are seeking additional 
comments in this final rule with comment period from the public for 
future notice-and-comment rulemaking on approaches to implementation of 
cross-cutting measures in future years of the MIPS program that could 
achieve these program goals and be meaningful to MIPS eligible 
clinicians and the patients they serve.
d. Miscellaneous Comments
    We received a number of comments for this section that are not 
related to specific measure proposals as well as comments spanning 
multiple measure proposals that contained common themes. We have 
summarized those comments below.
    Comment: Numerous commenters made requests for new measures to be 
included in the annual list of quality measures. For example, we 
received several comments requesting additional measures be added that 
pertain to palliative care and behavioral-health.
    Response: We appreciate the commenters' suggestions. We would 
encourage the commenters to submit potential new measures for inclusion 
in MIPS through the Call for Quality Measures process.
    Comment: Numerous commenters made requests for changes to existing 
measure specifications. For example, some commenters requested 
encounter codes be added or removed from measure specifications or 
certain denominator criteria be expanded to include additional target 
groups for various measures.
    Response: Although CMS has authority over all of its quality 
programs and measure changes within those programs, we also work with 
measure owners regarding the updates to measures. Measure changes are 
not automatically implemented within quality programs. We may adopt 
changes to measures in two ways: (1) For measures with substantive 
changes, the changes must be adopted through notice-and-comment 
rulemaking. Generally, measures with substantive changes are proposed 
through rulemaking and open for comment. (2) For measures with non-
substantive or technical changes, we can consider implementing the 
changes through subregulatory means.
    Comment: Numerous commenters made requests for additional specialty 
measure sets, as well as modifications to the proposed specialty 
measure sets.

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    Response: We appreciate the commenter's suggestions. We plan to 
work with the measure developers and specialty societies to 
continuously improve and expand the specialty-measure sets in the 
future. Further, several comments were not specific enough as to the 
measures that would be appropriate to the specialty measure set or 
where there were not enough measures within the current measure set to 
provide a sufficient number of measures for the specific specialty set. 
In instances where we received comments that were specific enough to 
develop or modify the specialty measure sets, and which we believed 
were appropriate, we have included those updates along with the 
rationale for those changes in the measure tables in the appendix.
    Comment: We received several requests to update measure steward 
information in the measure tables located in the appendix.
    Response: We appreciate the commenters' feedback and have made the 
necessary updates to the measures steward information in the measure 
tables.
    Comment: Some commenters asked that physician led specialty 
organizations be able develop evidence-based quality guidelines of 
their own and proceed with a simple attestation procedure to document 
compliance.
    Response: As discussed in section II.E.5.c. of this final rule with 
comment period, we have an annual call for measures where clinicians 
have the opportunity to submit additional measures covering the 
services that they provide. We have also made available a measure 
development plan for stakeholders' review, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf. 
While we recognize the simplicity of simple attestation, we believe it 
is important to receive actual performance information on how an MIPS 
eligible clinician or group reported, not just whether they did the 
measure.
    Comment: A few commenters requested the adoption of appropriate use 
criteria (AUC) as quality measures to ensure the best care for 
patients. The commenters recommended that the specialty areas covered 
by the AUCs include: Radiology, cardiology, musculoskeletal (includes 
specialized therapy management, interventional pain, large joint 
surgery, spine surgery), radiation therapy, genetics and lab 
management, medical oncology, sleep medicine, specialty drug, and post-
acute care. In addition, the commenters recommended that AUC be derived 
from leading specialty societies, be incorporated from current peer-
reviewed medical literature, have input from subject matter expert 
clinicians and community-based physicians, be available to any eligible 
clinicians free of charge on a Web site, and have a proven track record 
of effectiveness in a wide range of practice settings. The AUC should 
be subject to oversight and review by nationally recognized, 
independent accrediting bodies, and be reviewed annually.
    Response: We are finalizing quality measures that are based on the 
AUC in this rule.
    Comment: One commenter promoted the value of palliative care and 
encouraged CMS to monitor the effects of MACRA, specifically the 
quality and cost performance categories, on patient access to health 
care providers, particularly palliative care providers.
    Response: We appreciate the suggestion. We intend to monitor the 
effects of the MIPS program on all aspects of care.
    We have considered the comments received and will take them into 
consideration in future notice-and-comment rulemaking.
e. Cost Performance Category
(1) Background
(a) General Overview and Strategy
    Measuring cost is an integral part of measuring value. We envision 
the measures in the MIPS cost 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 cost performance category, we proposed 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). We also proposed that all cost 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. We proposed that all of the measures attributed to 
a MIPS eligible clinician or group would be weighted equally within the 
cost performance category, and there would be no minimum number of 
measures required to receive a score under the cost performance 
category. Lastly, we indicated that we plan to draw on standards for 
measure reliability, patient attribution, risk adjustment, and payment 
standardization from the 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 cost 
performance category in MIPS (81 FR 28196).
    We proposed that all measures used under the cost performance 
category would be derived from Medicare administrative claims data and 
as a result, participation would not require use of a data submission 
mechanism.
    In response to public comments, as detailed in section II.E.5.e.(2) 
of this final rule with comment period, we are lowering the weight of 
the cost performance category in the MIPS final score from 10 percent 
in the proposed rule to 0 percent for the transition year (MIPS payment 
year 2019). We are finalizing a weight of 10 percent for MIPS payment 
year 2020. For MIPS payment year 2021 and beyond, the cost performance 
category will have a weight of 30 percent of the final score as 
required by section 1848(q)(5)(E)(i) of the Act. Reducing the weight of 
the cost performance category provides MIPS eligible clinicians and 
groups the opportunity to better understand the cost measures in MIPS 
without an effect on their payments, especially the impact of 
adjustments to the attribution methodologies and their performance 
based on the MIPS decile scoring system. We are also limiting the cost 
measures finalized for the CY 2017 performance period to those that 
have been included in the VM or the 2014 sQRUR and that are reliable 
for both individual and group reporting. 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.
    The following is a summary of the comments we received on the 
general provisions of cost measurement within the MIPS program.
    Comment: Several commenters supported the inclusion of cost 
measures as part of the MIPS program, noting the important role of 
clinicians in ordering services and managing care so as to avoid 
unnecessary services.
    Response: We thank the commenters for their support and believe 
that cost is an important element of the MIPS program, reflecting the 
key role of clinicians in guiding care decisions. However, we also 
consider it important to phase in cost measurement. Therefore, we are 
limiting the number of cost measures for the CY 2017

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performance period and lowering the weight of the cost performance 
category to 0 percent in the final score for the transition year, 10 
percent in the second MIPS payment year, and 30 percent in the third 
and following MIPS payment years.
    Comment: Several commenters noted concern with the inclusion of 
cost measures in MIPS because it could cause unethical behavior and 
improper reductions in care, and clinicians control only a small part 
of healthcare costs. Some commenters noted that clinicians do not 
determine the costs of services such as hospital visits, durable 
medical equipment, or prescription drugs. Others asked that cost 
measures should only be used when there is a direct tie to quality 
measurement.
    Response: We agree that cost should be considered in the context of 
quality. The statutory design of the final score incorporates both 
quality and cost such that they are linked in the clinician's overall 
assessment in MIPS. We recognize that clinicians do not personally 
provide, order, or determine the price of all of the individual 
services in the cost measures, but we do believe that clinicians do 
have an effect on the volume and type of services that are provided to 
a patient through better coordination of care and improved outcomes. We 
plan to continue to assess best methods for attributing cost to MIPS 
eligible clinicians.
    Comment: Many commenters supported cost measures being calculated 
using claims data so as not to add additional reporting burden. Some 
commenters expressed concern with cost measures solely calculated based 
on claims and suggested that CMS consider other measures, such as 
appropriate use criteria or elements of Choosing Wisely.
    Response: We agree that claims data can provide valuable 
information on cost and this method has the advantage of not requiring 
additional reporting from MIPS eligible clinicians. We appreciate that 
there are some potential measures related to cost that would not 
necessarily be calculated using claims. Some of these measures, such as 
appropriate use measures, are included, as appropriate, in the quality 
and improvement activity performance categories. We will take into 
consideration the commenter's suggestion related to elements of the 
Choosing Wisely measures in the future and determine whether they may 
be considered as cost measures.
    Comment: Several commenters expressed concern that the proposed 
measures for the cost performance category did not adequately adjust 
costs to account for the risks associated with different types of 
patients. They commented that the measures do not adjust for the 
socioeconomic status, patient compliance, or other non-health factors 
that might contribute to spending. Many of these commenters encouraged 
socioeconomic status to be included as a risk adjustment variable for 
individual measures or the entire program.
    Response: We note that we are establishing, in this final rule with 
comment period, the cost performance category weight as 0 percent of 
the final score for the transition year (MIPS payment year 2019) to 
allow MIPS eligible clinicians to gain experience with these measures 
in MIPS. Although we believe the measures are valid and reliable, we 
will continue to evaluate the potential impact of risk factors, 
including socioeconomic status, on cost measure performance. Please see 
section II.E.5.b.(3) for a discussion of the integration of the 
findings of the ASPE report on socioeconomic factors into the overall 
MIPS program in the future.
    Comment: Several commenters expressed concern that the risk 
adjustment methods used in the cost performance category would not 
adequately address the issues of their particular specialty or field of 
medicine. Many recommended that they only be compared to clinicians who 
had the same specialty.
    Response: We will continue to explore methods to refine our risk 
adjustment methods to accommodate the different types of patients 
treated by clinicians in the Medicare system. We are applying a 
specialty adjustment to the total per capita cost measure because we 
found, when implementing this measure as part of the VM, that there 
were widely divergent costs among patients treated by various 
specialties that were not addressed by other risk adjustment methods. 
The other measures we are including in the cost performance category 
for the CY 2017 performance period accommodate clinical differences in 
other ways. The MSPB measure is adjusted on the basis of the index 
admission diagnosis-related groups (DRGs), which is likely to differ 
based on the specialty of the clinician attributed to the measure. The 
episode-based measures are triggered on the basis of the provision of a 
service that identifies a type of patient who is often seen by a 
certain specialty or limited number of specialties and this concurrent 
risk adjustment is an effective predictor of episode cost. We believe 
that the adjustments contained in these measures adequately 
differentiate patient populations by different specialties and we will 
continue to investigate methods to ensure that the unique attributes of 
various medical specialties are appropriately accounted for within the 
program.
    Comment: Some commenters expressed concern that cost measures would 
discourage the development of new therapies. One commenter suggested 
that CMS not include the costs of new technology within cost measures.
    Response: We wish to ensure that cost measurement does not hinder 
the appropriate uptake of new technologies. One challenge of new 
technologies is that the costs are not represented in the historical 
benchmarks. However, we are finalizing a policy to create benchmarks 
for the cost measures based on the performance period, so the 
benchmarks will build in the costs associated with adoption of new 
technologies in that period. We also anticipate that new technologies 
may reduce the need for other services, which could further reduce the 
cost of care. We believe that excluding new technology from the cost 
measures is not appropriate when the technology is being paid for by 
the Medicare program and its beneficiaries, but we will continue to 
monitor this issue to determine whether adjustments should be made in 
the future.
(b) MACRA Requirements
    Section 1848(q)(2)(A)(ii) of the Act establishes cost as a 
performance category under the MIPS. Section 1848(q)(2)(B)(ii) of the 
Act describes the measures of the cost performance category as the 
measurement of resource use for a MIPS 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.
    As discussed in section II.E.5.e.(1)(c) of the proposed rule, we 
previously established in rulemaking the VM, as required by section 
1848(p) of the Act, that provides for differential payment to a 
physician or a group of physicians (and EPs as the Secretary determines 
appropriate) under the PFS based on the quality of care furnished 
compared to cost. For the evaluation of costs of care, section 
1848(p)(3) of the Act 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

[[Page 77164]]

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 cost 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 Medicare 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 issues 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 CMS Web site an operational list of such groups and codes. 
As required by section 1848(r)(2)(H) of the Act, no 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 CMS 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 Medicare Parts A and B (and, if the Secretary determines 
appropriate, Medicare 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 VM 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) an MSPB measure.
    Total per capita costs (measures 1-5) and the MSPB measure include 
payments under both Medicare Part A and Part B, but do not include 
Medicare payments under Part D for drug expenses. Cost measures for the 
VM are attributed at the physician group and solo practice level using 
the Medicare-enrolled billing TIN. 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 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 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 to, 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

[[Page 77165]]

plurality of Medicare Part B claims (as measured by allowed 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 cost performance category. A summary of those comments 
is located in the proposed rule (81 FR 28198).
(2) Weighting in the Final Score
    As required by section 1848(q)(5)(E)(i)(II)(bb) of the Act, the 
cost performance category shall make up no more than 10 percent of the 
final score for the first MIPS payment year (CY 2019) and not more than 
15 percent of the final score the second MIPS payment year (CY 2020). 
Therefore, we proposed at Sec.  414.1350 that the cost performance 
category would make up 10 percent of the final score for the first MIPS 
payment year (CY 2019) and 15 percent of the final score for the second 
MIPS payment year (CY 2020) (81 FR 28384). As required by section 
1848(q)(5)(E)(i)(II)(aa) of the Act and proposed at Sec.  414.1350 (81 
FR 28384), starting with the third MIPS payment year and for each MIPS 
payment year thereafter, the cost performance category would make up 30 
percent of the final score.
    The following is a summary of the comments we received regarding 
our proposals for the cost performance category weight in the final 
score for the first and second MIPS payment years.
    Comment: Several commenters supported the weighting of the cost 
performance category as 10 percent of the MIPS final score for 2019. 
However, we also had many commenters that encouraged us to reduce the 
weight of the cost performance category to as low as 0 percent for 2019 
due to lack of familiarity with cost measures. Other commenters 
recommended a delay in the inclusion of the cost performance category 
within the final score because attribution methods did not properly 
identify the clinician who was responsible for the care and patients 
could be attributed to clinicians who had little influence on their 
overall care. Others recommended delay because risk adjustment methods 
based on administrative data could not properly capture the clinical 
risk differences among patients, placing clinicians who see more 
complex patients at a disadvantage. Others noted that more time was 
needed to perfect cost measures. Others recommended that cost measures 
be attributed to only those clinicians who volunteer to participate in 
a pilot in the transition year.
    Response: Clinicians have received feedback on cost measures 
through the VM and the Physician Feedback Program reports for a number 
of years; however, we agree that clinicians may need time to become 
familiar with cost measures in MIPS. The VM calculation and the 
Physician Feedback Program are different in two significant ways from 
the proposed approach to cost measurement in the MIPS. The first major 
difference is that we proposed to attribute measures at the TIN/NPI 
level for those submitting as individuals rather than at the TIN level 
used for the VM. While this would not make a difference for those in 
solo practice, it would present a significant change for those that 
practice in groups and participate in MIPS as individuals. In MIPS, we 
have finalized a policy in section II.E.5.a.(2) of this rule that those 
that elect to participate in MIPS as groups, must be assessed for all 
performance categories as groups. Conversely, those that elect to 
participate in MIPS as individual clinicians will be measured on all 
four performance categories as an individual. With the exception of 
solo practitioners (defined for the VM as a single TIN with one EP 
identified by an NPI billing under the TIN), the VM evaluates 
performance at the aggregate group level. For example, a surgeon in a 
multi-specialty group who elects to participate in MIPS as an 
individual would receive feedback on the cost measures attributed to 
him or her individually as opposed to that of the entire group. Second, 
as discussed in section II.E.5.e.(3)(c) of this final rule with comment 
period, to facilitate participation at the individual level, we will 
attribute cases at the TIN/NPI level, rather than at the TIN level, as 
is done currently under the VM. Even for groups that have received 
QRURs on cost measures under the VM, this global change to the 
attribution logic is likely to change the attributed cases, which in 
turn could affect their performance on cost measures.
    In addition, as discussed in section II.E.6.a.(3) of this final 
rule with comment period, scoring for the cost performance category 
under MIPS is different from the VM because it is based on performance 
within a decile system as opposed to the quality-tiering scoring system 
used in the VM. A group or solo practitioner that scored in the average 
range under the VM quality-tiering methodology may be scored ``above 
average'' or ``below average'' in MIPS because of the difference in the 
scoring methods. We believe it is important for this transition year 
for MIPS eligible clinicians to have the opportunity to become familiar 
with the attribution changes and the scoring changes by receiving 
performance feedback showing what their performance on the cost 
measures will look like under the MIPS attribution and scoring rules 
before cost measures affects payment.
    Section 1848(q)(5)(E)(i)(II)(bb) of the Act provides that for the 
first and second MIPS payment years, ``not more than'' 10 percent and 
15 percent, respectively, of a MIPS eligible clinician's final score 
shall be based on performance in the cost performance category. 
Accordingly, we believe that the statute affords discretion to adopt a 
weighting for the cost performance category lower than 10 percent and 
15 percent for the first and second payment years, respectively. For 
these reasons described above, we believe that a transition period 
would be appropriate; we are lowering the weight of the cost 
performance category for the first and second MIPS payment years. We 
are not finalizing our proposal for a weighting of 10 percent for the 
transition year and 15 percent for the second MIPS payment year. 
Instead we are finalizing a weighting of 0 percent for the transition 
year and 10 percent for the second MIPS payment year.
    We are not reducing the weight of the cost category due to concerns 
with attribution, risk adjustment, or the measure specifications. We 
intend to continue improving all aspects of the cost measures, but we 
believe our final methods are sound. However, due to the changes in 
scoring and attribution, we

[[Page 77166]]

agree that MIPS eligible clinicians should have more time to become 
familiar with these measures in the context of MIPS. Finally, we do not 
believe we should restrict the cost performance category to a pilot. 
MIPS eligible clinicians are not required to submit data and the cost 
performance category does not contribute to the final score for the 
transition year. Therefore, we will calculate a cost performance 
category score for all MIPS eligible clinicians for whom we can 
reliably calculate a score.
    Comment: Many commenters encouraged CMS to defer assigning any 
weight to the cost performance category for MIPS until patient 
relationship codes have been in use.
    Response: Section 1848(r)(3) of the Act requires us to develop 
patient relationship categories and codes that define and distinguish 
the relationship and responsibility of a physician or applicable 
practitioner with a patient. We are currently reviewing comments 
received on the draft list of patient relationship categories and will 
post an operational list of these categories and codes in April 2017. 
We disagree with commenters that we should wait until the patient 
relationship codes are in use before measuring cost. While we believe 
that these patient relationship codes can be an important contributor 
to better clarifying the particular role of a clinician in patient 
care, these codes will not be developed in time for the first MIPS 
performance period. Moreover, section 1848(r)(4) directs that such 
codes shall be included, as determined appropriate by the Secretary, on 
claims for items and services furnished on or after January 1, 2018. 
Following their inclusion on claims, we will need time to evaluate how 
best to incorporate those codes into cost measures. While this 
additional analysis of patient relationship codes takes place, the cost 
performance category will remain an important part of the MIPS. In 
their current form, we find the cost measures adopted in this final 
rule with comment period both reliable and valid.
    After consideration of the comments, we believe that a transition 
period for measuring cost would be appropriate; therefore, we are not 
finalizing the weighting of the cost performance category in the MIPS 
final score as proposed. Instead, we are finalizing at Sec.  
414.1350(b) a weighting of 0 percent for the 2019 MIPS payment year and 
10 percent for the 2020 MIPS payment year. Starting with the 2021 MIPS 
payment year, the cost performance category will be weighted at 30 
percent, as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act. We 
recognize that the individual attribution of cost measures for those 
MIPS eligible clinicians in group practices and the new MIPS scoring 
system is a change for clinicians and we would like to give them an 
opportunity to gain experience with the cost measures before increasing 
the weight of the performance category within the final score.
(3) Cost Criteria
    As discussed in section II.E.5.a. of the proposed rule (81 FR 
28181), performance in the cost performance category would be assessed 
using measures based on administrative Medicare claims data. We did not 
propose any additional data submissions for the cost performance 
category. As such, MIPS eligible clinicians and groups would be 
assessed based on cost 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) of the 
proposed rule would not be measured on cost. For more discussion of 
MIPS eligible clinicians and groups without a cost performance category 
score, please refer to II.E.6.a.(3)(d) and II.E.6.b.(2) of this final 
rule with comment period.
(a) Value Modifier Cost Measures Proposed for the MIPS Cost Performance 
Category
    For purposes of assessing performance of MIPS eligible clinicians 
on the cost performance category, we proposed at Sec.  414.1350(a) to 
specify cost measures for a performance period (81 FR 28384). For the 
CY 2017 MIPS performance period, we proposed 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 the proposed rule (81 
FR 28200) for the cost performance category. The total per capita costs 
measure and the MSPB measure are described in section II.E.5.e.(1)(c) 
of the proposed rule (81 FR 28197). We proposed including the total per 
capita cost measure as it is a global measure of all Medicare Part A 
and Part B resource use during the MIPS performance period and 
inclusive of the four condition-specific total per capita cost 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 and feedback has been reported through the annual QRUR to all 
groups starting in 2014.
    We proposed 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 (VBP) Program. 
However, we proposed two technical changes to the MSPB measure 
calculations for purposes of its adoption in MIPS which were discussed 
in the proposed rule at 81 FR 28200.
    We proposed to use the same methodologies for payment 
standardization, and risk adjustment for these measures for the cost 
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 did not propose to include the four condition-specific total per 
capita cost measures (chronic obstructive pulmonary disease, congestive 
heart failure, coronary artery disease, and diabetes mellitus). 
Instead, we generally proposed to assess performance in part using the 
episode-based measures (81 FR 28200). 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-specific total per capita cost measures 
under the VM are relevant to their practice and expressed support for 
episode-based measures under MIPS.
    The following is summary of the comments we received regarding our 
proposal to include the total per capita cost measure and MSPB measure 
as cost measures.
    Comment: Several commenters supported the inclusion of the total 
per capita cost measure.
    Response: We will include the total per capita cost measure in the 
CY 2017 performance period.
    Comment: Several commenters opposed the inclusion of the total per 
capita cost measure because it was developed to measure hospitals.
    Response: We believe that the commenters may have confused the 
total per capita cost measure with the MSPB measure, which was 
originally developed for use in the Hospital Value

[[Page 77167]]

Based Purchasing program and is triggered on the basis of an index 
admission. The total per capita cost measure was not developed for nor 
ever used to measure quality or cost by a hospital in a Medicare 
program. Many patients who are attributed under the total per capita 
cost measure are not admitted to a hospital in a calendar year. The 
total per capita cost measure has been a part of the VM program since 
inception.
    Comment: A commenter opposed the inclusion of the total per capita 
cost measure because it focused on primary care.
    Response: The MIPS program aims to measure the cost of all 
clinicians, both primary care and specialists. While the total per 
capita cost measure may be more likely to be attributed to clinicians 
that provide primary care and uses a primary care attribution method, 
other measures may be more likely to be attributed to specialists. 
Including a diversity of measures allows the program to measure all 
types of clinicians.
    Comment: A commenter opposed the inclusion of the total per capita 
cost measure and instead urged CMS to speed development of episode-
based measures.
    Response: We plan to incorporate episode-based measures within the 
cost performance category of the MIPS program. We proposed to include 
41 episode-based measures for the CY 2017 performance period (81 FR 
28200) and plan to continue to develop more episode groups. However, we 
believe there is value to continue to include the total per capita cost 
measure as well. Not all patients will necessarily be attributed in 
episode-based measures and the total per capita cost measure is the 
best current measure of all patients.
    Comment: A commenter supported the CMS decision not to propose for 
the cost performance category the four condition-specific total per 
capita cost measures that are used in the Value Modifier because they 
are duplicative of the total per capita cost measure covering all 
patients. Several commenters recommended that the four condition-
specific total per capita cost measures be used in the cost performance 
category.
    Response: We intend to use episode-based measures for specific 
disease focus areas in future years. We believe that the design of 
episode-based measures which incorporate clinical input and distinguish 
related from unrelated services will better allow clinicians to improve 
performance on a particular population of patients. We will not include 
the four condition-specific total per capita cost measures in MIPS.
    Comment: Several commenters opposed the inclusion of a specialty 
adjustment within the total per capita cost measure because this 
adjustment would reward specialties that provide more expensive 
treatments.
    Response: The specialty adjustment for the total per capita cost 
measure has been used since the 2016 VM, which was based on 2014 data. 
We reviewed the different expected costs associated with various 
specialties as part of the CY 2014 PFS rulemaking and found substantial 
differences in average costs for attributed patients. For example, 
specialties such as medical oncology tend to treat relatively costly 
beneficiaries and bill for expensive Part B drugs but other specialties 
such as dermatology tend to treat low cost patients. Although cost data 
are adjusted to account for differences in patient characteristics, the 
effects of this adjustment do not fully account for the differences in 
costs associated with different specialties under this measure; 
therefore, we believe this adjustment is still warranted in MIPS. We 
are open to ways to improve the risk adjustment of this measure in the 
future to ensure that it appropriately evaluates all specialties of 
medicine.
    Comment: Several commenters supported the inclusion of a specialty 
adjustment within the total per capita cost measure because patients 
who become sick often seek more care from specialists and their 
expected costs would not be reflected within the risk adjustment 
methodology.
    Response: We believe the specialty adjustment is a necessary 
element of the total per capita cost measure. The MSPB and episode-
based measures are designed with expected costs based in part on the 
clinical condition or procedure that triggers an episode. However, the 
total per capita cost measure is risk adjusted only on the basis of 
clinical conditions before the performance period. This risk adjustment 
cannot completely accommodate changes in source of care that are the 
result of new onset illness during the performance period. The 
specialty adjustment helps to accommodate for the differences in the 
types of patients seen by different specialists.
    Comment: A commenter recommended that costs associated with a 
hospital visit should not be included in the total per capita cost 
measure because multiple physicians are often involved.
    Response: We do not believe that excluding hospital services from 
the total per capita cost measure would be consistent with an overall 
focus on care coordination that may extend to periods when a patient is 
hospitalized.
    Comment: Several commenters supported the inclusion of the MSPB 
Measure.
    Response: We believe that this measure is both familiar to 
clinicians from use in the VM and QRUR and reflects a period of care in 
which a clinician may be able to influence cost. We will finalize the 
MSPB measure.
    Comment: Several commenters opposed the inclusion of the MSPB 
measure because it was developed to measure hospitals. Others suggested 
that it not be included in MIPS until it had been analyzed for use in a 
clinician program. Several comments opposed the inclusion of the MSPB 
measure because it focuses on primary care. Other commenters suggested 
the episode-based measures better measured specialists.
    Response: While this measure was originally used as part of the 
Hospital Value-Based Purchasing program, the MSPB measure has also been 
used in the VM, a clinician program, since 2016 and we continue to 
believe that the clinician who provides a significant number of 
services during a hospital visit also has some responsibility for 
overall cost. We also see value in using common measures to create 
parallel incentives for hospitals and MIPS eligible clinicians to 
coordinate care and achieve efficiencies. We believe that the MSPB 
measure will be attributed to all clinicians who provide significant 
care in the hospital, including specialists and primary care clinicians 
to the extent which they admit patients to the hospital. If a clinician 
does not provide hospital services, that clinician will not be 
attributed any cases to be scored on the measure.
    Comment: Several commenters expressed concern that cost measures 
could attribute patients for services before they are seen by the 
clinician to whom they are attributed. For example, a clinician could 
take over responsibility for primary care of a patient who had 
experienced health difficulties in the earlier part of the year that 
resulted in emergency room visits and hospital admissions that were 
partly due to the result of a lack of care coordination. This patient 
may not have had more than one visit with a particular clinician before 
this new clinician took over, resulting in all costs being attributed 
to the individual once he or she billed for two office visits for that 
patient.
    Response: Our attribution methods aim to measure the influence of a

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clinician on the cost of care of his or her patients. In some cases, 
certain elements within the cost measure may not be directly related to 
the performance of the attributed clinician. We aim to address this by 
requiring a minimum case volume and risk adjusting so that clinicians 
are compared on the basis of similar patient populations. We will 
continue to work with stakeholders to improve cost measures.
    Comment: Several commenters noted that the same costs could be 
included in the total per capita cost measure, the MSPB measure, and 
the episode-based measures and suggested that costs should only be 
counted once for an individual physician.
    Response: We believe that attempting to remove costs from one 
measure because they are reflected in another measure would make it 
much harder for clinicians to understand their overall performance on 
measures within the cost performance category. Measures are constructed 
to capture various components of care. In some cases, a clinician or 
group may provide primary care or episodic care for the same patient 
and we believe that costs should be considered in all relevant measures 
to make the measure performance comparable between MIPS eligible 
clinicians.
    Comment: One commenter recommended that CMS use a total cost of 
care measure developed using a different methodology that is not 
limited to Medicare and instead captures data from all payer claims 
databases.
    Response: We are unaware of a national data source that would allow 
us to accurately capture cost data for payers. Therefore, we are 
limited to using Medicare cost data for the total per capita cost 
measure. Following our consideration of the comments, we will finalize 
our proposal to include the total per capita cost measure and the MSPB 
measure within the MIPS cost performance category for the CY 2017 
performance period. We believe these measures have the advantage of 
having been used within the VM and covering a broad population of 
patients.
(i) Attribution
    In the VM, all cost measures are attributed to a TIN. In MIPS, 
however, we proposed to evaluate performance at the individual and 
group levels. Please refer to section II.E.5.e.(3)(c) of this rule for 
our discussion 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 proposed 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 allowed charges) for Medicare Part 
B services, rendered during an inpatient hospitalization that is an 
index admission for the MSPB measure during the applicable performance 
period 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 proposed to use a two-step attribution 
methodology that is similar to the methodology used in the 2017 and 
2018 VM. We also proposed to have the same two-step attribution process 
for the claims-based population measures in the quality performance 
category (81 FR 28192), CMS Web Interface measures, and CAHPS for MIPS. 
However, we also proposed 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 Healthcare Common Procedure Coding 
System (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 proposed to update this 
set to include new care coordination codes that have been implemented 
in the PFS: 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 (place of service 
(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 proposed 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 two-step attribution process.
    We note, however, that while we are aligning the definition for 
primary care services, the two-step attribution for MIPS would be 
different from 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 Savings Program final rule, we 
finalized a policy for the Shared Savings Program that we did not 
extend to the VM two-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 claims-based population measures which rely on 
the same two-step attribution. While we do not believe that many MIPS 
eligible clinicians or 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

[[Page 77169]]

and groups that should be measured for cost.
    We requested comments on these proposed changes.
    The following is a summary of the comments we received regarding 
our proposal to use the attribution methods from the VM for the MSPB 
and total per capita cost measure with changes to the definition of 
primary care services.
    Comment: Some commenters recommended that attribution be based in 
part on a patient attestation of their relationship with a clinician.
    Response: We do not currently have a method for patients to attest 
to their relationship with a clinician so are unable to incorporate 
this mechanism into cost measures at this time. We will continue to 
work on improving attribution.
    Comment: Several commenters opposed the attribution method used in 
the MSPB of assigning patients to all physicians who provided at least 
30 percent of inpatient care, indicating that the attribution method 
had not been fully tested.
    Response: The MSPB measure attributes patients to the clinician 
that provided the plurality of Medicare Part B charges during the index 
admission, not to all clinicians who provide at least 30 percent of 
inpatient care. We believe that this method is the best way to identify 
the single clinician who most influenced the care during a given 
hospital admission.
    Comment: A commenter supported the exclusion of skilled nursing 
facility codes from the list of codes used to attribute the total per 
capita cost measure because patients in skilled nursing facilities 
require high intensity time-limited care.
    Response: We are finalizing the exclusion of skilled nursing 
facility codes as proposed.
    Comment: Several commenters expressed concern that incident-to 
billing practices, in which physicians bill for services provided by 
other clinicians such as nurse practitioners or physician assistants, 
obscure the actual clinician providing care and make attribution 
difficult. A commenter suggested that a new modifier be created to 
indicate when a service was provided under incident-to rules.
    Response: ``Incident to'' billing is allowed, consistent with Sec.  
410.26 of our regulations, when auxiliary personnel provide services 
that are an integral, though incidental, part of the service of a 
clinician, and are commonly furnished without charge or included in the 
bill of a clinician. ``Incident to'' services are furnished under the 
supervision of the billing clinician, and with certain narrow 
exceptions, under direct supervision. These services are billed and 
paid under the PFS as if the billing clinician personally furnished the 
service. We recognize that some services of certain MIPS eligible 
clinicians may be billed as incident to the services of others. 
However, given that the billing clinician provides the requisite 
supervision and bills for the service as if it was personally 
furnished, we do not believe ``incident to'' billing interferes with 
appropriate attribution of services. If this is a concern for certain 
MIPS eligible clinicians, we believe billing practices could be 
adjusted such that services are billed by the individual MIPS eligible 
clinician who provides the service.
    Comment: A commenter expressed concern that attributing care to a 
single professional or group for costs could cause compartmentalization 
of care.
    Response: The cost measures that are used in MIPS aim to measure 
how a particular clinician or group impacts a patient's cost, both 
directly or indirectly. We have aimed to design a program that 
encourages more consideration of the costs of care associated with 
patients even after other clinicians become involved, so the measures 
require that clinicians who are most significantly responsible for 
their care, as measured by Medicare allowed amounts, assume 
accountability for it. We believe this system will encourage more 
coordination of care and consideration of cost.
    Comment: A commenter opposed the inclusion of transition care 
management within the list of codes used to attribute the total per 
capita cost measure, noting that these codes are often used by 
specialists that may not have overall responsibility for care.
    Response: We believe that those clinicians who are billing for 
transitional care management are providing significant services that 
reflect oversight for a patient. In some cases, the clinician providing 
transitional care management is different from the one providing 
primary care but in other cases it is the same individual. We believe 
that our attribution method of assigning patients to the clinician who 
provides the plurality of primary care services (which includes many 
services other than transitional care management) is the best method to 
attribute the total per capita cost measure. This change is consistent 
with the attribution methods that are used in the Shared Savings 
Program.
    After considering comments, we are finalizing our proposal to use 
modified attribution methods from the VM for the total per capita cost 
measure and the MSPB. Specifically, we are also finalizing the removal 
of skilled nursing facility codes (CPT codes 99304-99318) from and 
addition of transitional care management (CPT codes 99495-99496) and 
chronic care management codes (CPT code 99490) to the list of primary 
care services used to attribute the total per capita cost measure. We 
believe that the changes to the attribution methodology allow us to 
better identify the clinician or group and the extent of accountability 
for total per capita cost.
(ii) Reliability
    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 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 cost performance 
category in MIPS, we also proposed at Sec.  414.1380(b)(2)(ii) to use 
the minimum of 20 cases for the total per capita cost measure (81 FR 
28386), 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 the MSPB measure, 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

[[Page 77170]]

proposed two modifications to the MSPB measure.
    The first technical change we proposed was 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, and as our analysis below indicated, reliability for 
the measure improves when then adjustment is removed.
    The second technical change we proposed was 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 ratio for the MIPS eligible 
clinician or group and multiply it by the average of observed costs 
across all episodes nationally, in order to convert a ratio to a dollar 
amount.
    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 indicated 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 proposed 
to use a minimum of 20 cases for the MSPB measure (81 FR 28386). 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 welcomed public comment on these proposals.
    The following is summary of the comments we received regarding our 
proposals to use a 0.4 reliability threshold and a minimum of 20 cases 
for the total per capita cost measure.
    Comment: Many commenters expressed concern with the proposed 0.4 
reliability threshold for cost measures. Many commenters suggested that 
only measures with high reliability (over 0.7 or 0.8) be used within 
the program.
    Response: We believe that measures with a reliability of 0.4 with a 
minimum attributed case size of 20 meet the standards for being 
included as cost measures within the MIPS program. We aim to measure 
cost for as many clinicians as possible and limiting measures to 
reliability of 0.7 or 0.8 would result in few individual clinicians 
with attributed cost measures. In addition, a 0.4 reliability threshold 
ensures moderate reliability for most MIPS eligible clinicians or group 
practices that are being measured on cost.
    We will finalize our reliability threshold of 0.4 but will continue 
to work to develop measures and improve specifications to ensure the 
highest level of reliability feasible within the cost measures in the 
MIPS program. We did not receive any specific comments on the our 
proposal to use a minimum of 20 cases for the total per capita cost 
measure. We are finalizing at Sec.  414.1380(b)(2)(ii) that a MIPS 
eligible clinician must meet the minimum case volume specified by CMS 
to be scored on a cost measure. Therefore, a MIPS eligible clinician 
must have a minimum of 20 cases to be scored on the total per capta 
cost measure.
    The following is a summary of the comments we received regarding 
our proposal to modify the case minimum for the MSPB, the proposal to 
remove the specialty adjustment from the MSPB measure's calculation, 
and the proposal to modify the cost ratio used within the MSPB 
equation.
    Comment: Several comments opposed the 20 case minimum for MSPB, 
noting that CMS had previously increased the minimum to 125 within the 
VM program and that the 20 case minimum did not meet our standard of 
0.4 reliability threshold.
    Response: We understand the concerns of the commenters. We would 
like to reiterate that the proposed adjustments to the MSPB measure 
improve its reliability at 20 cases. As stated in the proposed rule, 
these changes result in the measure meeting 0.4 reliability for over 88 
percent of TINs with at least 20 attributed cases, including solo 
practitioners. In MIPS, however, we must assess reliability at the 
individual clinician level as well as the TIN level because clinicians 
may choose to be assessed as individuals or part of a group in the MIPS 
program. Therefore, we reran the reliability analysis for the proposed 
MSPB using 2015 data to assess the impact at the TIN/NPI level. Table 6 
summarizes the results for different case volumes. This analysis 
indicates only 77 percent of individual TIN/NPIs have 0.4 reliability 
at a 20 case volume. Therefore, we will increase the minimum case 
volume to 35 cases which has a 0.4 reliability threshold for 90 percent 
of individual TIN/NPIs and 97 percent of TINs that are attributed.

                           Table 6--Proposed MSPB Reliability With TIN/NPI Attribution
----------------------------------------------------------------------------------------------------------------
                                                                    Minimum 20      Minimum 30      Minimum 35
  Reliability of revised MSPB measure using TIN/NPI attribution     cases  (%)      cases  (%)      cases  (%)
----------------------------------------------------------------------------------------------------------------
Percent of TIN/NPIs with 0.4 reliability at different minimum                 77              86              90
 case volume requirements.......................................
Percent of TINs with 0.4 reliability at different minimum case                90              95              97
 volume requirements............................................
----------------------------------------------------------------------------------------------------------------


[[Page 77171]]

    Comment: Several comments supported the removal of specialty 
adjustment from the MSPB measure, noting that in some cases certain 
specialties may have higher spending that is not appropriate based on 
the condition of the patient. Several other commenters opposed the 
removal of the specialty adjustment from the MSPB measure because it 
would disadvantage those specialists who care for the sickest patients 
and not recognize the differences in the types of patients seen by 
different specialties. Some commenters opposed the change in the 
calculation of observed to expected ratio at the episode level rather 
than the clinician or group level.
    Response: The MSPB measure includes not only risk adjustment to 
capture the clinical conditions of the patients in the period prior to 
the index admission, but also includes risk adjustment that reflects 
the clinical presentation based on the index MS-DRG. We believe that 
including the index MS-DRG helps to identify a pool of patients either 
receiving a procedure or admitted for a particular medical condition 
and the HCC risk adjustment helps to adjust for comorbidities which may 
suggest that a clinician is treating patients who are sicker than most 
within that pool. Since there is less variation in the specialties 
caring for a particular type of MS-DRG, adding specialty adjustment 
reduces reliability. We will continue to analyze all cost measures to 
ensure they include the proper risk adjustment and meet our reliability 
threshold.
    We are finalizing at Sec.  414.1380(b)(2)(ii) that a MIPS eligible 
clinician must meet the minimum case volume specified by CMS to be 
scored on a cost measure. Following our consideration of the comments, 
we are not finalizing our proposal of a minimum case volume of 20 for 
the MSPB measure. Instead, we are finalizing a minimum case volume of 
35 for the MSPB. We are also adopting our proposals to not adjust the 
MSPB measure by specialty and to calculate observed to expected ratio 
at an episode level. We will continue to analyze the measure to ensure 
reliability.
(b) Episode-Based Measures Proposed for the MIPS Cost Performance 
Category
    As noted in the previous section, we proposed to calculate several 
episode-based measures for inclusion in the cost 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 cost 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 proposed 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 reiterated 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 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 proposed to include in the cost 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) 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 (81 FR 28202-28206) 
and 5 (81 FR 28207) of the proposed rule listed the 41 clinical 
condition and treatment episode-based measures proposed for the CY 2017 
performance period, as well as whether the episodes have previously 
been reported in a sQRUR.
    While we proposed the measures listed in Tables 4 and 5 of the 
proposed rule for the cost performance category, we stated in the 
proposed rule that we were uncertain as to how many of these measures 
we would ultimately include in the final rule with comment period. As 
these measures have never been used for payment purposes, we indicated 
that we may choose to specify a subset of these measures in the final 
rule with comment period. We requested public comment on which of the 
measures listed in Tables 4 and 5 of the proposed rule to include in 
the final rule with comment period. In addition to considering public 
comments, we intended 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 solicited comment on 
whether we should specialty adjust the episode-based measures.
    The following is summary of the comments we received regarding the 
episode-based measures proposed for the cost performance category for 
the CY 2017 performance period.
    Comment: Several comments supported the inclusion of episode-based 
measures because they more closely tracked a clinician's influence on 
the care provided than total per-capita cost measures.
    Response: Episode-based measures are an important component of the 
overall measurement of cost and we are finalizing a subset of episode-
based measures.
    Comment: Several commenters supported the eventual inclusion of 
episode-based measures in the cost performance category but opposed the 
inclusion of these measures in the transition year of MIPS because 
clinicians are not familiar with them yet and have not had the 
opportunity to receive feedback on them. Commenters

[[Page 77172]]

recommended a more transparent process in the development of episode 
groups. Others recommended that only those measures included in the 
sQRUR in previous years be included in the transition year of the MIPS 
program.
    Response: We agree with the commenters. Even though we have reduced 
the weight of the cost performance category to 0 percent for the first 
MIPS payment year, we believe that clinicians would benefit from more 
exposure to these episode-based measures and how they might be scored 
before they are included in the MIPS final score. While 14 of the 
episode-based measures we proposed were included in the 2014 sQRUR, a 
number of them have never been included in the VM or a sQRUR. 
Therefore, as discussed below, we are finalizing a subset of the 
proposed episode-based measures, which have been included in the sQRUR 
for 2014 and meet our reliability threshold of 0.4. We note that we 
selected episodes from the 2014 sQRUR because these measures have been 
included in 2 years of sQRUR (2014 and 2015) which provides clinicians 
an opportunity for initial feedback before the MIPS performance period 
begins although the feedback does not contain any scoring information, 
nor does it contain the updated attribution changes.
    In addition, we intend to provide performance feedback to 
clinicians on additional episode-based measures that we are not 
finalizing for inclusion in the MIPS cost performance category for the 
CY 2017 performance period but may want to consider proposing for 
inclusion in the MIPS cost performance category in the future. Section 
1848(q)(12)(A)(i) of the Act requires that we provide timely 
confidential feedback to MIPS eligible clinicians on their performance 
under the cost performance category. While the feedback on these 
additional episode-based measures would be for informational purposes 
only, we believe it will aid in MIPS eligible clinicians' ability to 
understand the measures and the attribution rules and methods that we 
use to calculate performance on these measures, which may be helpful in 
the event that we decide to propose the measures for the MIPS cost 
performance category in future rulemaking.
    Comment: Some commenters suggested that 41 episode-based measures 
was too many and that a smaller number should be used in the program. 
Another commenter suggested that CMS establish a maximum number of 
episode-based measures that may be attributed to a particular clinician 
or group.
    Response: We believe that a large number of episode-based measures 
is needed to capture the diversity of clinicians in the MIPS program, 
as many clinicians may only have a small number of attributable 
episodes. While some large multispecialty groups may have a large 
number of episodes attributed, we believe this reflects the diversity 
of care that they are providing to patients. However, for the CY 2017 
performance period, we are finalizing a reduced set of measures which 
are reliable at the group (TIN) and individual (TIN/NPI) level and 
where feedback has been previously presented to eligible clinicians or 
groups.
    As discussed in the preceding response, we also intend to provide 
performance feedback to MIPS eligible clinicians under section 
1848(q)(12)(A)(i) of the Act on additional episode-based measures for 
informational purposes only.
    Comment: A commenter suggested that CMS provide technical 
assistance to specialty societies and other organizations in order to 
develop episode groups for specialty care.
    Response: Episode development under section 1848(r) of the Act will 
continue. This process includes extensive communication with technical 
experts in the field and stakeholders but does not provide for 
technical assistance to organizations.
    Comment: A commenter opposes the use of episode-based measures for 
upper respiratory infection (measure 33) and deep vein thrombosis of 
extremity (measure 34) because they are likely to occur in high risk 
patients.
    Response: For the CY 2017 performance period, we are only 
finalizing episode-based measures which have been previously reported 
in the 2014 supplemental QRUR and meet our reliability thresholds. 
Upper respiratory infection and deep vein thrombosis of extremity were 
not included in the 2014 sQRUR, therefore we are not finalizing these 
measures for the MIPS CY 2017 performance period. We intend to develop 
episode-based measures that cover patients with various levels of risk. 
We believe that the advantage of episode-based measures is defining a 
certain patient population that will be similar even if everyone is 
high risk. In addition, episode-based measures are risk adjusted in the 
same fashion as the other cost measures that were proposed to be 
included within the program.
    Comment: Several commenters suggested development of future 
episode-based measures because many clinicians do not have episode-
based measures for patients they treat.
    Response: We intend to continue to develop episode-based measures 
that cover more procedures and conditions and invite stakeholder 
feedback on additional conditions or procedures.
    Comment: A commenter expressed concern that ICD-9-CM codes are 
insufficient to be used within episode-based measures because they do 
not contain enough clinical data to predict costs. Others suggested 
that the measures should be updated to use ICD-10-CM codes.
    Response: ICD-9-CM was used for diagnosis coding for Medicare 
claims until October 1, 2015. Because ICD-9-CM codes were required for 
billing for all services, we believe they are the richest source of 
clinical data available to allow us to specify and risk adjust episode-
based measures. The transition from ICD-9-CM to ICD-10-CM took place on 
October 1, 2015. There are many more diagnosis codes available in ICD-
10-CM than in ICD-9-CM which reflect increased specificity in some 
clinical areas. In preparation for the transition to ICD-10-CM, a 
crosswalk of diagnosis codes from ICD-9-CM to ICD-10-CM was created and 
this was used for the transition of coverage policies and other 
documents that include diagnosis codes. We expect to use this crosswalk 
as a baseline for our transition work but understand that there may be 
changes that need to be made to accommodate the different use of 
diagnostic codes with ICD-10-CM.
    Comment: Commenter suggests CMS consider episode-based measures for 
chronic conditions that do not have an inpatient trigger, so that costs 
for chronic conditions can be assessed under the cost performance 
category even if an inpatient stay does not occur.
    Response: We will continue to work to develop episode-based 
measures and our work is not limited to those conditions that include 
an inpatient stay.
    Comment: Commenter stated that there is difficulty in attributing 
an episode-based measure to a clinician providing a diagnostic service.
    Response: One feature of episode-based measures is that they allow 
for the creation of a list of related services for a particular 
condition or procedure. This means that episode-based measures could be 
triggered on the basis of a diagnostic service if experts could develop 
a list of services that are typically related. Among our ten finalized 
episode-based measures is one triggered on the basis of colonoscopy, 
which is a diagnostic service.
    Comment: A commenter indicated that future development of episode-
based measures should not be limited to

[[Page 77173]]

Methods A and B as described in the rule.
    Response: We generally believe that a consistent approach to cost 
measure development is easier to understand and fair to all clinicians. 
However, we recognize that cost measure development is ongoing and will 
continue to investigate methods to best capture the contributions of 
individual clinicians and groups to cost and will consider other 
methods if they are necessary.
    Comment: Several commenters expressed concern with particular 
elements of the technical specifications of certain episode-based 
measures. One commenter requested that pneumatic compression devices be 
added as a relevant service to the VTE episode-based measure, that 
patient-activated event recorders be removed from the list of relevant 
services from the heart failure (chronic) episode-based measure, that 
AV node ablation be removed from the list of relevant services from 
Atrial Fibrillation/Flutter Chronic episode-based measure along with 
other recommendations.
    Response: As we mentioned, we want to use episode-based measures 
that meet our reliability threshold and for which we have provided 
feedback through the 2014 sQRUR. We invite continued feedback on the 
episode-based measures as they are created and refined through the 
process outlined in section 1848(r) of the Act. However, we are not 
modifying the specifications for any of the episodes that we are 
finalizing in this rule.
    Comment: A commenter recommended that that the osteoporosis and 
rheumatoid arthritis episode-based measures should not be included in 
cost measurement in the transition year because the episode-based 
measures have not been thoroughly vetted.
    Response: Although all episode-based measures were created with 
clinical input, the measures identified by the commenters were not 
included in the 2014 sQRUR, so individual clinicians may be unfamiliar 
with them before the MIPS performance period. Therefore, we are not 
finalizing these episode-based measures for the CY 2017 performance 
period.
    Comment: A commenter expressed concern with the use of HCC scores 
to risk adjust episode-based measures because HCC scores have been 
shown to under-predict costs for high cost patients or for patients in 
rural areas.
    Response: We are unaware of other risk adjustment methodologies 
that are more appropriate than HCC for Medicare beneficiaries. We will 
continue to conduct analyses to ensure that risk adjustment is as 
precise as possible to ensure that clinicians are not inappropriately 
disadvantaged because of the use of this risk adjustment methodology.
    Comment: A commenter supported the use of procedure codes to 
trigger the episode-based measure for cataract surgery as opposed to 
the licensure status of the physician. Another commenter expressed 
concern with the episode-based measure for cataract surgery because it 
did not reflect previous discussions with CMS regarding this episode-
based measure.
    Response: We will continue to work to improve the specifications of 
the episode-based measures. We are finalizing the episode-based measure 
for Lens and Cataract Procedures because it meets our reliability 
threshold and was included in the 2014 sQRUR. We offered stakeholders 
the opportunity to review measure specifications for all of the 
episode-based measures under development in a posting in February 2016 
and invite continued feedback on the specifications going forward.
    Comment: A commenter recommended that CMS provide more guidance on 
the implications of billing for a trigger code for the lens and 
cataract episode-based measure and including a modifier for 
preoperative management only (modifier 56) or postoperative management 
only (modifier 55).
    Response: Clinicians who bill for services with modifiers that 
indicate that they did not actually perform the index procedure will 
not be attributed for the costs associated with that episode.
    We appreciate the enthusiasm expressed by many commenters for the 
development of episode-based measures and their more nuanced focus on 
particular types of care. We also understand the concerns expressed 
regarding lack of familiarity with the episode-based measures. For this 
reason, we are modifying our proposal and finalizing for the CY 2017 
performance period only 10 episode-based measures from the proposed 
rule. All of these measures were included in the 2014 sQRUR and meet 
the reliability threshold of 0.4 for the majority of clinicians and 
groups at a case minimum of 20. Table 7 includes the episode-based 
measures that are finalized for the CY 2017 performance period and 
includes their reliability, which we calculated using data from the 
2015 sQRUR when the measure is attributed at the TIN level, as in the 
VM, and when attributed at the TIN/NPI level, as we will do under the 
MIPS program. The measures listed in Table 7 will be used (along with 
the total per capita cost measure and the MSPB measure finalized in 
this rule) to determine the cost performance category score. As we 
noted earlier, the weight of the cost category is 0 percent for 2019 
MIPS payment year, therefore the performance category score will 
provide information to MIPS eligible clinicians, but performance will 
not affect the final score for the 2019 MIPS payment year.

                  Table 7--Episode-Based Measures Finalized for the CY 2017 Performance Period
----------------------------------------------------------------------------------------------------------------
Method type/ measure number from                                                      % TINs        % TIN/NPIs
 Table 4 (Method A)  and Table 5       Episode name and        Included in 2014     meeting 0.4     meeting 0.4
  (Method B) from  proposed rule          description                sQRUR          reliability     reliability
                *                                                                    threshold       threshold
----------------------------------------------------------------------------------------------------------------
A/1.............................  Mastectomy (formerly        Yes...............            99.6           100.0
                                   titled ``Mastectomy for
                                   Breast Cancer'')--
                                   Mastectomy is triggered
                                   by a patient's claim with
                                   any of the interventions
                                   assigned as Mastectomy
                                   trigger codes. Mastectomy
                                   can triggered by either
                                   an ICD procedure code, or
                                   CPT codes in any setting
                                   (e.g. hospital, surgical
                                   center).
A/5.............................  Aortic/Mitral Valve         Yes...............            93.9            92.0
                                   Surgery--Open heart valve
                                   surgery (Valve) episode
                                   is triggered by a patient
                                   claim with any of Valve
                                   trigger codes.

[[Page 77174]]

 
A/8.............................  Coronary Artery Bypass      Yes...............            96.9            94.8
                                   Graft (CABG)--Coronary
                                   Artery Bypass Grafting
                                   (CABG) episode is
                                   triggered by an inpatient
                                   hospital claim with any
                                   of CABG trigger codes for
                                   coronary bypass. CABG
                                   generally is limited to
                                   facilities with a Cardiac
                                   Care Unit (CCU); hence
                                   there are no episodes or
                                   comparisons in other
                                   settings.
A/24............................  Hip/Femur Fracture or       Yes...............            88.9            76.1
                                   Dislocation Treatment,
                                   Inpatient (IP)-Based--
                                   Fracture/dislocation of
                                   hip/femur (HipFxTx)
                                   episode is triggered by a
                                   patient claim with any of
                                   the interventions
                                   assigned as HipFxTx
                                   trigger codes. HipFxTx
                                   can be triggered by
                                   either an ICD procedure
                                   code or CPT codes in any
                                   setting.
B/1.............................  Cholecystectomy and Common  Yes...............            89.6            81.8
                                   Duct Exploration--
                                   Episodes are triggered by
                                   the presence of a trigger
                                   CPT/HCPCS code on a claim
                                   when the code is the
                                   highest cost service for
                                   a patient on a given day.
                                   Medical condition
                                   episodes are triggered by
                                   IP stays with specified
                                   MS-DRGs.
B/2.............................  Colonoscopy and Biopsy--    Yes...............           100.0            99.9
                                   Episodes are triggered by
                                   the presence of a trigger
                                   CPT/HCPCS code on a claim
                                   when the code is the
                                   highest cost service for
                                   a patient on a given day.
                                   Medical condition
                                   episodes are triggered by
                                   IP stays with specified
                                   MS-DRGs.
B/3.............................  Transurethral Resection of  Yes...............            95.2            95.5
                                   the Prostate (TURP) for
                                   Benign Prostatic
                                   Hyperplasia--For
                                   procedural episodes,
                                   treatment services are
                                   defined as the services
                                   attributable to the MIPS
                                   eligible clinician or
                                   group managing the
                                   patient's care for the
                                   episode's health
                                   condition.
B/5.............................  Lens and Cataract           Yes...............            99.7            99.5
                                   Procedures--Procedural
                                   episodes are triggered by
                                   the presence of a trigger
                                   CPT/HCPCS code on a claim
                                   when the code is the
                                   highest cost service for
                                   a patient on a given day.
B/6.............................  Hip Replacement or Repair-- Yes...............            97.8            97.7
                                   Procedural episodes are
                                   triggered by the presence
                                   of a trigger CPT/HCPCS
                                   code on a claim when the
                                   code is the highest cost
                                   service for a patient on
                                   a given day.
B/7.............................  Knee Arthroplasty           Yes...............            99.9            99.8
                                   (Replacement)--Procedural
                                   episodes are triggered by
                                   the presence of a trigger
                                   CPT/HCPCS code on a claim
                                   when the code is the
                                   highest cost service for
                                   a patient on a given day.
----------------------------------------------------------------------------------------------------------------
* Table 4 of the proposed rule is located on 81 FR 28202-28206; Table 5 of the proposed rule is located at 81 FR
  28207.

    In addition, for informational purposes, we intend to provide 
feedback to MIPS eligible clinicians under section 1848(q)(12)(A)(i) of 
the Act on the additional episode-based measures which may be 
introduced into MIPS in future years. We believe it will aid in MIPS 
eligible clinicians' ability to understand the measures and the 
attribution rules and methods that we use to calculate performance on 
these measures, which may be helpful in the event that we decide to 
propose the measures for the MIPS cost performance category in future 
rulemaking.
(i) Attribution
    For the episode-based measures listed in Tables 4 and 5 of the 
proposed rule (81 FR 28202), we proposed 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 or group level. Please 
refer to 81 FR 28208 of the 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 episode-based measures 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 2 
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

[[Page 77175]]

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 Medicare Part B claim with a trigger code 
for the episode, then that episode is not attributed to any MIPS 
eligible clinician.
    The following is a summary of the comments we received regarding 
our attribution methodology for the episode-based measures:
    Comment: A commenter suggested that episodes be attributed to the 
clinician with the highest Part B charges.
    Response: The episode-based measures each have different 
attribution methodologies. We believe that always attributing episodes 
to the clinician with the highest Part B charges is not necessarily 
appropriate in all cases, particularly in cases in which a procedure 
may trigger the beginning of an episode.
    Comment: A commenter suggested that until the patient relationship 
codes are developed, clinicians should be allowed to select the cost 
measures that apply to them.
    Response: We believe that the cost measures that are included in 
this final rule with comment period are constructed in such a way to 
ensure that clinicians or groups are measured for cost for the patients 
for which they provide care. For example, a clinician or group would be 
required to provide 20 coronary artery bypass grafts to be attributed 
an episode-based measure for that procedure. We believe that requiring 
a cardiothoracic surgeon or group to select this cost measure through 
some kind of administrative mechanism would not add value to the 
program and could potentially increase administrative burden for the 
clinician.
    Comment: A commenter suggested that CMS employ Method B, which 
examines episodes independently, rather than Method A, in which cost is 
assigned to episodes on the basis of hierarchical rules, in developing 
episode-based measures for podiatrists.
    Response: We continue to work on the development of episode groups 
and are evaluating the use of Method A and Method B within that context 
for a variety of medical conditions and procedures. Episode-based 
measures using both methods are included in this final rule with 
comment period.
    Comment: A commenter expressed concern that certain specialties 
such as hospital-based physicians and palliative care physicians will 
have a large number of episode-based measures attributed to them.
    Response: We believe that the episode-based measures represent a 
wide variety of procedural and medical episodes. For the transition 
year, we have limited the number of episode-based measures and reduced 
the weight of the cost performance category but recognize that some 
clinicians may have more attributed episode-based measures than others 
based on the nature of the patients that they treat. However, it is 
important to note that being attributed additional cost measures does 
not change the weight of the cost performance category in the final 
score, which is set at 0 percent for the 2019 MIPS payment year. In 
addition, having more attributed episode-based measures does not 
inherently disadvantage a clinician, particularly if the episodes are 
lower in cost compared to the cost for similar episodes with similarly 
complex patients. We intend to continue to develop episode-based 
measures to ensure that all specialties of medicine may be measured on 
cost in a similar fashion.
    Following our consideration of the comments, we will finalize the 
attribution methodology for episode-based measures as proposed.
(ii) Reliability
    To ensure moderate reliability, we proposed 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 of the proposed rule (81 FR 28386). 
We proposed to not include any measures that do not have average 
moderate reliability (at least 0.4) at 20 episodes.
    Comment: Several commenters opposed the inclusion of episode-based 
measures with a reliability of 0.4 at a 20 minimum case size and 
recommended that only measures with a 0.7 reliability at a 20 minimum 
case size be included.
    Response: We believe that episode-based measures with a reliability 
of 0.4 with a minimum attributed case size of 20 meet the standards for 
being included as cost measures within the MIPS program. We aim to 
measure cost for as many clinicians as possible and limiting episode-
based measures to reliability of 0.7 or 0.8 at a minimum case size of 
20 would result in few individual clinicians being attributed enough 
patients under these measures, particularly since the episode-based 
measures represent only a subset of patients seen by an individual 
clinician or group.
    Please see section II.E.5.e.(3)(b) for additional discussion of 
using 0.4 as the reliability threshold. All of the episode-based 
measures that we are finalizing are reliable at this threshold for 20 
cases at both the individual and group level. We are finalizing at 
Sec.  414.1380(b)(2)(ii) that a MIPS eligible clinician must meet the 
minimum case volume specified by CMS to be scored on a cost measure. 
After considering the comments, we are finalizing our proposal that a 
MIPS eligible clinician must have a minimum of 20 cases to be scored on 
an episode-based measure.
(c) Attribution for Individual and Groups
    In the VM and sQRUR, all cost measurement was attributed at the 
solo practitioner and group level, as identified by the TIN. In MIPS, 
however, we proposed 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 
proposed to attribute cost measures using the TIN/NPI rather than the 
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 practices, 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 proposed to attribute 
cost 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 
solicited 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 the MSPB is to assign the MSPB 
measure based on the plurality of claims (as measured by allowed 
charges) for Medicare Part B services rendered during an inpatient 
hospitalization that is an index admission for the MSPB measure. 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

[[Page 77176]]

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 requested comment on this proposal and alternative considered.
    Comment: A commenter supported the proposal to attribute cost 
measures at the TIN level for groups that select to be assessed on 
other MIPS performance categories as a group.
    Response: We believe both attribution methodologies are valid, but 
as described below, we are finalizing the alternative proposal.
    Comment: Several commenters supported the alternative proposal of 
attributing cost for all clinicians at the TIN/NPI level, regardless of 
whether they participate in MIPS as a group or as individual 
clinicians.
    Response: We believe having a consistent attribution methodology 
for individual and group reporting would be beneficial and simpler for 
clinicians to understand. Therefore, we are finalizing the alternative 
proposal.
    To reduce complexity in the MIPS program, we are finalizing the 
alternative proposal to attribute cost measures for all clinicians at 
the TIN/NPI level. For those groups that participate in group reporting 
in other MIPS performance categories, their cost performance category 
scores will be determined by aggregating the scores of the individual 
clinicians within the TIN. For example, if a TIN had one surgeon that 
billed for 11 codes and another surgeon in that TIN billed for 12 codes 
that would trigger the knee arthroplasty episode-based measure, neither 
surgeon would have enough cases to be measured individually. However, 
if the TIN elects group reporting, the TIN would be assessed on the 23 
combined cases.
(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 MIPS 
eligible clinician involved.
    For the 2017 MIPS performance period, we did not propose 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 cost 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 
cost 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 cost performance category under MIPS. We refer 
readers to section II.E.6.b.2. of this final rule with comment period 
where we discussed 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 cost measures for non-patient facing 
MIPS eligible clinicians and groups under MIPS in future years. Lastly, 
we solicited comment on how best to incorporate appropriate alternative 
cost measures for all MIPS eligible clinician types, including non-
patient facing MIPS eligible clinicians.
    The following is summary of the comments we received.
    Comment: Many commenters supported a policy to not attribute cost 
measures to those clinicians and groups that meet the requirements of 
non-patient facing MIPS eligible clinicians because these clinicians 
would have little influence on cost, particularly with regard to the 
measures that were proposed for the transition year of the program.
    Response: We did not propose to preclude non-patient facing MIPS 
eligible clinicians from receiving a score for the cost performance 
category. Rather, based on the cost measures that we proposed for the 
CY 2017 performance period, we did not anticipate many non-patient 
facing MIPS eligible clinicians would have sufficient case volume as 
the measures are generally attributed to clinicians who have patient-
facing encounters. If non-patient facing MIPS eligible clinicians do in 
fact have sufficient case volume, however, they would be attributed 
measures in accordance with the attribution methodology and would 
receive a score for the cost performance category.
    Comment: Many commenters recommended that CMS work to develop 
alternative cost measures that could be used for non-patient facing 
clinicians or groups in the future.
    Response: We will continue to investigate all methods to measure 
cost, including methods for those clinicians who provide services that 
are not included in the existing cost measure attribution criteria.
    We appreciate the comments received and will attribute cost 
measures to non-patient facing MIPS eligible clinicians who have 
sufficient case volume, in accordance with the attribution methodology.
(e) Additional System Measures
    Section 1848(q)(2)(C)(ii) of the Act, as added by section 101(c) of 
MACRA 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 cost 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 cost performance categories to ensure consistent 
policies for MIPS in future years. We refer readers back to section 
II.E.5.b.(5) of this rule which discusses our strategy and solicits 
comments related to this provision. Below is our response to comments 
related to measuring the cost of facility-based clinicians.
    Comment: Some commenters supported the consideration of inpatient 
hospital cost measures for MIPS but requested that CMS create a 
methodology with an appropriate attribution methodology that could 
account for clinicians practicing in multiple facilities. Some 
commenters supported the inclusion of inpatient hospital cost measures 
as an option for certain clinicians and others opposed their inclusion 
in MIPS.
    Response: We will take these comments into consideration if we 
propose system measures in future rulemaking.
    Comment: Many commenters expressed concern that the total per

[[Page 77177]]

capita cost measure, MSPB, and episode-based measures would not capture 
cost associated with their particular specialty or field of medicine, 
such as anesthesiology. Commenters encouraged CMS to develop measures 
that would capture cost covering the unique contributions of all 
specialties.
    Response: We will continue to develop more episode-based measures 
and other mechanisms of measuring cost that will cover a broader group 
of medical specialists in the coming years and will plan to work with 
stakeholders to identify gaps in cost measurement.
    We appreciate the comments and will take all comments into 
consideration as we develop future cost measures.
(4) Future Modifications to Cost Performance Category
    In the future, we intend to consider how best to incorporate 
Medicare Part D costs into the cost performance category, as described 
in section 1848(q)(2)(B)(ii) of the Act. We solicited public comments 
on how we should incorporate those costs under MIPS for future years. 
We also intend to continue developing and refining episode-based 
measures for purposes of cost performance category measure 
calculations.
    The following is summary of the comments we received regarding the 
inclusion of Medicare Part D costs within cost measurement.
    Comment: Several commenters expressed support the inclusion of Part 
D costs in future cost measures, some citing the contribution of 
prescribing behavior to overall health costs and that including costs 
from other categories without including oral prescription drugs 
presented an incomplete picture.
    Response: To the extent possible, we will investigate ways to 
account for the cost of drugs under Medicare Part D in the cost 
measures in the future, as feasible and applicable, in accordance with 
section 1848(q)(2)(B)(ii) of the Act.
    Comment: Several commenters opposed the inclusion of Part D drug 
costs in future cost measures, noting that certain physicians prescribe 
more expensive drugs than others and that there are technical 
challenges to price standardizing Part D data and others questioned the 
appropriateness of the data. Others commented that including Part D 
costs could create improper incentives to prescribe services based on 
the part of Medicare that covers the service.
    Response: Drugs covered under Medicare Part D are a growing 
component of the overall costs for Medicare beneficiaries and one in 
which clinicians have a significant influence. However, not all 
patients covered by Medicare A and B are covered under a Medicare Part 
D plan, which presents a technical challenge in assessing the cost of 
drugs for all patients. In addition, Medicare Part D is provided 
through private plans which independently negotiate payment rates for 
certain drugs or drugs within a particular class. We will continue to 
investigate methods to incorporate this important component of 
healthcare spending into our cost measures in the future.
    Comment: Several commenters suggested removing the costs associated 
with drugs covered under Medicare Part B from cost in addition to those 
covered under Medicare Part D.
    Response: We believe that clinicians play a key role in prescribing 
drugs for their patients and that the costs associated with drugs can 
be a significant contributor to the overall cost of caring for a 
patient. We do not believe it would be appropriate to remove the cost 
of Medicare Part B drugs from the cost measures.
    We appreciate the comments and will take all comments into 
consideration as we develop future cost measures.
f. Improvement Activities Performance Category
(1) Background
(a) General Overview and Strategy
    The improvement activities 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. Improvement activities emphasize activities that have a 
proven association with better health outcomes. The improvement 
activities performance category also focuses on another MIPS strategic 
goal which is to use design incentives that drive movement toward 
delivery system reform principles and participation in APMs. A further 
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 improvement activities performance category, we proposed 
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 an improvement 
activity 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 
improvement activities 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, 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 improvement activities and specify criteria 
for such improvement activities, 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 or rural 
practices. There were two overarching themes from the comments that we 
received in the MIPS and APMs RFI. 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 took these recommendations into consideration

[[Page 77178]]

while developing the proposed improvement activities policies.
    We are finalizing at Sec.  414.1305 the definition of improvement 
activities, as proposed, to mean an activity that relevant MIPS 
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.
(2) Contribution to Final Score
    Section 1848(q)(5)(E)(i)(III) of the Act specifies that the 
improvement activities performance category will account for 15 percent 
of the final score, subject to the Secretary's authority to assign 
different scoring weights under section 1848(q)(5)(F) of the Act. 
Therefore, we proposed at Sec.  414.1355, that the improvement 
activities performance category would account for 15 percent of the 
final score.
    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, must 
be given the highest potential score for the improvement activities 
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 the proposed rule (81 FR 28234).
    A patient-centered medical home would 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 would 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) patient-
centered medical home recognition; (3) The Joint Commission 
Designation; or (4) the Utilization Review Accreditation Commission 
(URAC).\18\ We refer readers to the proposed rule (81 FR 28330) for 
further description of the Medicaid Medical Home Model or Medical Home 
Model. The criteria for being an organization that accredits medical 
homes is that the organization 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 solicited 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 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 solicited comment on 
how to provide credit for patient-centered medical home designations in 
the calculation of the improvement activities 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).
---------------------------------------------------------------------------

    \18\ Gans, D. (2014). A Comparison of the National Patient-
Centered Medical Home Accreditation and Recognition Programs. 
Medical Group Management Association, www.mgma.com.
---------------------------------------------------------------------------

    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 improvement 
activities performance category for the performance period. For further 
description of improvement activities and the APM scoring standard for 
MIPS, we refer readers to the proposed rule (81 FR 28234). For all 
other MIPS eligible clinicians or groups, we refer readers to the 
scoring requirements for MIPS eligible clinicians and groups in the 
proposed rule (81 FR 28247).
    Section 1848(q)(5)(C)(iii) of the Act provides that a MIPS eligible 
clinician or group must not be required to perform activities in each 
improvement activities subcategory or participate in an APM to achieve 
the highest potential score for the improvement activities 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.
    The following is a summary of the comments we received regarding 
the improvement activities performance category contribution to the 
final score.
    Comment: Several commenters expressed concern about the burden of 
complying with this performance category in addition to the other three 
performance categories and some recommended that the performance 
category not be included in the MIPS program, believing it would be 
difficult to report. Some commenters requested that we remove the 
improvement activities performance category completely.
    Response: We recognize that there are challenges associated with 
understanding how to comply with a new program such as MIPS and the 
improvement activities performance category. However, the statute 
requires the improvement activities performance category be included in 
the Quality Payment Program. After consideration of the comments 
expressing concern about reporting burden, we are reducing the number 
of required activities we proposed from a maximum of six medium-
weighted or three high-weighted or some combination thereof for full 
credit to a requirement of no more than four medium-weighted 
activities, two high-weighted activities, or a combination of medium 
and high-weighted activities where each selected high-weighted activity 
reduces the number of medium-weighted activities required. We believe 
this is still aligned with the statute in measuring performance in this 
performance category. We will continue to provide education and 
outreach to provide further clarity.
    Comment: Some commenters expressed concern that improvement 
activities would not be successfully implemented because of the low 
percentage that this category was given in the final MIPS scoring 
methodology. The commenters suggested increasing the improvement 
activities performance categories percentage toward the final score. 
Another commenter recommended reducing the quality performance 
category's weighting from 50 percent to 35 percent and increasing the 
improvement activities performance category from 15 percent to 30 
percent for 2017, indicating this would increase the likelihood that 
more MIPS eligible clinicians would fully participate.
    Response: We believe we have appropriately weighted the improvement 
activities performance category within the final score, particularly 
given the statutory direction under section 1848(q)(5)(E)(i)(III) of 
the Act that the category account for 15 percent of the final score, 
subject to the Secretary's authority to assign different scoring 
weights under certain circumstances. However, we intend to

[[Page 77179]]

monitor the effects of category weighting under MIPS over time.
    Comment: Several commenters requested that CMS develop a definition 
of a Medical Home or certified patient-centered medical home that 
includes practices that are designated by private health plans such as 
Blue Cross and Blue Shield of Michigan (BCBSM) patient-centered medical 
home program. Some commenters also requested including regional 
patient-centered medical home recognition programs that are free to 
practices. Other commenters requested that CMS consider MIPS eligible 
clinicians or groups that have completed a certification program that 
has a demonstrated track record of support by non-Medicare payers, 
state Medicaid programs, employers, or others in a region or state. 
Some commenters requested that CMS consider other significant rigorous 
certification programs or state-level certification. One example of a 
state-level certification program, provided by a commenter, was the 
Oregon patient-centered medical home certification. One commenter 
suggested recognizing certified patient-centered medical homes that may 
not have sought national certification. The same commenter also 
suggested providing a MIPS eligible clinician or group full credit as a 
certified patient-centered medical home if they were performing the 
advanced primary care functions reflected in the Joint Principles of 
the Patient-Centered Medical Home and the five key functions of the 
Comprehensive Primary Care Initiative. One commenter suggested that any 
MIPS eligible clinician or group that has received a certification from 
any entity that meets the necessary criteria as a patient-centered 
medical home accreditor should receive full credit. One commenter 
requested that ``The Compliance Team'', a privately held, for-profit, 
healthcare accreditation organization that receives deeming authority 
from the CMS as an accreditation organization, be included as part of 
the accreditation organizations for patient-centered medical home. This 
commenter also stated that the exclusion of ``The Compliance Team'' 
from the final list of approved administering organizations would 
create artificial barriers to entry that will likely drive up the cost 
of accreditation because all the small practices and clinics that 
already went through accreditation with The Compliance Team would need 
to go through a second accreditation. One commenter requested that 
Behavioral Health Home Certification also be recognized for full credit 
as a patient-centered medical home. Some commenters further stated that 
CMS should ensure that the activities and standards included in such 
accredited programs are meaningful, incorporate private sector best 
practices, and directly improve patient outcomes. Other commenters 
agreed with using the accreditation programs that were proposed in the 
rule to qualify patient-centered medical home models under the 
improvement activities performance category for full credit, including 
recommending that practices undergo regular re-accreditation by the 
proposed bodies to ensure they are continuing to provide care in a 
manner consistent with being a medical home. In addition, some 
commenters recommended the Quality Payment Program develop a way to 
reward practices that may not have reached patient-centered medical 
home recognition but are in the process of transformation.
    Response: We were not previously aware of additional certifying 
bodies that are used by a large number of medical organizations that 
adhere to similar national guidelines for certifying a patient-centered 
medical home, meaning they are national in scope, as the ones cited in 
the proposal. Consistent with the credit provided for practices that 
have been certified as a patient-centered medical home or comparable 
specialty practice for certified bodies included in the proposal, we 
will also recognize practices that have received accreditation or 
certification from other certifying bodies that have certified a large 
number of medical organization and meet national guidelines. We further 
define large as certifying bodies that the certifying organizations 
must have certified 500 or more certified member practices. In addition 
to the 500 or more practice threshold for certifying bodies, the second 
criterion requires a practice to: (1) Have a personal clinician in a 
team-based practice; (2) have a whole-person orientation; (3) provide 
coordination or integrated care; (4) focus on quality and safety; and 
(5) provide enhanced access (Gans, 2014). The Oregon Patient-centered 
Primary Care Home Program described by comments and the Blue Cross Blue 
Shield of Michigan (BCBSM) are two examples of programs that would meet 
these two criteria in the proposed rule.
    While we believe that some of the advanced primary care functions 
in the Joint Principles of the Patient-Centered Medical Home and key 
functions of the Comprehensive Primary Care Initiative might count as 
improvement activities there is a distinction maintained between being 
an actual certified patient-centered medical home per the statute and 
performing some functions of one. Therefore, performing these functions 
alone would not qualify for full credit. Other certifications that are 
not for patient-centered medical homes or comparable specialty 
practices would also not qualify automatically for the highest score.
    MIPS eligible clinicians and groups that receive certification from 
other accreditation organizations that certify for a patient-centered 
medical home or comparable specialty practice, including accredited 
organizations that receive deeming authority from CMS, such as The 
Compliance Team, would receive full credit as long as those accredited 
bodies meet the two criteria. These two criteria are: (1) The 
accredited body must have certified 500 or more member practices as a 
patient-centered medical home or comparable practice; and (2) they must 
meet national guidelines.
    Comment: Some commenters agreed with CMS regarding not requiring 
that a MIPS eligible clinician select from any specific subcategories 
of activities. However, the commenters opposed CMS' suggestion to 
eventually calculate performance in this performance category due to 
the technical complexity of doing so, but also because it would ignore 
the overall intent of the performance category, which is to recognize 
engagement in innovative activities that contribute to quality rather 
than actual performance. One commenter encouraged CMS to re-consider 
the improvement activities and scoring criteria in future years to 
incentivize physician improvement.
    Response: We will take this suggestion into account as we continue 
implementation and refinement of the MIPS program in the future. While 
we recognize that it may be technically complex at this time to 
calculate performance within the improvement activities performance 
category, our expectation is that such a process would become simpler 
over time as MIPS eligible clinicians become accustomed to implementing 
improvement activities. For further discussion of improvement 
activities scoring as a component of the final score, we refer readers 
to section II.E.6.a.(4) in this final rule with comment period.
    After consideration of the comments regarding the contribution to 
final score we are finalizing at Sec.  414.1355, that the improvement 
activities performance category would account for 15 percent of the 
final score. We are not finalizing our policy on recognizing only 
practices that have received nationally recognized accredited or 
certified-patient centered

[[Page 77180]]

medical home certifications. Rather, we are finalizing at Sec.  
414.1380 an expanded definition of what is acceptable for recognition 
as a certified-patient centered medical home or comparable specialty 
practice. We are recognizing a MIPS eligible clinician or group as 
being a certified patient-centered medical home or comparable specialty 
practice if they have achieved certification or accreditation as such 
from a national program, or they have achieved certification or 
accreditation as such from a regional or state program, private payer 
or other body that certifies at least 500 or more practices for 
patient-centered medical home accreditation or comparable specialty 
practice certification. Examples of nationally recognized accredited 
patient-centered medical homes are: (1) The Accreditation Association 
for Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home (3) The Joint Commission 
Designation; or (4) the Utilization Review Accreditation Commission 
(URAC). We are finalizing that the criteria for being a nationally 
recognized accredited patient-centered medical home are 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 will also provide full credit for the improvement 
activities performance category for a MIPS eligible clinician or group 
that has received certification or accreditation as a patient-centered 
medical home or comparable specialty practice from a national program 
or from a regional or state program, private payer or other body that 
administers patient-centered medical home accreditation and certifies 
500 or more practices for patient-centered medical home accreditation 
or comparable specialty practice certification.
(3) Improvement Activities Data Submission Criteria
(a) Submission Mechanisms
    For the purpose of submitting under the improvement activities 
performance category, we proposed in the proposed rule (81 FR 28181) to 
allow for submission of data for the improvement activities performance 
category using the qualified registry, EHR, QCDR, CMS Web Interface, 
and attestation data submission mechanisms. If technically feasible, we 
would use administrative claims data to supplement the improvement 
activities submission. Regardless of the data submission method, all 
MIPS eligible clinicians or groups must select activities from the 
improvement activities inventory provided in Table H in in the Appendix 
to this final rule with comment period. We believe the proposed data 
submission methods would allow for greater access and ease in 
submitting data, as well as consistency throughout the MIPS program.
    In addition, we proposed at Sec.  414.1360, that for the transition 
year only, all MIPS eligible clinicians or groups, or third party 
intermediaries such as health IT intermediaries, 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 improvement 
activities inventory. In the case where a MIPS eligible clinician or 
group is using a health IT intermediary, QCDR, or qualified registry 
for their data submission, the MIPS eligible clinician or group will 
certify all improvement activities have been performed and the health 
IT intermediary, 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 
improvement activities as well as other performance data submitted 
outside of the improvement activities performance category could be 
contained in a single agreement, minimizing the burden on the MIPS 
eligible clinician or group. See the proposed rule (81 FR 28281) for 
additional details.
    We proposed to use the administrative claims method, if technically 
feasible, only to supplement improvement activities performance 
category submissions. For example, if technically feasible, MIPS 
eligible clinicians or groups, using the telehealth modifier GT, could 
get automatic credit for this activity. We requested comments on these 
proposals.
    The following is a summary of the comments we received regarding 
the improvement activities performance category data submission 
criteria and mechanisms.
    Comment: Some commenters noted that the definitions of some 
improvement activities (such as those that require patient-specific 
factors) are impossible for CEHRTs to determine from the data in the 
EHR. The commenters believed these will create usability problems and 
complicate clinical workflows.
    Response: If an EHR vendor or developer cannot complete system 
changes to support usability and simplify clinical workflows for some 
improvement activities, a MIPS eligible clinician or group may use 
another calculation method to support that attestation. For example, a 
MIPS eligible clinician or group may use their CEHRT to generate a list 
of patients for whom they have prescribed an antidiabetic agent (for 
example, insulin) and use an associated documented record with 
reference to an individual glycemic treatment goal that includes 
patient-specific factors to identify the competition rate through 
manual or other IT assisted calculation. We also encourage MIPS 
eligible clinicians to work with their CEHRT system developers to 
ensure that their systems consider the MIPS eligible clinician's 
workflow needs. In addition, we note that ONC recently relied an EHR 
Contract Guide, available at https://www.healthit.gov/sites/default/files/EHR_Contracts_Untangled.pdf, which is designed to help clinicians 
and developers work together to consider key issues related to product 
needs and product operation.
    Comment: One commenter opposed separate processes for attesting 
improvement activities when those activities are related to advancing 
care information or quality measures performance categories.
    Response: For the transition year of MIPS, we have concluded that 
we must require separate processes for attestation in separate 
performance categories, including cases where improvement activities 
are related to advancing care information or quality performance 
categories. Refer to section II.E.5.g. and Table H in in the Appendix 
to this final rule with comment period for more information on 
improvement activities that are designated activities which receive a 
10 percent bonus in the advancing care information performance 
category. MIPS eligible clinicians should factor this 10 percent bonus 
into their selection of activities to meet the requirements of the 
improvement activities performance category as well. We intend to 
continue to streamline reporting requirements under MIPS in the future. 
For the advancing care information performance category, however, we 
have revised the policy for the transition year of MIPS, so that 
additional designated activities in Table H in in the Appendix to this 
final rule with comment period may also qualify for a bonus in the 
advancing care information performance category. We refer readers to 
section II.E.5.g.(5) of this final rule with comment period for more 
information on this bonus; MIPS eligible clinicians should factor this 
into their selection of activities to meet the requirements of the 
improvement activities performance category as well.

[[Page 77181]]

We intend to continue examining how to streamline reporting 
requirements under MIPS in the future.
    Comment: Several commenters requested additional clarification on 
how MIPS eligible clinicians would report as a group for the 
improvement activities performance category. The commenters provided 
suggestions for how CMS should provide credit for those groups, 
including suggestions: (1) That CMS not require all MIPS eligible 
clinicians in a group to report all activities in the transition year; 
(2) that CMS specify how many clinicians in each group must participate 
in each activity to achieve points for the entire group; and (3) that 
CMS give credit to the entire group if at least part of a group is 
performing an activity.
    Response: We would like to explain that all MIPS eligible 
clinicians, reporting as a group, will receive the same score for the 
improvement activities performance category. If at least one clinician 
within the group is performing the activity for a continuous 90 days in 
the performance period, the group may report on that activity.
    Comment: A few commenters expressed concern with the improvement 
activities performance category noting that it will be necessary to 
have timely specifications on how to satisfy the qualifications for 
each activity to earn improvement activities credit.
    Response: The improvement activities inventory in Table H in in the 
Appendix to this final rule with comment period includes a description 
of the specifications for how to satisfy the qualifications for each 
project (activity) in order to earn points.
    Comment: Some commenters requested clarification on the submission 
mechanisms for the improvement activities performance category. The 
commenters believed that some activities require use of a third party 
vendor while others did not. The commenter stated it is unclear how 
MIPS eligible clinicians will report on activities within the 
improvement activities performance category.
    Response: The submission mechanisms for the improvement activities 
performance category are listed in section II.E.5.f.(3) of this final 
rule with comment period. We agree there are some activities such as 
those that reference the use of a QCDR that may require a third party 
vendor. There are many others, however, that do not require third party 
vendor engagement or suggest that use of certified EHR technology is 
one way to support a given activity but not the only way to support an 
activity. We will provide technical assistance through subregulatory 
guidance to further explain how MIPS eligible clinicians will report on 
activities within the improvement activities performance category. This 
subregulatory guidance will also include how MIPS eligible clinicians 
will be able to identify a specific activity through some type of 
numbering or other similar convention.
    Comment: One commenter requested clarification that if an EHR 
vendor reports the improvement activities performance category for a 
MIPS eligible clinician or group, the vendor is simply reporting the 
MIPS eligible clinician's or group's attestation of success, not 
attesting to that success.
    Response: The commenter is correct in that the vendor simply 
reports the MIPS eligible clinician's or group's attestation, on behalf 
of the clinician or group, that the improvement activities were 
performed. The vendor is not attesting on its own behalf that the 
improvement activities were performed.
    Comment: Another commenter recommended allowing improvement 
activities to be reported via the CMS Web Interface for the transition 
year, rather than through a QCDR or EHR.
    Response: The CMS Web Interface is one of the data submission 
mechanisms available for the improvement activities performance 
category reporting. We have included a number of possible submission 
mechanisms for MIPS and recognize the need to make the attestation 
process as simple as possible.
    Comment: One commenter recommended that CMS provide additional 
clarity in the final rule with comment period on how MIPS eligible 
clinicians should attest if they meet part, but not all, of the entire 
improvement activity. In order to provide a more accurate and fair 
score, this commenter recommended providing more prescriptive criteria 
so that points may be assigned for sub-activities within each activity.
    Response: A MIPS eligible clinician must meet all requirements of 
the activity to receive credit for that activity. Partial satisfaction 
of an activity is not sufficient for receiving credit for that 
activity. However, many activities offer multiple options for how 
clinicians may successfully complete them and additional criteria for 
activities are already included in the improvement activities 
inventory.
    Comment: Some commenters supported CMS' proposed ``yes/no'' 
responses via reporting mechanisms of MIPS eligible clinicians' choice, 
and requested that we consider collecting more detailed responses in 
the future. Other commenters called on CMS to ensure that improvement 
activities chosen by MIPS eligible clinicians are relevant and useful 
for improving care in their practices. One commenter expressed 
reservations about attestation and requested that CMS verify that MIPS 
eligible clinicians perform the activities. Still others, however, 
called on CMS to continue allowing flexibility for MIPS eligible 
clinicians, including attestation options.
    Response: We will continue examining changes in the data collection 
process with the expectation that where applicable specification and 
data collection may be added on an activity by activity basis. We will 
also verify data through the data validation and audit process as 
necessary.
    Comment: One commenter recommended that the certifying boards be 
included as reporting agents for improvement activities.
    Response: We will take this suggestion into consideration for 
future rulemaking. To the extent possible, we will work with the 
patient-centered medical home and comparable specialty practice 
certifying bodies and other certification boards to verify practice 
status.
    Comment: One commenter recommended that CMS align improvement 
activities across the country to facilitate shared learning and prevent 
against waste and inefficiency, and should create a ``single source'' 
option for clinicians for reporting, measurement benchmarking and 
feedback, that also counts toward the improvement activities 
performance category.
    Response: We will take this suggestion into consideration for 
future rulemaking.
    After consideration of the comments received regarding the 
improvement activities data submission criteria we are not finalizing 
the policies as proposed. Specifically, we are not finalizing the data 
submission method of administrative claims data to supplement the 
improvement activities as it is not technically feasible at this time.
    We are finalizing at Sec.  414.1360 to allow for submission of data 
for the improvement activities performance category using the qualified 
registry, EHR, QCDR, CMS Web Interface, and attestation data submission 
mechanisms. Regardless of the data submission method, with the 
exception of MIPS APMs, all MIPS eligible clinicians or groups must 
select activities from the improvement activities inventory provided in 
Table H in in the Appendix to this final rule with comment period.

[[Page 77182]]

    In addition, we are finalizing at Sec.  414.1360 that for the 
transition year of MIPS, all MIPS eligible clinicians or groups, or 
third party intermediaries such as health IT vendors, QCDRs and 
qualified registries that submit on behalf of a MIPS eligible clinician 
or group, must designate a yes response for activities on the 
improvement activities 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 improvement activities have been performed and 
the health IT vendor, QCDR, or qualified registry will submit on their 
behalf.
    We are also including a designation column in the improvement 
activities inventory that will show which activities qualify for the 
advancing care information bonus finalized at Sec.  414.1380 and refer 
readers to Table H in in the Appendix to this final rule with comment 
period.
(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 improvement activities performance category for patient-centered 
medical home participants, and a minimum 50 percent score for APM 
participants. For additional activities in this category, we proposed 
at Sec.  414.1380 a differentially weighted model for the improvement 
activities 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, improvement 
activities standards are not nationally recognized and there is no 
entity for improvement activities that serves the same function as the 
NQF does for quality measures). Improvement activities are weighted as 
high based on alignment with our national public health 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 priorities. 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 clinician's state Medicaid 
Program, or an activity identified as a public health priority (such as 
emphasis on anticoagulation management or utilization of prescription 
drug monitoring programs) were weighted as high.
    The statute references certified 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. We requested comments on this 
proposal, including criteria or factors we should take into 
consideration to determine whether to weight an activity medium or 
high.
    The following is a summary of the comments we received regarding 
weighted scoring for improvement activities.
    Comment: One commenter recommended that we establish three 
weighting categories for the improvement activities performance 
category: (1) High--30 percent; (2) Medium--20 percent; and (3) Low--10 
percent. The commenter stated that this weighting allocation would 
allow for the development of a third category for easier improvement 
activities.
    Response: Generally, we received comments on the two weightings, 
high and medium. We believe there were no activities that merited a 
classification as a lower weighted activity during the MIPS transition 
year. However, in future years, through the annual call for activities 
and when more data are available on which activities are most 
frequently reported, we will reevaluate the applicability of these 
weights and potential reclassification of activities into lower 
weights.
    Comment: Commenters noted an inconsistency regarding the weighting 
of activities related to the Prescription Drug Monitoring Program 
(PDMP). Section II.E.5.f.(3)(b) of the proposed rule (81 FR 28261) 
references this as a high priority activity; however, the PDMP related 
activity, ``Annual registration in the Prescription Drug Monitoring 
Program'' in Table H, in the Appendix of this final rule with comment 
period is listed as a medium-weighted activity (81 FR 28570).
    Response: There are two PDMP activities, one with a medium weight-
registering for the PDMP-and one with a high weight-utilizing the PDMP. 
We had added some additional language to the one PDMP activity with the 
high weight to differentiate it from the other medium-weighted PDMP 
activity. We refer readers to Table H in in the Appendix to this final 
rule with comment period for the additional language.
    Comment: Several commenters supported the proposed list of 
activities but recommended that the number of required activities be 
reduced and that more activities be highly weighted to reduce the 
reporting burden for MIPS eligible clinicians.
    Response: As discussed in section II.E.5.f.(2) of this final rule 
with comment period, we have reduced the number of activities that MIPS 
eligible clinicians are required to report to no more than four medium-
weighted activities, two high-weighted activities, or any combination 
thereof, for a total of 40 points. We are reducing the number of 
activities for small practices, practices located in rural areas, and 
geographic HSPAs and non-patient facing MIPS eligible clinicians to no 
more than one high-weighted activity or two medium-weighted activities, 
where each activity counts for doubled weighting to also achieve a 
total of 40 points.
    Comment: Several commenters suggested that CMS expand the number of 
high-weighted activities, noting that there were only 11 high-weighted 
activities out of 90, which may prevent MIPS eligible clinicians from 
reporting high-weighted improvement activities, and that the Emergency 
Response and Preparedness subcategory was the only subcategory with 
without a high-weighted activity.
    Response: We are changing one existing activity in the Emergency 
Response and Preparedness subcategory from ``Participation in domestic 
or international humanitarian volunteer work. MIPS eligible clinicians 
and groups must be registered for a minimum of 6 months as a volunteer 
for domestic or international humanitarian volunteer work'' to 
``Participation in domestic or international humanitarian volunteer 
work. Activities that simply involve registration are not sufficient. 
MIPS eligible clinicians attest to domestic or international 
humanitarian volunteer work for a period of a continuous 60 days or 
greater.'' We have changed this activity so that rather than requiring 
MIPS eligible clinicians to be registered for 6 months, we are 
requiring them to participate for 60 days. This change is in line with 
our overall new 90-day performance period policy. The 60-day 
participation would fall within that new 90-day window. We are also 
changing this existing activity from a medium to a high-weighted 
activity because such volunteer work is intensive, often involves 
travel, and working in challenging physical and clinical circumstances. 
Table H in in the

[[Page 77183]]

Appendix to this final rule with comment period reflects this revised 
description of the existing activity and revised weighting. We note, 
however, that this is a change for this transition year for the 2017 
performance period only. In addition, we are changing the weight from 
medium to high of the one activity related to ``Participating in a 
Rural Health Clinic (RHC), Indian Health Service Medium Management 
(IHS), or Federally Qualified Health Center (FQHC) in ongoing 
engagement activities that contribute to more formal quality 
reporting'' which we believe is consistent with section 
1848(q)(2)(B)(iii) of the Act, which requires the Secretary to give 
consideration to the circumstances of practices located in rural areas 
and geographic HPSAs. Rural health clinics would be included in that 
definition for consideration of practices in rural areas. Table H in in 
the Appendix to this final rule with comment period reflects this 
revised weighting.
    Comment: Some commenters recommended assigning a higher weight to 
QCDR-related improvement activities and QCDR functions, and one 
commenter recommended that use of a QCDR count for several activities.
    Response: Participating in a QCDR is not sufficient for 
demonstrating performance of multiple improvement activities, and we do 
not believe at this time that it warrants a higher weighting. In 
addition, QCDR participation was not proposed as a high-weighted 
activity because, while useful for data collection, it is neither 
critical for supporting certified patient-centered medical homes, which 
is what we considered in proposing whether an improvement activity 
would be high-weighted activity, nor does it require multiple actions. 
We also note that while QCDR participation may not automatically confer 
improvement activities credit, it may put MIPS eligible clinicians in a 
position to report multiple improvement activities, since there are 
several that specifically reference QCDR participation. We ask that 
each MIPS eligible clinician select from the broad list of activities 
provided in Table H in in the Appendix to this final rule with comment 
period in order to achieve their total score.
    Comment: Several commenters made suggestions for weighting within 
the improvement activities performance category. Some commenters 
recommended that CMS increase the number of high weight activities 
because they believed this would allow MIPS eligible clinicians to 
select activities that are more meaningful without sacrificing time and 
energy that should be spent with patients. Other commenters offered 
suggestions for additional activities that should be allocated high 
weight under the performance category, or suggested consolidating 
activities under subcategories that could be afforded high weight.
    Response: Additional reweighting, other than included in this final 
rule with comment period, will not occur until a revised improvement 
activities inventory list is finalized through the rulemaking process. 
We will take this recommendation into consideration for future 
rulemaking.
    Comment: Some commenters made several suggestions for providing 
additional credit to MIPS eligible clinicians under the improvement 
activities performance category. For example, one commenter recommended 
giving automatic credit to surgeons for providing 24/7 access to MIPS 
eligible clinicians, groups, or care teams for advice about urgent or 
emergent care because surgeons provide on-call coverage and are 
available to medical facilities that provide after-hours access. Other 
commenters suggested that specialists that qualify for additional 
credit under the Blue Cross Blue Shield of Michigan Value-Base 
Reimbursement program should receive full credit for improvement 
activities performance category. Additional commenters suggested that 
we consider providing automatic credit for the improvement activities 
performance category to MIPS eligible clinicians participating in a 
QCDR rather than requiring attestation for each individual improvement 
activity. One commenter recommended that ED clinicians automatically 
earn at least a minimum score of one-half of the highest potential 
score for this performance category simply for providing this access on 
an ongoing basis, noting that emergency clinicians are one of the few 
clinician specialties that truly provide 24/7 care.
    Response: We will consider these requests in future rulemaking for 
the MIPS program. As discussed in section II.E.f.(3)(c) of this final 
rule with comment period, we are revising our policy regarding the 
number of required activities for the transition year of MIPS. 
Specifically, we are asking MIPS eligible clinicians or groups that are 
not MIPS APMs, to select a reduced number of activities: Either four 
medium-weighted activities, or two medium-weighted and one high-
weighted, or two high-weighted activities. For MIPS eligible clinicians 
or groups, in small practices, practices in rural areas or geographic 
HPSAs, or non-patient facing MIPS eligible clinicians, who are only 
required to select one medium-weighted activity for one-half of the 
credit for this performance category or two medium-weighted or one 
high-weighted activity for full credit for this performance category.
    Comment: Some commenters requested that the CAHPS for MIPS survey 
be included as a medium-weighted improvement activity.
    Response: We disagree and believe assessing patients' experiences 
as they interact with the health care system is a valuable indication 
of merit. Please note, there are no reporting thresholds for 
improvement activities, this allows flexibility for MIPS eligible 
clinicians and groups to report surveys in a way that best reflects 
their efforts. Therefore, the CAHPS for MIPS survey is included as a 
high-weighted activity under the activity called ``Participation in the 
Consumer Assessment of Healthcare Providers and Systems Survey (CAHPS) 
or other Supplemental Questionnaire Items.''
    Comment: Some commenters supported patient-centered medical homes 
and supported these entities receiving full credit for improvement 
activities performance category. One commenter suggested that patient-
centered medical homes stratify data by disparity variables and 
implement targeted interventions to address health disparities. Some 
commenters were concerned that groups of less than 50 would receive the 
highest potential score under the improvement activities performance 
category, while groups with greater than 50 would receive partial 
credit. One commenter stated that larger groups have the inherent 
capability of assuming greater risk. One commenter also requested that 
the 50 group number be stricken from the language allowing any group 
size that has acquired patient-centered medical home certification by a 
recognized entity to be given full credit for improvement activities to 
encourage all groups, regardless of size, to pursue patient-centered 
medical home certification as patient-centered medical home 
certification is fundamental to good practice. Additional commenters 
suggested including activities under the improvement activities 
performance category that are associated with actions conducted by a 
certified patient-centered medical home. One commenter recommended the 
following subcategories of activities for the improvement activities 
performance category that are aligned with elements of a patient 
centered medical home: Expanded practice access, population management, 
care coordination, beneficiary engagement, and patient

[[Page 77184]]

safety and practice assessment. This commenter believed that the 
presentation of the information in this way will allow clinicians to 
better understand the patient-centered medical home model and decide 
how to best deliver care under MIPS.
    Response: We note that there is no limit on the size of a practice 
in a patient-centered medical home for eligibility for full improvement 
activities credit. We refer the commenter to section II.E.8. of this 
final rule with comment period on APMs to establishing thresholds of 
less than 50 as it relates to APM incentive payments. We encourage MIPS 
eligible clinicians and groups to working with appropriate certifying 
bodies to consider that in the future. We will also look for ways to 
reorganize the existing improvement activities inventory and working 
with clinicians and others in future years on the best way to present 
this list of activities.
    Comment: A few commenters supported giving 50 percent credit in the 
improvement activities performance category to MIPS APMs.
    Response: It is important to note that it was statutorily mandated 
that MIPS eligible clinicians participating in APMs receive at least 
one-half of the highest score in the improvement activities performance 
category.
    Comment: Other commenters recommended that we establish three 
weighting categories for the improvement activities performance 
category: (1) High--30 percent; (2) medium--20 percent; and (3) low--10 
percent. The commenter stated that this weighting allocation would 
allow for the development of a third category for easier improvement 
activities.
    Response: We will consider other weighting options as appropriate 
for improvement activities in future rulemaking.
    After consideration of the comments regarding weighted scoring we 
are finalizing at Sec.  414.1380 a differentially weighted model for 
the improvement activities performance category with two categories: 
Medium and high. We refer readers to the following sections of this 
final rule with comment period in reference to the improvement 
activities performance category: Section VI.H for the modified list of 
high-weighted and medium-weighted activities, section II.E.5.f.(3)(c) 
for information on the number of activities required to achieve the 
highest score, section II.E.6.a.(4)(a) for information on how points 
will be assigned, section II.E.6.a.(4)(b) how the highest potential 
score can be achieved, section II.E.6.a.(4)(c) on how we will recognize 
a MIPS eligible clinician or group for qualifying for the points for a 
certified patient-centered medical home or comparable specialty 
practices, and section II.E.6.a.(4)(d) for how the improvement 
performance activities will be calculated.
(c) Submission Criteria
    We proposed at Sec.  414.1380 to set the improvement activities 
submission criteria under MIPS, to achieve the highest potential score 
of 100 percent, at three high-weighted improvement activities (20 
points each) or six medium-weighted improvement activities (10 points 
each), or some combination of high and medium-weighted improvement 
activities to achieve a total of 60 points for MIPS eligible clinicians 
participating as individuals or as groups (refer to Table H in in the 
Appendix to this final rule with comment period for improvement 
activities and weights). MIPS eligible clinicians or groups that select 
less than the designated number of improvement activities will receive 
partial credit based on the weighting of the improvement activity 
selected. To achieve a 50 percent score, one high-weighted and one 
medium-weighted improvement activity or three medium-weighted 
improvement activities are required for these MIPS eligible clinicians 
or groups.
    Exceptions to the above apply for: Small practices, 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 or a patient-centered medical home 
submitting in MIPS.
    For MIPS eligible clinicians and groups that are small practices, 
located in rural areas or geographic HPSAs, or non-patient facing MIPS 
eligible clinicians or groups, to achieve the highest score of 100 
percent, two improvement activities are required (either medium or 
high). For MIPS eligible clinicians or groups that are small practices, 
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 improvement activity is required (either medium or high).
    MIPS eligible clinicians or groups that participate in APMs are 
considered eligible to participate under the improvement activities 
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 improvement activities performance category will receive one 
half of the total improvement activities score just through their APM 
participation. These are MIPS eligible clinicians or groups that we 
identify as participating in APMs for MIPS and may participate under 
the improvement activities performance category. To achieve the total 
improvement activities score, such MIPS eligible clinicians or groups 
will need to identify that they participate in an APM and this APM will 
submit the eligible clinicians' improvement activities score for that 
specific model type.
    For further description of MIPS eligible clinicians or groups that 
are required to report to MIPS under the APM scoring standard and their 
improvement activities scoring requirements, we refer readers to the 
proposed rule (81 FR 28234). 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 the proposed rule (81 FR 28237).
    Since we cannot measure variable performance within a single 
improvement activity, we proposed at Sec.  414.1380 to compare the 
improvement activities points associated with the reported activities 
against the highest number of points that are achievable under the 
improvement activities performance category which is 60 points. We 
proposed 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 
improvement activities 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 the scoring section of the 
proposed rule (81 FR 28237) for additional rationale for using 60 
points for the transition year of MIPS.
    If a MIPS eligible clinician or group reports only one improvement 
activity, we would 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 improvement activities, then the 
MIPS eligible clinician or group would receive a zero score for the 
improvement activities performance category. We

[[Page 77185]]

believe this proposal allows us to capture variation in the total 
improvement activities reported.
    In addition, we believe these are reasonable criteria for MIPS 
eligible clinicians or groups to accomplish within the transition 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 proposed 
that an activity must be performed for at least 90 days during the 
performance period for improvement activities 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 improvement activities. For the transition year of MIPS, 
there are several improvement activities in the inventory that 
incorporate QCDR participation. Each activity must be selected and 
achieved separately for the transition 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 
improvement activities inventory expands over time we were interested 
in receiving comments on what restrictions, if any, should be placed 
around improvement activities that incorporate QCDR participation.
    The following is a summary of the comments we received regarding 
submission criteria.
    Comment: One commenter recommended that CMS base performance in the 
improvement activities performance category on participating in a 
number of improvement activities rather than a specific number of 
hours.
    Response: We would like to explain that we proposed at Sec.  
414.1380 to require MIPS eligible clinicians to submit three high-
weighted improvement activities or six medium-weighted improvement 
activities, or some combination of high and medium-weighted improvement 
activities to achieve the highest possible score in this performance 
category (81 FR 28210). Credit awarded under the improvement activities 
performance category relies on the number of activities, not a specific 
number of hours. We refer readers to the section below entitled 
``Required Period of Time for Performing an Activity'' below where we 
discuss the 90-day time period policy.
    Comment: Other commenters did not support the improvement 
activities performance category because of some specialty concerns on 
the inability to report on two or more activities, such as one 
commenter that indicated that doctors of chiropractic practice in 
clinics, often with under 15 MIPS eligible clinicians, would have 
problems reporting on two improvement activities. This commenter noted 
that during the early adopter program for the NCQA Patient-Centered 
Connected Care recognition program, doctors of chiropractic did not 
experience favorable consideration because the TCPIs focused their 
funding on primary care clinicians.
    Response: We believe there are a sufficient number of broad 
activities from which specialty practices, as well as primary care 
clinicians, can select. Furthermore, as discussed previously in this 
section, we are finalizing a policy reducing the required number of 
activities for MIPS eligible clinicians and groups.
    After consideration of the comments received regarding the 
submission criteria, we are not finalizing the policies as proposed. 
Rather, we are reducing the maximum number of activities required to 
achieve the highest possible score in this performance category. 
Specifically, we are finalizing at Sec.  414.1380 to set the 
improvement activities submission criteria under MIPS, to achieve the 
highest potential score, at two high-weighted improvement activities or 
4 medium-weighted improvement activities, or some combination of high 
and medium-weighted improvement activities which will be less than four 
total number of activities for MIPS eligible clinicians participating 
as individuals or as groups (refer to Table H in in the Appendix to 
this final rule with comment period for improvement activities and 
weights).
    Exceptions to the above apply for: Small practices, located in 
rural areas, practices located in geographic HPSAs, non-patient facing 
MIPS eligible clinicians or groups or MIPS eligible clinicians, or 
groups that participate in a MIPS APM or a patient-centered medical 
home submitting in MIPS. As discussed in sections II.E.5.h. and II.E.6. 
of this final rule with comment period, we are reducing the maximum 
number of activities required for these MIPS eligible clinicians and 
groups to achieve the highest possible score in this performance 
category.
    Specifically, for MIPS eligible clinicians and groups that are 
small practices, practices located in rural areas or geographic HPSAs, 
or non-patient facing MIPS eligible clinicians or groups, to achieve 
the highest score, one high-weighted or two medium-weighted improvement 
activities are required. For these MIPS eligible clinicians and groups, 
in order to achieve one-half of the highest score, one medium-weighted 
improvement activity is required.
    We will also provide full credit for the improvement activities 
performance category for a MIPS eligible clinician or group that has 
received certification or accreditation as a patient-centered medical 
home or comparable specialty practice from a national program or from a 
regional or state program, private payer or other body that administers 
patient-centered medical home accreditation and certifies 500 or more 
practices for patient-centered medical home accreditation or comparable 
specialty practice certification.
    We believe that this approach is appropriate for the transition 
year of MIPS since this is a new performance category of requirements 
for MIPS eligible clinicians and we want to ensure all MIPS eligible 
clinicians understand what is required of them, while not being overly 
burdensome.
    All clinicians identified on the Participation List of an APM 
receive at least one-half of the highest score. To develop the 
improvement activities additional score assigned to all MIPS APMs, CMS 
will compare the requirements of the specific APM with the list of 
activities in the Improvement Activities Inventory in Table H in in the 
Appendix to this final rule with comment period and score those 
activities in the same manner that they are otherwise scored for MIPS 
eligible clinicians according to section II.E.6.a.(4) of this final 
rule with comment period. For further explanation of how MIPS APMs 
scores will be calculated, we refer readers to section II.E.5.h of this 
final rule with comment period. Should the MIPS APM not receive the 
maximum improvement activities performance category score then the APM 
entity can submit additional improvement activities. All other MIPS 
eligible clinicians or groups that we identify as participating in APMs 
will need to select additional improvement activities to achieve the 
improvement activities highest score.

[[Page 77186]]

(d) Required Period of Time for Performing an Activity
    We proposed Sec.  414.1360 that MIPS eligible clinicians or groups 
must perform improvement activities for at least 90 days during the 
performance period for improvement activities 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. One 
illustrative example of organizations that used 90 days as a window for 
reviewing clinical practice improvements are practice improvement 
activities undertaken by a large Veteran's Administration health care 
program that set a 90-day window for reviewing improvements in the 
management of opioid dispensing.\19\
---------------------------------------------------------------------------

    \19\ 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.
---------------------------------------------------------------------------

    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 in in the Appendix to this final rule with 
comment period. In addition, we proposed 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 improvement activities 
time periods will be needed for certain activities. We will monitor the 
time period requirement to assess 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 requested comments on this 
proposal.
    The following is a summary of the comments we received regarding 
the required period of time for performing an activity.
    Comment: Many commenters supported CMS's proposal to require 
improvement activities performance for at least 90 days during the 
performance period. Some commenters requested clarification about the 
applicable time period, noting that not all activities in Table H in in 
the Appendix to this final rule with comment period lend themselves to 
a 90-day performance period. Other commenters suggested limiting 
reporting to 30 days or other time periods shorter than 90 days to 
enable MIPS eligible clinicians to test innovative strategies for 
improvement activities. One commenter suggested requiring improvement 
activities be performed throughout the entirety of the performance 
period.
    Response: We note that we are requiring that each improvement 
activity be performed for a continuous 90-day period. Additionally, the 
continuous 90-day period must occur during the performance period.
    We do not believe that reporting periods as short as 30 days are 
sufficient to ensure that the activities being performed are robust 
enough to result in actual practice improvements. However, we are also 
cognizant of the inherent challenges associated with implementing new 
improvement activities, which is why we are finalizing our requirement 
that these activities be performed during a continuous 90-day period 
during the performance period. We view that reporting period as an 
appropriate balance for the transition year of MIPS, and will re-
examine reporting periods for improvement activities in the future.
    Comment: Several commenters requested further clarification on our 
proposal regarding points for patient-centered medical home recognition 
in the improvement activities performance category. Specifically, the 
commenters requested clarification regarding what specific date, either 
as of December 31, 2017 or as of January 1, 2017, by which a practice 
needs to be recognized as a patient-centered medical home in order to 
claim optimal improvement activities performance category points.
    Response: We would like to explain that a MIPS eligible clinician 
or group must qualify as a certified patient-centered medical home or 
comparable specialty practice for at least a continuous 90 days during 
the performance period. Therefore, any MIPS eligible clinician or group 
that does not qualify by October 1st of the performance year as a 
certified patient-centered medical home or comparable specialty 
practice cannot receive automatic credit as such for the improvement 
activities performance category.
    Comment: Other commenters were very concerned that the required 
90[hyphen]day reporting period for improvement activities was simply 
inapplicable to many of the improvement activities listed by CMS in the 
improvement activities inventory and in other cases that it is unclear 
what needs to be done for 90 days. The commenters believed the time 
period for improvement activities should be tailored to the particular 
activity being implemented. In some cases, positive change could occur 
in less than 90 days but even for activities with a longer time 
horizon, a practice should receive credit for the improvement 
activities as long as it is in place for a least one quarter. Another 
commenter recommended that CMS assign timeframes for each improvement 
activity for 2017, to gather empirical data regarding the time 
intervals, instead of assigning a 90-day timeframe to all activities.
    Response: While not all of the activities in the improvement 
activities inventory lend themselves to performance for a full 90 
consecutive days for all MIPS eligible clinicians, we believe that each 
activity can be performed for a full 90 consecutive days by some, if 
not all, MIPS eligible clinicians, and that there are a sufficient 
number of activities included that any eligible clinician may select 
and perform for a continuous 90 days that will allow them to 
successfully report under this performance category. Therefore, we are 
finalizing our proposal that for the transition year of MIPS, any 
selected activity must be performed for at least 90 consecutive days.
    After consideration of the comments regarding the required period 
of time for performing an activity, we are finalizing at Sec.  414.1360 
that MIPS eligible clinicians or groups must perform improvement 
activities for at least 90 consecutive days during the performance 
period for improvement activities performance category credit. 
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.
(4) Application of Improvement Activities 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 proposed 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 improvement activities submission criteria. These 
non-patient facing MIPS eligible

[[Page 77187]]

clinicians and groups receive 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 improvement 
activities. 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 clinicians, 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 
improvement activities they believed would be applicable. The comments 
on activities appropriate for non-patient facing MIPS eligible 
clinicians or groups are reflected in the proposed improvement 
activities 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 an improvement activity 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, and bronchitis treatment in adults) according to clinical 
guidelines for diagnostics and therapeutics. In addition, we requested 
comments on what activities would be appropriate for non-patient facing 
MIPS eligible clinicians or groups to add to the improvement activities 
inventory in the future. We requested comments on this proposal.
    The following is a summary of the comments we received regarding 
the application of improvement activities to non-patient facing MIPS 
eligible clinicians and groups.
    Comment: Some commenters expressed their support for the general 
approach of reducing the improvement activities performance category 
requirements for non-patient facing MIPS eligible clinicians and 
groups, as well as MIPS eligible clinicians practicing in rural areas 
or health professional shortage areas. Other commenters disagreed with 
that approach, stating that non-patient facing MIPS eligible clinicians 
should be able to obtain a full score of 60 points without any special 
modifications to improvement activities scoring while another commenter 
did not support reducing the improvement activities performance 
category requirements for these MIPS eligible clinicians and 
recommended that we hold all clinicians to the same standard. Other 
commenters suggested increasing the number of MIPS eligible clinicians 
in a practice required to meet the definition of a small practice from 
15 to 25 for purposes of the improvement activities performance 
category. The commenters were also concerned that there are several 
subcategories such as Beneficiary Engagement and Expanded Practice 
Access that may limit non-patient facing MIPS eligible clinicians from 
having access to a broader list of activities than other types of 
practices and suggested that CMS limit the number of activities in the 
transition year to two for non-patient facing MIPS eligible clinicians.
    Response: We believe there are several subcategories such as 
Beneficiary Engagement and Expanded Practice Access that may limit a 
non-patient facing MIPS eligible clinician from having access to the 
broader list of activities than for other types of practices and 
believe it is reasonable to limit the number of activities in the 
transition year for non-patient facing MIPS eligible clinicians. We 
refer readers to Sec.  414.1305 for the definition of small practice 
for the purposes of MIPS.
    After consideration of the comments regarding the application of 
improvement activities to non-patient facing MIPS eligible clinicians 
and groups we are not finalizing the policies as proposed. Rather, 
based on commenters' feedback, we believe that it is appropriate to 
reduce the number of activities that a non-patient facing MIPS eligible 
clinician must select to achieve credit to meet the improvement 
activities data submission criteria. Specifically, we are finalizing at 
Sec.  414.1380 that for non-patient facing MIPS eligible clinicians or 
groups, to achieve the highest score one high-weighted or two medium-
weighted improvement activities are required. For these MIPS eligible 
clinicians and groups, in order to achieve one-half of the highest 
score, one medium-weighted improvement activity is required.
(5) Special Consideration for Small, Rural, or Health Professional 
Shortage Areas Practices
    Section 1848(q)(2)(B)(iii) of the Act requires the Secretary, in 
establishing improvement activities, to give consideration to small 
practices and practices located in rural areas as defined 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 improvement activities 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 improvement activities 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 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 improvement activities inventory across 
multiple subcategories.
    After consideration of comments and listening sessions, we proposed 
at Sec.  414.1360 to accommodate small practices and practices located 
in rural areas, or geographic HPSAs for the

[[Page 77188]]

improvement activities 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 improvement activities. 
Therefore, we requested comments on what activities would be 
appropriate for these practices for the improvement activities 
inventory in future years.
    The following is a summary of the comments we received regarding 
special consideration for MIPS small practices, or practices located in 
rural areas or geographic HPSAs.
    Comment: Some commenters requested that to facilitate rapid 
learning in the area of improvement activities performance category, 
CMS should provide targeted, practical technical assistance to solo and 
small practices that is focused on the improvement activities tailored 
to their level of quality improvement activity.
    Response: We intend to provide targeted, practical technical 
assistance to MIPS eligible clinicians. Specifically, we intend to have 
a MACRA technical assistant that will be available to solo and small 
practices. In addition, MIPS eligible clinicians may contact the 
Quality Payment Program Service Center with specific questions.
    Comment: Some commenters proposed that CMS recognize improvement 
efforts for clinicians in small practices by awarding them ``full 
credit'' in the improvement activities for participation in a Practice 
Transformation Network.
    Response: Please note that Transforming Clinical Practice 
Initiative (TCPI) credit which includes activities such as a Practice 
Transformation Network is provided as a high-weighted activity for the 
transition year of MIPS.
    After consideration of the comments regarding special consideration 
for small practices, rural, or geographic HPSAs practices we are not 
finalizing the policies as proposed. Rather, based on stakeholders' 
feedback, we believe that it is appropriate to reduce the required 
number of activities required to achieve full credit in this 
performance category for small practices, rural, or health professional 
shortage areas practices. Specifically, we are finalizing at Sec.  
414.1380 that for MIPS eligible clinicians and groups that are small 
practices or located in rural areas, or geographic HPSAs, to achieve 
full credit, one high-weighted or two medium-weighted improvement 
activities are required. In addition, we are modifying our proposed 
definition of rural area and finalizing at Sec.  414.1305 that a rural 
area means clinicians in zip codes designated as rural, using the most 
recent HRSA Area Health Resource File data set available. We proposed 
using HRSA's 2014-2015 Area Resource File but decided a non-specific 
reference would be more broadly applicable. In addition, we are 
finalizing the following definitions, as proposed, at Sec.  414.1305: 
(1) small practices means practices consisting of 15 or fewer 
clinicians and solo practitioners; and (2) Health Professional Shortage 
Areas (HPSA) means areas as designated under section 332(a)(1)(A) of 
the Public Health Service Act.
    We refer readers to section II.E.6.a.(4) of this final rule with 
comment period for a more detailed explanation of the number of points 
and scoring for the improvement activities performance category.
(6) Improvement Activities Subcategories
    Section 1848(q)(2)(B)(iii) of the Act provides that the improvement 
activities performance category must include at least the subcategories 
listed below. The statute also provides the Secretary discretion to 
specify additional subcategories for the improvement activities 
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 
completed referrals to community and social services or evidence of 
partnerships and collaboration with the community and social services.
     Achieving Health Equity, such as 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 uniformed services 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

[[Page 77189]]

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 
improvement activities 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 transition year of MIPS, we proposed at Sec.  
414.1365 that the improvement activities performance category include 
the subcategories of activities provided at section 1848(q)(2)(B)(iii) 
of the Act. In addition, we proposed 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 proposed to 
include this subcategory because: (1) It is important and may require 
targeted effort to achieve and so should be recognized when 
accomplished; (2) it supports our national priorities and programs, 
such as Reducing Health Disparities; and (3) it 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 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 proposed 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 improvement activities inventory in all 
of these proposed subcategories and the subcategories included under 
section 1848(q)(2)(B)(iii) of the Act.
    We also solicited 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 requested activities that can 
demonstrate some improvement over time and go beyond current practice 
expectations. For example, maintaining existing medical equipment would 
not qualify for an improvement activity, 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 requested comments on these proposals.
    The following is summary of the comments we received regarding 
improvement activities subcategories.
    Comment: Some commenters recommended inclusion of activities under 
the two additional subcategories; Promoting Health Equity and Social 
and Community Involvement. One commenter suggested we include the ASCO/
CNS Chemotherapy Safety Administration Standards, potentially under the 
achieving health equity subcategory, with the highest weight. Other 
commenters recommended we include the following activities in this 
subcategory: Adhering to the U.S. Access Board standards for medical 
diagnostic equipment; reduced wait time for patients with disabilities 
for whom long wait times are a barrier to care; replacing inaccessible 
equipment; remodeling or redesigning an office to meet accessibility 
standards in areas other than medical diagnostic equipment, and 
training staff on best practices in serving people with disabilities, 
including appropriate appointment lengths, person-centered care, and 
disability etiquette. The commenters also suggested that CMS include 
people with disabilities in the subcategory of expanded practice 
access, stating that despite the Americans with Disabilities Act (ADA), 
many clinician offices remain inaccessible to people with disabilities.
    One commenter recommended that for this subcategory, CMS require 
both MIPS eligible clinicians and community service clinicians to 
demonstrate improvement in their respective functions, processes, or 
outcomes and consider developing metrics to evaluate the quality of 
health and well-being services that community-based organizations 
provide. Another commenter recommended that activities in the Social 
and Community Involvement subcategory include employing community 
health workers (CHWs) or integrating CHWs employed by community-based 
organizations into care teams, establishing a community advisory 
council, and creating formal linkages with social services clinicians 
and community-based organizations.
    Response: We will proceed with the current proposed list of 
subcategories included in Table H in in the Appendix to this final rule 
with comment period, as well as the subcategory for participation in an 
APM, for the transition year of MIPS. We will consider these 
recommendations in future years as part of the annual call for measures 
and activities in future rulemaking.
    Comment: A few commenters recommended that in order to encourage 
and allow MIPS eligible clinicians to proactively incorporate and test 
new technologies into their practice, while closely sharing the 
decision making process with patients, CMS should develop an additional 
improvement activities subcategory to encourage MIPS eligible 
clinicians and groups to engage patients to consider new technologies 
that may be an option for their care.
    Response: These recommendations will be considered during the call 
for activities and addressed in future rulemaking as necessary.
    Comment: Some commenters stated general support for the improvement 
activities performance category, including efforts to benefit long-term 
care, and the inclusion of the subcategories of Achieving Health Equity 
and Integration of Behavioral and Mental Health.

[[Page 77190]]

    Response: We have included the Achieving Health Equity and 
Integration of Behavioral and Mental Health subcategories.
    Comment: Other commenters recommended that CMS group similar 
activities together to reduce complexity and confusion, and provided an 
example to move all QCDR activities under the Population Health 
Management subcategory so MIPS eligible clinicians can easily determine 
which capabilities they already have or may adopt with use of a QCDR.
    Response: We believe that we have appropriately placed activities 
within their subcategories as proposed. However, we would like to note 
that we are committed to ease of reporting and we allow MIPS eligible 
clinicians to report across all subcategories. We will provide 
technical assistance through the Quality Payment Program Service Center 
and other resources.
    Comment: One commenter requested the ability to select an activity 
across any subcategory.
    Response: We are finalizing our proposed policy that MIPS eligible 
clinicians may select any activity across any improvement activities 
subcategory, as our intention is to provide as much flexibility for 
MIPS eligible clinicians as possible. We believe that where possible, 
MIPS eligible clinicians should choose activities that are most 
important or most appropriate for their practice across any 
subcategory.
    Comment: Many commenters supported CMS's flexibility in recognizing 
a broad range of improvement activities performance category for Care 
Coordination, Beneficiary Engagement, and Patient Safety and 
recommended that CMS include a fourth subcategory that allows practices 
to focus on office efficiency/operations in order to promote long term 
success. Some commenters also requested that CMS include two additional 
subcategories; Promoting Health Equity and Continuity and Social and 
Community Involvement.
    Response: We will proceed with the current proposed list of 
subcategories for the transition year of MIPS, included in Table H in 
in the Appendix to this final rule with comment period, as well as the 
subcategory for participation in an APM. Further determinations of 
improvement activities and subcategories will be addressed in future 
rulemaking and as part of the annual call for the subcategory and 
activities process that will occur simultaneously with the annual call 
for measures.
    After consideration of the comments regarding improvement 
activities subcategories we are finalizing at Sec.  414.1365 that the 
improvement activities performance category will include the 
subcategories of activities provided at section 1848(q)(2)(B)(iii) of 
the Act. In addition, we are finalizing at Sec.  414.1365 the following 
additional subcategories: ``Achieving Health Equity,'' ``Integrated 
Behavioral and Mental Health,'' and ``Emergency Preparedness and 
Response.''
(7) Improvement Activities Inventory
    To implement the MIPS program, we are required to create an 
inventory of improvement activities. 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 improvement 
activities and activities that may lend themselves to being measured 
for improvement in future years.
    We took several steps to ensure the initial improvement activities 
inventory is inclusive of activities in line with the statutory 
language. 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 
improvement activities performance category, including the patient-
centered medical homes, the Transforming Clinical Practice Initiative 
(TCPI), 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 improvement activiies performance category. The 
improvement activities inventory was compiled as a result of the 
stakeholder input, an environmental scan, 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 
improvement activities inclusion based on one or more of the following 
criteria (in any order):
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     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 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 
included if there was a strong policy rationale to include it in the 
improvement activities inventory. We proposed to use the improvement 
activities inventory for the transition year of MIPS, as provided in 
Table H in in the Appendix to this final rule with comment period. For 
further description of how MIPS eligible clinicians or groups would be 
designated to submit to MIPS for improvement activities, we refer 
readers to the proposed rule (81 FR 28177). 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 the 
proposed rule (81 FR 28234).
    We requested comments on the improvement activities inventory and 
suggestions for improvement activities for future years as well.
    The following is a summary of the comments we received regarding 
the statutory requirements for improvement activities related to the 
activities that must be specified under the improvement activities 
performance category. We refer readers to Table H in in the Appendix to 
this final rule with comment period.
General Comments Related to Activities Across More Than One Subcategory
    Comment: We received several comments supporting the broad 
descriptions provided for activities in the MIPS transition year to 
enable MIPS eligible clinicians to effectively and appropriately 
implement and report in a manner that best represents their 
performance. Other commenters requested more detail about the 
methodology used to assign weights to the activities, and questioned 
whether CMS intends to develop specifications for activities as it does 
for quality measures.
    Response: We appreciate the requests to provide further details 
around the methodology and specifications for improvement activities. 
Under the statute, we may contract with various entities to assist in 
identifying activities

[[Page 77191]]

and specifying criteria for the activities. Accordingly, the 
methodology we used to assign weights to the activities was to engage 
multiple stakeholder groups, including the Centers for Disease Control, 
Health Resources and Services Administration, Office of the National 
Coordinator for Health Information Technology, SAMHSA, Agency for 
Healthcare Research and Quality, Food and Drug Administration, the 
Department of Veterans Affairs, and several clinical specialty groups, 
small and rural practices and non-patient facing clinicians to define 
the criteria and establish weighting for each activity. Activities were 
proposed to be weighted as high based on the extent to which they align 
with activities that support the patient-centered medical home, since 
that is the standard under section 1848(q)(5)(C)(i) of the Act for 
achieving the highest potential score for the improvement activities 
performance category, as well as with our priorities for transforming 
clinical practice. Activities that require performance of multiple 
actions, such as participation in the 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) were also proposed to be weighted as high. 
Future revisions and specifications to the activities may be provided 
through future rulemaking, consistent with the needs and maturation 
process of the MIPS program in future years.
    Comment: Several commenters supported the proposed list of 
activities but recommended that the number of required activities be 
reduced and that more activities be highly weighted.
    Response: As discussed in section II.E.5.f.(2) of this final rule 
with comment period, we have reduced the number of activities that MIPS 
eligible clinicians are required to report on to no more than four 
medium-weighted activities or two high-weighted activities, or any 
combination thereof which would be less than four activities. We are 
reducing the number of activities for small practices, practices 
located in rural and geographic HPSAs and non-patient facing clinicians 
to no more than one high-weighted activities or two medium-weighted 
activities to achieve the highest score.
    Comment: Some comments recommended assigning a higher weight to 
QCDR-related improvement activities and QCDR functions, and one 
commenter recommended that use of a QCDR count for several activities.
    Response: Participating in a QCDR is not sufficient for 
demonstrating performance of multiple improvement activities and we do 
not believe at this time it warrants a higher weighting. In addition, 
QCDR participation was not proposed as a high-weighted activity 
because, while useful for data collection, it is neither critical for 
supporting certified patient-centered medical homes nor requires 
multiple actions, which are criteria we considered for high-weighting. 
We also note that while QCDR participation may not automatically confer 
improvement activities performance category credit, it may put MIPS 
eligible clinicians in a position to report multiple improvement 
activities, since there are several that specifically reference QCDR 
participation. We ask that each MIPS eligible clinician or group select 
from the broad list of activities that is included in Table H in in the 
Appendix to this final rule with comment period.
    Comment: One commenter suggested that we list ID numbers for 
activities listed in the improvement activities inventory.
    Response: We will include IDs in the on-line portal, as well as a 
short title.
    Comment: Many commenters suggested that we adopt more specialty-
specific activities, citing their belief that many improvement 
activities are focused on primary care. The commenters made many 
suggestions for specialty-specific activities, including care 
coordination, patient safety, and other activities.
    Response: There are many future activities that we would like to 
develop and consider for inclusion in MIPS, including those specific to 
specialties. We intend to take these comments into account in future 
rulemaking and as part of the annual call for the subcategory and 
activities process that will occur simultaneously with the annual call 
for measures. We note that the current improvement activities inventory 
does offer activities that can benefit all practice types and we 
believe specialists will be able to successfully report under this 
performance category.
    Comment: One commenter requested that CMS clarify and distinguish 
between activities under the direction and ability of a user, as 
opposed to activities under the clinical supervision and control of 
MIPS eligible clinicians or groups. Another commenter stated that 
activities under the improvement activities performance category needed 
to reward active participation in an activity rather than rewarding the 
MIPS eligible clinicians for being part of an entity that pays for the 
activity. For example, the commenter stated that a teaching hospital 
might be the awardee in a BPCI contract, but the faculty practice 
clinicians are leading the effort to redesign care.
    Response: To reward for active participation in an activity rather 
than rewarding for being part of an entity that pays for the activity, 
we believe that the requirement that the MIPS eligible clinician or 
group must actually perform the activity for a continuous 90-day period 
addresses that concern since the clinician would need to perform that 
activity for that period of time. In the example that the commenter 
provided, the practices reporting at the TIN/NPI level would receive 
the credit for the improvement activities.
    Comment: Some commenters believe that the activities in this 
performance category would not lead to improvement.
    Response: For the transition year of MIPS, we intend for MIPS 
eligible clinicians to focus on achievement of these activities; they 
do not need to show that the activity led to improvement. We believe 
these activities are important for all MIPS eligible clinicians because 
their purpose is to encourage movement toward clinical practice 
improvement.
    Comment: Another commenter noted that the proposal that MIPS 
eligible clinicians are required to consult with clinical decision 
support (CDS) under this mandate ``are encouraged'' to select 
improvement activities other than those related to the use of CDS. The 
commenter suggested that CMS maintain this statement as a 
recommendation and not require that a MIPS eligible clinician or group 
report another improvement activity if they are participating under the 
mandate and report an improvement activity related to CDS.
    Response: We would like to note that we encourage MIPS eligible 
clinicians or groups who are already required to use AUC (for example, 
for advanced imaging) to report an improvement activity other than one 
related to appropriate use. We do not mandate any activity that must be 
reported. Further, we do not require MIPS eligible clinicians to 
consult with CDS. We also do not require that an MIPS eligible 
clinician or group report another improvement activity if they are 
already participating and reporting on an existing activity related to 
CDS.
    Comment: One commenter suggested that CMS consider the existing 
reporting burdens on hospital-based MIPS eligible clinicians, and 
encouraged CMS to work closely with third party recognition programs to 
ensure that information on recognized MIPS eligible clinicians can

[[Page 77192]]

be accurately reported directly to CMS and linked to MIPS eligible 
clinicians accordingly. Another commenter suggested that CMS ensure 
that specifications for improvement activities undergo proper 
stakeholder comment, including a public comment period prior to 
finalization. A few commenters also requested that CMS allow additional 
stakeholder comment on the improvement activities specifications.
    Response: We intend to continue assessing hospital based MIPS 
eligible clinician's reporting burden under the MIPS program. While the 
current activity list is expansive, there remain opportunities to 
expand the list further in future years. The current list, however, 
does offer activities that can benefit all practice types and we 
believe hospital based specialists will be able to successfully report 
improvement activities. Additionally, we provided earlier opportunities 
for public input and comment on activities as part of both the 2015 
MIPS and APM RFI and the 2016 proposed rule.
    Comment: Another commenter recommended that CMS change language 
regarding the definition of medical homes to those that are 
``nationally recognized accredited or certified'' as the commenter 
regularly uses certified and accredited interchangeably.
    Response: We refer readers to section II.E.5.f. of this final rule 
with comment period for discussions on the definition of recognized 
certifying or accrediting bodies for patient-centered medical homes.
    Comment: One commenter recommended a flexible approach to quality 
assessment that emphasizes outcomes of care and that favors continuous 
quality improvement methodologies rather than rigid, process-oriented 
patient-centered medical home certification models. The commenter 
believed that relying on patient-centered medical home certification as 
a means of quality assessment runs the risk of practices not actually 
realigning efforts to produce higher quality and more cost effective 
care.
    Response: We refer readers to section II.E.6.a.(4)(c) of this final 
rule with comment period where we discuss patient-centered medical home 
certification models.
Activities Related to the Patient Safety and Practice Assessment 
Subcategory
    Comment: We received more than 25 comments requesting changes or 
additions to activities under the Patient Safety and Practice 
Assessment subcategory. Under this subcategory, several commenters 
suggested that CMS consider Maintenance of Certification (MOC) Part IV 
participation as an improvement activity in all improvement activities 
subcategories, not just the Patient Safety/Practice Assessment 
subcategory. Other commenters suggested that Participation in 
Maintenance of Certification Part IV should be re-designated as a high 
priority. A few commenters also pointed out inconsistencies with 
reference to PDMP as a high-weighted activity in this section compared 
to what is included in the improvement activities inventory and 
requested for the change to a high weight be made for this activity in 
the inventory list.
    Response: We recognize that some activities may align with more 
than one subcategory but have assigned each activity to one and only 
one subcategory to minimize confusion and avoid an unwieldy list of too 
many or duplicative activities that may be difficult to select from for 
the transition year of MIPS. MIPS eligible clinicians may select any 
activity across any subcategories to meet the criteria for the 
improvement activities performance category. We look forward to working 
with stakeholders on activity alignments with subcategories in future 
years. We also believe that high weighting should be used for 
activities that directly address practice areas with the greatest 
impact on beneficiary care, safety, health, and well-being. We have 
focused high weighting under the subcategories on those activities. We 
do not believe there is an inconsistency as PDMP Consultation is listed 
as a high-weighted activity and annual registration in a PDMP is listed 
as a medium-weighted activity. We have made a revision in the 
Consultation of PDMP activity to further elaborate and explain the 
requirements.
    Comment: Many commenters suggested that CMS recognize continuing 
medical education (CME) activities provided by national recognized 
accreditors, completion of other state/local licensing requirements and 
providing free care to those in need as improvement activities, 
particularly those CME activities that involve assessment and 
improvement of patient outcomes or care quality, best practice 
dissemination and aid in the application of the ``three aims'' (better 
care; healthier people and communities; smarter spending), the National 
Quality Standards and the CMS Quality Strategy. The commenters also 
recommended that inclusion of surveys or interviewing clinicians to 
determine if they have applied lessons learned to their practice for at 
least 90 days following an activity should meet compliance 
requirements.
    Response: We appreciate the suggestions that we grant improvement 
activities credit for activities already certified as CME activities, 
however, for the transition year of the MIPS program we do not have 
sufficient data to identify which CMEs could be included as activities. 
We will consider these recommendations for additional activities in 
future years as part of the nomination process.
    Comment: One commenter recommended that the improvement activities 
performance category be used to evaluate what activities, in what 
quantity, contribute to increased value and improve quality, and that 
CMS avoid using overly prescriptive thresholds or quantities of 
activities requirements, such as those used in CPC, that show no 
correlation to outcomes, quality, or costs. The commenter suggested 
that CMS align its criteria for improvement activities with activities 
that are included as components of patient-centered home model. Another 
commenter advised significantly reducing process-oriented measures in 
the improvement activities performance category and building on 
activities that clinicians were already completing, because process-
oriented measures could be perceived as busy work. This commenter also 
stated that when relevant improvement activities were not otherwise 
available, CMS could reduce the burden by allowing certified 
improvement activities as partial or complete satisfaction of 
improvement activities requirements.
    Response: We believe that MIPS eligible clinicians are dedicated to 
the care of beneficiaries and will only attest to activities that they 
have undertaken in their practice that follow the specific guideline of 
each improvement activity. We note we have not proposed prescriptive 
thresholds for activities beyond an attestation that a certain 
percentage of patients were impacted by a given activity and that in 
establishing the improvement activities performance category we 
included activities that align with those patient-centered medical 
homes typically perform. We are not reducing process-oriented 
improvement activities in this performance category because these were 
activities that multiple practices recommended as contributing to 
practice improvements. We are also not allowing partial completion of 
an activity to count toward the improvement activities score. We refer 
readers to section II.E.5.f.(3)(c) of this final rule with comment 
period for discussions on how we have reduced

[[Page 77193]]

the number of activities required for the improvement activities 
performance category which we believe also addresses burden. In 
addition, we would like to explain that the activities in the 
improvement activities inventory were identified by different types of 
practices such as rural and small practices, as well as large 
practices, who indicated these are improvement activities that 
clinicians are already performing and believed they should be included 
in the improvement activities inventory.
Activities Related to the Population Management Subcategory
    Comment: We received more than 10 comments related to the 
Population Management subcategory. One commenter expressed support for 
the 2014 AHA/ACC/HRS Guideline for the Management of Patients with 
Atrial Fibrillation, noting that comprehensive patient education, care 
coordination, and appropriate dosing decisions are important for 
managing patients on anticoagulants, including warfarin and novel oral 
anticoagulants. The commenter also indicated that the use of validated 
electronic decision support and clinical management tools, particularly 
those that support shared decision making, may benefit all patients 
treated with anticoagulants. The commenter recommended that improvement 
activities be inclusive of patients treated with all anticoagulants 
while recognizing differences in management requirements.
    Response: We agree that comprehensive patient education, care 
coordination, and appropriate dosing decisions are important for 
managing patients on anticoagulants. We acknowledge that that the use 
of validated electronic decision support and clinical management tools, 
particularly those that support shared decision making, may benefit all 
patients treated with anticoagulants. We refer the readers to section 
II.E.5.g. of this final rule with comment period for more information 
on electronic decision support. We also acknowledge that improvement 
activities should be inclusive of patients treated with all 
anticoagulants while recognizing differences in management 
requirements.
    We note that because anticoagulants have been consistently 
identified as the most common causes of adverse drug events across 
health care settings, the Population Management activity starting with 
``Participation in a systematic anticoagulation program (coagulation 
clinic, patient self-reporting program, patient self-management program 
highlights)'' highlights the importance of close monitoring of Vitamin 
K antagonist therapy (warfarin) and the use of other coagulation 
cascade inhibitors.
    Comment: One commenter suggested adding the NCQA Heart/Stroke 
Recognition Program as an activity for the Population Management 
subcategory. The commenter expressed their belief that attending an 
educational seminar on new treatments that covers medication management 
and side effects for cancer treatments such as neutropenia or immune 
reactions would improve safety and result in better care for 
beneficiaries.
    Response: We appreciate this additional recommendation and will 
consider it in future years.
Activities Related to the Behavioral Health Subcategory
    Comment: We received more than 20 comments related to activities 
under the Behavioral Health subcategory. One commenter agreed with our 
proposed activity: ``Tobacco use: Regular engagement of MIPS eligible 
clinicians or groups in integrated prevention and treatment 
interventions, including tobacco use screening and cessation 
interventions (refer to NQF #0028) for patients with co-occurring 
conditions of behavioral or mental health and at risk factors for 
tobacco dependence,'' and in addition, requested that CMS consider 
adding features from a successful model such as the Million Hearts 
Multidisciplinary Approach to Increase Smoking Cessation Interventions 
that was demonstrated in New York City.
    Response: We will consider the best way to incorporate additional 
smoking cessation efforts in MIPS and our other quality programs in the 
future.
    Comment: Several commenters requested that CMS expand various 
descriptions in the improvement activities inventory list, such as for 
the activity ``Participation in research that identifies interventions, 
tools or processes that can improve a targeted patient population,'' to 
include reference to engagement in federally funded clinical research.
    Response: We will take this suggestion into consideration for 
future rulemaking.
Activities Under the Expand Practice Access Subcategory
    Comment: We received only a few unique comments related to 
Expanding Practice Access, most related to telehealth. These commenters 
suggested that we consider additional activities under the improvement 
activities performance category, potentially including telehealth 
services or other activities nominated by MIPS eligible clinicians or 
groups. The commenters made specific suggestions ranging from follow-up 
inpatient telehealth consultations furnished to beneficiaries in 
hospitals or SNFs, office or other outpatient visits to transitional 
care management services with high medical decision complexity, 
psychoanalysis, and family psychotherapy.
    Response: In developing improvement activities, some of the 
developer's considerations should include whether the activity is 
evidenced based and applicable across service settings, and aligns with 
the National Quality Strategy and CMS Quality Strategy. We will take 
the commenters' suggestions into account for future rulemaking.
Activities Related to the Beneficiary Engagement Subcategory
    Comment: Commenters suggested numerous nomenclatural changes within 
the Activities Under Beneficiary Engagement subcategory. For example, 
one commenter suggested that we refer to ``clinical registries'' in 
general rather than QCDRs, since many MIPS eligible clinicians may 
participate in clinical registries without using them for MIPS 
participation. Other commenters suggested that we revise the wording of 
the proposed activity ``Participation in CMMI models such as Million 
Hearts Campaign'' to reflect that this is a model, not a ``campaign,'' 
and suggested that we include the wording ``standardized treatment 
protocols'' in the proposed activity ``Use decision support and 
protocols to manage workflow in the team to meet patient needs.'' Other 
commenters suggested changes to the activities labels in Table H in in 
the Appendix to this final rule with comment period.
    Response: We have revised the wording of the Million Hearts 
activity to read ``Participation in CMMI models such as the Million 
Hearts Cardiovascular Risk Reduction Model.'' In addition, we have 
revised the decision support activity to read ``Use decision support 
and standardized, evidence-based treatment protocols to enhance 
effective workflow in the team to meet patient needs.''
    Comment: Another commenter expressed concern that the proposed 
activity ``Use tools to assist patients in assessing their need for 
support for self-management (for example, the Patient Activation 
Measure or How's My Health)'' mentioned the Patient Activation Measure, 
which the commenter stated was proprietary and expensive if widely 
used. The commenter recommended that we

[[Page 77194]]

consider the variety of psychometric tools that can be used to measure 
not only patient motivation, but also confidence and intent to act. The 
commenter stated that for example, specifically calling out activation 
inhibits health behavior change innovation. The commenter stated that 
it is possible to measure the burden of patient symptoms by using 
instruments like impact index assessments. The commenter further stated 
that asking patients about how much they are bothered by their symptoms 
can help healthcare professionals assess the quality of life a patient 
is experiencing.
    Response: We recognize that the Patient Activation Measure (PAM) 
survey is proprietary and does require an investment on the practices' 
part if they choose to utilize it. However, in the activity noted above 
related to PAM, we explain that this is an example of a tool that could 
be used. Other tools to assist patients in assessing their need for 
support for self-management would be acceptable for this activity.
    Comment: Some commenters questioned whether a Million Hearts award 
received in prior years can count for improvement activities credit as 
prior awardees are not allowed to compete again. The commenters 
suggested that prior year awards should count for improvement 
activities credit and bonus points as well.
    Response: We recognize the importance of the Million Hearts 
Cardiovascular Risk Reduction Model and have included that activity in 
the improvement activities inventory. All activities within the 
improvement activities inventory, however, must be performed for a 
continuous 90-day period that must occur within the performance period.
Activities Related to the Emergency Preparedness and Readiness 
Subcategory
    Comment: Some commenters noted that the Emergency Response and 
Preparedness subcategory was the only subcategory with no high-weighted 
activities and several asked for more high-weighted activities.
    Response: We are changing one existing activity in the Emergency 
Response and Preparedness Subcategory ``Participation in domestic or 
international humanitarian volunteer work. MIPS eligible clinicians and 
groups must be registered for a minimum of 6 months as a volunteer for 
domestic or international humanitarian volunteer work'' to a high-
weighted activity that is ``Participation in domestic or international 
humanitarian volunteer work. Activities that simply involve 
registration are not sufficient. MIPS eligible clinicians must attest 
to domestic or international humanitarian volunteer work for a period 
of a continuous 60 days or greater.'' We have changed this activity 
from requiring being registered for 6 months to participating for 60 
days to be in line with our overall new performance period policy which 
only requires a 90-day period. The 60-day participation would fall 
within that new 90-day window. We are also changing this to a high-
weighted activity because such volunteer work is intensive, often 
involves travel and working under challenging physical and clinical 
circumstances. Table H in in the Appendix to this final rule with 
comment period reflects this revised description of the existing 
activity and revised weighting.
    Comment: One commenter recommended the exclusion of ``Participation 
in domestic or international humanitarian volunteer work'' activity, 
stating that it is unlikely to lead to improvements in the quality or 
experience of care for a MIPS eligible clinician's patients. Another 
commenter expressed concern that their patient satisfaction ratings 
will suffer because they are actively attempting to reduce prescription 
drug overdoses. The commenter suggested removing the patient 
satisfaction component.
    Response: We disagree that this activity is unlikely to improve 
quality of care. Caring for injured and medically unwell patients 
during disasters is widely described by the generations of clinicians 
who have volunteered for these efforts as an excellent learning 
experience and that their volunteer work improved their clinical skills 
in their routine practice upon their patients. We believe that 
``Participation in domestic or international humanitarian volunteer 
work'' will have a similar positive impact for MIPS eligible clinicians 
and their patients.
    Comment: A few commenters believed that the Congress expressly 
defined remote monitoring and telehealth as a component of care 
coordination in improvement activities and understood the vital role of 
personal connected health in delivery of high quality clinical 
practice. The commenters suggested that CMS modify improvement 
activities in a manner that would reflect statutory language and 
provide incentive for the conduct of improvement activities using 
digital, interoperable communications.
    Response: We have provided appropriate incentives through other 
performance categories aligned with the policy goals for 
interoperability of EHRs and for achieving widespread exchange of 
health information. We also note the statutory example of ``use of 
remote monitoring or telehealth)'' in several activities, which include 
under the Care Coordination subcategory, ``Ensuring that there is 
bilateral exchange of necessary patient information to guide patient 
care that could include participating in a Health Information 
Exchange.'' This would require interoperable communications. Under the 
Population Management subcategory, we provide incentive for using 
remote monitoring or telehealth through the activity related to Oral 
Vitamin K antagonist therapy (warfarin) that includes, for rural or 
remote patients, that they can be managed using remote monitoring or 
telehealth options.
    Comment: Other commenters supported the MIPS program in including 
improvement activities as a new performance category for clinician 
performance, particularly incentivizing the use of health IT, 
telehealth and connection of patients to community-based services. In 
addition, specifically for the improvement activities performance 
category activities regarding connections to community-based services 
and the use of health IT and telehealth, the commenters supported CMS 
increasing their weight by rating them as ``high'' in the final rule 
with comment period.
    Response: We believe that high weighting should be used for 
activities that directly address areas with the greatest impact on 
beneficiary care, safety, health, and well-being. We have focused high 
weighting under the subcategory on those activities.
    Comment: Another commenter recommended that we enhance the clarity 
of the improvement activities definitions in the final rule with 
comment period and with subregulatory guidance so that MIPS eligible 
clinicians know what they must do to qualify for a given improvement 
activity. For example, where a general and non-specific definition is 
intentional to permit clinicians flexibility, commenter requested that 
CMS define expectations on how MIPS eligible clinicians can meet and 
substantiate such an improvement activity requirement and specify the 
evidence that MIPS eligible clinicians would be expected to retain as 
documentation for a potential audit including documentation for non-
percentage-based measures. The commenter stated their concern that, 
given short and ambiguous definitions in Table H in in the Appendix to 
this final rule with comment period, clinicians may avoid a given

[[Page 77195]]

improvement activity based on varied understandings of what satisfying 
the activity entails.
    Response: MIPS eligible clinicians may retain any documentation 
that is consistent with the actions they took to perform each activity. 
We also note that any MIPS eligible clinician may report on any 
activity; for example, a cardiologist may choose to select an 
improvement activity related to an emergency response and preparedness, 
if applicable. We will provide MIPS eligible clinicians more 
information about documentation expectations for the transition year of 
MIPS in subregulatory guidance.
Activities Related to the Health Equity Subcategory
    Comment: We received over 10 comments related to activities under 
Health Equity. One commenter recommended that we add an activity that 
encourages referrals to a clinical trial for a minority population. 
Another commenter requested inclusion of an established health equity 
council. Another commenter supported a Promoting Health Equity and 
Continuity subcategory, and recommended including the Bravemann et al. 
definition of health equity and the Tool for Health and Resilience in 
Vulnerable Environments or THRIVE framework.
    Response: We will consider these recommendations in future years as 
part of the nomination process.
Activities Related to the Care Coordination Subcategory
    Comment: We received at least 10 comments related to Care 
Coordination activities. One commenter recommended that we expand the 
subset of activities listed for the Care Coordination subcategory in 
the improvement activities inventory list to include long-term services 
and supports. Another commenter supported our proposal to retain the 
activities related to care management and individualized plans of care 
in the proposed improvement activities inventory, and refine these 
activities over time by incorporating the concept of principles of 
person-centered care to coordinate care and identifying, tracking and 
updating individual goals as they relate to the care plan. One 
commenter recommended that participation in a Rural Health Innovation 
Collaborative (RHIC) count as an improvement activity since RHIC are 
recognized by Congress as organizations that can give technical support 
to small practices, rural practices, and areas experiencing a shortage 
of clinicians.
    Response: We will work with stakeholders as part of the future 
nomination process to identify additional activities.
    After consideration of the comments regarding the improvement 
activities inventory, we are finalizing the improvement activities and 
weighting provided in Table H in the Appendix to this final rule with 
comment period as proposed with the exception of the following: One 
change for one activity in the Emergency Response and Preparedness 
Subcategory from a medium to a high-weighted activity; one change for 
one activity in the Population Management Subcategory from a medium to 
a high-weighted activity; we have included the addition of an asterisk 
(*) in Table H in the Appendix to this final rule with comment period, 
next to activities that also qualify for the advancing care information 
bonus, and refer readers to section II.E.6.a.(5) of this final rule 
with comment period. We also included language, elaborating on the 
requirements for the Consultation PDMP activity. We are correcting the 
reference to Million Hearts Cardiovascular Risk Reduction Model instead 
of describing it as a ``campaign;'' and revising the wording of the 
proposed activity ``Use decision support and protocols to manage 
workflow in the team to meet patient needs'' to read ``Use decision 
support and standardized treatment protocols to manage workflow in the 
team to meet patient needs;'' and ``removing the State Innovation Model 
participation activity.'' Our reasoning for these changes is to 
alleviated confusion related to the activity based on comments, to 
correct a previous incorrect term such as the use of the word 
``campaign'' or as a result of some other change in another section of 
the final rule with comment period, specifically inclusion of 
qualifying improvement activities for the advancing care information 
bonus. Our reasoning for changing the CAHPS for MIPS survey weighting 
to high is because the CAHPS for MIPS survey will be optional for large 
groups under the quality performance category and we want to encourage 
use of this survey. Another contributing element was the need to ensure 
options beyond the CAHPS for MIPS survey were available to provide 
credit for surveying and for CAHPS that did not meet thresholds/
standards for reporting in measure category (largely because they did 
not have enough beneficiaries). Our reasoning for removing the State 
Innovation Model (SIM) activity is that SIM is a series of a different 
agreements between CMS and states. Clinicians are not direct 
participants. In addition, we do not collect TIN/NPI combinations, so 
there is no way to validate participation based on attestation. Our 
reasoning for changing the weighting on the Emergency Response and 
Preparedness activity is that this improvement activity requires the 
clinician pay out of pocket to travel and do volunteer work (personal 
costs/risks), likely contributing some donated medical durables/
expendables (practice material resources). In addition, the clinician 
also misses scheduled appointments with patients (foregoing practice 
financial revenue). Our reasoning for changing the weighting on the 
Population Management activity is that this improvement activity is 
consistent with section 1848(q)(2)(B)(iii) of the Act, which requires 
the Secretary to give consideration to the circumstances of practices 
located in rural areas and geographic HPSAs. Rural health clinics would 
be included in that definition for consideration of practices in rural 
areas. All of these changes are reflected in Table H in the Appendix to 
this final rule with comment period.
(a) CMS Study on Improvement Activities and Measurement
(1) Study Purpose
    Previous experience with the PQRS, VM, and Medicare EHR Incentive 
programs have shown that many clinicians have errors within their data 
sets, as well as problems in understanding and choosing the data that 
corresponds to their selected quality measures. In CMS' quest to create 
a culture of improvement using evidence based medicine on a consistent 
basis, fully understanding the strengths and limitations of the current 
processes is crucial to better understand the current processes, we 
proposed to conduct a study on clinical improvement activities and 
measurement to examine clinical quality workflows and data capture 
using a simpler approach to quality measures.
    The lessons learned in this study on practice improvement and 
measurement may influence changes to future MIPS data submission 
requirements. The goals of the study are to see whether there will be 
improved outcomes, reduced burden in reporting, and enhancements in 
clinical care by selected MIPS eligible clinicians desiring:
     A more data driven approach to quality measurement.
     Measure selection unconstrained by a CEHRT program or 
system.

[[Page 77196]]

     Improving data quality submitted to CMS.
     Enabling CMS get data more frequently and provide feedback 
more often.
(2) Study Participation Credit and Requirements: Study Participation 
Eligibility
    This present study will select 10 non-rural individual MIPS 
eligible clinicians or groups of less than three non-rural MIPS 
eligible clinicians, 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 20 MIPS 
eligible clinicians, three groups of 21 to 100 MIPS eligible 
clinicians, two groups of greater than 100 MIPS eligible clinicians, 
and two specialist groups of MIPS eligible clinicians. Participation 
would 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. MIPS eligible 
clinicians and groups would need to sign up from January 1, 2017, to 
January 31, 2017. The sign up process will utilize a web-based 
interface. Participants would be approved on a first come first served 
basis and must meet all the required criteria. Selection criteria will 
also be based on different states and also within different clinician 
settings that falls in the participation eligibility criteria.
    MIPS eligible clinicians and groups in the CMS study on practice 
improvement and measurement will receive full credit (40 points) for 
the improvement activities performance category of MIPS after 
successfully electing, participating and submitting data to the study 
coordinators at CMS for the full calendar year.
(3) Procedure
    Based on feedback and surveys from MIPS eligible clinicians, study 
measurement data will be collected at baseline and at every three 
months (quarterly basis) afterwards for the duration of the calendar 
year. Study participants who can submit data on a more frequent basis 
will be encouraged to do so.
    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 would 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 would be used to learn from the practices on how 
to be more agile as we test new ways of measure recording and workflow.
    For CY 2017, the participating MIPS eligible clinicians or groups 
would submit their data and workflows for a minimum of three MIPS CQMs 
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, we would use the same data validation process described 
in the proposed rule (81 FR 28279). We would only collect the numerator 
and denominator for the measures selected for the overall population, 
all patients/all payers. This would enable the practices to build the 
measures based on what is important for their area of practice while 
increasing the quality of care.
    The first round of the study will last for 1 year after which new 
participants will be recruited. Participants electing to continue in 
future years would be afforded the opportunity to opt-in or opt-out 
following the successful submission of data to us. The first 
opportunity to continue in the study would be at the end of the 2017 
performance period. Eligible clinicians who elect to join the study but 
fail to participate in the study requirements 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 improvement activities performance category.
    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.
    We requested comment on the study and welcome suggestions on future 
study topics.
    The following is a summary of the comments we received regarding 
the CMS study on improvement activities and measurement.
    Comment: Commenters recommended that CMS monitor performance of the 
activities by the various MIPS eligible clinicians and groups for 
trends and consider whether activities result in better outcomes.
    Response: We will consider these issues as we develop the study.
    Comment: Some commenters supported CMS' proposal to conduct a study 
on improvement activities and measurement, in general, to examine 
clinical quality workflows and data capture using a simpler approach to 
quality measures. The commenters believed that CMS proposes an 
appropriate incentive by allowing a limited number of selected 
clinicians and groups to receive full credit (60 points) for the 
improvement activities performance category if they participate in the 
study. However, the commenters recommended that CMS expand this 
opportunity so that it is available to a broader and more diverse swath 
of practices, including emergency medicine practices. Other commenters 
supported our plans to conduct an annual call for activities to build 
the improvement activities inventory and our plans to study 
measurement, workflow, and current challenges for clinical practices. 
The commenters suggested that we ensure that we study a diverse range 
of participants when conducting that analysis.
    Response: We plan to expand as we learn from the initial study, 
which is currently open to all types of practices. We acknowledge that 
there are many variables affecting measurement and will continue to 
make sure we look at this diversification as we study different methods 
of measurement.
    Comment: One commenter was concerned about the study and wanted to 
know if CMS expects vendors to develop EHR workflows and reports for 
study measures and if vendors would be expected to support the study's 
requirements for more frequent data submission.
    Response: We will work with these vendors and others as the study 
evolves. We note that for this study, we will use measures that already 
exist in programs, so that new development is required for technical 
workflows or documentation requirements for those products included on 
the ONC certified health IT product list (CHPL).
    Comment: Another commenter agreed that improvement activities study 
participants should receive full credit for improvement activities and 
that those participants that do not adhere to the study guidelines 
should be removed and subject to typical improvement activities 
requirements. This commenter recommended that CMS provide a final date 
by which it plans to make these exclusion determinations and that after 
this date, CMS can work with the ex-

[[Page 77197]]

participant to help them complete the year. They also recommended that 
all participants who get excluded from the study not be allowed to 
participate in the study the following year.
    Response: We will work with stakeholders to further define future 
participation requirements as this study evolves.
    After consideration of the comments regarding the CMS study on 
improvement activities and measurement we are finalizing the policies 
with the exception that successful participation in the pilot would 
result in full credit for the improvement activities performance 
category of 40 points, not 60 points, in accordance with the revised 
finalized scoring. If participants do not meet the study guidelines 
they will be removed from the study and need to follow the current 
improvement activities guidelines.
(8) Improvement Activities Policies for Future Years of the MIPS 
Program
(a) Proposed Approach for Identifying New Subcategories
    We proposed, for future years of MIPS, to consider the addition of 
a new subcategory to the improvement activities performance category 
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 an improvement 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 cost performance categories.
    In future years, MIPS eligible clinicians or groups would 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 in the proposed rule. We 
requested comments on this proposal.
    We did not receive any comments regarding policies for identifying 
new improvement activities subcategories in future years of the MIPS 
program. We therefore are finalizing the addition of a new subcategory 
to the improvement activities performance category 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 an improvement 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 cost performance categories.
(b) Request for Comments on Call for Measures and Activities Process 
for Adding New Activities
    We plan to develop a call for 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 
improvement activities 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 improvement activities 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 improvement activities inventory for the performance year would 
be published in accordance with the overall MIPS rulemaking timeline. 
In addition, in future years we anticipate developing a process and 
establishing criteria to remove or add new activities to improvement 
activities performance category.
    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 improvement activities inventory based on specific 
criteria noted above. MIPS eligible clinicians or 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 
requested 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 improvement activities only via QCDR from 1 year to the next or 
to require the same activity from 1 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 improvement activities inventory. 
The data would 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 us for final inclusion 
in the improvement activities 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 improvement activities data points for all MIPS 
eligible clinicians and to award scores based on performance and 
improvement. We solicited comment on how best to collect such 
improvement activities data and factor it into future scoring under 
MIPS.
    We requested comments on these approaches and on any other 
considerations we should take into account when developing these type 
of approaches for future rulemaking.
    The following is summary of the comments we received regarding 
improvement activities policies for identifying new improvement 
activities in future years of the MIPS program.
    Comment: Some commenters recommended that CMS limit participants 
from reporting on the same activity over several performance periods in 
future years.
    Other commenters recommended that CMS allow MIPS eligible 
clinicians to maintain improvement activities over time and opposed CMS 
proposals to have more stringent requirements. These commenters were 
concerned that by imposing limits on frequency of reporting of the same 
activity over several years, CMS would be encouraging practices to 
implement temporary instead of permanent improvements and would risk 
creating short-lived activities that lack consistency across time, 
which is not beneficial to patients and is confusing and disruptive to 
MIPS eligible clinicians' workflow.
    A few commenters recommended that CMS permit MIPS eligible 
clinicians to select from a wide range of improvement activities, allow 
MIPS eligible clinicians to perform them in a way that is effective and 
reasonable for both the MIPS eligible clinicians and their patient 
population, and refrain from imposing restrictive specifications

[[Page 77198]]

regarding how MIPS eligible clinicians document and report their 
activities. One commenter suggested that CMS keep the broad list of 
improvement activities and publish additional detail through non-
binding clarification or guidance, rather than in regulatory text, 
which may limit innovation and flexibility.
    Response: We recognize that some activities may be improved upon 
over time which would support reporting on the same activity across 
multiple performance periods. We also note that other activities, such 
as providing 24/7 access may provide limited opportunity to demonstrate 
improvement over time and would minimize the value of reporting this 
same activity over subsequent years. We will consider this for future 
rulemaking. It is our intention to continue to allow MIPS eligible 
clinicians to select from a wide range of improvement activities, allow 
MIPS eligible clinicians to perform them in a way that is effective and 
reasonable for both the MIPS eligible clinicians and their patient 
population, and refrain from imposing restrictive specifications 
regarding how MIPS eligible clinicians document and report their 
activities. In addition, we intend to keep the broad list of 
improvement activities and publish additional detail through non-
binding clarification or guidance as we are able.
    Comment: Other commenters suggested that in the future, CMS 
evaluate whether: (1) Improvement activities should be worth more than 
15 percent of the final score; (2) individual activity weights should 
be increased; the number and type of MIPS eligible clinicians reporting 
on health equity improvement activities should be changed; (3) how 
performance on health equity improvement activities correlates with 
quality performance; (4) whether improvement activities result in 
better outcomes; and (5) what additional improvement activities should 
be included in MIPS. Some commenters suggested that some activities in 
the improvement activities performance category require considerable 
additional resources, and may warrant more points than 20--the proposed 
standard for ``high.'' Other commenters expressed concern about the 
proposed scoring for improvement activities, noting that the category 
is a new one that has not been implemented in previous programs and 
that activities may favor outpatient primary care.
    Response: We intend to consider these comments in future 
rulemaking, and will monitor MIPS eligible clinicians' performance in 
the improvement activities performance category carefully to inform 
those policy decisions. We welcome commenters' specific suggestions for 
additional activities or activities that may merit additional points 
beyond the ``high'' level we are adopting in the future. We refer 
readers to the section II.E.6. of this final rule with comment period 
for additional discussion of the public comments that we received on 
the MIPS program's scoring methodology.
    Comment: A few commenters agreed with the proposal that future 
scores for improvement activities should be based on outcomes and 
improvement. The commenters believed that MIPS eligible clinicians 
engaged in improvement activities should submit quality measures that 
reflect the focus of their improvement activities and demonstrate the 
quality improvement by engaging in those improvement activities. Other 
commenters suggested that we use improvement activities as a test bed 
for innovation to identify how activities could lead to improved 
outcomes and readiness for APM participation. The commenters encouraged 
collaboration with specialty physicians, medical societies, and other 
stakeholders to evaluate improvement activities continually.
    Response: We will take the commenter's suggestion that we should 
more closely link measures selected under the quality performance 
category with activities selected under the improvement activities 
performance category into consideration in the future. We note that for 
the transition year of MIPS, we believe we should provide MIPS eligible 
clinicians with flexibility in selecting measures and activities that 
are relevant to their practices.
    We intend to monitor MIPS eligible clinicians' participation in 
improvement activities carefully, and as the commenters suggested, we 
will continue examining potential relationships to quality measurement, 
advancing care information measures leveraging CEHRT, and APM 
participation readiness. We intend to continue collaborating with 
specialty clinicians, medical societies, and other stakeholders when 
conducting these evaluations.
    Comment: Some commenters opposed adding additional measurement and 
reporting requirements for improvement activities in future years and 
stated that this would increase MIPS eligible clinician burden and is 
not in line with CMS's objective to simplify MIPS. The commenters 
suggested that CMS view the improvement activities inventory as fluid 
and to formalize a standard process to add new activities each year.
    Response: We will take these comments into account as we consider 
improvement activities policy for future program years. Our intent, 
however, is to minimize burden on MIPS eligible clinicians. We will 
consider whether or not we should adopt a standard process for adding 
activities in the future.
    Comment: Some commenters recommended that CMS allow MIPS eligible 
clinicians or groups to nominate additional activities that CMS would 
consider adding to the improvement activities inventory. Specifically, 
they recommended that CMS draw upon working sessions with groups such 
as AHRQ, ONC, HRSA, and other federal agencies to create a patient-
generated health data framework which would seek to identify best 
practices, gaps, and opportunities for progress in the collection and 
use of health data for research and care delivery.
    Response: We intend to follow a similar process that is now 
employed in the annual Call for Measures for changes in the improvement 
activities inventory. It is important to keep in mind that in 
developing activities, some of the developer's considerations should 
include whether the activity is evidenced based and applicable across 
service settings and aligns with the National Quality Strategy and CMS 
Quality Strategy.
    Comment: Several commenters stated, as CMS implements new 
improvement activities in future years, the commenters were in support 
of a process similar to the current CMS Call for Quality Measures and 
recommended that CMS clearly communicate the timelines and requirements 
to the public early and often to allow for the preparation of 
submissions.
    Response: Our intent is to proceed with this process for the 
transition year of MIPS.
    Comment: A few commenters expressed concern about program 
requirements for MIPS eligible clinicians reporting as a group and 
future changes in the program. The commenters also requested more 
direction regarding documentation to maintain for these activities in 
the event of an audit.
    Response: We will verify data through the data validation and audit 
process as necessary. MIPS eligible clinicians may retain any 
documentation that is consistent with the actions they took to perform 
each activity.
    Comment: Other commenters proposed that CMS allow, for the 
improvement activities performance category, that individual activities 
may be pursued by an individual MIPS eligible clinician for up to 3 
years, but

[[Page 77199]]

that following this period, MIPS eligible clinicians be required to 
select a different area of focus.
    Response: We will consider this in the future.
    Comment: One commenter supported CMS's proposal to study workflow 
and data capture to understand the limitations. This commenter 
encouraged CMS to include MIPS eligible clinicians from specialty 
behavioral health organizations as part of this study.
    Response: We will work with key stakeholders on the workflow and 
data capture for better understanding of how to measure improvement of 
activities.
    Comment: Some commenters expressed support for the approach for 
identifying new subcategories and activities in the future and one 
suggested that CMS develop a template designed to ensure that proposed 
improvement activities are clearly measurable and also that the 
``value'' of the improvement activity can be related to an existing 
improvement activity.
    Response: We will work with stakeholders to further refine this 
approach for future consideration.
    Comment: Another commenter suggested rather than looking to 
restrictions on the use of QDCRs as improvement activities, in future 
years, we should include an assessment of how well an improvement 
activity was accomplished, including demonstration of resulting 
improvements in outcomes and/or patient experience from the improvement 
activity. This commenter believed that we should take this more 
positive approach to ensure improvement activities are being effective 
rather than trying to determine whether the clinician is using a QCDR 
to achieve ``too many'' improvement activities.
    Response: We will work with the stakeholder community in future 
years for how this could be best addressed.
    Comment: One commenter was concerned that MIPS did not recognize 
practices are likely to develop multi-year improvement strategies and 
that removal of an approved improvement activity in the annual update 
would undermine program stability. To address this concern, this 
commenter recommended that improvement activity topics identified for 
termination should be allowed to continue for the transition year 
beyond initial notification to allow for sufficient notice to 
participating practices.
    Response: We will work with the stakeholder community in future 
years to best determine how to maintain the annual activity list.
    We will take the comments regarding improvement activities policies 
for identifying new improvement activities in future years of the MIPS 
program into consideration 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 improvement 
activities 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 
improvement activities than are possible to list under the current 
improvement activities 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 would be allowed to define specific improvement 
activities for specialty and non-patient facing MIPS eligible 
clinicians or groups through the already-established QCDR approval 
process for measures and activities. We requested comments on this 
approach. We did not receive any comments regarding the use of QCDRs 
for identification and tracking of future activities.
(d) Request for Comments on Activities That Will Advance the Usage of 
Health IT
    The use of health IT is an important aspect of care delivery 
processes described in many improvement activities. In this final rule 
with comment period we have finalized a policy to allow MIPS eligible 
clinicians to achieve a bonus in the advancing care information 
performance category when they use functions included in CEHRT to 
complete eligible activities from the improvement activities inventory. 
Please refer to section II.E.5.g. of this final rule with comment 
period for details on how improvement activities using CEHRT relate to 
the objectives and measures of the advancing care information and 
improvement activities performance categories.
    In addition to those functions included under the CEHRT definition, 
ONC certifies technology for additional emerging health IT capabilities 
which may also be important for enabling activities included in the 
improvement activities inventory, such as technology certified to 
capture social, psychological, and behavioral data according to the 
criterion at 80 FR 62631, and technology certified to generate and 
exchange an electronic care plan (as described at 80 FR 62648). In the 
future, we may consider including these emerging certified health IT 
capabilities as part of activities within the improvement activities 
inventory. By referencing these certified health IT capabilities in 
improvement activities, clinicians would be able to earn credit under 
the improvement activities performance category while gaining 
experience with certification criteria that may be reflected as part of 
the CEHRT definition at a later time. Moreover, health IT developers 
will be able to innovate around these relevant standards and 
certification criteria to better serve clinicians' needs.
    We invite comments on this approach to encourage continued 
innovation in health IT to support improvement activities.
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 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 CY 2015, 
for EPs who

[[Page 77200]]

are not meaningful users of CEHRT 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 and 44317).)
    A primary policy goal of the EHR Incentive Program is to encourage 
and promote the adoption and use of CEHRT among Medicare and Medicaid 
health care providers to help drive the industry as a whole toward the 
use of CEHRT. As described in the final rule titled ``Medicare and 
Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 
and Modifications to Meaningful Use in 2015 Through 2017'' (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 CEHRT as a performance category 
under the MIPS, referred to in the proposed rule and in this final rule 
with comment period 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 final score for each MIPS eligible clinician. In general, MIPS 
eligible clinicians will be evaluated under all four of the MIPS 
performance categories, including the advancing care information 
performance category. 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 CEHRT and the objectives and measures under the EHR 
Incentive Program, we proposed a scoring methodology within the 
advancing care information performance category that provides 
flexibility for MIPS eligible clinicians from early adoption of CEHRT 
through advanced use of health IT. In the proposed rule (81 FR 28230 
through 28233), we also proposed to reweight the advancing care 
information performance category to zero in the MIPS final 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 CEHRT 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 us to effectively measure performance for MIPS 
eligible clinicians in the advancing care information performance 
category who have taken incremental steps toward the use of CEHRT, 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 CEHRT 
in their practice.
    Below is a summary of the comments received on our overall approach 
to the advancing care information performance category under MIPS:
    Comment: A commenter did not support the name change, expressing 
concern that it is attempting to draw a distinction without a 
difference and is going to cause confusion. The commenter urged CMS to 
return to the term ``meaningful use''.
    Response: We believe that the name ``advancing care information'' 
is appropriate to distinguish the MIPS performance category from 
meaningful use under the EHR Incentive Programs. We note that the term 
``meaningful use,'' still applies for purposes of the Medicare and 
Medicaid EHR Incentive Programs. The reporting requirements and scoring 
to demonstrate meaningful use were established in regulation under the 
EHR Incentive Programs and vary substantially from the requirements and 
scoring finalized for the advancing care

[[Page 77201]]

information performance category in the MIPS program.
(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 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.
    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 CEHRT 
as defined under the HITECH Act. In the proposed rule (81 FR 28220), we 
proposed substantial flexibility in how we would assess MIPS eligible 
clinician performance for the new advancing care information 
performance category. We proposed 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 to advance 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 CEHRT to improve care. At the same time, we 
proposed 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 EHRs 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 sought 
to improve and encourage the use of CEHRT over time by adopting a new, 
more flexible scoring methodology, as discussed in the proposed rule 
(81 FR 28220) 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 CEHRT 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 have significant room for continued improvement. Through this 
flexibility, MIPS eligible clinicians would be incentivized to focus on 
those aspects of CEHRT that are most relevant to their practice, which 
we believe would lead to improvements in health care quality.
    We also sought to increase the adoption and use of CEHRT by 
incorporating such technology into the other MIPS performance 
categories. For example, in section II.E.6.a.(2)(f) of the proposed 
rule (81 FR 28247), we proposed to incentivize electronic reporting by 
awarding a bonus point for submitting quality measure data using CEHRT. 
Additionally, in section II.E.5.f. of the proposed rule (81 FR 28209), 
we aligned some of the activities under the improvement activities 
performance category such as Care Coordination, Beneficiary Engagement 
and Achieving Health Equity with a focus on enhancing the use of CEHRT. 
We believe this approach would strengthen the adoption and use of 
certified EHR systems and program participation consistent with the 
provisions of section 1848(o)(2)(A) of the Act.
    Below is a summary of the comments received regarding our overall 
approach to requirements under the advancing care information 
performance category:
    Comment: Many commenters noted that what we proposed is even more 
complicated than Stage 3 of meaningful use. Most commenters appreciated 
the increased flexibility. One commenter appreciated the proposal but 
did not believe that it went far enough. They noted that there should 
be widespread health data interoperability throughout the clinical data 
ecosystem and not just between meaningful users. Many commenters did 
not support the retention of the all-or-nothing approach to scoring for 
the advancing care information performance category. Many wanted a less 
prescriptive approach to allow clinicians to be creative in applying 
technology to their own unique workflows. Some noted that clinicians 
should not be penalized for actions that they cannot control such as 
patient actions in certain measures. One recommended that CMS focus its 
efforts on increasing functional interoperability between and among EHR 
vendors. Another commenter explained that the CMS efforts to date do 
not go far enough toward the attainment of widespread health data 
interoperability. Further CMS should provide advancing care information 
performance category credit for activities that demonstrate a MIPS 
eligible clinician's use of digital clinical data to inform patient 
care. Many noted that this category is too similar to the existing 
meaningful use framework and should be further modified.
    Response: We have carefully considered and will address these 
comments in more detail in the following sections of this final rule 
with comment period as we further describe the final policies for the 
advancing care information performance category. We note that within 
the proposed requirements for the performance category, we sought to 
balance the new requirements under MACRA with our goal to allow greater 
flexibility and providing consistency for clinicians with prior 
experience in the Medicare and Medicaid EHR Incentive Programs. This 
consistency includes maintaining

[[Page 77202]]

the definition of CEHRT (as adapted from the EHR Incentive Program) and 
specifications for the applicable measures. We believe this consistency 
will ease the transition to MIPS and allow MIPS eligible clinicians to 
adapt to the new program requirements quickly and with ease. We also 
believe this will aid EHR vendors in their development efforts for MIPS 
as many of the requirements are consistent with prior policy finalized 
for the EHR Incentive Program in previous years.
    We hope to continue to work with our stakeholders over the coming 
years so that we can continue to improve the framework and 
implementation of this performance category in order to improve health 
outcomes for patients across the country.
(b) Future Considerations
    The restructuring of program requirements described in this final 
rule with comment period are geared toward increasing participation and 
EHR adoption. We believe this is the most effective way to encourage 
the adoption of CEHRT, and introduce new MIPS eligible clinicians to 
the use of certified 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 and the 
Medicare Program, 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 solicited comment on 
further methods to increase the stringency of the advancing care 
information performance category measures in the future.
    We additionally solicited 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 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 
solicited 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 CEHRT would be needed, and how such an approach 
could be implemented.
    The following is a summary of the comments we received:
    Comment: Several commenters expressed an interest in advancing the 
use of certified health IT in a clinical setting. Some commenters 
suggested combining advancing care information performance category 
measures and improvement activities in the improvement activities 
performance category, though cautioned that improvement activities 
should not require the use of CEHRT, more so that CEHRT should be 
optional for improvement activities and should allow MIPS eligible 
clinicians to earn credit in the advancing care information performance 
category. Some commenters recommended that CMS award credit in both the 
advancing care information performance category and improvement 
activities performance category for overlapping activities.
    Response: We agree that tying applicable improvement activities 
under the improvement activities performance category to the objectives 
and measures under the advancing care information performance category 
would reduce reporting burden for MIPS eligible clinicians. Our first 
step toward that goal of reducing reporting burden, and toward a more 
holistic approach to EHR measurement is to award a bonus score in the 
advancing care information performance category if a MIPS eligible 
clinician attests to completing certain improvement activities using 
CEHRT functionality. We believe tying these performance categories 
encourages MIPS eligible clinicians to use their CEHRT products not 
only for documenting patient care, but also for improving their 
clinical practices by using their CEHRT in a meaningful manner that 
supports clinical practice improvement. The objectives and measures of 
the advancing care information performance category measure specific 
functions of CEHRT which are the building blocks for advanced use of 
health IT. In the improvement activities performance category, these 
same functions may be tied to improvement activities which focus on a 
specific improvement goal or outcome for continuous improvement in 
patient care.
    In Table 8, we identify a set of improvement activities from the 
improvement activities performance category that can be tied to the 
objectives, measures, and CEHRT functions of the advancing care 
information performance category and would thus qualify for the bonus 
in the advancing care information performance category. For further 
explanation of these improvement activities, we refer readers to the 
discussion in section II.E.5.f. of this final rule with comment period. 
While we note that these activities can be greatly enhanced through the 
use of CEHRT, we are not suggesting that these activities require the 
use of CEHRT for the purposes of

[[Page 77203]]

reporting in the improvement activities performance category. More so, 
we are suggesting that the use of CEHRT in carrying out these 
activities can further the outcomes of clinical practice improvement, 
and thus, we are awarding a bonus score in the advancing care 
information performance category if a MIPS eligible clinician can 
attest to using the associated CEHRT functions when carrying out the 
activity. A MIPS eligible clinician attesting to using CEHRT for 
improvement activities would use the same certification criteria in 
completing the improvement activity as they would for the measures 
under advancing care information as listed in Table 8; for the 2017 
performance period, this may include 2014 or 2015 Edition CEHRT. For 
example, for the first improvement activity in Table 8, in which a MIPS 
eligible clinician would provide 24/7 access for advice about urgent 
and emergent care, a MIPS eligible clinician may accomplish this 
through expanded practice hours, use of alternatives to increase access 
to the care team such as e-visits and phone visits, and/or provision of 
same-day or next-day access. The Secure Messaging measure under the 
advancing care information performance category requires that a secure 
message was sent using the electronic messaging function of CEHRT to 
the patient (or the patient-authorized representative), or in response 
to a secure message sent by the patient (or the patient-authorized 
representative). If secure messaging functionality is used to provide 
24/7 access for advice about urgent and emergent care(for example, 
sending or responding to secure messages outside business hours), this 
would meet the requirement of using CEHRT to complete the improvement 
activity and would qualify for the advancing care information bonus 
score.
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BILLING CODE 4120-01-C
    After consideration of the comments, we will award a 10 percent 
bonus in the advancing care information performance category if a MIPS 
eligible clinician attests to completing at least one of the 
improvement activities specified in Table 8 using CEHRT. We note that 
10 percent is the maximum bonus a MIPS eligible clinician will receive 
whether they attest to using CEHRT for one or more of the activities 
listed in the table. This bonus is intended to support progression 
toward holistic health IT use and measurement; attesting to even one 
improvement activity demonstrates that the MIPS eligible clinician is 
working toward this holistic approach to the use of their CEHRT. We 
additionally note that the weight of the improvement activity has no 
bearing on the bonus awarded in the advancing care information 
performance category.
    We are seeking comment on this integration of the improvement 
activities with the advancing care information performance category, 
and other ways to further the advancement of health IT measurement.

[[Page 77210]]

(3) Clinical Quality Measurement
    Section 1848(o)(2)(A)(iii) of the Act requires the reporting of 
CQMs using CEHRT. Section 1848(q)(5)(B)(ii)(II) of the Act provides 
that under the methodology for assessing the total performance of each 
MIPS eligible clinician, the Secretary shall, for 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 CQM 
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 did not 
propose separate requirements for CQM 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 CEHRT. We refer readers to section II.E.5.a.of the proposed 
rule (81 FR 28184-28196) for discussion of reporting of CQMs with data 
captured in CEHRT under the quality performance category.
    Below is a summary of the comments received regarding CQM reporting 
for the advancing care information category:
    Comment: Many commenters supported our proposal not to include the 
submission of CQMs in this category. Several noted that this 
elimination will reduce burden for MIPS eligible clinicians, streamline 
reporting and reduce overlap. Others supported the elimination of 
duplicative reporting that existed under PQRS and the EHR Incentive 
Programs.
    Response: We appreciate commenters' support and note that the 
submission of CQMs is a requirement for the Medicare EHR Incentive 
Program. For the advancing care information performance category, we 
will require submission of quality data for measures specified for the 
quality performance category, in which we encourage reporting of CQMs 
with data captured in CEHRT. This approach helps to avoid unnecessary 
overlap and duplicative reporting. Therefore, we have not included 
separate requirements for clinical quality measurement in the advancing 
care information performance category, and direct readers to the 
quality performance category discussed in section II.E.5.b. of this 
final rule with comment period for information on clinical quality 
measurement.
(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). In 
addition we have proposed a 90-day EHR reporting period in 2016 for the 
EHR Incentive Programs in a recent proposed rule, the Calendar Year 
(CY) 2017 Changes to the Hospital Outpatient Prospective Payment System 
(OPPS) and Ambulatory Surgical Center (ASC) (81 FR 45753).
    Moving forward, the implementation of MIPS creates a critical 
opportunity to align performance periods to ensure that quality, 
improvement activities, cost, 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 MIPS eligible clinicians can use common systems and reporting 
pathways.
    Under MIPS, we proposed to align the performance period for the 
advancing care information performance category to the proposed MIPS 
performance period of one full calendar year and the intent of the 
proposal was to 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 (81 FR 28179-28181). Therefore, we noted 
there would not be a separate 90-day performance period for the 
advancing care information performance category and 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 also stated that 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 
(81 FR 28179-28181). Under that proposal, MIPS eligible clinicians 
would need to possess CEHRT and report on the objectives and measures 
(without meeting any thresholds) during the calendar year performance 
period to achieve the advancing care information performance category 
base score. Finally, we stated 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.
    The following is a summary of the comments we received regarding 
our advancing care information performance period proposal.
    Comment: The majority of commenters did not support our proposal 
for a performance period of one full calendar year. Instead they 
overwhelmingly recommended a 90-day performance period in 2017. 
Commenters noted the need for time and resources to understand and 
adjust to the new MIPS program. Others suggested that 90 days would 
give MIPS eligible clinicians flexibility to acquire and implement 
health IT products. A commenter noted that a shorter performance period 
would enable MIPS eligible clinicians to adopt innovative uses of 
technology as it would permit them to test new health IT solutions. 
Additionally with the final rule with comment period not expected until 
late in 2016, commenters noted there is not sufficient time to review 
and understand the rule and begin data collection on January 1, 2017.
    Other commenters noted that MIPS eligible clinicians must perform 
improvement activities for the improvement activities performance 
category for at least a 90-day performance period, and suggested 
adopting the same for the advancing care information performance 
category as it would create alignment. Some commenters requested a 
performance period of 90-days for the first several years of the 
program. A few recommended a 90-day performance period every time a new 
edition of

[[Page 77211]]

CEHRT is required. Others suggested partial year reporting or reporting 
for a quarter. One recommended that solo practitioners report for 60 
days. We note that only a few commenters supported our proposal.
    Response: We understand the challenges of a full year performance 
period. As discussed in the proposed rule (81 FR 28179 through 28181), 
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, and thus, would not need to report 
for one full year, rather, they could report whatever data they had 
available even if that data represented less than a full-year period.
    Additionally, we understand the commenters' concerns and rationale 
for requesting a 90-day performance period. As discussed in section 
II.E.4. of this final rule with comment period, for the first 
performance period of CY 2017, we will accept a minimum of 90 days of 
data within CY 2017, although we greatly encourage MIPS eligible 
clinicians to submit data for the full year performance period. Also in 
recognition of the switch from CEHRT certified to the 2014 Edition to 
CEHRT certified to the 2015 Edition, for the 2018 performance period we 
will also accept a minimum of 90 days of data within CY 2018. We refer 
readers to section II.E.4. of this final rule with comment period for 
further discussion about the MIPS performance period and the 90-day 
minimum.
    Comment: One commenter encouraged CMS to extend the transition 
timeframe to performance periods under MIPS in 2017 and 2018. They 
indicated that their vendors struggle to provide budgetary estimates 
needed to plan staff and financial resources due to the lack of clarity 
on what would be required for the MIPS program.
    Response: We recognize that vendors will require varying levels of 
effort to transition their technology to the MIPS reporting 
requirements. We note that our proposal to adopt substantively the same 
definition of CEHRT for the 2015 Edition under MIPS that was adopted in 
the 2015 EHR Incentive Programs final rule was intended to provide 
consistency for MIPS eligible clinicians, as well as to allow EHR 
vendors to begin development based on the specifications finalized in 
October of 2015 and released by ONC for testing beginning in 2016 
unimpeded by the timeline related to any rulemaking for the MIPS 
program. This would allow vendors to work toward certification on a 
longer timeline and allow MIPS eligible clinicians to adopt an 
implement the technology in preparation for the performance period in 
2018. The MIPS performance period in 2017 will serve as a transition 
year for MIPS eligible clinicians, vendors and others parties 
supporting MIPS eligible clinicians. Further, in section II.E.5.a. of 
this final rule with comment period, we have established multiple 
reporting mechanisms to allow MIPS eligible clinicians to report their 
advancing care information data in the event that their vendor is 
unable to support new submission requirements. We are adopting for MIPS 
the 2017 Advancing Care Information Transition objectives and measures 
(referred to in the proposed rule as Modified Stage 2 objectives and 
measures) and Advancing Care Information objectives and measures 
(referred to in the proposed rule as adapted from the Stage 3 
objectives and measures) and allowing MIPS eligible clinicians and 
groups to use technology certified to either the 2014 Edition or the 
2015 Edition or a combination of the two editions to support their 
selection of objectives and measures for 2017. We intend this 
consistency with prior programs to help ease the transition and reduce 
the development work needed to transition to MIPS. Finally, we will 
accept a minimum of any consecutive 90 days in the 2018 performance 
period for the advancing care information performance category to 
support eligible clinicians and groups as they transition to technology 
certified to the 2015 Edition for use in 2018. For these reasons, we 
believe a 1 year transition during the 2017 MIPS performance period is 
sufficient.
    After consideration of the public comments received, we are 
finalizing our proposal to align the performance period for the 
advancing care information performance category with the MIPS 
performance period of one full calendar year. For the first performance 
period of MIPS (CY 2017), we will accept a minimum of 90 consecutive 
days of data in CY 2017, however, we encourage MIPS eligible clinicians 
to report data for the full year performance period. For the second 
performance period of MIPS (CY 2018), we will accept a minimum of 90 
consecutive days of data in 2018, however, we encourage MIPS eligible 
clinicians to report data for the full year performance period. We 
refer readers to section II.E.4. of this final rule with comment period 
for further discussion of the MIPS performance period.
(5) Advancing Care Information Performance Category Data Submission and 
Collection
(a) Definition of Meaningful EHR User and Certification Requirements
    In the 2015 EHR Incentive Programs final rule (80 FR 62873), we 
outlined the requirements for EPs using CEHRT in 2017 for the Medicare 
and Medicaid EHR Incentive Programs as it relates to the objectives and 
measures they select to report. In the proposed rule, we proposed to 
adopt a definition of CEHRT at Sec.  414.1305 for MIPS eligible 
clinicians that is based on the definition that applies in the EHR 
Incentive Programs under Sec.  495.4.
    We proposed 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 the proposed rule (81 
FR 28221 through 28223), 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 the proposed rule (81 FR 28223 and 28224), 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 the 
proposed rule (81 FR 28221 through 28223), 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 the proposed rule (81 FR 28223 and 28224), 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 the proposed rule (81 FR 
28221 through 28223) that correlate to a Stage 3 measure that requires 
the support of technology certified to the 2015 Edition. These MIPS 
eligible clinicians would be

[[Page 77212]]

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 the proposed rule (81 FR 28223 and 28224), 
which correlate to modified Stage 2 objectives and measures.
    We proposed 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 the 
proposed rule (81 FR 28222 and 28223), which correlate to Stage 3.
    We welcomed comments on the proposals, which were intended to 
maintain consistency across MIPS, the Medicare EHR Incentive Program 
and the Medicaid EHR Incentive Program.
    Finally, we proposed to define at Sec.  414.1305 a meaningful EHR 
user under MIPS as a MIPS eligible clinician who possesses CEHRT, uses 
the functionality of CEHRT, 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.
    The following is a summary of the comments we received regarding 
our proposal for EHR certification requirements.
    Comment: Most commenters supported the proposal to allow MIPS 
eligible clinicians to use either technology certified to 2014 or 2015 
Edition for the performance period in 2017. Many commenters urged CMS 
to allow MIPS eligible clinicians to continue to use either EHR 
technology certified to the 2014 or 2015 Edition in the performance 
period 2018 and beyond, citing concerns over the time required for 
health IT development and certification and MIPS eligible clinician 
readiness concerns that the 2015 Edition technology may not be 
available in time for the performance period or reporting timeframe. A 
few commenters suggested that flexibility in the form of a hardship 
exception to reporting to MIPS be offered to accommodate MIPS eligible 
clinicians who are unable to implement EHR technology certified to the 
2015 Edition in time for the 2018 performance period. Other commenters 
found the requirement to use EHR technology certified to the 2015 
Edition in 2018 unacceptable. Commenters noted that as of the comment 
due date there are zero products certified to the 2015 Edition and 
recommended that we allow the use of products certified to the 2014 
Edition through 2020. Some commenters were also concerned that the 
small amount of products certified to the 2015 Edition would require 
MIPS eligible clinicians to find alternatives to meeting the advancing 
care information requirements and possibly limit those in APMs from 
utilizing the benefits of the new technology.
    Response: We appreciate the comments and feedback we received, and 
the support of the proposal for performance periods in 2017 to allow 
the use of technology certified to the 2014 or 2015 Edition or a 
combination of the two. We believe this will allow MIPS eligible 
clinicians the flexibility to transition to EHR technology certified to 
the 2015 Edition for use for performance periods in 2018 in a manner 
that works best for their systems, workflows, and clinical needs. We 
additionally understand the concerns raised by commenters regarding the 
timeline to implement the 2015 Edition in time for use for performance 
periods in 2018. We note the requirements for technology certified to 
the 2015 Edition were established in October 2015 in ONC's final rule 
titled 2015 Edition Health Information Technology (Health IT) 
Certification Criteria, 2015 Edition Base Electronic Health Record 
(EHR) Definition, and ONC Health IT Certification Program Modifications 
(80 FR 62602-62759). The EHR Incentive Programs final rule adopted the 
requirement that EPs, eligible hospitals, and CAHs use technology 
certified to the 2015 Edition beginning in 2018. We intend to maintain 
continuity for MIPS eligible clinicians and health IT vendors who may 
already have CEHRT or who have begun planning for a transition to 
technology certified to the 2015 Edition based on the definition of 
CEHRT finalized for the EHR Incentive Programs in the 2015 EHR 
Incentive Programs final rule (80 FR 62871 through 62889). Therefore, 
there are no new certification requirements in the definition we are 
finalizing for MIPS eligible clinicians participating in the advancing 
care information performance category of MIPS at Sec.  414.1305 in 
order to maintain consistency with the EHR Incentive Programs CEHRT 
definition at 42 CFR 495.4. Our proposal to adopt a substantively 
similar definition of CEHRT that was finalized in the 2015 EHR 
Incentive Programs final rule was intended to provide consistency for 
MIPS eligible clinicians and also to allow EHR vendors to begin 
development based on the specifications finalized in October of 2015 
and released by ONC for testing beginning in 2016 unimpeded by the 
timeline related to any rulemaking for the MIPS program. This allows 
vendors to work toward certification on a longer timeline and allows 
MIPS eligible clinicians to adopt an implement the technology in 
preparation for the performance period in 2018. In addition, in order 
to allow eligible clinicians and groups adequate time to transition to 
EHR technology certified to the 2015 Edition for use in CY 2018, we 
will accept a minimum of 90 consecutive days of data within the CY 2018 
performance period for the advancing care information performance 
category. In partnership with ONC, we are monitoring the development 
and certification process for health IT products certified to the 2015 
Edition and will continue to gauge MIPS eligible clinician readiness 
for the 2018 performance period. At this time, we believe it is 
appropriate to require the use of EHR technology certified to the 2015 
Edition for the performance period in 2018 and encourage MIPS eligible 
clinicians to work with their EHR vendors in the coming months to 
prepare for the transition to 2015 Edition in for the performance 
period in CY 2018.
    Comment: One commenter suggested that the CEHRT definition be 
expanded to include requirements beyond those finalized for meeting the 
advancing care information performance category and commenters noted 
that vendors other than EHR vendors could support the criteria listed 
in the proposed rule, to include Health Information Exchanges (HIE) or 
Health Information Service Providers (HISPs).
    Response: The definition of CEHRT does contain elements that are 
not included in the advancing care information performance category. As 
noted in the proposed rule (81 FR 28218-28219), and consistent with 
prior EHR Incentive Program policy, removing a measure from the 
reporting requirements does not remove the functions supporting that 
measure from the definition of CEHRT unless we make corresponding 
changes to that definition. Therefore, a MIPS eligible clinician must 
implement that function in their practice in order to have their system 
meet the technological specifications required for participation in the 
program. For example, in the 2015 EHR Incentive Programs final rule (80 
FR 62786), we noted that the Stage 1 ''Record Demographics'' measure 
was designated as topped out and no longer required for reporting, but 
CEHRT must still capture and record demographics as structured data 
using the appropriate standards. For MIPS, we did not propose to 
include the CPOE and CDS objectives and measures in the

[[Page 77213]]

advancing care information performance category although the technology 
functions supporting these measures were included in our proposed 
definition of CEHRT for MIPS.
    Comment: Some commenters were encouraged by the CMS' commitment to 
collaborate with ONC on the 2015 Edition CEHRT requirements for MIPS to 
align with the evolving standards to support health IT capabilities.
    Response: We appreciate these comments and will continue to 
collaborate with ONC on the alignment of MIPS requirements and CEHRT in 
future rulemaking.
    Comment: A few commenters requested that the definitions of CEHRT 
incorporate the roles of non-physician practitioners, including Nurse 
Practitioners (NPs), Physician Assistants (PAs), Certified Registered 
Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs). They 
noted that current EHR vendor software usually does not allow non-
physician practitioners to make entries or be identified. The 
commenters suggested that CEHRT vendors should be required include 
provisions so that non-physician practitioners can also utilize the 
CEHRT so that they can meet MIPS requirements.
    Response: The requirements for the use of CEHRT do not specify the 
type of provider or clinician that can enter data, nor do ONC's 
certification criteria in any way limit the entry of data by non-
physician practitioners. In some states, the MIPS eligible clinicians 
mentioned by the commenter may already be participating in the Medicaid 
EHR Incentive Programs as an EP and using CEHRT to support their 
clinical practice. In addition, many practices across a wide range of 
settings where EPs have participated in the Medicare EHR Incentive 
Programs have developed different workflows to meet their practice 
needs including the various staff beyond the eligible clinician that 
enter data. We encourage MIPS eligible clinicians and groups to work 
with their vendor, and with their own practice and clinical workflows 
to identify and establish best practices for data capture and data 
mapping to support their unique practice needs.
    Comment: Some commenters recommended that CMS consider ways to 
measure possible clinical workflow disruptions caused by health IT 
(EHRs). The commenters suggested that CMS use Medicare beneficiary 
surveys, focus groups, patient reported outcome measures, and the CAHPS 
for MIPS survey; and to incorporate those results when designing health 
IT specifications and regulations to be used across settings.
    Response: We appreciate the feedback and will take this suggestion 
into consideration in the future. We encourage MIPS eligible clinicians 
to work with their EHR vendor to improve the clinical workflow in a way 
that best suits their individual practice needs.
    Comment: Other commenters noted that while patient access to data 
is important, MIPS eligible clinicians also need interoperable data 
from a variety of sources to integrate seamlessly into their work flow. 
The commenters believe that third party applications will play a major 
role in satisfying this need to ensure data ``quality'' so that 
physicians get the most relevant data in a useable format, when and 
where they need it.
    Response: CMS and ONC agree with the comments that interoperability 
and the seamless integration of data and systems into clinical 
workflows is essential to improving health care quality. For this 
reason, the 2015 Edition certification criteria include testing and 
certification for API functionality as a certified health IT module (80 
FR 62601-62759), as well as criteria related to ensuring the ability to 
receive and consume electronic summary of care records from external 
sources into the provider's EHR and to developing a path for bi-
directional exchange of immunization data with public health 
registries.
    After consideration of the comments we received, we are finalizing 
our proposal regarding EHR certification requirements at Sec.  414.1305 
as proposed and encourage MIPS eligible clinicians to prepare for the 
migration to the 2015 Edition of CEHRT in 2018. In 2017, MIPS eligible 
clinicians may use EHR technology certified to the 2014 Edition or the 
2015 Edition or a combination of the two. We note that a MIPS eligible 
clinician who only has technology certified to the 2014 Edition would 
not be able to report certain measures specified for the advancing care 
information performance category that correlate to a Stage 3 measure 
for which there was no Stage 2 equivalent. These MIPS eligible 
clinicians may instead report the objectives and measures specified for 
the advancing care information performance category which correlate to 
Modified Stage 2 objectives and measures. In 2018, MIPS eligible 
clinicians must use EHR technology certified to the 2015 Edition.
    The following is a summary of the comments we received regarding 
our proposal for defining a meaningful EHR user under MIPS.
    Comment: Many commenters expressed an overall desire to maintain a 
moderate to high level standard and category weight for the distinction 
of meaningful EHR user. These commenters noted that the definition of 
meaningful EHR user will have an important impact on heath IT adoption 
and that reducing the stringency or lowering the advancing care 
information performance category weight in the MIPS final score could 
hinder progress toward robust, person-centered use of health IT across 
the health care industry.
    Response: We agree that defining a meaningful EHR user is critical 
for all of the reasons that the commenter raises; it is an important 
piece of health IT adoption and promoting interoperability. We seek to 
balance this critical aspect of EHR reporting with our desire to 
increase widespread adoption of health IT and clinical standards among 
MIPS eligible clinicians. We believe our final policies will encourage 
more widespread adoption and use of health IT in a practice setting. We 
are also dedicated to increasing the stringency of the measures 
specified for the advancing care information performance category in 
future years of the MIPS program to further the advancement of health 
IT use.
    After consideration of the public comments we received, we are 
finalizing our proposal to define a meaningful EHR user for MIPS under 
Sec.  414.1305 as a MIPS eligible clinician who possesses CEHRT, uses 
the functionality of CEHRT, 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.
(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 site. For the purpose of reporting advancing care 
information performance category objectives and measures under the 
MIPS, we proposed 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

[[Page 77214]]

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 us, 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 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.
    The following is a summary of the comments we received regarding 
our proposal to allow for multiple methods for data submission for the 
advancing care information performance category.
    Comment: The majority of commenters supported the proposed data 
submission approach to allow for MIPS eligible clinicians to submit 
data for the advancing care information performance category through 
multiple submission methods, which includes, for example, via 
attestation, qualified registries, QCDRs, EHRs and CMS Web Interface. 
Many agreed that the proposal alleviates the need for individual MIPS 
eligible clinicians and groups to use a separate reporting mechanism to 
report data for different performance categories.
    Response: We appreciate the supportive comments and reiterate that 
our goals include reducing the reporting burden, aligning reporting 
requirements across MIPS performance categories, and supporting 
efficient data submission mechanisms.
    Comment: Some commenters expressed concern that many third party 
data submission entities do not have the necessary data submission 
functionality and will not have enough time to develop, distribute and 
adopt the needed functionality for a performance period in 2017. One 
commenter requested that CMS provide detailed guidance to vendors and 
QCDRs as they implement data submission functionality. Another 
commenter expressed concern about the potential for vendors and 
developers of QCDRs and registries to fail to fulfill the technical 
requirements for data submission and advised CMS to finalize a policy 
indicating that MIPS eligible clinicians would not be penalized for 
failure of data submission due to vendor issues. One commenter 
suggested offering bonus points for the use of QCDRs or registry 
adoption to recognize the investment needed to participate.
    Response: We appreciate the concerns raised by commenters and note 
that we intend to provide detailed guidance for EHR vendors, as well as 
third party data intermediaries who submit data on behalf of MIPS 
eligible clinicians to help them be successful in data submission. 
However, we acknowledge that some EHRs, QCDRs and registry vendors may 
not be able to support data submission for the advancing care 
information performance category for 2017 due to the time needed to 
develop the technology and functionality to collect and submit these 
data. For this reason, as discussed in section II.E.5.a. of this final 
rule with comment period, we offer MIPS eligible clinicians several 
reporting mechanisms from which to choose. While we believe that in the 
long term, it is more convenient for MIPS eligible clinicians to submit 
data one time for all performance categories, we acknowledge that this 
may not be possible in the transition year for the aforementioned 
reasons. Therefore, we offer the option of attestation for those MIPS 
eligible clinicians who's CEHRT, QCDR or registry are not prepared to 
support advancing care information performance category data submission 
in 2017. For further discussion of MIPS submission methods, we refer 
readers to section II.E.5.a. of this final rule with comment period.
    Comment: One commenter requested that CMS provide greater 
flexibility in the submission standards set forth for health IT 
vendors, particularly in the transition year of MIPS, including the 
ability to submit data via QCDR XML. The commenter stated that QCDR 
vendors often experience issues submitting data using the uniform 
standards in QRDA implementation guides and that many QRDA variables 
that are clinical in nature do not easily map to the variables in 
CEHRT.
    Response: We note that our proposal does allow for submission of 
the advancing care information performance category data via QCDR, as 
well as registry, CEHRT, CMS Web Interface and attestation. We believe 
this flexibility allows MIPS eligible clinicians the ability to submit 
through their chosen submission mechanism that is most appropriate for 
their practice.
    Comment: One commenter believed the attestation process is 
cumbersome and expensive for large groups and suggested that CMS 
develop a process that will allow larger groups to attest as a group.
    Response: Because the EPs reporting under EHR Incentive Program 
reported using their individual NPIs, attestation and data submission 
was completed at the NPI level which was not conducive to groups 
combining their data and attesting for all of their NPIs together. We 
agree that this same approach under the MIPS would be cumbersome for 
group submission. Under the MIPS, groups will have the ability to 
attest or submit their advancing care information data through a 
qualified registry, QCDR, EHR, attestation, or CMS Web Interface as a 
group, meaning the data would be aggregated to the group level and 
submitted once on behalf of all MIPS eligible clinicians within the 
group. MIPS eligible clinicians will also have the ability to submit as 
individuals, if their group is not submitting using the group method. 
In these cases, the attestation or data submission would be done at the 
individual (TIN/NPI) level.
    Comment: One commenter recommended the mandatory publication of EHR 
source code in order to reduce bias and errors.
    Response: We appreciate the suggestion, however, we note that this 
is outside our authority under section 1848(q) of the Act and outside 
the scope of this rule.
    We note that there were several other comments related to data 
submission for MIPS, and we direct readers to section II.E.5.a. of this 
final rule with comment period for discussion of those comments. After 
consideration of the comments we received, we are finalizing our policy 
as proposed.
(c) Group Reporting
    Under the Medicare EHR Incentive Program, we adopted a reporting 
mechanism for EPs that are part of a group, to attest using one common 
form, or a batch reporting process. To determine whether those EPs 
meaningfully used CEHRT, under that batch reporting process, we 
assessed the individual performance of the EPs that made up the group, 
not the group as a whole.
    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

[[Page 77215]]

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 proposed 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 the proposed rule (81 FR 28178 and 28179), 
consistent with section 1848(q)(1)(D)(i)(I) & (II) of the Act.
    Under this option, we proposed 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 the group, 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 the proposed rule (81 FR 28178 and 28179) for more 
discussion of how to participate as a group under MIPS.
    The following is a summary of the comments we received regarding 
our proposal to allow for group reporting starting in 2017.
    Comment: The majority of commenters strongly support the allowance 
of group reporting in the advancing care information performance 
category. Reasons for support include the reduction in reporting 
burden, as well as alignment with other MIPS performance categories.
    Response: We appreciate the supportive comments.
    Comment: Many commenters expressed concern about allowing group 
reporting for the advancing care information performance category in 
2017 given the short timeframe between the publication for this final 
rule with comment period and the start of the 2017 performance period. 
Commenters believe that this would offer too little time to implement 
group reporting capabilities in CEHRT, stating that report logic will 
require clear specifications and time for development and distribution 
of report updates.
    Response: We recognize that the implementation of group reporting 
may require varying levels of effort for different practices and 
therefore may not be the best choice for all MIPS eligible clinicians 
for the 2017 performance period. However, we believe that making group 
reporting available for performance periods in CY 2017 offers a 
significant reduction in reporting burden for many group practices that 
have a large number of MIPS eligible clinicians, all of whom would 
otherwise have to report the MIPS requirements individually. We 
additionally note that groups and MIPS eligible clinicians have the 
ability to report through multiple reporting mechanisms providing 
flexibility should their CEHRT be unable to support group reporting in 
2017.
    Comment: Some commenters requested clarification on how group 
reporting of the base and performance scores will be calculated if one 
or more individual MIPS eligible clinicians within a group practice 
does not report on an objective or can claim an exclusion from 
reporting on an objective. In addition, a few commenters asked how to 
avoid counting more than once the unique patients seen by multiple MIPS 
eligible clinicians within the group practice. They also asked for 
detailed instructions for calculating the numerators and denominators 
of the measures reported.
    Response: We understand that additional explanation is needed in 
order for groups to determine whether the group reporting option is 
best for their practice.
    As with group reporting for the other MIPS performance categories, 
to report as a group, the group will need to aggregate data for all the 
individual MIPS eligible clinicians within the group for whom they have 
data in CEHRT. For those who choose to report as a group, performance 
on the advancing care information performance category objectives and 
measures would be reported and evaluated at the group level, as opposed 
to the individual MIPS eligible clinician level. For example, the group 
calculation of the numerators and denominators for each measure must 
reflect all of the data from all individual MIPS eligible clinicians 
that have been captured in CEHRT for the given advancing care 
information measure. If the group practice has CEHRT that is capable of 
supporting group reporting, they would submit the aggregated data 
produced by the CEHRT. If the group practice does not have CEHRT that 
is capable of or updated to support group reporting, the group would 
aggregate the data by adding together the numerators and denominators 
for each MIPS eligible clinician within the group for whom the group 
has data captured in their CEHRT. If an individual MIPS eligible 
clinician meets the criteria to exclude a measure, their data can be 
excluded from the calculation of that particular measure only.
    We understand and agree that it can be difficult to identify unique 
patients across a group for the purposes of aggregating performance on 
the advancing care information measures, particularly when that group 
is using multiple CEHRT systems. We further recognize that for 2017, 
groups may be using systems which are certified to different CEHRT 
editions further adding to this challenge. We consider ``unique 
patients'' to be individual patients treated by the group who would 
typically be counted as one patient in the denominator of an advancing 
care information measure. This patient may see multiple MIPS eligible 
clinicians within the group, or may see MIPS eligible clinicians at 
multiple group locations. When aggregating performance on advancing 
care information measures for group reporting, we do not require that 
the group determine that a patient seen by one MIPS eligible clinician 
(or at one location in the case of groups working with multiple CEHRT 
systems) is not also seen by another MIPS eligible clinician in the 
group or captured in a different CEHRT system. While this could result 
in the same patient appearing more than once in the denominator, we 
believe that the burden to the group of identifying these patients is 
greater than any gain in measurement accuracy. Accordingly, this final 
policy will allow groups some flexibility as to the method for counting 
unique patients in the denominators to accommodate these scenarios 
where aggregation may be hindered by systems capabilities across 
multiple CEHRT platforms. We note that this is consistent with our data 
aggregation policy for providers practicing in multiple locations under 
the EHR Incentive Program (77 FR 53982).
    Comment: A few commenters voiced concerns that group reporting and 
many EHR systems, particularly hospital EHRs, mask who actually 
performs the service and may not recognize the ability of MIPS eligible 
clinicians who are not physicians to provide and document care. For 
example, non-physicians who are not considered MIPS eligible 
clinicians, such as nurse-midwives, physical or occupational

[[Page 77216]]

therapists and psychologists often perform services and complete their 
actions using CEHRT. However, the commenter notes that CEHRT 
functionality usually does not offer the ability to distinguish which 
clinician actually performed the action, thus making it difficult to 
calculate an accurate numerator and denominator for measures in the 
advancing care information performance category. One commenter 
requested that CMS require that CEHRT be able to identify which 
clinician is using the CEHRT, ensuring that clinicians other than 
physicians are able to make entries and actions are attributed to MIPS 
eligible clinicians.
    Response: We appreciate the feedback and agree that there are 
issues related to group reporting that we will continue to monitor as 
the program develops. We note that the vast majority of commenters 
supported the group reporting option as it represents a reduction in 
reporting burden for MIPS eligible clinicians who choose to report as 
groups rather than as individuals. As we move forward with the 
advancing care information performance category we will be working with 
ONC to refine capabilities in CEHRT that could further support group 
reporting.
    Comment: One commenter urged CMS to avoid issuing guidance that 
assigns nurses the role of scribe or data entry for physicians because 
this would adversely affect the quality of care delivered to patient.
    Response: We do not intend to issue guidance that define or 
redefine the role of non-physician practitioners, such as nurse 
practitioners or nurse specialists.
    After consideration of the comments, we are finalizing our proposal 
to allow group reporting for the advancing care information performance 
category with the additional explanation of data aggregation 
requirements for group reporting provided in our response above, 
particularly as it relates to aggregating unique patients seen by the 
group.
    For our final policy, we considered and rejected imposing a 
threshold for group reporting. For example, in future years we may 
require that groups can only submit their advancing care information 
performance category data as a group if 50 percent or more of their 
eligible patient encounters are captured in CEHRT. While we considered 
this as an option for 2017, the transition year of MIPS, we chose not 
to institute such a policy at this time and will instead consider it 
for future years. We are seeking comment in this final rule with 
comment period on what would be an appropriate threshold for group 
reporting in future years.
    We note that group reporting policies for the MIPS program, 
including the other performance categories, are discussed in section 
II.E.5.a. of this final rule with comment period, and we refer readers 
to that section for additional discussion of group reporting.
(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 final score shall be 
based on performance for the advancing care information performance 
category. Therefore, we proposed at Sec.  414.1375 that performance in 
the advancing care information performance category will comprise 25 
percent of a MIPS eligible clinician's MIPS final score 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 CEHRT 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 proposed 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''.
    The following is a summary of the comments we received regarding 
overall scoring for the advancing care information performance 
category.
    Comment: Overall, most commenters found the scoring to be 
cumbersome, complex, and complicated and recommended that it be 
simplified. Suggestions included removing distinction between the base 
score and performance score. Others suggested removing objectives and 
measures or moving them to other MIPS performance categories, such as 
moving Public Health and Clinical Data Registry Reporting to the 
improvement activities performance category. One commenter suggested 
simplifying the assignment of points for each measure. For example, 
they suggested that 10 percent per measure be awarded for the 
following: 1. Patient Access; 2. Electronic Prescribing; 3. 
Computerized Provider Order Entry (CPOE); 4. Patient-Specific 
Education; 5. View, Download, Transmit; 6. Secure Messaging; 7. 
Patient-Generated Health Data; 8. Patient Care Record Exchange; 9. 
Request/Accept Patient Care Record; 10. Clinical Information 
Reconciliation.
    Response: We appreciate the constructive feedback from commenters. 
Our priority is to finalize reporting requirements for the advancing 
care information performance category that incentivizes performance and 
reporting with minimal complexity and reporting burden. We have 
addressed many of these comments and concerns in our final scoring 
methodology outlined in section II.E.5.g.(6)(a) of this final rule with 
comment period.
    Comment: Some commenters appreciated the split between base and 
performance scores in the advancing care information performance 
category, citing the flexibility offered compared to the EHR Incentive 
programs. Many commenters also praised the elimination of the 
requirement to meet measure thresholds.
    Response: We appreciate commenters' support for our proposal. Our 
priority is to finalize a scoring methodology for the advancing care 
information performance category that promotes the use of CEHRT 
reporting requirements in an efficient, effective and flexible manner.
    Comment: Some commenters did not support the elimination of measure 
thresholds. They believed that incorporating measure thresholds enables 
MIPS eligible clinicians to earn higher score for the advancing care 
information performance score and would encourage a higher level of 
success using CEHRT. Another commenter suggested replacing the base 
score requirement of at least one in the numerator with a requirement 
to meet a 5 percent threshold for each measure reported beginning for 
the performance period of CY 2019.
    Response: We believe the scoring approach, as proposed and then as 
finalized in this final rule with comment period, promotes performance 
on the advancing care information performance category measures by 
rewarding high performance rather than requiring MIPS eligible 
clinicians to meet one threshold across the board. We agree that in 
future years of the program, we may consider higher minimum thresholds 
for reporting, however, we also seek to allow flexibility for MIPS

[[Page 77217]]

eligible clinicians to report on the measures that are most meaningful 
to their practice.
    Comment: Most commenters supported the proposal to move away from 
the overall all-or-nothing scoring approach previously used in the EHR 
Incentive Programs. However, many commenters do not support the all-or-
nothing approach proposed to earn the base score and subsequent points 
in the performance score, for the advancing care information 
performance category. More than one commenter recommended offering 
partial credit for each objective in the base score rather than an all-
or-nothing approach. Other comments include removing the base score and 
only awarding points toward a performance score, as well as adding more 
measure exclusions. Some suggested awarding points toward the 
performance score even if the MIPS eligible clinician fails to meet a 
base score.
    Response: In order to provide more flexibility for MIPS eligible 
clinicians, we have moved away from the all-or-nothing approach in our 
final policy. We note that certain measures under our final policy 
remain required measures in the base score. For example, section 
1848(o)(2)(A) of the Act includes certain requirements that we have 
chosen to implement through measures such as e-Prescribing, Send 
Summary of Care (formerly Patient Care Record Exchange) and Request/
Accept Patient Care Record, and thus, certain measures under our final 
policy remain required measures for the base score in the advancing 
care information performance category. In addition to those measures 
listed above, there are other measures such as Security Risk Analysis 
that are essential to protecting patient privacy, which we believe 
should be mandatory for reporting. We have addressed these comments 
further with our final scoring methodology outlined in section 
II.E.5.g.(6)(a) of this final rule with comment period. We have reduced 
the total number of required measures from 11 in the base score as 
proposed to only five in the final policy, which addresses some of the 
concerns raised by commenters while meeting our statutory requirements, 
as well as our commitment to patient privacy and access.
    Comment: Many commenters requested that the distribution of points 
for the base score and performance score of the advancing care 
information performance category be reweighted. More than one commenter 
suggested reducing the weight of the base score and increasing the 
weight of the performance score over time. For example, some commenters 
requested that the base be worth 40 percent and the performance be 60 
percent of the points. Another commenter believed the base score should 
initially be more heavily weighted, with the base score at 60 points, 
Protect Patient Health Information score at 10 points, and performance 
score at 80 points.
    Response: Based on the overwhelming comments received, and our goal 
to simplify the scoring methodology wherever possible, we agree with 
commenters that the base and performance scores should be reconsidered 
for the final policy. We have outlined the final scoring methodology in 
section II.E.5.g.(6)(a) of this final rule with comment period, in 
which the performance score is reweighted and the total possible score 
for the advancing care information performance category is increased to 
155 percent which would be capped at 100 percent when applied to the 25 
possible points for the advancing care information performance category 
in the MIPS final score.
    Comment: Many commenters disliked that no credit is awarded if the 
numerator for any measure is not at least one or the response is not 
``yes'' for yes/no measures. Some commenters propose changing the 
policy to allow MIPS eligible clinicians to earn a performance score 
and bonus score even if they fail the base score. Others suggest 
reducing the number of objectives to report to earn the base score. For 
example, one commenter suggested requiring only the measures within the 
following objectives to achieve the base score: Protect Patient Health 
Information, Patient Electronic Access and Health Information Exchange.
    Response: We appreciate the suggestions raised by commenters and 
have taken these comments into account for our final policy discussed 
in section II.E.5.g(6)(a) We note that for required measures in the 
base score, we would still require a one in the numerator or a ``yes'' 
response to yes/no measures. Section 1848(o)(2)(A) of the Act includes 
certain requirements that we have chosen to implement through three of 
the measures in the base score (e-Prescribing, Send a Summary of Care 
(formerly Patient Care Record Exchange) and Request/Accept Summary of 
Care (formerly Patient Care Record), and thus, we believe these 
measures should be required in order for a MIPS eligible clinician to 
earn any score in the advancing care information performance category. 
The other two required measures, Security Risk Analysis and Provide 
Patient Access (formerly Patient Access) are of paramount importance to 
CMS, and thus, we have maintained them as required measures in the base 
score.
    Comment: Many commenters support the emphasis on health information 
exchange and patient engagement in both the base score and performance 
score. Some commenters recommended an even more weight given to these 
areas in the performance score.
    Response: We appreciate this feedback. We agree that health 
information exchange and coordination of care through patient 
engagement are essential to improving the quality of care.
(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) (81 FR 28226 through 28228)), 
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 proposed 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 CEHRT 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 the proposed rule (81 FR 28221), and 
an advancing care

[[Page 77218]]

information performance category score of zero.
    The primary proposal at section II.E.5.g.(6)(b)(ii) of the proposed 
rule (81 FR 28221) 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, we proposed that 
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 stated our belief that 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, we 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 
CEHRT, 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 CEHRT. 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 CEHRT.
    The alternate proposal at section II.E.5.g.(6)(b)(iii) of the 
proposed rule (81 FR 28222) 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 CDS and a numerator and denominator 
for CPOE objectives. We included these objectives in the alternate 
proposal as MIPS eligible clinicians may believe the continued 
measurement of these objectives is valuable to the continued use of 
CEHRT as this would maintain the previously established objectives 
under the EHR Incentive Program.
    We stated our belief that both proposed approaches to the base 
score are consistent with the statutory requirements under HITECH and 
previously established CEHRT 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.
    Comment: Several commenters were disappointed that our proposals 
for the base score are so similar to the current meaningful use 
requirements. They requested a more streamlined approach as they 
believe the statute intended. Another commenter believed that advancing 
care information performance category should reflect a MIPS eligible 
clinician's use of digital clinical data to inform patient care and 
encourage bi-directional data interoperability.
    Response: While we did draw on the meaningful use foundation in 
drafting the requirements for the advancing care information 
performance category, our proposals have lessened those requirements 
and provided additional flexibility as compared with all stages of the 
EHR Incentive Programs. We note that we have made significant revisions 
to the scoring methodology and reporting requirements in our final 
policy discussed in section II.E.5.g.(6)(a) in response to these 
comments. We would also welcome concrete proposals for new measures as 
we move forward with EHR reporting requirements under the MIPS. We are 
eager to improve interoperability and would welcome suggestions for 
improvement.
    Comment: We received many comments on the allocation of points in 
the base score. Some commenters asked CMS to simplify the base score 
calculation and weight the base score higher. Alternatively commenters 
recommended that CMS reweight the base score to 75 percent of the total 
advancing care information performance category. Other commenters 
recommended that increasing the weight of the base score only occur if 
CMS also moves away from the pass-fail approach to scoring this 
section. Others suggested removing the base component of the scoring 
methodology, and instead just have a set amount of points that it is 
possible to achieve for each measure.
    In regard to the base score calculation, most commenters requested 
that we remove the all-or-nothing scoring of the base score. Some asked 
that CMS give clinicians the option to report on a subset of measures 
to satisfy the base score. Many requested partial credit. Some 
commenters expressed concern that not reporting at least a numerator of 
one for the base measures will result in a score or zero for the entire 
category. A commenter proposed reporting a zero numerator or 
denominator on a measure would satisfy successfully submitting data, 
and thus, the clinician should achieve full points for the base score. 
Another recommended CMS grant credit for each reported measure under 
the base score and make clear that a physician will not fail the entire 
advancing care category if they fail to report all base score measures.
    Commenters also suggested giving full credit in the advancing care 
information performance category if a MIPS eligible clinician attests 
to using technology certified to the 2014 or 2015 Edition for MIPS year 
1, and 75 percent credit toward advancing care information performance 
category for subsequent years. Another asked that 50 percent in the 
base score be awarded to clinicians that implemented CEHRT for at least 
90 days of the performance period to ease newer users into EHR. While 
most requested less stringent requirements, some thought that it is too 
easy to achieve the 50 percent base score. Others believed the ``one 
patient threshold'' for advancing care information performance category 
reporting for all measures in the base score is far too low.
    Response: We have taken commenters' feedback into consideration as 
we have constructed our final policy as outlined in section 
II.E.5.g.(6)(a) of this final rule with comment period. While we 
appreciate commenters concerns about low thresholds, we believe that 
the reporting requirements we set (a one in the numerator for 
numerator/denominator measures, and a ``yes' for yes/no measures) are 
appropriate as we transition to the MIPS. We note the definition of 
MIPS eligible clinician includes many practitioners that were not 
eligible under the EHR Incentive Programs and thus have little to no

[[Page 77219]]

experience with the objectives and measures. While the reporting 
requirements are lower than the thresholds established for Modified 
Stage 2 and Stage 3 of the EHR Incentive Programs, we believe they are 
appropriate for the first performance period of MIPS. Further we have 
tried to limit the composition of the base score so that MIPS eligible 
clinicians can distinguish themselves through reporting on the 
performance score measures. We are finalizing additional flexibilities 
to address the concern about an all-or-nothing approach and reduced the 
number of required measures from 11 in the proposed base score to five 
in our final policy. We note that certain measures which implement 
statutory requirements or that we consider high priority to protect 
patient privacy and access are required for reporting. MIPS eligible 
clinicians are required to report on all five of the required measures 
in the base score in order to earn any points in the advancing care 
information performance category. Considering this significant 
reduction in the number of required measures for the base score, we do 
not believe it is appropriate to increase the weight of the base score 
as some commenters suggested and will keep it at 50 percent in our 
final scoring methodology.
    We are finalizing our policy that a MIPS eligible clinician must 
report either a one in the numerator for numerator/denominator 
measures, or a ``yes'' response for yes/no measures in order to earn 
points in the base score, and a MIPS eligible clinician must report all 
required measures in the base score in order to earn a score in the 
advancing care information performance category. We note that the 
remainder of a MIPS eligible clinician's score will be based on 
performance and/or meeting the requirements to earn a bonus score for 
Public Health and Clinical Data Registry Reporting or improvement 
activities as described in section II.E.5.g.(7)(b) and II.E.5.g.(2)(b) 
of this final rule with comment period.
(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, as defined in 45 CFR 
160.103) created or maintained by the CEHRT 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 proposed that a MIPS eligible clinician must 
meet this objective and measure 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 
outlined proposal, as well as a performance score of zero (discussed in 
section II.E.5.g. of the proposed rule (81 FR 28215) and an advancing 
care information performance category score of zero.
    The following is a summary of the comments we received regarding 
our proposal to require that a MIPS eligible clinician must meet the 
Protect Patient Health Information objective and measure to earn any 
score within the advancing care information performance category.
    Comment: Many commenters supported the proposal requiring the 
Protect Patient Health Information objective and measure in order to 
receive the full base score and any performance score in the advancing 
care information performance category.
    Response: We agree as we continue to believe that there are many 
benefits of safeguarding ePHI. Unintended and/or unlawful disclosures 
of ePHI puts EHRs, interoperability and health information exchange at 
risk. It is paramount that ePHI is properly protected and secured and 
we believe that requiring this objective and measure remains 
fundamental to this goal.
    Comment: A few commenters expressed uncertainty about the 
effectiveness of the Protect Patient Health Information objective and 
measure in ensuring the security and privacy of patient health 
information, as well as maintaining doctor-patient confidentiality.
    Response: We understand that in some cases this measure may not be 
enough to protect data as data breaches become more sophisticated. 
However we continue to believe that widespread performance of security 
risk analyses on a regular basis remains an important component of 
protecting ePHI. The measure is a foundation of protection and we 
expect that individuals and entities subject to HIPAA will also be 
meeting the requirements of HIPAA.
    Comment: Some commenters believed that reporting the Protect 
Patient Health Information objective and measure is redundant and 
burdensome, as the security risk analysis and other privacy and 
security areas are already included under HIPAA requirements.
    Response: Yes, we agree that a security risk analysis is included 
in the HIPAA rules. However, it is our experience that some EPs are not 
fulfilling this requirement under the EHR Incentive Programs. To 
reinforce its importance, we are including it as a requirement for MIPS 
eligible clinicians.
    Comment: Some commenters expressed concern that meeting the Protect 
Patient Health Information objective and measure requirements presents 
a burden to small group practices, practices in rural settings, new 
adopters of CEHRT and some MIPS eligible clinicians who experience 
varying hardships.
    Response: We disagree. The HIPAA Privacy and Security Rules, which 
are more comprehensive than the Advancing Care Information measure and 
with which certain entities must also comply, have been effective for 
over 10 years. In addition, the Department of Health and Human Services 
has produced a security risk assessment tool designed for use by small 
and medium sized providers and clinicians available at https://www.healthit.gov/providers-professionals/security-risk-assessment and 
also http://www.hhs.gov/hipaa/for-professionals/security/index.html. 
This tool should help providers and clinicians with compliance and 
additional resources are also available at http://www.hhs.gov/hipaa/for-professionals/security/guidance/index.html. We understand that 
there are many sources of education available in the commercial market 
regarding HIPAA compliance.
    Comment: Many commenters stated that EHR use could jeopardize 
patient confidentiality because personal information can be stolen. 
Some stated that EHRs are a violation of privacy. Others do not want 
their medical information accessible to the government or third party 
vendors. Several stated that the proposed rule is contrary to the HIPAA 
regulations.
    Response: We agree that it is important to address the unique risks 
and challenges that EHRs may present. We maintain that a focus on the 
protection of ePHI is necessary for all clinicians. We also note that a 
security risk analysis is required under the HIPAA regulations (45 CFR 
164.308(a)(1)).
    Comment: A few commenters offered suggestions to modify the Protect 
Patient Health objective and measure, such as aligning the architecture 
of CEHRT with the Hippocratic Oath or

[[Page 77220]]

working with Office for Civil Rights (OCR) or the Office of the 
Inspector General (OIG) to develop additional guidance to physicians 
regarding privacy practices.
    Response: We appreciate this feedback. We will continue to work 
with the OCR and ONC to develop and refine guidance.
    We are finalizing the requirement that a MIPS eligible clinician 
must meet the Protect Patient Health Information objective and measure 
in order to earn any score within the advancing care information 
performance category.
(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 CEHRT 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 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. As 
proposed in the proposed rule, failure to meet the submission criteria 
(numerator/denominator or yes/no statement as applicable) and measure 
specifications (81 FR 28226 through 28230) 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 the proposed rule 81 FR 28215) 
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 proposed 
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 proposed 
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 81 FR 28230.
(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 of the proposed 
rule (81 FR 28223). 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 0 (discussed in section II.E.5.g. of the 
proposed rule), and an advancing care information performance category 
score of 0.
    We proposed the same approach in the alternate proposal for the 
Public Health and Clinical Data Registry Reporting objective as for the 
primary outlined proposal. We direct readers to 81 FR 28226 through 
28230 for further details on the individual objectives and measures.
    The following is a summary of the comments we received regarding 
our base score primary and alternate proposals which differ based on 
whether reporting the CDS and CPOE objectives would be required.
    Comment: Most commenters support the adoption of the base score 
primary proposal, which eliminates the objectives and associated 
measures for CPOE and CDS and agreed that most MIPS eligible clinicians 
already use CPOE and CDS and do very well on those measures. Several 
noted that measures require additional data entry and the pop-up alerts 
interfere with clinical workflow, and thus, removal of these measures 
could improve clinical workflow in the EHR.
    Response: We agree and appreciate the support of these commenters. 
As we have done previously under the EHR Incentive Programs we will 
continue to monitor performance on objectives and measures and plan to 
propose to refine measures and add new measures in future years.
    Comment: Since CPOE and CDS continue to be valuable to practices, 
many commenters support the alternate proposal to require the CPOE and 
CDS objectives in the base score for the advancing care information 
performance category. One commenter stated that maintaining these two 
objectives offers an opportunity for the development of important 
measures for specialists, including anesthesia-focused measures. 
Another commenter suggested including the CPOE objective in for the 
performance score of the advancing care information performance 
category to give more flexibility and offer an opportunity to MIPS 
eligible clinicians to earn more points, especially for those MIPS 
eligible clinicians who will be using an EHR technology certified to 
the 2014 Edition in 2017.
    Response: While we agree that CPOE and CDS are valuable, we 
continue to believe that it is important to streamline and simplify the 
reporting requirements under MIPS. We note that the functionality 
supporting these objectives will continue to be required as part of 
CEHRT requirements.
    Comment: One commenter urged CMS to clarify that even if the 
reporting of CPOE and CDS measures is eliminated under the primary 
proposal base score of the advancing care information performance 
category, MIPS eligible clinicians who utilize CPOE are still expected 
to utilize appropriately credentialed clinical staff to enter the 
orders and those who utilize CDS must have the required functionality 
turned on to receive credit in the advancing care information 
performance category base score.
    Response: As for the functionality, even if the CPOE and CDS 
objectives and measures are not included for reporting under the 
advancing care information performance category, it is

[[Page 77221]]

still expected that MIPS eligible clinicians will continue to have the 
functionality enabled as a part of CEHRT.
    Comment: Some commenters recommended retaining the CPOE and CDS 
objectives and associated measures, noting that while the two 
functionalities are widely adopted by those who were already 
participating in the Medicare and Medicaid EHR Incentive Programs, MIPS 
eligible clinicians include practitioners who were not eligible for 
those programs, many of whom have not yet adopted the functionalities 
and activities required for those objectives. Some commenters asked 
that, if retaining the CPOE objective and associated measures, that CMS 
include the low volume threshold exclusions.
    Response: While we appreciate these concerns, we continue to 
believe that it is important to streamline and simplify the reporting 
requirements under MIPS. Practitioners who are not eligible to 
participate in the EHR Incentive Programs but are MIPS eligible 
clinicians will be subject to many new requirements and will have a 
considerable amount of learning to do in their initial years of the 
program, thus we do not believe it is necessary to add more to that 
list of requirements and also increase the reporting burden for 
clinicians with more experience using EHR who have historically had 
high performance on these measures in the past under the EHR Incentive 
Program. We note that the functionality supporting these objectives 
will continue to be required as part of certification requirements and 
available to new adopters of EHR technology.
    Comment: One commenter expressed skepticism about the applicability 
of the objectives with special emphasis in the base score to 
specialists. For example, the commenter expressed concern that many 
anesthesiologists may have difficulty attesting to the Patient 
Electronic Access, Coordination of Care Through Patient Engagement and 
Health Information Exchange objectives. They suggested developing 
equally valuable substitute measures and objectives that focus on the 
use of CEHRT by specialists and MIPS eligible clinicians who work in 
settings that vary from traditional office-based practices.
    Response: We understand that the practice settings of MIPS eligible 
clinicians vary and that meeting the proposed objectives and measures 
may require different levels of effort. We will consider the 
development of objectives and measures for specialists and other 
clinicians who do not work in office settings in future rulemaking.
    Comment: We received many suggested changes to the measures 
included in our primary proposal. Some requested that we allow MIPS 
eligible clinicians to choose which measures are most relevant to their 
practice. Others recommended that the base score be streamlined and 
focus on three critical objectives of meaningful use: Protection of 
personal health information, patient electronic access to his/her 
health information, and health information exchange. Some commenters 
recommended including the smallest set of objectives in the base score 
required by statute and including any additional objectives in the 
performance score category.
    Response: We appreciate the many suggested changes to measures and 
measure reporting requirements and will take them into consideration in 
this and future rules. We are also conscious of the need to balance 
complexity or reporting requirements with reporting goals. In our final 
policy, we have restructured our base score to reduce reporting burden, 
and limited the required measures keeping only those measures that 
implement certain requirements under section 1848(o)(2)(A) of the Act, 
which include e-Prescribing and two of the measures under the Health 
Information Exchange objective; as well as Security Risk Analysis, 
which we have previously stated is of paramount importance to 
protecting patient privacy; and Provide Patient Access which is 
critical to increasing patient engagement and allowing patients access 
to their personal health data. We note that this reduction of measures 
is responsive to the comments we received requesting that we move away 
from the all-or-nothing scoring methodology in the proposed base score. 
While we believe all measures under the advancing care information 
performance category are of upmost importance, we acknowledge that we 
must balance the need for these data with data collection and reporting 
burden. We refer readers to section II.E.5.g.(6)(a) for more discussion 
of our final scoring policy.
    After consideration of the comments, we are finalizing our primary 
proposal with modifications described in section II.E.5.g.(6)(a) for 
the base score. This proposal does not require the reporting of the 
objectives and measures for CDS and CPOE. We note that the 
functionalities required for these objectives and associated measures 
are still required as part of ONC's certification criteria for CEHRT.
    The following is a summary of the comments we received related to 
the bonus for Public Health and Clinical Data Registry Reporting.
    Comment: The majority of commenters recommended that more bonus 
credit should be awarded to MIPS eligible clinicians for reporting to 
additional registries by either increasing the bonus to 5 or 10 percent 
or by offering a bonus for each additional registry to which the MIPS 
eligible clinician reports. One commenter specifically expressed 
concern that only awarding 1 percent downplays the importance and 
benefit of submitting data to multiple registries. Many commenters 
supported the proposal that Immunization Registry Reporting should be 
the only registry required for the base score, but encouraged CMS to 
provide more than 1 percent as a bonus for additional registry 
reporting. Another suggested that for CY 2017, CMS require two public 
health reporting measures in the Public Health and Clinical Data 
Registry Reporting objective for the base score, including mandatory 
reporting to immunization registries and any of the optional public 
health measures.
    Response: The Public Health and Clinical Data Registry reporting 
objective focuses on the importance of the ongoing lines of 
communication that should exist between MIPS eligible clinicians and 
public health agencies and clinical data registries thus, we agree that 
a larger bonus should be awarded for reporting to additional registries 
under the Public Health and Clinical Data Registry Reporting objective. 
These registries play an important part in monitoring the health status 
of patients across the country and some, for example syndromic 
surveillance registries, help in the early detection of outbreaks which 
is critical to public health overall.
    After consideration of the comments we received, and for the 
reasons mentioned above, we are increasing the bonus score to 5 percent 
in the advancing care information performance category score for 
reporting to one or more public health or clinical data registries 
beyond the Immunization Registry Reporting measure. We note that in our 
effort to reduce the number of required measures in the base score and 
simplify reporting requirements, the Immunization Registry Reporting 
measure is no longer required as part of the base score, however MIPS 
eligible clinicians can earn 10 percent in the performance score for 
reporting this measure. Additionally, if the MIPS eligible clinician 
reports to one or more additional registries under the Public Health 
and Clinical Data Registry Reporting objective, they will earn the 5

[[Page 77222]]

percent bonus score. We note that the bonus is only available to MIPS 
eligible clinicians who earn a base score.
(iv) 2017 Advancing Care Information Transition Objectives and Measures 
(Referred to in the Proposed Rule as Modified Stage 2)
    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 (81 FR 28218 and 28219) of the proposed rule, we 
proposed the requirements for MIPS eligible clinicians using various 
editions of CEHRT 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 
proposed 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 
outlined proposals in regard to scoring and data submission, but vary 
in the number of measures required under the Coordination of Care 
Through Patient Engagement and Health Information Exchange objectives 
as demonstrated in Table 8 of the proposed rule (81 FR 28224).
    This approach allows MIPS eligible clinicians to continue moving 
toward advanced use of CEHRT in 2018, but allows for flexibility in the 
implementation of upgraded technology and in the selection of measures 
for reporting in 2017.
    The following is a summary of the comments we received regarding 
the proposals for reporting on the Modified Stage 2 objectives and 
measures for the advancing care information performance category in 
2017. We note that in this final rule with comment period we will refer 
to these measures as the 2017 Advancing Care Information Transition 
objectives and measures instead of Modified Stage 2, which is a term 
specific to the EHR Incentive Program.
    Comment: Many commenters supported the proposal to allow MIPS 
eligible clinicians to report on the 2017 Advancing Care Information 
Transition objectives and measures in the 2017 performance period to 
meet the requirements of the advancing care information performance 
category. They stated that this approach offers flexibility to MIPS 
eligible clinicians who do not yet use a 2015 Edition CEHRT.
    Response: We agree. We are aware that in 2017 many MIPS eligible 
clinicians might not yet have access to EHR technology certified to the 
2015 Edition. Therefore, to accommodate these MIPS eligible clinicians 
we will allow the option for them to report for the 2017 performance 
period using EHR technology certified to the 2014 Edition or a 
combination of both 2014 and 2015 Editions.
    Comment: A majority of commenters suggested retaining 2017 
Advancing Care Information Transition objectives and measures beyond 
performance periods in 2017, citing vendor, as well as clinician 
readiness with implementing and using EHR technology certified to the 
2015 Edition in time for the 2018 performance period. Additionally, 
some commenters believed that the 2017 Advancing Care Information 
Transition reporting requirements are less stringent, and therefore, 
more feasible for MIPS eligible clinicians to achieve, resulting in 
more MIPS eligible clinician success in the advancing care information 
performance category. One commenter suggested continuing to allow the 
reporting of 2017 Advancing Care Information Transition objectives and 
not requiring the reporting of Advancing Care Information objectives 
until a performance period in 2019.
    Response: For the majority of measures in the EHR Incentive 
Programs, the difference between the Modified Stage 2 measures and the 
Stage 3 measures is the threshold required to successfully demonstrate 
meaningful use. For the advancing care information performance 
category, there are no thresholds and MIPS eligible clinicians are 
allowed to select the objectives and measures most applicable to their 
practice for reporting purposes. For this reason, we disagree that 
either set of measures for the advancing care information performance 
category is more stringent than the other. While we understand the 
commenters' concerns about readiness for subsequent years as it relates 
to adopting new technologies, we continue to believe that it is 
important to move forward with a single set objectives and measures 
focused on the top priorities of clinical effectiveness, patient 
engagement and health information exchange. We further maintain our 
belief that it reduces complexity and burden to have all MIPS eligible 
clinicians reporting on the same set of objectives and measures and the 
same specifications for those measures. We note that we will accept a 
minimum of 90 consecutive days of data within the CY 2018 performance 
period for the advancing care information performance category in order 
to support MIPS eligible clinicians and groups transitioning to 
technology certified to the 2015 Edition for use in 2018. At this time, 
we believe it is appropriate to require the use of EHR technology 
certified to the 2015 Edition for the CY 2018 performance period and 
encourage MIPS eligible clinicians to work with their EHR vendors in 
the coming months to prepare for the transition to 2015 Edition CEHRT.
    Comment: A few commenters requested clarification of the objectives 
and measures to use for performance periods in CY 2017 if the MIPS 
eligible clinician uses a combination of technologies certified to the 
2014 and 2015 Editions during the performance period. The commenters 
anticipate that many practices could begin the performance period using 
2014 Edition and upgrade during the performance period to begin use of 
2015 Edition. Others expect that MIPS eligible clinicians may use a 
combination of 2014 and 2015 Editions during the performance period. 
Commenters also requested clarification on how MIPS eligible clinicians 
will be scored if the objectives and measures to which they report only 
apply to part of the performance period and not the full calendar year.
    Response: In 2017, a MIPS eligible clinician who has technology 
certified to a combination of 2015 Edition and 2014 Edition may choose 
to report on either the Advancing Care Information objectives and 
measures specified for the advancing care information performance 
category in section II.E.5.g.(7) of this final rule or the 2017 
Advancing Care Information Transition objectives and measures specified 
for the advancing care information performance category as described in 
section II.E.5.g.(7) of this final rule if they have the appropriate 
mix of technologies to support each measure

[[Page 77223]]

selected. If a MIPS eligible clinician switches from 2014 Edition to 
2015 Edition CEHRT during the performance period, the data collected 
for the base and performance score measures should be combined from 
both the 2014 and 2015 Edition of CEHRT.
    After consideration of the comments we received, we are finalizing 
our proposal as proposed. We note that because we will accept a minimum 
of 90 consecutive days of data from the CY 2017 performance period, 
MIPS eligible clinicians who have EHR technology certified to the 2014 
Edition and then transition to EHR technology certified to the 2015 
Edition in 2017 have flexibility and may select which measures they 
want to report on for the 2017 performance period.
(c) Performance Score
    In addition to the base score, which includes submitting each of 
the objectives and measures to achieve 50 percent of the possible 
points within the advancing care information performance category, we 
proposed 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 us to focus on leveraging CEHRT 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 MIPS 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 
CEHRT.
    We proposed 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 the proposed rule. Table 9 of the proposed rule (81 FR 28225), 
provided an example of the proposed performance score methodology.
    We noted 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. We stated that this methodology would allow 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 CEHRT to support 
quality improvement, interoperability, and patient engagement. We 
invited comments on our proposal.
    The following is a summary of the comments we received regarding 
our proposal.
    Comment: A few commenters suggested removing the base score and 
instead scoring MIPS eligible clinicians solely on performance for the 
following measures: (1) Patient Electronic Access; (2) Electronic 
Prescribing; (3) Computer Provider-Order Entry; (4) Patient-Specific 
Education; (5) View, Download, Transmit; (6) Secure Messaging; (7) 
Patient-Generated Health Data; (8) Patient Care Record Exchange; (9) 
Request/Accept Patient Care Record; and (10) Clinical Information 
Reconciliation. Others requested that the patient engagement measures, 
View, Download or Transmit, Secure Messaging, and Patient-Generated 
Health Data be voluntary in order to provide flexibility.
    Response: We appreciate the feedback and have significantly reduced 
the number of required measures in the base score which adds both 
flexibility and simplicity to the scoring methodology while addressing 
statutory requirements. We refer readers to section II.E.5.g.(6)(b) of 
this final rule with comment period for further discussion of our final 
policy.
    Comment: A commenter suggested that the performance score measures 
should reflect the patient population because many MIPS eligible 
clinicians treat patients that are poor, elderly, or have limited 
English proficiency, and suggested that these factors strongly 
disadvantage MIPS eligible clinicians on measures as compared to MIPS 
eligible clinicians whose patient populations are better educated and 
better off financially. Another suggested the advancing care 
information performance category be renamed Health IT-related 
activities score and reflect the improvement activities performance 
category such that MIPS eligible clinicians select activities from a 
long list.
    Response: While we understand that the demographics and education-
level of patient populations of MIPS eligible clinicians may vary, we 
disagree that measures in the advancing care information performance 
category should be adjusted to accommodate for different patient 
populations. We believe MIPS eligible clinicians who have CEHRT have 
the ability to adequately use CEHRT to perform the actions required for 
the measures, regardless of their patient population. We also believe 
we have offered enough flexibility for MIPS eligible clinicians who are 
concerned about patient action requirements by not establishing measure 
thresholds and instead requiring a minimum of one in the numerator for 
numerator/denominator measures. We direct readers to the discussion of 
the advancing care information performance category scoring in section 
II.E.5.g.(6)(a) of this final rule with comment period. We look forward 
to continuing to refine the advancing care information performance 
category over time.
(d) Overall Advancing Care Information Performance Category Score
    To determine the MIPS eligible clinician's overall advancing care 
information performance category score, we proposed 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)

[[Page 77224]]

for the advancing care information performance category would then be 
multiplied by the weight (25 percent) of the advancing care information 
performance category and incorporated into the MIPS final score, as 
described at 81 FR 28220 through 28271 of the proposed rule. Table 10 
of the proposed rule (81 FR 28226) provides an example of the 
calculation of the advancing care information performance category 
score based on these proposals. For our final policy, we revised the 
proposed scoring approach by reducing the number of required measures 
in the base score and adding measures to the performance score in an 
effort to address commenters' concerns (as described above) and add 
flexibility wherever possible. The base score and performance score are 
added together, along with any additional bonus score if applicable, to 
determine the overall advancing care information performance category 
score.
    Under the final policy, a MIPS eligible clinician must report all 
required measures of the base score to earn any base score, and thus to 
earn any score in the advancing care information performance category. 
We understand that many commenters preferred that we do away entirely 
with the all-or-nothing approach to the base score and we have made 
adjustments to the base score to be responsive to those commenters' 
concerns. We note that section 1848(o)(2)(A) of the Act includes 
certain requirements that we have chosen to implement through certain 
measures such as e-Prescribing, Send a Summary of Care and Request/
Accept Summary, and thus, we continue to require these measures in the 
advancing care information performance category base score. In 
addition, we have maintained the Security Risk Analysis measure as a 
required measure as we believe it is essential to protecting patient 
privacy as discussed in the proposed rule (81 FR 28221), and thus, we 
believe should be mandatory for reporting. We have also maintained 
Provide Patient Access as the fifth required measure under the base 
score because we believe it is essential for patients to have access to 
their health care information in order to improve health, provide 
transparency and drive patient engagement. To address commenters' 
concerns, we have reduced the total number of required measures in the 
base score to only these five, and moved other measures to the 
performance score where MIPS eligible clinicians can choose which 
measures to report based on their individual practice. While we believe 
all measures under the advancing care information performance category 
are of upmost importance, we acknowledge that we must balance the need 
for these data with data collection and reporting burden. Given the 
considerable reduction in required measures, we do not believe it is 
appropriate to increase the weight of the base score, and thus, it 
remains at 50 percent of the advancing care information performance 
category score.
    The performance score builds upon the base score and is based on a 
MIPS eligible clinician's performance rate for each measure reported 
for the performance score (calculated using the numerator/denominator). 
A performance rate of 1-10 percent would earn 1 percentage point, a 
performance rate of 11-20 percent would earn 2 percentage points and so 
on. For example, if the clinician reports a numerator/denominator of 
85/100 for the Patient-Specific Education measure, their performance 
rate would be 85 percent and they would earn 9 percentage points toward 
their performance score for the advancing care information performance 
category. With nine measures included in the performance score, a MIPS 
eligible clinician has the ability to earn up to 90 percentage points 
if they report all measures in the performance score.
    We note that the measures under the Public Health and Clinical Data 
Registry Reporting objective are yes/no measures and do not have a 
numerator/denominator to calculate the performance rate. For the 
Immunization Registry Reporting measure, we will award 0 or 10 
percentage points for the performance score (0 percent for a ``no'' 
response, 10 percent for a ``yes'' response). Active engagement with a 
public health or clinical data registry to meet any other measure 
associated with the Public Health and Clinical Data Registry Reporting 
objective will earn the MIPS eligible clinician a bonus of 5 percentage 
points as outlined in section II.E.5.g.(6)(b)f this final rule with 
comment period. MIPS eligible clinicians are not required to report the 
Immunization Registry Reporting measure in order to earn the bonus 5 
percent for reporting to one or more additional registries.
    Two of the measures in the base score are not included in the 
performance score. The Security Risk Analysis and e-Prescribing 
measures are required under the base score, but a MIPS eligible 
clinician will not earn additional points under the performance score 
for reporting these measures. Due to the critical nature of the 
Security Risk Analysis measure, and as we stated in the proposed rule, 
we believe this measure is of paramount importance and applicable 
across all objectives. Therefore, the Protect Patient Health 
Information objective and Security Risk Analysis measure are 
foundational requirements for the advancing care information 
performance category (81 FR 28221). For this reason, we are including 
it as a required measure in the base score, but are not awarding any 
additional score for performance. The e-Prescribing measure is one of 
the measures that fulfills a statutory requirement under section 
1848(o)(2)(A) of the Act, and thus, we are requiring it as part of the 
base score. Given the historically high performance on this measure 
under the EHR Incentive Program with EPs achieving an average of 87 
percent of all permissible prescriptions written and transmitted 
electronically using CEHRT in 2015, we are not including it in the 
performance score for the advancing care information performance 
category.
    Under our final policy, MIPS eligible clinicians have the ability 
to earn an overall score for the advancing care information performance 
category of up to 155 percentage points, which will be capped at 100 
percent when the base score, performance score and bonus score are all 
added together. We believe this addresses commenters' requests for 
additional opportunities to earn credit in all aspects of the advancing 
care information performance category including the base score, 
performance score and bonus score. In addition, we believe this scoring 
approach adds flexibility for MIPS eligible clinicians to choose 
measures that are most applicable to their practice and best represent 
their performance. While certain measures are still required for 
reporting, we have reduced this number from 11 required measures in the 
proposed base score to only five in this final policy. We have also 
increased the number of measures for which a MIPS eligible clinician 
has the ability to earn performance score credit from eight measures in 
the proposed performance score to nine in this final policy. We note 
that MIPS eligible clinicians can choose which of these measures to 
focus on for their performance score allowing clinicians to customize 
their reporting and score.

[[Page 77225]]



             Table 9--Advancing Care Information Performance Category Scoring Methodology Advancing Care Information Objectives and Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Advancing care information          Advancing care     Required/ not required for   Performance score (up to
             objective               information measure *       base score  (50%)                 90%)                     Reporting requirement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protect Patient Health Information.  Security Risk          Required..................  0.........................  Yes/No Statement.
                                      Analysis.
Electronic Prescribing.............  e-Prescribing........  Required..................  0.........................  Numerator/Denominator.
Patient Electronic Access..........  Provide Patient        Required..................  Up to 10..................  Numerator/Denominator.
                                      Access.
                                     Patient-Specific       Not Required..............  Up to 10..................  Numerator/Denominator.
                                      Education.
Coordination of Care Through         View, Download, or     Not Required..............  Up to 10..................  Numerator/Denominator.
 Patient Engagement.                  Transmit (VDT).
                                     Secure Messaging.....  Not Required..............  Up to 10..................  Numerator/Denominator.
                                     Patient-Generated      Not Required..............  Up to 10..................  Numerator/Denominator.
                                      Health Data.
Health Information Exchange........  Send a Summary of      Required..................  Up to 10..................  Numerator/Denominator.
                                      Care.
                                     Request/Accept         Required..................  Up to 10..................  Numerator/Denominator.
                                      Summary of Care.
                                     Clinical Information   Not Required..............  Up to 10..................  Numerator/Denominator.
                                      Reconciliation.
Public Health and Clinical Data      Immunization Registry  Not Required..............  0 or 10...................  Yes/No Statement.
 Registry Reporting.                  Reporting.
                                     Syndromic              Not Required..............  Bonus.....................  Yes/No Statement.
                                      Surveillance
                                      Reporting.
                                     Electronic Case        Not Required..............  Bonus.....................  Yes/No Statement.
                                      Reporting.
                                     Public Health          Not Required..............  Bonus.....................  Yes/No Statement.
                                      Registry Reporting.
                                     Clinical Data          Not Required..............  Bonus.....................  Yes/No Statement.
                                      Registry Reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Bonus (up to 15)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Report to one or more additional public health and clinical data registries beyond the  5 bonus...................  Yes/No Statement.
 Immunization Registry Reporting measure.
                       Report improvement activities using CEHRT                        10 bonus..................  Yes/No Statement.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Several measure names have been changed since the proposed rule. This table reflects those changes. We refer readers to section II.E.5.g.(7)(a) of
  this final rule with comment period for further discussion of measure name changes.

    Comment: In addition to the scoring comments we summarized in the 
above sections, many commenters expressed concerns related to the 
difference in scoring for the 2017 Advancing Care Information 
Transition objectives and measures (referred to in the proposed rule as 
the Modified Stage 2 Objectives and Measures). Commenters highlighted 
that for the proposed policy, there are eight available measures in the 
Advancing Care Information Objectives and Measures while there are only 
six available measures in the 2017 Advancing Care Information 
Transition objectives and measures for which MIPS eligible clinicians 
can earn credit in the performance score of the advancing care 
information performance category. Commenters believed this would pose a 
disadvantage to those MIPS eligible clinicians with EHR technology 
certified to the 2014 Edition who would only be able to report on 2017 
Advancing Care Information Transition objectives and measures, and 
consequently have a lesser opportunity to earn credit in the 
performance score.
    Response: We appreciate the comments and have outlined our final 
scoring methodology for the 2017 Advancing Care Information Transition 
objectives and measures in Table 10 to demonstrate that those MIPS 
eligible clinicians reporting the 2017 Advancing Care Information 
Transition objectives and measures will not be disadvantaged. MIPS 
eligible clinicians will have the ability to earn up to 155 percentage 
points for the advancing care information performance category, which 
will be capped at 100 percent, regardless of which set of measures they 
report. We note that in order to make up the difference in the number 
of measures included in the performance score for the two measure sets, 
we have increased the number of percentage points available for the 
performance weight of the Provide Patient Access and Health Information 
Exchange measures (up to 20 percent for each measure), as these 
measures are critical to our goals of patient engagement and 
interoperability.

  Table 10--Advancing Care Information Performance Category Scoring Methodology for 2017 Advancing Care Information Transition--Objectives and Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       2017 Advancing care
  2017 Advancing care information    information transition   Required/ not required for   Performance score (up           Reporting requirement
  transition objective (2017 only)    measure * (2017 only)        base score (50%)               to 90%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protect Patient Health Information.  Security Risk Analysis  Required...................  0......................  Yes/No Statement.
Electronic Prescribing.............  E-Prescribing.........  Required...................  0......................  Numerator/Denominator.
Patient Electronic Access..........  Provide Patient Access  Required...................  Up to 20...............  Numerator/Denominator.
                                     View, Download, or      Not Required...............  Up to 10...............  Numerator/Denominator.
                                      Transmit (VDT).
Patient-Specific Education.........  Patient-Specific        Not Required...............  Up to 10...............  Numerator/Denominator.
                                      Education.
Secure Messaging...................  Secure Messaging......  Not Required...............  Up to 10...............  Numerator/Denominator.
Health Information Exchange........  Health Information      Required...................  Up to 20...............  Numerator/Denominator.
                                      Exchange.
Medication Reconciliation..........  Medication              Not Required...............  Up to 10...............  Numerator/Denominator.
                                      Reconciliation.

[[Page 77226]]

 
Public Health Reporting............  Immunization Registry   Not Required...............  0 or 10................  Yes/No Statement.
                                      Reporting.             Not Required...............  Bonus..................  Yes/No Statement.
                                     Syndromic Surveillance  Not Required...............  Bonus..................  Yes/No Statement.
                                      Reporting.
                                     Specialized Registry
                                      Reporting.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Bonus up to 15%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Report to one or more additional public health and clinical data registries beyond the    5% bonus...............  Yes/No Statement.
 Immunization Registry Reporting measure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Report improvement activities using CEHRT                         10% bonus..............  Yes/No Statement.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Several measure names have been changed since the proposed rule. This table reflects those changes. We refer readers to section II.E.5.g.(7)(a) of
  this final rule with comment period for further discussion of measure name changes.

    We are seeking comment on our final scoring methodology policies, 
and future enhancements to the methodology.
(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 final score, 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 proposed 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 
performance category 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 performance 
category base score) under our proposed scoring methodology for the 
advancing care information performance category for a performance 
period, and we solicited comments on both of these proposed thresholds.
    We proposed 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 final score for the 2019 MIPS payment 
year based on an estimation using the data from the 2017 performance 
period. We noted that in section II.E.5.g.(8) of the proposed rule (81 
FR 28231-28232) we 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.
    The following is a summary of the comments we received regarding 
our proposed definition of meaningful EHR user.
    Comment: Commenters overwhelmingly supported the proposal to define 
meaningful EHR users as those MIPS eligible clinicians who earn a score 
of 75 percent in the advancing care information performance category. 
They believed that a lower score, such as 50 percent, would not be 
stringent enough and that the majority of MIPS eligible clinicians 
would achieve the meaningful EHR user status by simply reporting and 
attesting to just one patient encounter for each measure. Additionally, 
many commenters pointed out that this would result in a reduction of 
the applicable weight of the advancing care information performance 
category in the MIPS final score and would reduce the focus and 
emphasis on increased patient engagement and health information 
exchange.
    Response: We appreciate this feedback and agree that 50 percent 
would be a very low threshold to be considered a meaningful EHR user in 
the advancing care information performance category.
    Comment: A few commenters supported the alternate proposal to 
define meaningful EHR users as those MIPS eligible clinicians who earn 
a score of 50 percent in the advancing care information performance 
category. This approach would only require MIPS eligible clinicians to 
achieve the base score of 50 percent to achieve the meaningful EHR user 
status. They cited the overall complexity of the reporting 
requirements, as well as level of difficulty for small practices to 
score well in the performance category.
    Response: We understand the commenters' concerns regarding the 
complexity of reporting requirements, and note that we have addressed 
this through our final scoring policy outlined in section 
II.E.5.g.(6)(d) of this final rule with comment period. We

[[Page 77227]]

believe the adjustments made in the scoring methodology address 
commenters' concerns by reducing the requirements to earn the base 
score, and thus, there is no need to lower the threshold for being 
considered a meaningful EHR user.
    Comment: One commenter requested that the definition of a 
meaningful EHR user and the requirements to achieve this status in the 
MIPS be further clarified in this rule stating that it is important to 
clearly define expectations and set a higher standard in order to 
achieve interoperability and EHR-aided improved health outcomes for 
Medicare beneficiaries.
    Response: We appreciate this feedback and reiterate that a 
meaningful EHR user under this policy is a physician, as defined in 
section 1861(r) of the Act who earns an advancing care information 
performance category overall score of 75 percent per our primary 
proposal outlined above. To earn a score of 75 percent in the advancing 
care information performance category, a physician would need to 
accomplish the base score, plus additional performance and/or bonus 
score for a total of 75 percent or 18.75 performance category points as 
they are applied to the MIPS final score.
    After consideration of the comments we received, in combination 
with our final scoring methodology and its impact on this policy, we 
are finalizing as proposed our primary proposal for purposes of 
applying section 1848(q)(5)(E)(ii) of the Act, to estimate the 
proportion of physicians as defined in section 1861(r) of the Act 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 for a performance period. We will base this estimation 
on data from the relevant performance period, if we have sufficient 
data available from that period. We will not include in this estimation 
physicians for whom the advancing care information performance category 
is weighted at zero percent under section 1848(q)(5)(F) of the Act.
(7) Advancing Care Information Performance Category Objectives and 
Measures Specifications
(a) Advancing Care Information Objectives and Measures Specifications 
(Referred to in the Proposed Rule as MIPS Objectives and Measures)
    We proposed the objectives and measures for the advancing care 
information performance category of MIPS as outlined in the proposed 
rule. We noted 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 through 62871), however, we 
did not propose to maintain the previously established thresholds for 
MIPS. Any additional changes to the objectives and measures were 
outlined in 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 through 62871).
    Objective: Protect Patient Health Information.
    Objective: Protect electronic protected health information (ePHI) 
created or maintained by the CEHRT 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 CEHRT in accordance with requirements in 45 
CFR164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement security 
updates as necessary, and correct identified security deficiencies as 
part of the MIPS eligible clinician's risk management process.
    Objective: Electronic Prescribing.
    Objective: Generate and transmit permissible prescriptions 
electronically.
    e-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
     Denominator: Number of prescriptions written for drugs 
requiring a prescription in order to be dispensed other than controlled 
substances during the performance period; or number of prescriptions 
written for drugs requiring a prescription in order to be dispensed 
during the performance period.
     Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
    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 therefore 
proposed 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 MIPS eligible clinicians 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 MIPS eligible 
clinician 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.

[[Page 77228]]

     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 CEHRT.
     Denominator: The number of unique patients seen by the 
MIPS eligible clinician during the performance period.
     Numerator: The number of patients in the denominator (or 
patient authorized representative) who are provided timely access to 
health information to view online, download, and transmit to a third 
party and to access using an application of their choice that is 
configured meet the technical specifications of the API in the MIPS 
eligible clinician's CEHRT.
    Patient-Specific Education Measure: The MIPS eligible clinician 
must use clinically relevant information from CEHRT to identify 
patient-specific educational resources and provide electronic access to 
those materials to at least one unique patient seen by the MIPS 
eligible clinician.
     Denominator: The number of unique patients seen by the 
MIPS eligible clinician during the performance period.
     Numerator: The number of patients in the denominator who 
were provided electronic access to patient-specific educational 
resources using clinically relevant information identified from CEHRT 
during the performance period.
    Objective: Coordination of Care Through Patient Engagement.
    Objective: Use CEHRT to engage with patients or their authorized 
representatives about the patient's care.
    View, Download, Transmit (VDT) Measure: During the performance 
period, at least one unique patient (or patient-authorized 
representatives) seen by the MIPS eligible clinician actively engages 
with the EHR made accessible by the MIPS eligible clinician. A 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 CEHRT; or (3) a combination of (1) and (2).
     Denominator: Number of unique patients seen by the MIPS 
eligible clinician during the performance period.
     Numerator: The number of unique patients (or their 
authorized representatives) in the denominator who have viewed online, 
downloaded, or transmitted to a third party the patient's health 
information during the performance period and the number of unique 
patients (or their authorized representatives) in the denominator who 
have accessed their health information through the use of an API during 
the performance period.
    Secure Messaging Measure: For at least one unique patient seen by 
the MIPS eligible clinician during the performance period, a secure 
message was sent using the electronic messaging function of CEHRT to 
the patient (or the patient-authorized representative), or in response 
to a secure message sent by the patient (or the patient-authorized 
representative).
     Denominator: Number of unique patients seen by the MIPS 
eligible clinician during the performance period.
     Numerator: The number of patients in the denominator for 
whom a secure electronic message is sent to the patient (or patient-
authorized representative) or in response to a secure message sent by 
the patient (or patient-authorized representative), during the 
performance period.
    Patient-Generated Health Data Measure: Patient-generated health 
data or data from a non-clinical setting is incorporated into the CEHRT 
for at least one unique patient seen by the MIPS eligible clinician 
during the performance period.
     Denominator: Number of unique patients seen by the MIPS 
eligible clinician during the performance period.
     Numerator: The number of patients in the denominator for 
whom data from non-clinical settings, which may include patient-
generated health data, is captured through the CEHRT into the patient 
record during the performance period.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinician into their EHR using the functions of 
CEHRT.
    Send a Summary of Care (formerly 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 clinician--(1) creates a summary of care 
record using CEHRT; and (2) electronically exchanges the summary of 
care record.
     Denominator: Number of transitions of care and referrals 
during the performance period for which the MIPS eligible clinician was 
the transferring or referring clinician.
     Numerator: The number of transitions of care and referrals 
in the denominator where a summary of care record was created using 
CEHRT and exchanged electronically.
    Request/Accept Summary of Care (formerly 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

[[Page 77229]]

received is incorporated by the clinician into the CEHRT.
    Clinical Information Reconciliation Measure: For at least one 
transition of care or referral received or patient encounter in which 
the MIPS eligible clinician has never before encountered the patient, 
the MIPS eligible clinician performs clinical information 
reconciliation. The MIPS eligible clinician must implement clinical 
information reconciliation for the following three clinical information 
sets: (1) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication. (2) Medication 
allergy. Review of the patient's known medication allergies. (3) 
Current Problem list. Review of the patient's current and active 
diagnoses.
     Denominator: Number of transitions of care or referrals 
during the performance period for which the MIPS eligible clinician was 
the recipient of the transition or referral or has never before 
encountered the patient.
     Numerator: The number of transitions of care or referrals 
in the denominator where the following three clinical information 
reconciliations were performed: Medication list, medication allergy 
list, and current problem list.
    Objective: Public Health and Clinical Data Registry Reporting.
    Objective: The MIPS eligible clinician is in active engagement with 
a public health agency or clinical data registry to submit electronic 
public health data in a meaningful way using CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    Immunization Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
immunization data and receive immunization forecasts and histories from 
the public health immunization registry/immunization information system 
(IIS).
    Syndromic Surveillance Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
syndromic surveillance data from a non-urgent care ambulatory setting 
where the jurisdiction accepts syndromic data from such settings and 
the standards are clearly defined.
    Electronic Case Reporting Measure: The MIPS eligible clinician is 
in active engagement with a public health agency to electronically 
submit case reporting of reportable conditions.
    Public Health Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
data to public health registries.
    Clinical Data Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement to submit data to a clinical data 
registry.
(b) 2017 Advancing Care Information Transition Objectives and Measures 
Specifications (Referred to in the Proposed Rule as Modified Stage 2)
    We proposed the 2017 Advancing Care Information Transition 
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 CEHRT 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 CEHRT 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.
    E-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
     Denominator: Number of prescriptions written for drugs 
requiring a prescription in order to be dispensed other than controlled 
substances during the performance period; or number of prescriptions 
written for drugs requiring a prescription in order to be dispensed 
during the performance period.
     Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
    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.

[[Page 77230]]

    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 CEHRT 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 CEHRT during the 
performance period.
    Objective: Secure Messaging.
    Objective: Use CEHRT 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 CEHRT to the patient 
(or the patient-authorized representative), or in response to a secure 
message sent by the patient (or the patient authorized representative) 
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 information from 
other health care clinicians into their EHR using the functions of 
CEHRT.
    Health Information Exchange Measure: The MIPS eligible clinician 
that transitions or refers their patient to another setting of care or 
health care clinician (1) uses CEHRT to create a summary of care 
record; and (2) electronically transmits such summary to a receiving 
health care clinician 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 clinician.
     Numerator: The number of transitions of care and referrals 
in the denominator where a summary of care record was created using 
CEHRT and exchanged electronically.
    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 CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    Immunization Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
immunization data.
    Syndromic Surveillance 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 note that the 2017 Advancing Care Information Transition 
objectives and measures specifications that we proposed are for those 
MIPS eligible clinicians that are using 2014 Edition CEHRT. We are 
referring to this as the ``2017 Advancing Care Information Transition 
objectives and measures'' in this final rule with comment period, 
although it was referred to in the proposed rule as the ``Modified 
Stage 2 objectives and measures'' set. In addition, in this final rule 
with comment period, we refer to the measures specified for the 
advancing care information performance category described in section 
II.E.5.g.(7) of the proposed rule (81 FR 28221 through 28223) that 
correlate to a Stage 3 as the ``Advancing Care Information objectives 
and measures'' although it was referred to in the proposed rule as 
``MIPS objectives and measures'' set. We note that these terms more are 
more specific

[[Page 77231]]

to MIPS, and to the advancing care information performance category 
than the terms used in the proposed rule. We have also decided to re-
name several of the proposed measures to use titles that we believe are 
more illustrative of the substance of the measures. We note that are 
not changing the names of the objectives associated with these 
measures. The measures being renamed are as follows:

------------------------------------------------------------------------
              Proposed title                        Revised title
------------------------------------------------------------------------
Patient Access............................  Provide Patient Access.
Patient Care Record Exchange..............  Send a Summary of Care.
Request/Accept Patient Care Record........  Request/Accept Summary of
                                             Care.
------------------------------------------------------------------------

    We will be referring to these measures by their revised titles 
throughout the remainder of this final rule with comment period.
    The following is a summary of the comments we received regarding 
the proposal to adopt the objectives and measures detailed at 81 FR 
28226-28230 for the advancing care information performance category.
    Comment: One commenter suggested the e-Prescribing measure be 
included in both the base score as well as the performance score of the 
advancing care information performance category to give more 
flexibility and offer an opportunity for MIPS eligible clinicians to 
earn more points, especially for those MIPS eligible clinicians who 
will be using a 2014 Edition CEHRT in 2017.
    Response: As several commenters have stated, MIPS eligible 
clinicians should not be disadvantaged due to having to report on the 
2017 Advancing Care Information Transition objectives and measures in 
2017 and we agree. While we have not added the e-Prescribing measure to 
the performance score, we have added many other measures to give MIPS 
eligible clinicians the opportunity to increase their performance score 
under the advancing care information performance category. We refer 
readers to section II.E.5.g.(6)(a) of this final rule with comment 
period for further discussion of the scoring policy to see how we have 
equalized the opportunities for MIPS eligible clinicians reporting 
using technology certified to the 2014 Edition and those using 
technology certified to the 2015 Edition for the advancing care 
information performance category for 2017.
    Comment: Many commenters supported the inclusion of the e-
Prescribing measure in the base score of the advancing care information 
performance category. Some recommended modifications to the measure 
such as changing the threshold to yes/no. A commenter supported 
adoption of the e-Prescribing measure on the condition that it have no 
minimum threshold and no performance measurement.
    Response: We disagree that the threshold should be yes/no as we 
continue to believe that reporting a numerator and denominator is more 
appropriate because it will provide us with the data necessary to 
monitor performance on this measure. Performance on the measure, under 
the EHR Incentive Programs, has been consistently much higher than the 
thresholds set. We believe that through e-Prescribing, errors from 
paper prescriptions are reduced, and therefore, inclusion in the base 
score is justified. We also disagree with commenters who recommended 
adding e-Prescribing to the performance score. Since historical 
performance on this measure under the EHR Incentive Program has been 
high, we do not believe that this measure will help MIPS eligible 
clinicians distinguish themselves from others in regard to performance, 
and thus we have not included it in the performance score.
    Comment: A commenter urged CMS to take into account that 
measurement of e-Prescribing is often not a measurement of the 
physician's diligence or capability, but rather a measurement of 
factors completely outside the physician's control, such as the ability 
of nearby pharmacies to accept electronic prescriptions. Another 
commenter recommended an exception to e-Prescribing for MIPS eligible 
clinicians in rural areas where most pharmacies do not have capability 
to accept electronic prescriptions.
    Response: While we understand these concerns, section 
1848(o)(2)(A)(i) of the Act requires electronic prescribing as part of 
using CEHRT in a meaningful manner. We note that we proposed an 
exclusion for MIPS eligible clinicians who write fewer than 100 
permissible prescriptions. Further, we believe the inclusion of the 
Electronic Prescribing objective in the base score is appropriate 
because, as noted in the Medicare and Medicaid Programs; Electronic 
Health Record Incentive Program; Final Rule (75 FR 44338), it is the 
most widely adopted form of electronic exchange occurring and has been 
proven to reduce medication errors.
    Comment: For the e-Prescribing measure, a commenter requested 
clarification that MIPS eligible clinicians are permitted to optionally 
exclude from the denominator any ``standing'' or ``protocol'' orders 
for medications that are predetermined for a given procedure or a given 
set of patient characteristics.
    Response: We disagree that the denominator should exclude 
``standing'' prescriptions and continue to believe that the denominator 
should be the 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.
    Comment: One commenter stated that the e-Prescribing measure will 
be topped out by the time that MIPS is implemented and should be 
removed.
    Response: While performance on the e-Prescribing measure may be 
high for EPs participating in the EHR Incentive Programs, the MIPS 
program includes many other clinicians who may have limited experience 
with this measure. Furthermore, as we have previously stated, section 
1848(o)(2)(A)(i) of the Act requires electronic prescribing as part of 
using CEHRT in a meaningful manner, and thus, we have chosen to make it 
a required measure under the advancing care information performance 
category.
    Comment: A commenter asked how e-Prescribing for the prescription 
of controlled substances should be measured for MIPS eligible 
clinicians who have not yet adopted the upgraded technology associated 
with the 2015 Edition.
    Response: We proposed (81 FR 28227) that MIPS eligible clinicians 
would continue to have the option to include or not include controlled 
substances that can be electronically prescribed in the denominator of 
the e-Prescribing measure. This means that MIPS eligible clinicians 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 MIPS 
eligible clinician 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. This policy is the same for MIPS 
eligible clinicians using EHR technology certified to the 2014 and the 
2015 Editions.
    Comment: Many commenters supported the inclusion of the Patient 
Electronic Access objective. Many commenters appreciated the emphasis 
on patient electronic access throughout the advancing care information 
performance category and agreed with

[[Page 77232]]

providing flexibility for MIPS eligible clinicians to provide 
information to patients.
    Response: We appreciate the support and will require the Provide 
Patient Access measure of the Patient Electronic Access objective in 
the base score of the advancing care information performance category. 
We continue to believe that through providing access to information and 
increased patient engagement, health care outcomes can be improved.
    Comment: Many commenters claimed that MIPS eligible clinicians will 
continue to struggle meeting the Patient Electronic Access objective. 
Some commenters believe the Patient Electronic Access objective holds 
MIPS eligible clinicians responsible for the actions of patients and 
other physicians outside of their control. A few noted that internet 
access issues will suppress small and rural MIPS eligible clinicians' 
performance scores in the advancing care information performance 
category, particularly in achieving success with Patient Electronic 
Access. Another commenter expressed concern regarding the Patient 
Electronic Access objective due to a lack of computers and electronic 
access among minority and non-English speaking patients. One commenter 
recommended that MIPS eligible clinicians be given 4 business days to 
provide this information, rather than 48 hours because MIPS eligible 
clinicians need time to review, correct and verify the accuracy of the 
information.
    Response: While we understand these concerns, we believe providing 
patients' access to their health information is a critical step in 
improving patient care, increasing transparency and engaging patients. 
Under the Patient Electronic Access Objective, the Provide Patient 
Access measure only requires that patients are provided timely access 
to view online, download, and transmit his or her health information; 
and that the information is available to access using any application 
of their choice that is configured to meet the technical specifications 
of the Application Programing Interface (API) in the MIPS eligible 
clinician's CEHRT. This measure is required for the base score. The 
base score requirement is for MIPS eligible clinicians to report a 
numerator (of at least one) and a denominator, which we believe is 
reasonable and achievable by most MIPS eligible clinicians regardless 
of their practice circumstances or the characteristics of their patient 
population. This measure does not require that the patient take any 
action. (Note the View, Download or Transmit measure under the 
Coordination of Care Through Patient Engagement Objective depends on 
the actions of the patient but the measure is part of the performance 
score and is not required.) The other measure under the Patient 
Electronic Access Objective is the Patient-Specific Access measure 
which is part of the performance score and is not required.
    We additionally note that we have increased flexibility of our 
scoring methodology allowing MIPS eligible clinicians to focus on 
measures that best represent their practice in the performance score, 
and thus this measure is optional for reporting as part of the 
performance score.
    Comment: A few commenters suggested that both measures in the 
Patient Electronic Access objective be retired. They believe that CMS 
data shows most clinicians score very well on Patient-Specific 
Education and Provide Patient Access measures, and thus, should not 
have to report on them. One commenter suggests that the Patient-
Specific education measure be considered ``topped out'' due to 
historically high performance and stated concern that the manner in 
which the Patient-Specific education measure is currently specified is 
overly constrained and limiting to providers who may prefer workflows 
to provide patient education beyond what is permitted by CMS and 
certification.
    Response: We disagree. As we have indicated previously, we believe 
these measures are a critical step to improving patient health, 
increasing transparency and engaging patients in their care. We 
additionally note there are certain types of clinicians that were not 
eligible to participate under the EHR Incentive Programs but are 
considered MIPS eligible clinicians, and we believe that it is 
appropriate to include the Patient Electronic Access objective and its 
associated measures. We note that under the Stage 2 of the EHR 
Incentive Programs, EPs achieved an average of 91 percent on the 
Provide Patient Access measure. While under the EHR Incentive Programs 
EPs performed well, we will be gathering data on MIPS eligible 
clinicians to determine whether the Patient-Specific Education and 
Patient Electronic Access measures should be included in future MIPS 
performance periods. We welcome specific examples suggestions for 
changes to the existing measures and potential new measures to replace 
the existing ones.
    Comment: A commenter sought clarification on the Patient Electronic 
Access objective around the API availability and the use of 2014 
Edition CEHRT. Another commenter asked what is meant by the phrase 
``subject to the MIPS eligible clinician's discretion to withhold 
certain information'' and asked why it was included.
    Response: The specifications of the 2017 Advancing Care Information 
Transition Provide Patient Access measure do not require use of an API, 
and thus MIPS eligible clinicians who use EHR technology certified to 
the 2014 Edition and report this measure would not need to use an API 
for this measure. We refer readers to section II.E.5.g.(7) of this 
final rule with comment period for a description of the measure 
specifications. The Advancing Care Information Provide Patient Access 
measure is identical to the Patient Electronic Access measure that was 
finalized in the 2015 EHR Incentive Programs final rule for Stage 3. We 
maintain that MIPS eligible clinicians who provide electronic access to 
patient health information should have the ability to withhold any 
information from disclosure if the disclosure of the information is 
prohibited by federal, state or local laws or such information, if 
provided, may result in significant patient harm. We refer readers to 
the 2015 EHR Incentive Programs final rule (80 FR 62841-FR 62852) for a 
discussion of the Stage 3 Patient Electronic Access measure.
    Comment: A commenter suggested that the View, Download and Transmit 
and Secure Messaging measures be made optional and noted the previous 
reductions in thresholds as an indication that there are significant 
challenges to meeting these measures.
    Response: While we understand that there are challenges with these 
measures we continue to believe that the measures in the Coordination 
of Care Through Patient Engagement objective is an essential component 
of improving health care. We note that under our revised scoring 
methodology, these measures will not be required in the base score of 
the advancing care information category.
    Comment: One commenter believed that although it is a reasonable 
policy for CMS to require MIPS eligible clinicians to make information 
electronically available to their patients within a reasonable time 
frame, they are very concerned about numerator requirements of the 
View, Download, or Transmit measure that only takes into account the 
actions of patients. Some stated that MIPS eligible clinicians who are 
diligent in making information securely available to their patients 
should not be penalized simply because the patient is not interested in 
accessing the information.
    Response: The View, Download, or Transmit measure is not required 
in the

[[Page 77233]]

base score of the advancing care information performance category under 
our final scoring policy. It is available for MIPS eligible clinicians 
who choose to report on the measure to increase their performance 
score.
    Comment: A few commenters recommended removing the Send a Summary 
of Care measure (formerly named the Patient Care Record Exchange 
measure) under the Health Information Exchange objective from the base 
score because some specialists may not have any transitions of care. 
One suggested that a minimum exclusion be provided for MIPS eligible 
clinicians that do not transition care or refer patients during the 
performance period.
    Response: We disagree with the recommendation to remove this 
measure from the base score. One of the primary focuses of the 
advancing care information performance category is to encourage the 
exchange of health information using CEHRT. The Send a Summary of Care 
measure encourages the incorporation of summary of care information 
from other health care providers and clinicians into the MIPS eligible 
clinician's EHR to support better patient outcomes. We believe that 
MIPS eligible clinicians, particularly specialists, have the 
opportunity to send or receive a summary of care record from another 
care setting or clinician at least once during a MIPS performance 
period. In addition, since meeting the requirements of this measure to 
earn the base score involves reporting a numerator and denominator of 
at least one rather than meeting a percentage threshold, we believe 
this offers enough flexibility for MIPS eligible clinicians who are 
concerned that they rarely exchange patient health information with 
other providers.
    Comment: A commenter requested that the Patient-Specific Education 
measure under the Patient Electronic Access objective not be limited to 
educational materials identified by CEHRT as they believe many medical 
specialty societies have developed patient-facing Web sites and 
educational materials.
    Response: We appreciate this suggestion and will consider in future 
years of MIPS. However, as finalized for the 2017 performance period, 
the Patient-Specific Education measure is limited to educational 
materials identified by CEHRT. We note that we have refined our 
proposal and in 2017, this measure is not required in the base score of 
the advancing care information category. MIPS eligible clinicians may 
choose whether to report this measure as part of the performance score.
    Comment: One commenter asked for clarification about when the 
patient-specific education was to be provided. The 2017 Advancing Care 
Information Transition measure in the proposed rule (based on Modified 
Stage 2 measure of the EHR Incentive Program) requires that patient-
specific education be provided during the performance period while the 
2015 EHR Incentive Programs final rule allows patient education to be 
provided any time between the start of the EHR reporting period and the 
date of attestation to count toward the numerator.
    Response: While the commenter is correct about the policy 
established for the EHR Incentive Programs, under the MIPS, the 
patient-specific education must be provided within the performance 
period. We additionally note for the commenter that we included a 
proposal for the EHR Incentive Programs related to measure calculations 
for actions outside the EHR reporting period in the recent hospital 
Outpatient Prospective Payment System Proposed Rule (81 FR 45745 
through 45746) for reporting in CY 2017 for the EHR Incentive Program.
    Comment: A commenter requested that we stay consistent with the 
Stage 3 measure exclusion for the Patient-Specific Education measure 
and allow MIPS eligible clinicians with no office visits during the 
performance period be permitted to report a ``null value'' and achieve 
full base and performance score credit.
    Response: In our final scoring methodology for the advancing care 
information category, the Patient-Specific Education measure is not a 
required measure for reporting in the base score, and thus we do not 
believe it is necessary to provide an exclusion for this measure. 
Instead MIPS eligible clinicians may choose to report the measure to 
earn credit in the advancing care information performance score. We 
believe it is appropriate to require the reporting of a numerator and 
denominator to add to the performance score. We refer readers to 
section II.E.5.g.(6)(a) for more discussion of our final scoring 
policy. We additionally note that there are exclusions for MIPS 
eligible clinicians who are considered non-patient facing, and direct 
readers to section II.E.3. of this final rule with comment period for 
further discussion of this policy.
    Comment: A commenter questioned whether the MIPS eligible clinician 
or the patient is responsible for the View, Download, and Transmit 
measure under the Coordination of Care Through Patient Engagement 
objective as the description states that the MIPS eligible clinician 
may meet the measure and does not reflect that the necessity of a 
patient viewing, downloading, and transmitting.
    Response: We appreciate that the commenter brought this error to 
our attention. Our intention was that a MIPS eligible clinician may 
meet the measure if at least one unique patient viewed, downloaded, or 
transmitted to a third party their health information. We are revising 
the Advancing Care Information measure under the Coordination of Care 
Through Patient Engagement objective to reflect our intended policy.
    Comment: Some commenters supported the inclusion of the Secure 
Messaging measure. A few recommended that it be converted into a yes/no 
measure. A commenter supported adoption of the proposed Secure 
Messaging measure, provided that the finalized measure have no minimum 
threshold and no performance measurement. A few commenters requested 
the removal of the requirement for secure messaging between patient and 
MIPS eligible clinician for nursing home residents and to patients who 
receive their primary care at home, since patients will not sign-up. A 
commenter recommended changing the numerator of the Secure Messaging 
measure to ``responses to secure messages sent by patients,'' and the 
denominator to ``all secure messages sent by patients,'' to address the 
misalignment between the numerator and denominator in the proposed 
measure.
    Response: We appreciate the comments and the support for the Secure 
Messaging measure. In our revised scoring policy, we are finalizing our 
scoring methodology such that the Secure Messaging measure is not one 
of the required measures of the advancing care information performance 
category. MIPS eligible clinicians may still choose to report the 
measure to earn credit in the performance score, and thus have the 
option to determine whether this measure represents their practice. We 
refer readers to section II.E.5.g.(6)(a) of this final rule with 
comment period for further discussion of our final scoring policy.
    We disagree with the suggestion to change Secure Messaging to a 
yes/no measure, or to change the numerator and denominator as this 
measure is meant to promote the sending of secure messages by the MIPS 
eligible clinician and not by patients. We believe that it is more 
appropriate for the numerator to consist of the number of patients 
found in the denominator to whom a secure electronic message is sent or 
in response

[[Page 77234]]

to a secure message sent by the patient (or patient-authorized 
representative), during the performance period.
    Comment: Some commenters opposed the inclusion of the Health 
Information Exchange objective and the associated measures: Send a 
Summary of Care, Request/Accept Summary of Care, and Clinical 
Information Reconciliation. They noted that it holds MIPS eligible 
clinicians responsible for information over which they have no control 
and recommended the objective be removed. The commenters believed that 
the Health Information Exchange objective holds MIPS eligible 
clinicians responsible for the actions of patients and other physicians 
outside of their control. Other commenters opposed the measures 
included in the Health Information Exchange objective because those 
measures overestimate the interoperability of EHR technology. 
Commenters also expressed concern that this measure would emphasize 
quantity of information, rather the sharing of relevant information. A 
few commenters indicated that past experience with the Health 
Information Exchange objective in the EHR Incentive Programs has been 
challenging for EPs. Challenges include costs, lack of contacts at 
hospital systems to effective communicate where an electronic 
transition of care document should be sent, and inadequate training and 
understanding of how to use EHR functionality even if fully enabled.
    Response: While we appreciate these concerns, we believe the 
benefits health information exchange outweigh the challenges. As we 
stated in the 2015 EHR Incentive Programs final rule (80 FR 62804), we 
believe that the electronic exchange of health information between 
providers and clinicians would encourage the sharing of the patient 
care summary from one provider or clinician to another and important 
information that the patient may not have been able to provide. This 
can significantly improve the quality and safety of referral care and 
reduce unnecessary and redundant testing. EHRs and the electronic 
exchange of health information, either directly or through health 
information exchanges, can reduce the burden of such communication. 
Therefore, we believe it is appropriate to include the Health 
Information Exchange objective and include the Send the Summary of Care 
and the Request/Accept Summary of Care measures as required in the base 
score of the advancing care information performance category.
    Comment: A commenter was concerned about MIPS eligible clinicians 
who do not have access to a health information exchange and in these 
cases, recommended a hardship exception option for this objective.
    Response: We note that there is no requirement to have access to a 
health information exchange for the Health Information Exchange 
objective. Rather for the Request/Accept Summary of Care measure 
(formerly Patient Care Record measure), the summary of care record must 
be electronically exchanged. We note that the intent for flexibility 
around exchange via any electronic means is to promote and facilitate a 
wide range of options. We refer readers to the discussion of the Health 
Information Exchange objective at 80 FR 62852 through 62862 as it 
provides a thorough discussion of transport mechanisms for the summary 
of care record.
    Comment: Some commenters believe that internet access issues will 
stifle performance in the advancing care information performance 
category for MIPS eligible clinicians in small and rural settings, 
especially those with high staff turnover, in trying to satisfy the 
Health Information Exchange objective.
    Response: We understand this concern and recognize that nationwide 
access to broadband is still a challenge for some MIPS eligible 
clinicians. If a MIPS eligible clinician does not have sufficient 
internet access, they may qualify for reweighting of the advancing care 
information performance category score. We refer readers to the 
discussion of MIPS eligible clinicians facing a significant hardship in 
section II.E.5.g.(8)(a)(ii) of this final rule with comment period.
    Comment: A commenter stated that the Health Information Exchange 
objective does not adequately reflect EHR interoperability. They 
believe the metric is too focused on the quantity of information moved 
and not the relevance of these exchanges. They urged CMS to re-focus 
the advancing care information performance category on interoperability 
by developing specialty-specific interoperability use cases rather than 
the measuring the quantity of data exchanged.
    Response: We are very interested in adopting measures that reflect 
interoperability. We urge interested parties to participate in our 
solicitation call for new measures that will be available in the next 
few months.
    Comment: A commenter urged CMS to clarify whether the denominator 
of the Request/Accept Summary of Care measure under the Health 
Information Exchange objective includes the number of transitions of 
care sent to the MIPS eligible clinicians with CEHRT, and whether MIPS 
eligible clinicians are able to exclude referrals from this measure if 
the receiving clinician does not have CEHRT fully implemented.
    Response: The calculation of the denominator for the 2017 Advancing 
Care Information Transition measure, Health Information Exchange, is 
different from that of the Advancing Care Information measure, Request/
Accept Summary of Care. As we noted in the 2015 EHR Incentive Programs 
final rule (80 FR 62804-62806) we did not adopt a requirement for the 
Modified Stage 2 Health Information Exchange measure (which correlates 
to the 2017 Advancing Care Information Transition measure) that the 
recipient to whom the EP sends a summary of care document possess CEHRT 
or even an EHR in order to be the recipient of an electronic summary of 
care document. However, measure 2 of the Stage 3 Health Information 
Exchange objective (which correlates to the Advancing Care Information 
measure, Request/Accept Summary of Care) was finalized such that the 
EP, as a recipient of a transition or referral, incorporates an 
electronic summary of care document into CEHRT. Therefore, as we 
proposed for MIPS, we are finalizing our policy such that transitions 
and referrals from recipients who do not possess CEHRT could be 
excluded from the denominator of the 2017 Advancing Care Information 
Transition measure, Health Information Exchange, but should be included 
for the denominator of the MIPS measure, Request/Accept Summary of 
Care.
    We disagree that the Advancing Care Information measure should be 
limited to only include recipients who possess CEHRT for the Request/
Accept Summary of Care measure, as that would limit support for MIPS 
eligible clinicians exchanging health information with providers and 
clinicians across a wide range of settings. We further note that, 
consistent with the policy set forth in the 2015 EHR Incentive Programs 
final rule (80 FR 62852-62862), MIPS eligible clinicians and groups may 
send the electronic summary of care document via any electronic means 
so long as the MIPS eligible clinician sending the summary of care 
record is using the standards established for the creation of the 
electronic summary of care document.
    Comment: Many commenters strongly supported the inclusion of the 
Health Information Exchange objective and associated measures. They 
noted benefits such as the incorporation and use of both non-clinical 
and patient-generated health data as well as supplementing medication 
reconciliation for transitions of care

[[Page 77235]]

with medication allergies and problems as part of the Health 
Information Exchange objective. They supported the prioritization of 
measures that promote the policy objectives of interoperability, care 
coordination, and patient engagement. They supported measures that 
incorporate the use of online access to health information and secure 
email, and the collection and integration of data from non-clinical 
sources.
    Response: We agree and will continue to require the Health 
Information Exchange objective in the advancing care information 
performance category. In addition section 1848(o)(2)(A)(ii) of the Act 
requires the electronic exchange of health information.
    Comment: A commenter noted that the definition of patient-generated 
health data inappropriately focuses on the device generating the data 
rather than the patient and recommended expanding the definition to 
include other more relevant data sources such as filling out forms and 
surveys, and by self-report. One commenter believed there should be a 
distinction between patient-generated and device-generated data and 
that MIPS eligible clinicians should have the ability to review data 
sources as part of the record similar to a track change function.
    Response: For the Patient-Generated Health Data measure, the 
calculation of the numerator incorporates both health data from non-
clinical settings, as well as health data generated by the patient. We 
will consider the suggestion for expanding the types of health data to 
include for this measure, such as some patient-reported information, in 
future rulemaking.
    Comment: For the Clinical Information Reconciliation measure, 
specifically the medication reconciliation portion, the commenter 
believed the updated measure for Stage 3 adds further definition to the 
data that must be reviewed.
    Response: We note that the Clinical Information Reconciliation 
measure under the Health Information Exchange objective, we are 
adopting for the advancing care information performance category is the 
same as the Stage 3 measure under the EHR Incentive Program with the 
threshold and exclusion removed.
    Comment: For the Medication Reconciliation measure, the proposed 
2017 Advancing Care Information Transition measure adds the medication 
allergy list and current problems list to the items that must be 
reconciled. One commenter indicated that this significantly expands the 
current Modified Stage 2 measure such that a change in workflow is 
required. In addition, functionality to reconcile medication allergies 
and problems are not included in the 2014 Edition of CEHRT.
    Response: The 2017 Advancing Care Information Transition Medication 
Reconciliation measure is still limited to medication reconciliation as 
it was for the Modified Stage 2 measure. For the Advancing Care 
Information measure, we proposed to include medication list, medication 
allergy list and current problem list under the Clinical Information 
Reconciliation measure which aligns with the third measure under the 
Health Information Exchange objective for Stage 3 of the EHR Incentive 
Programs and requires technology certified to the 2015 Edition.
    Comment: A few commenters requested, in addition to eliminating the 
requirement to report the CPOE and CDS objectives and associated 
measures that MIPS eligible clinicians only be required to report on 
the remaining objectives and measures that are relevant to their 
practice.
    Response: In developing our final scoring methodology for the 
advancing care information performance category for a performance 
period in 2017, we have significantly reduced the number of required 
measures from 11 to five. We have moved more measures to the 
performance score so the MIPS eligible clinicians are able to tailor 
their participation by relevance to their practices. We refer readers 
to section II.E.5.g.(6)(a) for more discussion of our final scoring 
policy.
    Comment: The majority of commenters supported the proposal to 
include the Public Health and Clinical Data Registry Reporting 
objective in the advancing care information performance category. Many 
commenters particularly praised the reduction in requirements of the 
objective by only requiring the reporting of the Immunization Registry 
Reporting measure while including the remaining measures as optional to 
earn a bonus point. However, some commenters expressed concern that by 
only requiring one measure to report, the importance of public health 
registry reporting is downplayed. Many commenters suggested MIPS 
eligible clinicians be encouraged and incentivized to report to 
registries beyond Immunization Registry Reporting.
    Several commenters indicated that the Public Health Registry 
reporting objective would be better suited as an activity in the 
improvement activities performance category and public health registry 
reporting should be counted for points in that performance category 
rather than the advancing care information performance category.
    Response: We appreciate the support of our proposal to reduce the 
reporting burden for the Public Health and Clinical Data Registry 
Reporting objective. We agree that given the importance and benefit to 
MIPS eligible clinicians of submitting data to multiple registries, 
that more points should be awarded for reporting to additional 
registries under the objective. As we have amended our proposal and the 
Immunization Registry Reporting measure is no longer a required measure 
in the base score, MIPS eligible clinicians may still choose to report 
the measure to increase their performance score. In addition, we are 
increasing the bonus to 5 percent for reporting one or more public 
health or clinical data registries.
    We disagree that the Public Health and Clinical Data Registry 
reporting objective should be in the improvement activities performance 
category. The proposed measures in the Public Health and Clinical Data 
Registry Reporting objective focus on active, ongoing engagement with 
registries, as well as electronic submission of data, which we believe 
are within the scope of effectively using CEHRT to achieve the goals of 
the advancing care information performance category.
    Comment: A commenter supported the proposal to include the Public 
Health and Clinical Data Registry reporting but encouraged CMS to 
require reporting to cancer registries, because accurate and detailed 
cancer information enables better public policy development.
    Response: We have not created a separate cancer registry reporting 
measure for MIPS because we believe that such reporting is captured 
under existing public health registry reporting measures. If a MIPS 
eligible clinician is reporting under the 2017 Advancing Care 
Information Transition objectives and measures, they may report cancer 
registry data under the specialized registry measure. However, if the 
eligible clinician or group chooses to do so, they must use the 2014 
Edition certification criteria specific to cancer case reporting in 
order to meet the measure. This measure is an exception to the flexible 
CEHRT requirements for the 2017 Advancing Care Information Transition 
objectives and measures Specialized Registry Reporting measure and for 
this reason we previously finalized a policy that if a participant has 
the CEHRT available and chooses to report to meet the measure they may 
do so but they are not required to consider a cancer registry in their 
specialized

[[Page 77236]]

registry selection (80 FR 62823). If the MIPS eligible clinician is 
reporting under the MIPS advancing care information performance 
category measures, active engagement with a cancer registry would meet 
the Public Health Registry Reporting measure and would require the use 
of technology certified to the cancer case reporting criteria of the 
2014 or 2015 Edition.
    If a MIPS eligible clinician is reporting under the 2017 Advancing 
Care Information Transition objectives and measures, they may report 
cancer registry data under the Specialized Registry measure. If they 
are reporting under the Advancing Care Information objectives and 
measures, they would report under the Public Health Registry Reporting 
measure.
    Comment: One commenter expressed concern that many of the measures 
under the Public Health and Clinical Registry Reporting objective do 
not apply to all practices, and for those to whom it does apply, the 
measures should not burden MIPS eligible clinicians by requiring them 
to join a registry in order to report.
    Response: We appreciate the concern that different registries have 
different requirements for participation and they may not apply to a 
MIPS eligible clinician's practice. We note that we have amended our 
proposal and the Immunization Registry Reporting measure is no longer a 
required measure, but MIPS eligible clinicians may report the measure 
to earn credit in the performance score. In addition, we are only 
awarding a bonus score for reporting to additional public health or 
clinical data registries. We believe this offers enough flexibility for 
MIPS eligible clinician who may experience challenges engaging with a 
public health or clinical registry.
    Comment: A commenter recommended that for performance period 2017, 
MIPS eligible clinicians be required to be in active engagement with 
two public health registries and to report on two public health 
registry reporting measures, for example, Immunization Registry 
Reporting and one optional public health registry reporting measure. 
Several commenters recommended that for performance periods in 2018 and 
beyond, MIPS eligible clinicians be required to be in active engagement 
with three public health registries and to report on three public 
health registry reporting measures, for example, Immunization Registry 
Reporting, Electronic Public Health Registry Reporting, and one 
specialized public health registry.
    Response: While we appreciate these comments, we are not requiring 
Public Health and Clinical Data Registry Reporting in the base score of 
the advancing care information performance category. MIPS eligible 
clinicians can increase their performance score if they choose to 
report on the Immunization Registry Reporting measure in 2017. We are 
also finalizing as part of our scoring policy that MIPS eligible 
clinicians can earn a bonus score for reporting to additional public 
health registries.
    Comment: A commenter stated that our proposal to only require 
Immunization Registry Reporting measure will likely result in a 
decrease in public health reporting. They urged CMS to retain the 
public health reporting requirements from the EHR Incentive Programs. 
While another noted that after putting significant effort into meeting 
EHR Incentive Program Stage 2 requirements of submitting to two public 
health registries, they were disappointed that the proposed MACRA rule 
would only require data submission to an immunization registry.
    Response: While we understand these concerns, and we believe that 
the Public Health and Clinical Registry Reporting measures should not 
be included in the base score of the advancing care information 
performance category and have amended our proposal to specify that the 
Immunization Registry Reporting measure is no longer a required measure 
in the base score. We agree with the commenter that many EPs have 
successfully achieved active engagement with more than one clinical 
data registry over the past few years. However, we also know that many 
MIPS eligible clinicians are still working diligently toward meeting 
the requirements of this objective. We believe that an opportunity for 
growth and improvement continues to exist, especially among a large 
proportion of MIPS eligible clinicians who did not previously 
participate in the Medicare and Medicaid EHR incentive programs. 
Therefore, MIPS eligible clinicians may still choose to report the 
Immunization Registry Reporting measure to increase their performance 
score. In addition, MIPS eligible clinicians who choose to report on 
additional public health and clinical data registry reporting measures 
may increase their bonus score toward their advancing care information 
performance category score.
    Comment: Some commenters supported the inclusion of the 
Immunization Registry Reporting measure. They noted that immunization 
registries are the most widely available and applicable public health 
registries and previously included for EPs in meaningful use. The 
continuation of the exclusions for MIPS eligible clinicians who do not 
administer immunizations, or whose local registries do not accept data 
according to the standards adopted in certification, ensures that MIPS 
eligible clinicians are not penalized for factors beyond their control.
    Response: While we appreciate these comments, we are not requiring 
public health reporting in the base score of the advancing care 
information performance category. However, MIPS eligible clinicians may 
still choose to report the Immunization Registry Reporting measure to 
increase their advancing care information performance score.
    Comment: A commenter recommended that there be a resource or 
listing of all available public health and clinical registries that 
MIPS eligible clinicians could engage with to meet the measures of the 
Public Health and Clinical Data Registry Reporting objective.
    Response: We are planning a to develop a centralized public health 
registry repository to assist MIPS eligible clinicians in finding 
public health registries available and clinically relevant to their 
practice that are accepting electronic submissions.
    Comment: A commenter questioned why we had modified the Stage 3 
measure for syndromic surveillance from an ``urgent care setting'' to a 
``non-urgent'' care setting under MIPS.
    Response: This was an oversight on our part. As we noted in the 
2015 final rule (80 FR 62866) few jurisdictions accept syndromic 
surveillance from non-urgent care EPs. We are modifying the measure for 
MIPS so that it aligns with the Stage 3 measure that we finalized for 
the EHR Incentive Program and limit the surveillance data to be 
submitted to data from an urgent care setting.
    After consideration of the comments, we are finalizing our proposal 
for the Advancing Care Information objectives and measures and the 2017 
Advancing Care Information Transition objectives and measures as 
proposed with modifications to correct language in certain measures as 
noted as follows:
    For the 2017 Advancing Care Information Transition Medication 
Reconciliation measure: We are maintaining the Modified Stage 2 
numerator as follows: ``Numerator: The number of transitions of care in 
the denominator where medication reconciliation was performed.
    For the Advancing Care Information 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

[[Page 77237]]

by the MIPS eligible clinician. An MIPS eligible clinician may meet the 
measure by a patient either--(1) viewing, downloading. or transmitting 
to a third party their health information; or (2) accessing their 
health information through the use of an API that can be used by 
applications chosen by the patient and configured to the API in the 
MIPS eligible clinician's CEHRT; or (3) a combination of (1) and (2).
    For the Advancing Care Information Syndromic Surveillance Reporting 
measure: The MIPS eligible clinician is in active engagement with a 
public health agency to submit surveillance data from an urgent care 
ambulatory setting where the jurisdiction accepts syndromic data from 
such settings and the standards are clearly defined.
    We note that we will consider new measures for future years of the 
program, and invite comment on what types of EHR measures and 
measurement should be considered for inclusion in the program. In 
addition we invite comments on how to make the measures that we are 
adopting in this final rule more stringent in the future, especially in 
light of the statutory requirements.
(c) Exclusions
    In the 2015 EHR Incentive Programs final rule (80 FR 62829 through 
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 proposed at (81 FR 28173-28176) and as further discussed in 
section II.E.1. of this final rule with comment period, 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 performance category 
measures. By excluding from MIPS those clinicians who do not exceed the 
low-volume threshold (proposed in section II.E.3.c. of the proposed 
rule, 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 performance category 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 noted that EPs who write less than 100 permissible prescriptions 
during the EHR reporting period are allowed an exclusion for the e-
Prescribing measure under the EHR Incentive Program (80 FR 62834), 
which we did 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 proposed 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 therefore proposed to maintain the 
previously established exclusions for the Immunization Registry 
Reporting measure. We therefore proposed 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 did not propose to maintain any of the other 
exclusions established under the EHR Incentive Program, however, we 
solicited comment on whether other exclusions should be considered 
under the advancing care information performance category under the 
MIPS.
    The following is a summary of the comments we received regarding 
our exclusion proposal.
    Comment: Many commenters supported our proposal to provide an 
exclusion for the e-Prescribing measure to those MIPS eligible 
clinicians who write less than 100 permissible prescriptions during the 
performance period, and many commenters requested additional 
exclusions. Commenters disagreed with the removal of exclusions for 
other objectives, such as the transitions of care measure under the 
Health Information Exchange objective that existed under the EHR 
Incentive Programs. Many suggested continuing all EHR Incentive 
Programs Modified Stage 2 and Stage 3 exclusions under MIPS. Others 
suggested that exclusions be added to the Health Information Exchange 
measure under 2014 Edition CEHRT and the MIPS Clinical Information 
Reconciliation measure. Some suggested an exclusion for the Health 
Information Exchange Objective be added if a MIPS eligible clinician 
has fewer than 100 external referrals. Commenters also requested 
exclusions for clinicians who do not refer patients and those with 
insufficient broadband availability. Commenters recommended low-volume 
exclusions for various measures including e-Prescribing, Provide 
Patient Access, and the measures under the Coordination of Care Through 
Patient Engagement, and Health Information Exchange objectives. 
Commenters also urged the addition of an exclusion for MIPS eligible 
clinicians practicing in multiple locations because they may encounter 
specific hardships due to CEHRT availability. Some requested that any 
meaningful use exclusions for Public Health and Clinical Data Registry 
Reporting remain in effect for those using the 2014 CEHRT. Some 
requested an exclusion should exist for the Syndromic Surveillance 
Reporting measure for those physicians who do not directly or rarely 
diagnose or treat conditions related to syndromic surveillance. Another 
commenter requested that we maintain the meaningful use Stage 3 
exclusion for the Patient-Specific Education and that MIPS eligible 
clinicians with no office visits during the performance period be 
permitted to report a ``null value'' and achieve full base and 
performance score credit.
    Response: We note that we are finalizing fewer required measures 
for the base score of the advancing care information performance 
category than we had proposed. As there are now fewer required 
measures, we do not believe that it is necessary to create additional 
exclusions for measures which are now optional for reporting. In

[[Page 77238]]

addition, as we have moved the Immunization Registry Reporting measure 
from ``required'' in the base score to ``not required'' in the base 
score, we are not finalizing our proposal to provide an exclusion for 
those MIPS eligible clinicians who do not administer immunizations 
during the performance period. The exclusion is no longer necessary 
because MIPS eligible clinicians now have the option of whether or not 
to report on Immunization Registry Reporting to receive credit for this 
measure under the performance score of the advancing care information 
performance category.
    Comment: A few commenters supported the elimination of exclusions 
and noted that the elimination of thresholds enable MIPS eligible 
clinicians to focus more on quality patient care and less on meeting 
thresholds.
    Response: We appreciate the support of these commenters and agree 
that the fewer required measures and elimination of thresholds have 
enabled the removal of many of the exclusions that existed under the 
EHR Incentive Programs.
    After consideration of the comments, we are finalizing our 
exclusion policy as proposed with the following modification. We are 
not finalizing the exclusions for the Immunization Registry Reporting 
measure under the Public Health and Clinical Data Registry Reporting 
objective for those MIPS eligible clinicians who do not administer 
immunizations as part of their practice.
(8) Additional Considerations
(a) Reweighting of the Advancing Care Information Performance Category 
for MIPS Eligible Clinicians Without Sufficient Measures Applicable and 
Available
    As discussed in the 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 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 the 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 in the proposed rule, we proposed to assign a weight of 
zero to the advancing care information performance category for 
purposes of calculating a MIPS final score for these MIPS eligible 
clinicians. We refer readers to section II.E.6. of the proposed rule 
for more information regarding how the quality, cost and improvement 
activities 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 CEHRT. These MIPS eligible clinicians therefore may have no control 
over the type of CEHRT 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 Provide 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 
clinician, 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.

[[Page 77239]]

    In addition, we noted 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 noted 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 proposed 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 
proposed 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 3 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 proposed, 
consistent with the EHR Incentive Program, that we would determine 
which MIPS eligible clinicians qualify as ``hospital-based'' for a MIPS 
payment year. We invited comments on these proposals.
    In addition, we sought 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 also sought 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 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.
    The following is a summary of the comments we received regarding 
our proposal for defining hospital-based MIPS eligible clinicians.
    Comment: Many commenters supported our proposed definition of a 
hospital-based MIPS eligible clinician as those who furnish 90 percent 
or more of his or her covered professional services in either Place of 
Service 21 or 23. Many also supported the proposal to assign a weight 
of zero to the advancing care information performance category for 
hospital-based MIPS eligible clinicians, citing that health IT 
decisions for these MIPS eligible clinicians are often made at the 
hospital level and are out of their control.
    Response: We thank commenters for their support of our proposal. 
For the reasons stated in the proposed rule, and based on the measures 
we are finalizing in this final rule with comment period, we agree that 
there may not be sufficient measures applicable and available to 
hospital-based MIPS eligible clinicians to report for the advancing 
care information performance category.
    Comment: A few commenters disagreed with our proposal and provided 
alternate hospital-based thresholds. They recommended that the 
threshold be lowered to a majority (or more than 50 percent). Several 
commenters recommended a 75 percent threshold, while another suggested 
reducing the threshold to 60 percent. One commenter recommended that 
CMS adopt a flexible approach that accommodates eligible clinicians who 
work in multiple settings.
    Response: Although commenters suggested alternate thresholds, they 
did not provide specific rationale to support the lowered thresholds or 
the factors that should be applied to determine the threshold for 
hospital-based MIPS eligible clinicians. With commenter feedback in 
mind, we have reevaluated the data and found that historical claims 
data support a lower threshold as suggested in these comments. With 
consideration of the comments and data we have reviewed, we are 
reducing the percentage of covered professional services furnished in 
certain sites of service to determine hospital-based MIPS eligible 
clinicians from 90 percent to 75 percent. The data analyzed supports 
the comments we received while still allowing MIPS eligible clinicians 
with 25 percent or more of their services in a settings outside of 
inpatient hospital, on-campus outpatient hospital (as referenced below) 
or emergency room settings to participate and earn points in the 
advancing care information performance category.
    Comment: Many commenters proposed that CMS broaden the definition 
of ``hospital-based clinician'' to include those MIPS eligible 
clinicians who are employed by a hospital, but still bill outpatient 
services, as those MIPS eligible clinicians will not have input into 
the selection of the EHR, pointing out that facility-based clinicians 
in both inpatient and outpatient settings experience the similar 
difficulties in meeting the proposed objectives and measures in the 
advancing care information performance category. Another commenter 
believed that CMS should include other clinician settings, such as 
ambulatory surgery centers, with hospital inpatient and ED settings as 
clinicians in other settings may also lack control over EHR technology. 
Another urged CMS to revise the criteria to include care provided in 
hospital outpatient departments and ASCs, excluding evaluation and 
management services. One commenter supported our proposal for hospital-
based MIPS eligible clinicians and recommended that CMS also include 
POS 22 (on-campus outpatient hospital) because many hospitalists 
provide care in both the inpatient setting, as well as on-campus 
outpatient hospital departments. Another commenter suggested that the 
definition of hospital-based MIPS eligible clinicians include 
observation services.
    Response: We agree with commenters that there are MIPS eligible 
clinicians who bill using place of service codes other than POS 21 and 
POS 23 but who predominantly furnish covered professional services in a 
hospital setting and have no control over EHR technology. We believe 
these clinicians should be considered hospital-based for purposes of 
MIPS, and therefore, we are expanding our hospital-based definition to 
include POS 22, on-campus outpatient hospital.
    Comment: One commenter recommended using the newly-introduced 
Medicare specialty billing code for hospitalists in the definition of 
``hospital-based.''
    Response: The official use of the Medicare specialty billing code 
for hospitals does not begin until after the start of the MIPS program, 
and therefore we have no historical data to support its

[[Page 77240]]

inclusion in the definition of hospital-based at this time. We will 
consider this recommendation for future rulemaking.
    Comment: One commenter recommended that CMS describe this group of 
MIPS eligible clinicians as facility-based rather than hospital-based.
    Response: We appreciate the comment although we continue to believe 
that hospital-based is the more appropriate term. We believe facility-
based is too broad a term and could be misleading.
    Comment: A commenter requested that CMS be transparent about the 
time period used for determining whether an MIPS eligible clinician is 
hospital-based.
    Response: We proposed to use data from the year preceding the 
performance period, otherwise stated as the year that is 3 years 
preceding the MIPS payment year. We are adopting a modified final 
policy and will instead use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period. For example, for the 2017 performance period (2019 MIPS payment 
year) we will use the data available at the end of October 2016 for 
Medicare claims with dates of service between September 1, 2015, 
through August 31, 2016, to determine whether a MIPS eligible clinician 
is considered hospital-based by our definition. In the event that it is 
not operationally feasible to use claims from this exact time period, 
we will use a 12-month period as close as practicable to September 1 of 
the calendar year 2 years preceding the performance period and August 
31 of the calendar year preceding the performance period. We have 
adopted this change in policy in an effort to provide transparency to 
MIPS eligible clinicians; this change in timeline will allow us to 
notify MIPS eligible clinicians of their hospital-based status prior to 
the start of the performance period. By adopting this policy and 
notifying MIPS eligible clinicians of their hospital-based 
determination prior to the performance period, we enable MIPS eligible 
clinicians to better plan and prepare for reporting.
    Comment: One commenter noted that specialists who meet the criteria 
for being considered a hospital-based MIPS eligible clinician may still 
have access and the ability to effectively use CEHRT, and may 
sufficiently meet the requirements of the advancing care information 
performance category, while those MIPS eligible clinicians who do not 
meet the hospital-based criteria as proposed would not be able to meet 
those requirements. The commenter suggested taking this into 
consideration and proposed allowing some MIPS eligible clinicians who 
are not hospital-based, but who still face the same hardships, to 
reweight and redistribute their advancing care information performance 
category score.
    Response: We realize that some MIPS eligible clinicians face 
similar challenges around the inability to control their access to 
CEHRT even if they are not determined to be hospital-based. We refer 
readers to section II.E.5.g.(8)(a)(ii) of this final rule with comment 
period for further discussion of reweighting applications for those 
MIPS eligible clinicians who face a significant hardship.
    Comment: Commenters recommended offering MIPS eligible clinicians 
or groups the option to petition for a change in their hospital-based 
status when there is a change in their organizational affiliation.
    Response: We agree that circumstances change from year to year and 
MIPS eligible clinicians' hospital-based determination should be 
reevaluated for each MIPS payment year. We note that we are finalizing 
a policy to determine hospital-based status for each MIPS payment year 
by looking at a MIPS eligible clinician's covered professional services 
based on claims with dates of service between September 1 of the 
calendar year 2 years preceding the performance period through August 
31 of the calendar year preceding the performance period. We appreciate 
the suggestion that MIPS eligible clinicians should have the ability to 
petition their hospital-based status. However, we believe this annual 
reevaluation in combination with our policy that hospital-based MIPS 
eligible clinicians may choose to report to the advancing care 
information performance category should they determine that there are 
applicable and available measures for them to submit allow sufficient 
flexibility for hospital-based MIPS eligible clinicians without the 
need to petition their hospital-based status.
    After consideration of the public comments and the data we have 
available, we are finalizing our proposal for MIPS under Sec.  414.1305 
with the following modifications. Under the MIPS, a hospital-based MIPS 
eligible clinicians is defined as a MIPS eligible clinician who 
furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the Place of Service (POS) 
codes used in the HIPAA standard transaction as an inpatient hospital 
(POS 21), on campus outpatient hospital (POS 22), or emergency room 
(POS 23) setting, based on claims for a period prior to the performance 
period as specified by CMS. We intend to use claims with dates of 
service between September 1 of the calendar year 2 years preceding the 
performance period through August 31 of the calendar year preceding the 
performance period, but in the event it is not operationally feasible 
to use claims from this time period, we will use a 12-month period as 
close as practicable to this time period.
    We note that this expanded definition of hospital-based MIPS 
eligible clinician will include a greater number of MIPS eligible 
clinicians than the previously proposed definition. We have expanded 
this definition because we believe it better represents hospital-based 
eligible clinicians and acknowledges the challenges they face with 
regard to EHR reporting as stated above. For the reasons stated in the 
proposed rule, our assumption remains that MIPS eligible clinicians who 
are determined hospital-based do not have sufficient advancing care 
information measures applicable to them, and thus we will reweight the 
advancing care information performance category to zero percent of the 
MIPS final score for the MIPS payment year in accordance with section 
1848(q)(5)(F) of the Act. If a MIPS eligible clinician disagrees with 
our assumption and believes there are sufficient advancing care 
information measures applicable to them, they have the option to report 
the advancing care information measures for the performance period for 
the MIPS payment year for which they are determined hospital-based. 
However, if a MIPS eligible clinician who is determined hospital-based 
chooses to report on the advancing care information measures, they will 
be scored on the advancing care information performance category like 
all other MIPS eligible clinicians, and the performance category will 
be given the weighting prescribed by section 1848(q)(5)(E) of the Act 
regardless of their advancing care information performance category 
score.
(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),

[[Page 77241]]

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 CEHRT (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 proposed 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 e-Prescribing 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 proposed 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 CEHRT 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 proposed 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 CEHRT 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 proposed 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 noted 
that in such cases, the MIPS eligible clinician must have no control 
over the availability of CEHRT. 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 CEHRT, because they can influence the group's purchase 
of CEHRT, 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 CEHRT 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 CEHRT 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 CEHRT.
    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 proposed 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 the proposed rule 
for further discussion of non-patient facing MIPS eligible clinicians. 
We also sought 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 proposed 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 proposed that all applications may be submitted on 
a rolling basis, but must be received by us no later than the close of 
the submission period for the relevant performance period, or a later 
date specified by us. For example, for the 2017 performance period, 
applications must be submitted no later than March 31, 2018 (or later 
date as specified by us) 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.
    The following is a summary of comments received.
    Comment: Most commenters supported the inclusion of something 
similar to a hardship exception under the EHR Incentive Program for the 
advancing care information performance category and the reweighting of 
the advancing care information score to zero. Other commenters 
expressed appreciation that CMS has moved away

[[Page 77242]]

from the 5 year limitation to hardship exceptions.
    Response: We appreciate the support of our proposal, and note that 
we did not propose exceptions from reporting on the advancing care 
information performance category or from application of the MIPS 
payment adjustment factor based on hardship. Rather, we are recognizing 
that there may not be sufficient measures applicable and available 
under the advancing care information performance category to MIPS 
eligible clinicians who lack sufficient internet connectivity, face 
extreme and uncontrollable circumstances, lack control over the 
availability of CEHRT, or do not have face-to-face interactions with 
patients. For those MIPS eligible clinicians, we proposed to reweight 
the advancing care information performance category to zero percent in 
the MIPS final score.
    Comment: We received many comments suggesting various additions to 
our proposal. One commenter suggested hardship exceptions under the 
advancing care information performance category for both 2017 and 2018 
for practices that are experiencing transitional, infrastructural 
changes. One commenter suggested expanding the exceptions for 
unforeseen circumstances to a minimum of 5 years. Another requested 
that one of the hardship categories for the 2017 performance period 
include the lateness of the publication of the final rule with comment 
period, which will create a short timeline for adjustment to new 
requirements. A commenter strongly recommended that hospitalist be 
added to the list because they do the majority of their work in a 
hospital.
    Response: We note that, in some cases, transitional infrastructure 
changes might be considered under the extreme and uncontrollable 
circumstances category, depending upon the particular circumstances of 
the clinician practice. We believe that it is necessary for MIPS 
eligible clinicians to submit an application to reweight their 
advancing care information performance category score to zero for each 
applicable year. We do not believe it is appropriate to automatically 
reweight to zero the advancing care information performance category 
score for a span of multiple years as circumstances change year to 
year. We believe that our policy to allow a minimum of 90-days data for 
the transition year of MIPS helps to address any issues related to the 
timing of the release of this final rule with comment period. We refer 
readers to section II.E.4. of this final rule with comment period for 
further discussion of the MIPS performance period. Finally we note that 
hospital medicine is not a clinician specialty that is identified 
through the Medicare enrollment process. Those MIPS eligible clinicians 
that are considered hospital-based by our definition would have their 
advancing care information performance category weighted at zero 
percent of the MIPS final score as was previously discussed in this 
final rule with comment period.
    Comment: Many commenters suggested additional categories related to 
CEHRT. One commenter asked CMS to create hardship exceptions to ensure 
that clinicians are not unfairly punished for the failures of their 
CEHRT, citing concerns of past failures with technologies in meeting 
standards imposed by CMS and ONC. Yet another commenter recommended 
that we consider expanding the criteria for 2017 and 2018 to include 
specific clinician types that can prove that they would incur major 
administrative and financial burdens by adopting EHR technology for the 
first and second performance period. Another commenter suggested that 
exceptions be developed to avoid negative payment adjustments in 2019 
for EHR migration difficulties. Other commenters suggested exception 
for switching CEHRT and providing hardships when CEHRT is decertified.
    Response: We appreciate this input and understand that there may be 
many issues related to CEHRT that may result in a MIPS eligible 
clinician being unable to report on measures under the advancing care 
information performance category due to circumstances outside of their 
control. As we do not want to limit potential unforeseen circumstances 
we will consider issues with vendors and CEHRT under the ``extreme and 
uncontrollable circumstances'' category, but we note that not all 
issues may qualify as extreme and outside of control of the clinician.
    Comment: One commenter supported continued hardship exceptions for 
clinicians who practice in settings such as skilled nursing facilities 
where they do not have control over availability of CEHRT, however they 
also believe this proposal does not go far enough. The commenter 
explained that without a hardship exception granted, these facilities 
will be encouraged to limit the number of patients seen by their 
clinicians so that they can avoid being eligible to participate in 
MIPS, which would adversely affect the access to care provided to this 
vulnerable population. They requested that skilled nursing facility 
visits (POS 31) and nursing facility visits (POS 32) (CPT codes 99304-
99318) simply be exempt from meaningful use, and by extension the 
advancing care information performance category.
    Response: While we acknowledge this issue, we believe that it is 
adequately addressed by the ``lack of control over CEHRT'' category and 
does not warrant the exemption of certain evaluation and management 
codes. As we have noted previously, this final rule with comment period 
only addresses policies related to MIPS eligible clinicians and not 
Medicaid EPs, eligible hospitals or CAHs under the Medicare and 
Medicaid EHR Incentive Programs.
    Comment: Other commenters believed that CMS should continue a 
hardship exception for medical centers because the medical centers will 
have to monitor more programs requiring some but less of the same data. 
The commenters stated that the processes are confusing and time-
consuming.
    Response: We currently do not allow a hardship exception specific 
to medical centers under the EHR Incentive Program. Medical centers are 
not subject to the application of the MIPS payment adjustment factors 
and are not addressed in this rulemaking.
    Comment: A few commenters requested that, as was included in the 
Medicare and Medicaid EHR Incentive Programs, an automatic hardship 
exception be granted to the following PECOS specialties: diagnostic 
radiology (30), nuclear medicine (36), interventional radiology (94), 
anesthesiology (05) and pathology (22).
    Response: We disagree that we should reweight to zero the advancing 
care information performance category score based on specialty code, 
and note that our proposal and final policy for reweighting the 
advancing care information performance category is based on the number 
of patient-facing encounters billed during a performance period, not 
based on specialty type. In the EHR Incentive Programs, we offered an 
exception to the Medicare payment adjustments to certain specialties as 
designated in PECOS because we recognized that EPs within the 
specialties that lack face-to-face interactions and lack follow up with 
patients with sufficient frequency (77 FR 54099-54100). Under the MIPS, 
we proposed to automatically reweight the advancing care information 
performance category to zero for any hospital-based MIPS eligible 
clinicians and/or non-patient facing MIPS eligible clinicians who may 
not have sufficient measures applicable and available to them. Some of 
the MIPS eligible clinicians in specialties referenced by the commenter 
may have sufficient patient encounters to report the measures under the 
advancing care information performance

[[Page 77243]]

category, and thus, the advancing care information performance category 
measures would be applicable to these MIPS eligible clinicians.
    Comment: A commenter suggested that CMS publish an explanation of 
what constitutes ``limited'' internet access and list limited access 
areas per the Federal Communications Commission (FCC).
    Response: We have stated that MIPS eligible clinicians located in 
an area without sufficient Internet access to comply with objectives 
requiring Internet connectivity, and faced insurmountable barriers to 
obtaining such Internet connectivity could be apply for significant 
hardship. The FCC's National Broadband Map allows MIPS eligible 
clinicians to search, analyze, and map broadband availability in their 
area: http://www.broadbandmap.gov/.
    Comment: One commenter recommended a new option to allow 
applications to reweight advancing care information performance 
category to zero for MIPS eligible clinicians who did not previously 
intend to participate in meaningful use in CY 2017, and instead planned 
to obtain a significant hardship to avoid the Electronic Health Record 
Incentive Program 2019 payment adjustment.
    Response: We note that under section 101(b)(1) of the MACRA, the 
payment adjustments under the Medicare EHR incentive program will end 
after the 2018 payment adjustment year, which is based on the EHR 
reporting period in 2016. Therefore, MIPS eligible clinicians are not 
required to participate in the Medicare EHR incentive programs in the 
2017 EHR reporting period to avoid a 2019 payment adjustment. MIPS 
eligible clinicians may qualify for reweighting of their advancing care 
information performance category score if they meet the criteria 
outlined in our policy for reweighting under MIPS.
    Comment: A commenter recommended that CMS explicitly clarify that 
the ``lack of influence over the availability of CEHRT'' option for 
reweighting advancing care information performance category to zero is 
not limited to multi-location/practice MIPS eligible clinicians.
    Response: The ``lack of control over the availability of CEHRT'' is 
not limited to MIPS eligible clinicians who practice at multiple 
locations, instead, it is available to any MIPS eligible clinicians who 
may not have the ability to impact their practices' health IT 
decisions. We noted that in such cases, the MIPS eligible clinician 
must have no control over the availability of CEHRT. We further 
specified that a majority (50 percent or more) of their outpatient 
encounters must occur in locations where they have no control over the 
health IT decisions of the facility. Control does not imply final 
decision-making authority as demonstrated in the example given in our 
proposal.
    Comment: A commenter recommended granting MIPS eligible clinicians 
that are eligible for Social Security benefits a hardship exception 
because of the considerable expenditures of both human and financial 
capital that would require several years to see a return on investment.
    Response: While we understand this suggestion, we do not believe 
that it is appropriate to reweight this category solely on the basis of 
a MIPS eligible clinicians' age or Social Security status. We have 
analyzed EHR Incentive Program data, as well as provider feedback, and 
believe that while other factors such as the lack of access to CEHRT or 
unforeseen environmental circumstances may constitute a significant 
hardship, the age of an MIPS eligible clinician alone or the preference 
to not obtain CEHRT does not.
    Comment: Commenters requested that application for reweighting not 
be burdensome for MIPS eligible clinicians to submit. One commenter 
requested that CMS clarify whether MIPS eligible clinicians will need 
to submit an annual application to be excluded from the advancing care 
information performance category or if this will occur automatically 
and the commenter preferred the latter.
    Response: We noted that CMS would specify the form and manner that 
reweighting applications are submitted outside the rulemaking process. 
Additional information on the submission process will be available 
after the rule is published. We do note that if an application is 
required, it must be submitted annually.
    Comment: Some commenters stated that MIPS eligible clinicians, who 
did not qualify for meaningful use, will need more time to familiarize 
themselves with EHR and could receive a low MIPS final score and 
negative payment adjustment due to lack of CEHRT. They believed that 
these MIPS eligible clinicians most likely serve high-disparity 
populations and that the most vulnerable patient populations could be 
negatively impacted.
    Response: We acknowledge that under MIPS more clinicians will be 
subject to the requirements of EHR reporting than were previously 
eligible under the EHR Incentive Program and may not have advancing 
care information measures that are applicable or available for them to 
submit. For this reason, we have proposed to reweight the advancing 
care information performance category to zero for hospital-based MIPS 
eligible clinicians, NPs, PAs, CRNAs and CNSs. We have also allowed for 
MIPS eligible clinicians to apply for a reweighting of their advancing 
care information performance category score should the MIPS eligible 
clinician not have measures that are applicable or available to them 
for various reasons as discussed in section II.E.5.g. of this final 
rule with comment period. We do not agree that MIPS eligible clinicians 
who were not eligible for the EHR Incentive Programs are concentrated 
in high disparity populations, nor do we believe that serving such a 
population would limit a MIPS eligible clinician's ability to report on 
the advancing care information objectives and measures.
    After consideration the comments, we are finalizing our policy to 
re-weight the advancing care information performance category to zero 
percent of the MIPS final score for MIPS eligible clinicians facing a 
significant hardships as proposed. For the reasons discussed in the 
proposed rule, we continue to assume that these clinicians may not have 
sufficient measures applicable and available to them for the advancing 
care information performance category. Should a MIPS eligible clinician 
apply for their advancing care information performance category to be 
reweighted under this policy but subsequently determine that their 
situation has changed such that they believe there are sufficient 
measures applicable and available to them for the advancing care 
information performance category, they may report on the measures. If 
they choose to report, they will be scored on the advancing care 
information performance category like any other MIPS eligible 
clinician, and the category will be given the weighting prescribed by 
section 1848(q)(5)(E) of the Act regardless of the MIPS eligible 
clinician's advancing care information performance category score.
(iii) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    The definition of a MIPS eligible clinician 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

[[Page 77244]]

Medicaid for the adoption and meaningful use of CEHRT (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 CEHRT. Similarly, NPs and PAs may also lack experience with the 
adoption or use of CEHRT, as they are not subject to the payment 
adjustment under section 1848(a)(7)(A) of the Act. We further noted 
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 FQHC or a 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 
proposed 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 noted 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 invited comments on our proposal. We additionally sought 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.
    The following is a summary of the comments we received regarding 
our proposal.
    Comment: Commenters generally supported our proposal to reweight 
the advancing care information performance category for those MIPS 
eligible clinicians without sufficient measures. Most commenters 
supported CMS' proposal that submission under the advancing care 
information performance category for NPs, PAs, CNSs, and CRNAs, would 
be optional in 2017 given these non-physicians' lack of past 
participation in meaningful use.
    Response: We appreciate commenters for their support of this 
proposal and we agree for the reasons stated in the proposed rule that 
it is appropriate to assign a weight of zero only if the aforementioned 
practitioners do not submit data for any of the advancing care 
information performance category measures.
    Comment: One commenter urged CMS to revise the proposed rule so 
that NPs and advanced practice nurses (APNs) can obtain EHR Incentive 
Program incentives.
    Response: This final rule with comment period implements the MIPS 
as authorized under section 1848(q) of the Act. Eligibility for 
incentive payments under the EHR Incentive Program is determined under 
a separate section of the statute. Any change to the eligibility or 
extension of incentive payments under the EHR Incentive Program would 
require a change to the law and is not in the scope of this final rule 
with comment period.
    Comment: One commenter requested CMS make advancing care 
information performance category participation optional for clinicians 
who primarily provide services in post-acute care settings, which have 
not been part of the EHR Incentive Program in the past. Several 
commenters supported excluding clinicians not eligible to participate 
in the Medicare/Medicaid EHR Incentive Programs.
    Response: While we understand the concerns of the commenters, we 
disagree with their suggestions. Section 1848(q)(1)(C)(i) of the Act 
defines a MIPS eligible clinician to include specific types of 
clinicians and provides discretion to include other types of clinicians 
in later years. In the future, we expect additional clinician types 
will be added to the definition of MIPS eligible clinician.
    Comment: A commenter noted that by allowing additional non-
physician practitioners (NPs, PAs, and in the future, dietitians, etc.) 
to be eligible to participate in the advancing care information 
performance category, the number of eligible clinicians under MIPS will 
greatly increase from the number of eligible clinicians in the EHR 
Incentive Program. The increased number of eligible clinicians will 
cause an unnecessary burden for organizational support staff to track 
and report their data. Commenters recommend advancing care information 
performance category data reporting be rolled up to the clinicians that 
they bill under so that clinician reporting includes data representing 
their MIPS eligible clinicians.
    Response: As we noted above, the definition of MIPS eligible 
clinician is broader than the definition of an EP in the EHR Incentive 
Program, and we intend to add additional clinician types to the 
definition of MIPS eligible clinician in future years. Under this 
program, we have added a group reporting option in which MIPS eligible 
clinicians who have reassigned their billing rights to a TIN may report 
at the group or TIN level instead of the individual level. We believe 
this addresses the administrative concerns raised by this comment and 
allows MIPS eligible clinicians to aggregate their data for reporting, 
therefore reducing reporting burden.
    After consideration of the comments, we are finalizing our NPs, 
PAs, CRNAs, and CNSs policy as proposed. These MIPS eligible clinicians 
may choose to submit advancing care information measures should they 
determine that these measures are applicable and available to them; 
however, we note that if they choose to report, they will be scored on 
the advancing care information performance category like all other MIPS 
eligible clinicians and the performance category will be given the 
weighting prescribed by section 1848(q)(5)(E) of the Act regardless of

[[Page 77245]]

their advancing care information performance category score.
(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). Certain 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 in the 
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 proposed 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 noted 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. We did 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 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 solicited 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.
    The following is a summary of the comments we received regarding 
our proposal to separate the reporting requirements of MIPS and the 
Medicaid EHR Incentive Programs:
    Comment: Many commenters stated the reporting burden imposed on 
MIPS eligible clinicians who also participate in the Medicaid EHR 
Incentive Programs, would have to report separately to achieve points 
in the advancing care information performance category, and to receive 
an incentive payment in the Medicaid EHR Incentive Programs. Some 
commenters urged CMS to align reporting requirements and submission 
methods across both programs to eliminate duplication in reporting 
effort. Some commenters requested that CMS eliminate the need to report 
duplicative quality measures by modifying its proposal to require that 
if quality is reported in a manner acceptable under MIPS or an APM, 
then it would not need to be reported under the Medicaid EHR Incentive 
Program. Other commenters expressed concern that varying reporting 
requirements for MIPS eligible clinicians, for hospitals and Medicaid 
EPs who participate in the EHR Incentive Programs will bring hardship 
to clinician staff, as well as EHR vendors.
    Response: We understand that reporting burden is a concern to MIPS 
eligible clinicians and CMS remains committed to exploring 
opportunities for alignment when possible. However, MIPS and the 
Medicare and Medicaid EHR Incentive Program are two separate programs 
with distinct requirements. The reporting requirements and scoring 
methods of the Medicaid EHR Incentive Program and those finalized for 
the advancing care information performance category in the MIPS program 
differ significantly. For example, in the Medicaid EHR Incentive 
Programs, EPs must report on all objectives and meet measure thresholds 
finalized in the 2015 EHR Incentive Programs final rule. In the 
advancing care information performance category, MIPS eligible 
clinicians must report on objectives and measures, but are not required 
to meet measure thresholds to be considered a meaningful EHR user.
    We remind commenters that while MIPS eligible clinicians would be 
required to meet the requirements of the advancing care information 
performance category to earn points toward their MIPS final score, 
there is no longer a requirement that EPs demonstrate meaningful use 
under the Medicaid EHR incentive program as a way to avoid the Medicare 
EHR payment adjustments. However, MIPS eligible clinicians who meet the 
Medicaid EHR Incentive Program eligibility requirements are encouraged 
to additionally participate in the Medicaid EHR Incentive Program to be 
eligible for Medicaid incentive payments through program year 2021.
    Comment: A few commenters proposed that MIPS eligible clinicians 
who are participating in the Medicaid EHR Incentive Program be exempted 
from reporting to MIPS until after the completion of their final EHR 
performance period. Others proposed allowing clinicians to choose 
either to report in the Medicaid EHR Incentive Program or the advancing 
care information performance category of MIPS. One commenter suggested 
awarding MIPS eligible clinicians 30 points toward the advancing care 
information performance category score if they successfully attest to 
meaningful use in the Medicaid EHR Incentive Program.
    Response: As previously mentioned, objective and measure 
requirements of the Medicaid EHR Incentive Program and those finalized 
for the advancing care information performance category in the MIPS 
program vary too greatly to enable one to serve as proxy for another.
    We are finalizing our Medicaid policy as proposed.

[[Page 77246]]

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 MACRA and as discussed in section II.F.5. of this final 
rule with comment period, 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 who are 
MIPS eligible clinicians are 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 proposed at Sec.  414.1370 to establish a scoring standard for 
MIPS eligible clinicians participating in certain types of APMs (``APM 
scoring standard'') to reduce participant reporting burden by 
eliminating the need for such APM eligible clinicians to submit data 
for both MIPS and their respective APMs. In accordance with section 
1848(q)(1)(D)(i) of the Act, we proposed 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 sought 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 cost 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 cost performance 
categories and the evaluation of quality and cost 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 proposed to apply the APM scoring standard to MIPS eligible 
clinicians in APM Entity groups participating in certain APMs (``MIPS 
APMs'') that meet the criteria listed below (and would be identified as 
``MIPS APMs'' on the CMS Web site). In the proposed rule, we defined 
the proposed criteria for MIPS APMs, the MIPS performance period for 
APM Entity groups, the proposed MIPS scoring methodology for APM Entity 
groups, and other information related to the APM scoring standard (81 
FR 28234-28247).
(1) Criteria for MIPS APMs
    We proposed at Sec.  414.1370 to specify that the APM scoring 
standard under MIPS would only be applicable to eligible clinicians 
participating in MIPS APMs, which we proposed to define as APMs (as 
defined in section II.F.4. of the proposed rule) that meet the 
following criteria: (1) APM Entities participate in the APM under an 
agreement with CMS; (2) the APM requires that APM Entities include at 
least one MIPS eligible clinician 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 understood 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 proposed not to 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 also 
proposed that the APM scoring standard would not apply for certain APMs 
in which the APM Entities participate under statute or our regulations 
rather than under an agreement with us. We solicited 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.4. of this final rule with comment period, 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 described in section II.F.4. of this 
final rule with comment period. 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. APMs that do not base payment on cost/utilization and 
quality measures also would 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 we explained in the proposed rule, we believe the proposed APM 
scoring standard would help alleviate certain duplicative, unnecessary, 
or competing data submission requirements for MIPS eligible clinicians 
participating in MIPS APMs. However, we were 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 proposed that the APM scoring standard would not apply to MIPS 
eligible clinicians participating in APMs that are not MIPS APMs. 
Rather, such MIPS eligible clinicians 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 final rule 
with comment period. 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 proposed that even if the APM meets the criteria to 
be a MIPS APM, MIPS eligible clinicians who are not included in the 
MIPS APM Participation List would not be considered part of the 
participating APM Entity group for purposes of the

[[Page 77247]]

APM scoring standard. For instance, MIPS eligible clinicians in the 
Next Generation ACO Model might be involved in the APM through a 
business arrangement with the APM Entity as ``preferred providers'' but 
are not directly tied to beneficiary attribution or quality measurement 
under the APM.
    The following is a summary of the comments we received regarding 
our proposals for the criteria for an APM to be a MIPS APM, and for the 
APM scoring standard to apply only to MIPS eligible clinicians who are 
included in the APM Entity group on a MIPS APM Participation List.
    Comment: A commenter sought clarity on the term ``MIPS APM''.
    Response: The term ``MIPS APM'' is used to describe an APM that 
meets the three criteria for purposes of the APM scoring standard: (1) 
APM Entities participate in the APM under an agreement with CMS; (2) 
the APM requires that APM Entities include at least one MIPS eligible 
clinician 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. Individuals 
and groups that do not participate in MIPS APMs will be scored under 
the generally applicable MIPS scoring standards. We note that the APM 
scoring standard has no bearing on the QP determination for eligible 
clinicians in Advanced APMs.
    Comment: Some commenters stated that the definition of MIPS APMs is 
too limiting and prevents eligible clinicians in APMs that are not 
considered MIPS APMs from reporting as APM Entities. Other commenters 
indicated that basing payment on quality measures should not be a MIPS 
APM criterion.
    Response: We continue to believe the criteria we proposed for a 
MIPS APM will appropriately identify APMs in which the eligible 
clinicians would be subject to potentially duplicative and conflicting 
incentives and reporting requirements if they were required to report 
and be scored under the generally applicable MIPS standard. The 
eligible clinicians in a MIPS APM that is not also an Advanced APM are 
considered MIPS eligible clinicians and are subject to MIPS reporting 
requirements and payment adjustments (unless they are otherwise 
excluded). The eligible clinicians in a MIPS APM that is an Advanced 
APM are also considered MIPS eligible clinicians unless they meet the 
threshold to be a QP for a year. In any MIPS APM, whether or not it is 
also an Advanced APM, eligible clinicians may already be required to 
report on the quality, cost and other measures on which their 
performance is assessed as part of their participation in the APM, 
leading to potentially duplicative or conflicting reporting under MIPS. 
Additionally, eligible clinicians in these MIPS APMs already have 
payment incentives tied to performance on quality and cost/utilization 
measures, creating the potential for conflicting assessments based on 
the same or similar data. Although other APMs may have similar 
reporting requirements to the MIPS APMs such that there is some level 
of duplicative reporting, unless an APM includes performance metrics 
tied to payment incentives in the APM, we do not believe there is the 
same potential for duplication and conflict. We continue to believe 
that eligible clinicians in APMs that meet all three of the criteria to 
be MIPS APMs would face a substantial level of duplication and/or 
conflict between reporting and assessment under the APM and the 
generally applicable MIPS standard. In addition, the participants in 
other APMs may not be subject to MIPS at all because the participants 
are not MIPS eligible clinicians. To the extent that eligible 
clinicians do participate in APMs that are not MIPS APMs, we believe 
they would often be in a position to consider group reporting options 
under MIPS.
    Comment: A few commenters suggested CMS simplify MIPS reporting and 
scoring by requiring no additional reporting requirements for any MIPS 
eligible clinicians in MIPS APMs to receive a MIPS final score. One 
commenter stated the APM Scoring Standard does not go far enough to 
reduce reporting burden because APM participants will still be required 
to report improvement activities and advancing care information.
    Response: We believe the proposed policy included meaningful 
reductions in reporting burden for MIPS APM participants. The 
additional policies we are finalizing in this rule (such as assigning a 
MIPS APM improvement activities score) will reduce this burden further. 
However, we do not believe it would be feasible to fully eliminate 
reporting requirements for MIPS APM participants while adhering to the 
core goals and structure of MIPS.
    Comment: A few commenters stated it is untenable to require 
physician groups to simultaneously pursue quality metrics, reduce 
costs, and build the infrastructure required to participate in APMs and 
MIPS. A few commenters indicated that the APM scoring standard may 
undermine the intent of the statute to have eligible clinicians join 
APMs by not providing sufficient reductions in burden under MIPS. 
Another commenter recommended that the third MIPS APM criterion be 
changed to ``the APM bases payment incentives on performance on cost/
utilization and/or quality measures'' instead of requiring that the APM 
base payment incentives on both cost/utilization and quality measures. 
Several commenters recommended that CMS make QP determinations early 
enough so that eligible clinicians participating in Advanced APMs would 
know in advance of the MIPS submission period whether they are QPs for 
the year and, as such would not have to report to MIPS at all. One 
commenter did not support implementation of the APM scoring standard 
because the commenter stated that the proposal was confusing and may 
incentivize physicians to remain in the FFS program rather than 
progress towards APMs.
    Response: We recognize that MIPS APM participants are diligently 
working to provide high quality, cost-effective care to their patients. 
We also recognize the burden of reporting to more than one CMS program. 
We proposed to adopt the APM scoring standard with the intent of 
reducing the reporting burden for eligible clinicians and alleviating 
duplicative and/or conflicting payment methodologies that could 
potentially distract eligible clinicians from the goals and objectives 
they agreed to as an APM participant, or provide incentives that 
conflict with those under the APM. We also acknowledge that some 
stakeholders may find the APM scoring standard requirements confusing, 
and we will continue to consider ways to further simplify the APM 
scoring standard in future rulemaking. We believe much of this 
confusion will be resolved through continued discussions with all of 
our stakeholders, participants, and patients, through CMS's planned 
technical assistance and education and outreach activities for the 
Quality Payment Program, and through experience with this new program 
in the first performance year. We also note that the finalized QP 
Performance Period, described in section II.F.5. of this final rule 
with comment period, modifies the proposed QP determination timeframe 
so that eligible clinicians who are QPs for a year will not need to 
report MIPS data. However, an eligible clinician that is in an Advanced 
APM but does not meet the QP threshold will still be subject to MIPS. 
Furthermore, eligible clinicians who are participants in a MIPS APM 
that is not an Advanced APM cannot be QPs and thus will be

[[Page 77248]]

subject to MIPS under the APM scoring standard.
    Comment: A commenter recommended that CMS not reward low-value 
care. The commenter indicated that by reducing the cost performance 
category to zero and reducing the weight for the quality performance 
category to zero for MIPS APMs other than the Shared Savings Program 
and Next Generation ACO Model, CMS may allow such MIPS APMs to perform 
poorly on measures of efficiency and quality at the expense of other 
clinicians who are truly delivering high-value care. The commenter 
suggested that CMS either measure all MIPS eligible clinicians in the 
same way, or allow MIPS APM participants to elect a neutral score for 
the quality and cost MIPS performance categories.
    Response: We do not believe the APM scoring standard rewards low-
value care, but rather that it provides MIPS eligible clinicians in 
MIPS APMs a way to meet the requirements of the MIPS while focusing on 
the goals of the APM to improve quality and lower the cost of care. The 
terms and conditions of MIPS APMs themselves hold participants 
accountable for the cost and quality of care. In accordance with the 
statute, only Partial QPs have the option whether to report and be 
subject to a MIPS payment adjustment for a year, as described in 
section II.F.5. of this final rule with comment period. All MIPS 
eligible clinicians, including those subject to the APM scoring 
standard, will continue to receive final scores and MIPS payment 
adjustments.
    Comment: A commenter indicated the creation of the APM scoring 
standard provides a large advantage to MIPS APM participants, 
disadvantaging other MIPS eligible clinicians.
    Response: We acknowledge that eligible clinicians in MIPS APMs may 
achieve high scores in some MIPS performance categories. In some 
categories such as improvement activities, the statute encourages and 
credits participation in an APM. In others, MIPS eligible clinicians 
may perform well because of the requirements they meet by virtue of 
participating in MIPS APMs. However, we believe all MIPS eligible 
clinicians have the opportunity to score highly, and as such we do not 
believe the APM scoring standard will necessarily disadvantage other 
MIPS eligible clinicians. We believe MIPS eligible clinicians under the 
APM scoring standard have the potential to receive high MIPS payment 
adjustments because they successfully perform the requisite activities, 
not simply because they participate in an APM.
    Comment: One commenter recommended CMS ensure that the APM scoring 
standard actually reduces administrative burden in order to allow MIPS 
APM participants to focus on APM efforts.
    Response: We believe this final rule with comment period addresses 
many of the concerns expressed by commenters about the MIPS reporting 
burden for MIPS APM participants and we will continue to work to 
identify ways to ensure APMs and their participants can focus their 
efforts to achieve the care transformation goals of the APM.
    Comment: Several commenters expressed support for the APM scoring 
standard as proposed and applauded CMS for its efforts to reduce 
reporting burden and allow MIPS APM participants to focus on the aims 
of those APMs without misaligning incentives or having redundant or 
conflicting requirements across programs. One commenter stated they 
supported the proposed APM scoring standard, but thought CMS should 
offer sufficient education and outreach to clinicians so they 
understand it, as it adds complexity to the program. Two commenters 
requested that CMS develop a flexible scoring methodology for MIPS APMs 
that would recognize the significant investments to transform 
healthcare made by APM participants. One commenter requested that the 
APM scoring standard incorporate all MIPS eligible clinicians in large 
multispecialty groups that may have some but not all MIPS eligible 
clinicians participating in MIPS APMs. Another commenter recommended 
that the APM scoring standard be retained in the future, allowing APM 
decisions to be made with clarity, while another commenter supported 
the APM scoring standard generally but thought it should be optional.
    Response: We appreciate the general support for the proposed APM 
scoring standard. We will continue to consider future refinements to 
the APM scoring standard to ensure we are supporting eligible 
clinicians in their efforts to transform health care and participate in 
new payment and care delivery models. Although we understand that some 
organizations may have some members of their practices in APMs and 
others not in APMs, we do not believe that the APM scoring standards 
should apply more broadly than the identified group of actual 
participants in MIPS APMs, that is, the eligible clinicians included on 
an APM Entity's Participation List.
    Comment: A few commenters disagreed with our statements in the 
proposed rule suggesting that APMs focused on hospitals do not have any 
MIPS eligible clinicians as participants, stating that surgeons will be 
involved in hip and knee replacements under CJR and CJR quality 
performance measures should count for them for purposes of MIPS. 
Another commenter stated that the MIPS APM criteria should be broader 
to include the BPCI Initiative, CJR, and other episode payment models. 
A few commenters stated that such APMs have been successful at reducing 
costs and improving quality and that not including them as MIPS APMs 
discourages clinicians from participation. A few commenters suggested 
that CMS should amend facility-based APMs to require Participation 
Lists. One commenter suggested that the APM scoring standard 
requirement that a MIPS APM must require APM Entities to include at 
least one eligible clinician on a Participation List should be delayed 
until more MIPS APMs are available. A few commenters suggested the 
criteria for a MIPS APM be expanded to include other APMs such as those 
APMs that have an agreement with another payer outside the Medicare 
program or those that have a CMS agreement to participate in an APM 
through another entity such as a convener. One commenter expressed 
concern that by not including all APMs as MIPS APMs some APM 
participants will be forced to report twice on quality.
    Response: An APM that is hospital-based may be a MIPS APM if it 
meets all of the MIPS APM criteria, including the criterion that the 
APM must require APM Entities to include at least one MIPS eligible 
clinician on a Participation List. If this criterion is not met, the 
APM is not a MIPS APM and the APM scoring standard does not apply.
    Particularly relevant to facility- or hospital-based APMs (because 
some do not require APM Entities to maintain Participation Lists), any 
MIPS eligible clinicians that do not qualify as QPs or Partial QPs, and 
are not included on a Participation List of an APM Entity that 
participates in the MIPS APM, would report to MIPS and be scored 
according to the generally applicable MIPS requirements for an 
individual or group. The APM scoring standard is intended to ensure 
that the MIPS eligible clinicians that are directly and collectively 
accountable for beneficiary attribution and quality and cost/
utilization performance under the MIPS APM are able to focus their 
efforts on the care transformation objectives of the APM rather than on 
potentially duplicative reporting of measures. We note that the MIPS 
eligible clinicians that are subject to the APM scoring

[[Page 77249]]

standard are not necessarily the same as the eligible clinicians who 
could become QPs via participation in Advanced APMs, as described in 
section II.F.5. of this final rule with comment period. For instance, 
in certain circumstances, Affiliated Practitioners could become QPs, 
but because the Advanced APM does not base payment incentives for these 
eligible clinicians (either at the APM Entity or the eligible clinician 
level) on their performance on cost/utilization and quality measures we 
do not consider the APM requirements to be sufficiently related to MIPS 
reporting requirements such that the APM scoring standard should be 
applied. In other words, the QP determination for the APM incentive and 
the MIPS performance categories measure different aspects of 
performance that align differently with the roles of affiliated 
practitioners. The QP determination depends on the level of payments or 
patients furnished services through an Advanced APM. In contrast, MIPS 
payment adjustments depend on an assessment of performance on cost and 
quality in four categories. Whereas affiliated practitioners may 
furnish services through an Advanced APM, contributing to collective 
achievement under the APM, the QP threshold, in and of itself, does not 
assess or directly incentivize their performance based on cost and 
quality. Therefore, we do not believe there is the same potential for 
overlapping requirements under MIPS and APMs for such MIPS eligible 
clinicians. Under certain Advanced APMs such as CJR, Affiliated 
Practitioners may be the primary eligible clinicians receiving payment 
through the Advanced APM, but cost and quality measurement and 
reporting under the Advanced APM are the responsibility of 
participating hospitals rather than eligible clinicians. As such, there 
is minimal potential for overlap between requirements under MIPS and 
the APM for these MIPS eligible clinicians.
    We agree with commenters that we should continue to consider 
whether there are opportunities for additional APMs, including existing 
episode payment models, to become MIPS APMs. As we work toward that 
goal we believe we should move forward with the policy to avoid 
potentially duplicative or conflicting reporting or incentives for MIPS 
eligible clinicians participating in APMs that currently meet the MIPS 
APM criteria. In the future, we may consider amending existing APMs to 
meet MIPS APM criteria. However, as stated in the previous response, we 
do not believe that application of the APM scoring standard should be 
expanded to include MIPS eligible clinicians such as Affiliated 
Practitioners whose roles are not directly linked to quality and cost/
utilization measures under the APM, or that the MIPS APM criteria 
should be expanded to include APMs that do not tie payment incentives 
to performance on quality and cost/utilization measures or APMs (such 
as CJR) that do not require APM Entities to have at least one eligible 
clinician on a Participation List. In these instances, we do not 
believe the requirements of the APM are sufficiently connected to MIPS 
reporting requirements and scoring such that there is significant 
potential for duplicative reporting or conflicting incentives between 
the APM and MIPS, the avoidance of which is the underlying purpose of 
the APM scoring standard.
    Comment: Two commenters requested that CMS clarify that the MIPS 
APM payment adjustments resulting from the MIPS APM scoring standard 
will not be included in the Shared Savings Program and Next Generation 
ACO Model expenditures for benchmark calculations.
    Response: MIPS payment adjustments resulting from the APM scoring 
standard are the same as MIPS adjustments for all other MIPS eligible 
clinicians. There are no unique ``MIPS APM payment adjustments.'' 
Rather, the APM scoring standard is only a particular scoring 
methodology for deriving a final score that results in a MIPS payment 
adjustment for an eligible clinician. Each APM has its own benchmarking 
methodology--benchmarking is not necessarily standard across APMs. 
Making a single determination with respect to the use of MIPS payment 
adjustments in APM benchmarking is outside the scope of this final rule 
with comment period.
    Comment: One commenter suggested that CMS create an ``Other Payer 
MIPS APM'' category.
    Response: We appreciate the idea of allowing MIPS scoring to be 
affected by participation in certain payment arrangements with other 
payers and we may consider the feasibility of doing so in the future in 
concert with the introduction of the All-Payer Combination Option.
    After considering these comments, we are finalizing the criteria 
for an APM to be a MIPS APM as proposed with one modification to the 
first criterion in order to encompass APMs with terms defined through 
law or regulation. MIPS APMs are APMs that meet the following criteria: 
(1) APM Entities participate in the APM under an agreement with CMS or 
by law or regulation; (2) the APM requires that APM Entities include at 
least one MIPS eligible clinician 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.
    Below we describe in detail how MIPS APM participants will be 
identified from an APM Participation List to be included in the APM 
Entity group under the APM scoring standard.
    We are also finalizing the proposal that the APM scoring standard 
does not apply to MIPS eligible clinicians who are not on a 
Participation List for an APM Entity group in a MIPS APM. MIPS eligible 
clinicians who are not part of the APM Entity group to which the APM 
scoring standard applies may choose to report to MIPS as individuals or 
groups according to the generally applicable MIPS rules.
(2) APM Scoring Standard Performance Period
    We proposed 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 
the proposed rule. We proposed 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 the proposed rule) except 
in the case of 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 us 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). We might not have continuing resources 
dedicated or available to continue to support the MIPS APM activities 
under the APM scoring standard if the MIPS

[[Page 77250]]

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 proposed that the 
eligible clinicians in the MIPS APM would be made aware of this 
decision in advance of the relevant MIPS performance period.
    The following is a summary of the comments we received regarding 
our proposal that the APM scoring standard performance period will be 
same as the MIPS performance period.
    Comment: A few commenters recommended CMS maintain consistency 
between the reporting period for MIPS and MIPS APMs to reduce 
administrative burden, and a commenter supported the same 12-month 
performance period for use by MIPS and APMs. One commenter requested a 
90-day reporting period for 2017.
    Response: We agree with the commenters that aligning the 
performance periods reduces administrative burden. We will maintain the 
12-month performance period for the APM scoring standard, but data 
submitted for the advancing care information and, if necessary, 
improvement activities performance categories will follow the generally 
applicable MIPS data submission requirements regarding the number of 
measures and activities required to be reported during the performance 
period in order to receive a score for these performance categories. 
The quality performance category data for MIPS APMs will be submitted 
in accordance with the specific reporting requirements of the APM, 
which for most MIPS APMs covers the same 12-month performance period 
that will be used for the APM scoring standard.
    Comment: Two commenters requested CMS provide guidance for eligible 
clinicians in a MIPS APM that closes before the end of the performance 
period.
    Response: We will post the list of MIPS APMs prior to the first day 
of the MIPS performance period for each year. If the APM would have 
qualified as a MIPS APM but the APM is ending before the end of the 
performance period, then the APM will not appear on this list. We will 
notify participants in any such APMs in advance of the start of the 
performance period if they will need to report to MIPS using the MIPS 
individual or group reporting option.
    We are finalizing the APM scoring standard performance period to 
align with the 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 
will allow APM Entities and their participating eligible clinicians to 
focus on the goals and objectives of the MIPS APM to improve quality 
and lower costs of care while avoiding potentially conflicting 
incentives and duplicative reporting that could occur as a result of 
having to submit separate or additional data to MIPS. The APM scoring 
standard we proposed is similar to group assessment under MIPS as 
described in section II.E.3.d. of the 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 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 
proposed for the APM scoring standard that we would generate a MIPS 
final score 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. As we explained in the proposed rule, 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 a MIPS 
APM and collectively focus on care transformation activities to improve 
the quality of care.
    Further, depending on the type of MIPS APM, we proposed that 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 proposed that under the APM scoring 
standard, the weight for the cost performance category will be zero and 
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 
cost performance categories to the improvement activities and advancing 
care information performance categories to maintain a total weight of 
100 percent.
    To implement certain elements of the APM scoring standard, we 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. For each section in which we 
proposed scoring methodologies and waivers to enable the proposed 
approaches, we described 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 FFS payment and 
to test new ways of measuring and assessing performance. If the data 
submission requirements and associated adjustments under MIPS are not 
aligned with APM-specific goals and incentives, the participants 
receive conflicting messages from us 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 explained our belief that, for the reasons stated in section 
II.E.5.h. of the proposed rule certain waivers are necessary for 
testing and operating

[[Page 77251]]

APMs and for maintaining the integrity of our evaluation of those APMs.
    In the proposed rule we noted that for at least the first 
performance year, we do not anticipate that any APMs other than those 
under sections 1115A or 1899 of the Act would meet the criteria to be 
MIPS APMs. In the event that we do anticipate other types of APMs 
(demonstrations under section 1866C of the Act or required by federal 
law) will become MIPS APMs for a future year, we will address MIPS 
scoring for eligible clinicians in those APMs in future rulemaking.
    The following is a summary of the comments we received regarding 
our proposals 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 to implement the APM Scoring Standard for MIPS APMs and to 
apply the MIPS final score at the APM Entity level.
    Comment: A few commenters expressed support for CMS' use of waiver 
authorities to establish the APM scoring standard. Several commenters 
also supported the proposal to calculate the final score at the APM 
Entity level. One commenter supported averaging scores for all 
clinicians in a MIPS APM Entity for purposes of the MIPS payment 
adjustment. A few commenters had concerns about aggregating all data 
for the clinicians linked to an APM Entity, and one commenter 
recommended that the APM scoring standard be optional.
    Response: We continue to believe the final score derived at the APM 
Entity level should be the score used for purposes of determining the 
MIPS payment adjustment for each MIPS eligible clinician in that APM 
Entity group. As part of their participation in any MIPS APM, eligible 
clinicians should be working collaboratively and advancing shared care 
goals for aligned patients. We believe this collaboration toward shared 
goals under the MIPS APM differentiates these MIPS eligible clinicians 
from those in a MIPS group defined by a billing TIN, and supports our 
proposal to score these clinicians as a group.
    The APM Entity final score is derived by aggregating the scores for 
each of the performance categories as applicable. For example, if the 
CPC+ model is determined to be a MIPS APM, participating MIPS eligible 
clinicians in CPC+ will not be evaluated in the cost and quality 
performance categories, which will have a zero weight for the first 
performance year. In this example, the final score will be calculated 
for MIPS eligible clinicians at the APM Entity level by adding the 
weighted advancing care information score and the assigned improvement 
activities score for the MIPS APM (see below for the final policies on 
the scoring for these performance categories). This same final score 
calculated at the APM Entity level will be applied to each MIPS 
eligible clinician TIN/NPI combination in the APM Entity as identified 
on the APM Entity's Participation List.
    Comment: A commenter requested clarification on how reporting will 
be accomplished with groups where MIPS eligible clinicians participate 
in multiple APMs, especially multiple Advanced APMs.
    Response: As finalized in section II.E.6. of this final rule with 
comment period, if a single TIN/NPI combination for a MIPS eligible 
clinician is in two or more MIPS APMs, we will use the highest final 
score to determine the MIPS payment adjustment for that MIPS eligible 
clinician. MIPS adjustments apply to the TIN/NPI combination, so to the 
extent that a MIPS eligible clinician (NPI) participates in multiple 
MIPS APMs with different TINs, each of those TIN/NPI combinations would 
be assessed separately under each respective APM Entity.
    We are finalizing the proposal to use the Shared Savings Program 
and CMS Innovation Center authorities under sections 1899 and 1115A of 
the Act, respectively, to waive specific statutory requirements related 
to MIPS reporting and scoring in order to implement the APM scoring 
standard. We note that although we proposed to use our authority under 
section 1899(f) of the Act to waive these statutory requirements in 
order to implement the APM scoring standard for MIPS eligible 
clinicians participating in Shared Savings Program ACOs, we believe we 
could also use our authority under section 1899(b)(3)(D) of the Act to 
accomplish this result. Section 1899(b)(3)(D) of the Act allows us to 
incorporate reporting requirements under section 1848 of the Act into 
the reporting requirements for the Shared Savings Program, as we 
determine appropriate, and to use alternative criteria than would 
otherwise apply. Thus, we believe that section 1899(b)(3)(D) of the Act 
also provides authority to apply the APM scoring standard for MIPS 
eligible clinicians participating in a Shared Savings Program ACO 
rather than requiring these MIPS eligible clinicians to report 
individually or as a group using one of the MIPS data submission 
mechanisms.
    We are also finalizing our proposal to score MIPS eligible 
clinicians in the MIPS APM at the APM Entity level. The final score 
calculated at the APM Entity level will be applied to each MIPS 
eligible clinician in the APM Entity group.
(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 
proposed to establish and maintain an APM participant database that 
would 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 proposed that each APM Entity be identified 
in the MIPS program by a unique APM Entity identifier, and we also 
proposed that the unique APM participant identifier for a MIPS eligible 
clinician would be a combination of four identifiers including: (1) APM 
identifier established by CMS (for example, AA); (2) APM Entity 
identifier established by CMS (for example, A1234); (3) the eligible 
clinician's billing TIN (for example, 123456789); and (4) NPI (for 
example, 1111111111). The use of the APM participant identifier will 
allow us to identify all MIPS eligible clinicians participating in an 
APM Entity, including instances in which the MIPS eligible clinicians 
use a billing TIN that is shared with MIPS eligible clinicians who are 
not participating in the APM Entity. In the proposed rule, we stated 
that 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). Under 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

[[Page 77252]]

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 proposed that 
only those MIPS eligible clinicians who are on the Participation List 
for the APM Entity in a MIPS APM on December 31 (the last day of the 
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 MIPS performance categories. For 
example, under the proposal, 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 an individual MIPS eligible clinician or as part of a group. This 
approach for defining the applicable group of MIPS eligible clinicians 
was consistent with our proposal for identifying eligible clinician 
groups for purposes of QP determinations outlined in section II.F.5.b. 
of the proposed rule; the group of eligible clinicians we use 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.
    The following is a summary of the comments we received regarding 
our proposals to establish an APM participant identifier, a CMS 
database to identify and track the APM participants, and the dates that 
we will use to determine if an MIPS APM eligible clinician will be 
included in the MIPS APM for purposes of MIPS reporting under the APM 
scoring standard.
    Comment: A commenter suggested CMS use the current CMS enrollment 
infrastructure such as PECOS to identity and track APM participants to 
provide an incentive for eligible clinicians to update their Medicare 
enrollment information, which in turn would provide CMS with more 
accurate data on the MIPS eligible clinicians that are in a MIPS APM.
    Response: We will be using existing systems to the extent feasible 
to ensure we have accurate data on MIPS eligible clinicians and APM 
participants. Depending on the results of our assessment of available 
data and systems, we may or may not include any particular system, such 
as PECOS.
    Comment: A number of commenters supported the use of an APM 
participant identifier that includes the TIN and NPI for the MIPS APM 
eligible clinicians and urged collaboration with vendors to build a 
useful infrastructure. One commenter thought CMS should simplify this 
APM participant identifier. Two commenters encouraged CMS to make the 
APM participant identifiers available to stakeholders in real time via 
an Application Program Interface (API). One commenter indicated the APM 
participant identifier would add administrative complexity. Another 
commenter encouraged CMS to make sure there is a consistent approach to 
identifying both APM and MIPS participants.
    Response: We believe the use of the APM participant identifier will 
ensure we use accurate information regarding MIPS eligible clinicians 
and their participation in APMs, and we believe that this will reduce 
administrative complexity by reducing ambiguity. We appreciate the 
suggestion to make the APM participant identifier available via an API, 
and we are exploring a variety of methods to communicate this 
information.
    Comment: A few commenters were opposed to the December 31 date for 
determining if the APM Entity participant would be included in the MIPS 
APM for purposes of the APM scoring standard. A commenter did not 
support this proposal because MIPS eligible clinicians could be 
excluded if they were participating throughout the year but not on 
December 31st. One commenter suggested that the eligible clinician 
should be included in the group if they were in the MIPS APM for more 
than half of the performance period and another commenter suggested 
they be considered as participating in the group if they were in the 
MIPS APM for 90 days. Yet another commenter stated that CMS's proposed 
policy for determining who participates in a given APM does not 
sufficiently respond to the often complex billing relationships 
clinicians maintain across TINs, and that these complex billing 
relationships are especially true for academic medical center 
clinicians who often relocate due to changes in employment based on the 
academic year. The commenter suggested having a more flexible list of 
dates for updating the list of MIPS eligible clinicians participating 
in a MIPS APM (and therefore subject to the APM scoring standard) or 
looking at claims rather than Participation Lists.
    Response: We agree with the commenters that only using the December 
31 date to determine whether an eligible clinician is a MIPS APM 
participant could potentially impact a clinician's decision on whether 
or when to leave a MIPS APM and their ability to report to MIPS if they 
leave the MIPS APM prior to the end of the performance period. We also 
recognize that an eligible clinician who participates in a MIPS APM in 
the first 6 months of the performance period and then leaves the MIPS 
APM may have difficulty reporting to MIPS independent of the APM 
Entity. If the MIPS eligible clinician leaves the MIPS APM and joins a 
group or another APM that is not a MIPS APM, the individual would 
likely be included in the new group's MIPS reporting. But if the MIPS 
eligible clinician does not join another group, then they would need to 
report to MIPS as an individual. In such a case, the MIPS eligible 
clinician may not be able to meet one or more of the MIPS performance 
category reporting requirements. For example, a MIPS eligible clinician 
who used CEHRT in an APM Entity through July of a performance period 
may not have the CEHRT available to report the advancing care 
information performance category as an individual MIPS eligible 
clinician during the MIPS submission period. We are revising the points 
in time at which we will assess whether a MIPS eligible clinician is on 
a Participation List for purposes of the APM scoring standard. We will 
review the Participation Lists for MIPS APMs on March 31, June 30, and 
August 31. A MIPS eligible clinician on the Participation List for an 
APM Entity in a MIPS APM on at least one of these three dates will be 
included in the APM Entity group for the purpose of the APM scoring 
standard. For example, if the Oncology Care Model (OCM) is determined 
to be a MIPS APM, a MIPS eligible clinician who is identified on the 
Participation List of an APM Entity participating in OCM from January 1 
through April 25 of the performance year would be included in the APM 
Entity group for purposes of the APM

[[Page 77253]]

scoring standard for that performance year.
    Comment: A commenter requested clarification on whether a MIPS 
eligible clinician who participates in a MIPS APM for part of the year 
but leaves prior to the end of the performance period is allowed to 
submit a partial year of MIPS data for the time they were not in the 
MIPS APM.
    Response: As discussed in section II.F.5. of this final rule with 
comment period, we are adopting a modified version of the proposed 
policy for defining the APM Entity group, which will be applicable to 
both QP determinations and the APM scoring standard. Under the final 
policy, if a MIPS eligible clinician is on the APM Participation List 
on at least one of the APM participation assessment (Participation List 
``snapshot'') dates, the MIPS eligible clinician will be included in 
the APM Entity group for purposes of the APM scoring standard for the 
applicable performance year. If the MIPS eligible clinician is not on 
the APM Entity's Participation List on at least one of the snapshots 
dates (March 31, June 30, or August 31), then the MIPS eligible 
clinician will need to submit data to MIPS using the MIPS individual or 
group reporting option and adhere to all generally applicable MIPS data 
submission requirements to avoid a negative payment adjustment. 
Therefore, if the applicable data submission requirements include full-
year reporting, the MIPS individual or group would need to report for 
the full year.
    Comment: A commenter recommended that CMS: (1) Allow ACOs to report 
quality data and other information for MIPS on behalf of participating 
clinicians who join an ACO mid-performance year but are not included on 
the ACO Participation List until the following year, and (2) hold 
harmless from negative MIPS payment adjustments those clinicians who 
join the ACO mid-performance year but are not included on the ACO 
Participation List until the following year. Another commenter 
requested that MIPS APM participants who leave prior to the end of the 
performance period be exempt from MIPS reporting because this may 
hinder employment mobility. Some commenters suggested CMS indemnify 
clinicians who joined an ACO mid-year from any negative MIPS payment 
adjustments because the commenters believe these clinicians should not 
be penalized for the hard work they put into the APM during the year 
solely because they joined the APM Entity after the start of the 
performance year.
    Response: Each APM has specific rules as to when participants can 
be added or removed from Participation Lists. If the MIPS eligible 
clinician is on the MIPS APM Participation List on at least one of the 
three snapshot dates (March 31, June 30, or August 31), then the MIPS 
eligible clinician will be included in the APM Entity group and scored 
according to the APM scoring standard for purposes of MIPS for that 
performance year. Once an eligible clinician is determined to be part 
of the APM Entity group in a MIPS APM at one of the snapshot dates, the 
eligible clinician will be part of the group for purposes of MIPS and 
the APM scoring standard for that performance period even if they leave 
the APM Entity at a later date.
    Comment: A commenter requested clarification about whether the APM 
Entities will submit new Participation Lists for the purpose of MIPS or 
if CMS will use Participation Lists submitted for the MIPS APM. One 
commenter indicated it may be easier if the APM Entity provides CMS 
with the list of MIPS APM participants. Another commenter suggested 
that instead of using a Participation List CMS should design other 
approaches to discern which eligible clinicians are in an APM Entity.
    Response: We will use the Participation Lists that the APM Entity 
provides to us in accordance with the particular MIPS APM's rules. Each 
APM has particular rules for how the Participation Lists may be updated 
during a performance year to reflect the APM Entities and their 
participating eligible clinicians, as identified by their TIN/NPI 
combinations. We will maintain these Participation Lists for each APM 
in a dedicated database, and we will use the same Participation Lists 
for operational purposes within the APM, for QP determinations, and to 
determine which MIPS eligible clinicians are in the APM Entity group 
for purposes of the APM scoring standard. Therefore, APM Entities such 
as ACOs would not be required to submit any additional Participant 
Lists for purposes of the Quality Payment Program.
    Comment: A commenter requested CMS provide clear guidance as to how 
each eligible clinician would be scored if they are a QP in a MIPS APM 
so they can make informed decisions regarding APM participation.
    Response: An eligible clinician who becomes a QP is exempt from 
MIPS reporting requirements and the payment adjustment for the 
applicable payment year. For example, if the eligible clinician is 
determined to be a QP for the 2019 payment year based on 2017 
performance, then the clinician is exempt from a MIPS payment 
adjustment in 2019 and does not need to report data to MIPS data for 
the 2017 performance period.
    We are finalizing the use of the proposed APM participant 
identifier to define the APM Entity group that is participating in a 
MIPS APM. The APM Participation List information will be stored in a 
database so that, among other uses, we can identify and include the 
appropriate MIPS eligible clinicians in an APM Entity group to which 
the APM scoring standard applies. We are revising our proposal to use 
December 31 as the date on which an eligible clinician must appear on 
the Participation List to be included in the APM Entity group for a 
MIPS APM. Instead of identifying MIPS eligible clinicians participating 
in a MIPS APM at a single point in time on December 31 of the 
performance year, we will review the MIPS APM Participation Lists on 
March 31, June 30 and August 31. All eligible clinicians who appear on 
an APM Entity's list for a MIPS APM on at least one of those three 
dates will be included in the APM Entity group for purposes of the APM 
scoring standard for the year. We describe the determination of the APM 
Entity group in full detail in section II.F.5. of this final rule with 
comment period.
(5) 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) 
cost; (3) improvement activities; and (4) advancing care information. 
We proposed at Sec.  414.1370 to calculate one final score 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 the proposed rule, and we would calculate one final score for the 
APM Entity 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 to each MIPS eligible 
clinician in the group. Thus, the final score for the APM Entity group 
and the participating MIPS eligible clinician score are the same. For

[[Page 77254]]

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 final score that would be applied to each of its participating 
MIPS eligible clinicians. Similarly, in the OCM, the MIPS eligible 
clinicians identified on an APM Entity's Participation List would 
comprise an APM Entity group. That group would receive a single final 
score that would be applied to each of the MIPS eligible clinicians in 
the group. We note that this APM Entity group final score 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 using the 
final score for purposes of evaluation within the APM. Rather, the APM 
Entity group final score would be used only for the purposes of the APM 
scoring standard under MIPS. It should be noted that although we 
proposed that the APM scoring standard would only apply 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 earn a minimum score of 50 percent of the 
highest potential improvement activities performance category score as 
long as such MIPS eligible clinicians are on a list of participants for 
an APM and are identifiable by the APM participant identifier.
    We explained in the proposed rule that 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 FFS system based on independent clinician 
activity.
    We proposed, 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 
proposed criteria for a MIPS APM. In the proposed rule, we described 
the APM Entity data submission requirements and proposed 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).
    The following is a summary of the comments we received regarding 
our proposal to calculate one final score per APM Entity group in a 
MIPS APM, and to apply that final score to each MIPS eligible clinician 
(identified by the billing TIN/NPI combination) in the APM Entity group 
and our proposal to give one-half of the maximum improvement activities 
score to any MIPS eligible clinicians who are on a list of participants 
and identified by the APM participant identifier, regardless of whether 
they participate in an Advanced APM, MIPS APM, or other APM.
    Comment: A number of commenters supported our proposal. Another 
commenter was concerned that in a group, poor performance by some 
eligible clinicians may affect the final score for other eligible 
clinicians who perform better. A commenter suggested that CMS allow APM 
participants to receive the MIPS score that is the higher of the APM 
Entity group score and the group TIN score.
    Response: As previously discussed, we are finalizing MIPS APM 
scoring at the APM Entity level, and the final score will be applied to 
each TIN/NPI combination in the APM Entity group. In any group 
reporting structure, the resulting final score reflects the collective 
performance of the group. Unless all APM Entity group members score 
exactly equally, some will receive higher or lower final scores than 
they would have achieved individually. We believe that, although some 
group members' lower final scores may offset the final score for higher 
performers in the APM Entity, the APM Entity level score appropriately 
reflects the aggregate performance of the eligible clinicians in the 
APM Entity. APMs are premised on a group of MIPS eligible clinicians 
working together to collectively achieve the goals of the APM, and 
providing different MIPS payment adjustments within an APM Entity is 
not consistent with those goals.
    Under specific circumstances, described below, in which a Shared 
Savings Program ACO fails to report quality under the Shared Savings 
Program requirements, participant TINs of such ACOs would be considered 
the APM Entity groups for purposes of the APM scoring standard. Even 
under this exception, those TIN groups would still be scored as a 
cohesive unit, with no individual final score variation within the TIN.
    Comment: A commenter supported allowing participants in other APMs, 
such as the Accountable Health Communities Model, to receive 
improvement activities credit. A few commenters requested that CMS 
clarify how eligible clinicians and groups participating in APMs that 
are not MIPS APMs would receive credit for APM participation in the 
improvement activities category.
    Response: MIPS eligible clinicians that participate in an APM that 
is not a MIPS APM will need to be identified by their APM participant 
identifier on a CMS-maintained list during the MIPS performance year in 
order to receive one-half of the maximum improvement activities score 
for APM participation. This list may be a Participation List, an 
Affiliated Practitioner List, or another CMS-maintained list, as 
applicable. Such CMS-maintained lists define APM participation; 
therefore, MIPS eligible clinicians are not considered to be 
participating in an APM unless included on a CMS-maintained list. We 
will notify APM Entities in advance of the first day of the performance 
period if the APM utilizes such a list. If the specific APM does 
utilize such a list, then the MIPS eligible clinicians will be eligible 
for the improvement activities credit.
    Comment: A commenter requested that CMS clarify in the final rule 
with comment period that a rheumatologist participating in other APMs 
not listed as an Advanced or MIPS APM in this rule would receive one-
half of the maximum improvement activities score for such 
participation.
    Response: As stated above, an eligible clinician that participates 
in an APM, even one that is not an Advanced APM or MIPS APM, would 
still receive one-half the maximum score for improvement activities 
through APM participation. CMS defines participation in APMs by 
presence on a CMS-maintained list associated with an APM. Therefore, we 
will use those lists to validate the APM participation improvement 
activities credit.
    Comment: A number of commenters supported scoring MIPS eligible 
clinicians at the APM Entity level, and other commenters supported 
scoring MIPS eligible clinicians at the TIN level. A commenter stated 
that evaluating APM Entities, such as ACOs, at the APM Entity level 
reinforces the APM Entity purpose and avoids fractures within the APM 
Entity. Another commenter recommended CMS have all ACOs scored at the 
APM Entity level for the advancing care information performance 
category to recognize that the health information technology work in 
most APMs is best measured as a whole. A few commenters requested that 
the APM participants have a choice as to being scored at the APM Entity 
level or participant TIN level. A

[[Page 77255]]

commenter further suggested that scoring at the APM Entity level 
instead of the participant TIN level overstates the relationship 
between these clinicians. One commenter stated that the policies in 
which the primary TIN for an ACO reports the primary-care focused CMS 
Web Interface measures result in a double standard whereby specialists 
in ACOs are not held to the same individual level of accountability as 
those in small group or solo practices where reporting is done at the 
individual clinician level.
    Response: We believe that APM Entities should be scored at the APM 
Entity level because the APM Entity is a group of eligible clinicians 
focused on achieving the collective goals of the APM, which include 
shared responsibility for cost and quality. That stated, we 
specifically recognize that there may be rare instances in which an ACO 
in the Shared Savings Program may fail to report quality as required by 
the Shared Savings Program, which would adversely impact the MIPS final 
score of all MIPS eligible clinicians billing under ACO participant 
TINs. Accordingly, in the event that a Shared Savings Program ACO does 
not report quality measures as required by the Shared Savings Program, 
scoring under the APM scoring standard would be calculated at the ACO 
participant TIN level for MIPS eligible clinicians in that ACO, and 
each of the ACO participant TINs would receive its own TIN-level final 
score instead of an APM Entity-level final score. We note, however, 
that our final policy would not cancel or mitigate any of the negative 
consequences associated with non-reporting on quality as required under 
the Shared Savings Program, including ineligibility for shared savings 
payments and/or potential termination of the ACO from the program.
    We are finalizing our proposal to calculate one final score at the 
APM Entity level that will be applied to the billing TIN/NPI 
combination of each MIPS eligible clinician in the APM Entity group. We 
are also finalizing our policy to give one-half of the maximum 
improvement activities score to eligible clinicians who are APM 
participants, with the clarification that we would extend such 
improvement activities scoring credit to any MIPS eligible clinicians 
identified by an APM participant identifier on a Participation List, an 
Affiliated Practitioners List, or other CMS-maintained list of 
participants at any time during the MIPS performance period.
    In the event that a Shared Savings Program ACO does not report 
quality measures as required under the Shared Savings Program 
regulations, then scoring on all MIPS performance categories will be at 
the ACO participant TIN level, and the resulting TIN-level final score 
will be applied to each of its constituent TIN/NPI combinations. For 
purposes of both the Shared Savings Program quality performance 
requirement and the APM scoring standard, any ``partial'' reporting of 
quality measures through the CMS Web Interface that does not satisfy 
the quality reporting requirements under the Shared Savings Program 
will be considered a failure to report. We note that in this scenario, 
each ACO participant TIN would need to report quality data to MIPS 
according to MIPS group reporting requirements in order to avoid a 
score of zero for the quality performance category.
    We believe that this exception for the Shared Savings Program 
recognizes the recommendations of several commenters that the APM 
scoring standard should apply at the TIN level and concerns that in 
some cases ACOs are not representative of the potentially widely-
varying MIPS performance across ACO participant TINs. Although we 
maintain that the APM Entity-level scoring is generally appropriate to 
reflect the collective goals and responsibilities of the group, we 
believe that ACOs that fail to report quality as required under the 
Shared Savings Program do not necessarily represent the quality 
performance of their constituent TINs. Therefore, we believe it is 
appropriate in such cases to allow ACO participant TINs to avoid a 
score of zero in the quality performance category and to take 
responsibility for their own MIPS reporting and scoring independent of 
the ACO and other TINSs in the ACO. Further, this policy is generally 
consistent with similar policies that have been proposed for ACO 
participant TINs under PQRS and the Value Modifier program at (81 FR 
46408-46409, 46426-46427).
    Additionally, we recognize that there may be instances when an APM 
Entity's participation in the APM is terminated during the MIPS 
performance period. As we state in section II.F.5. of this final rule 
with comment period, we will not make the first assessment to determine 
whether a MIPS eligible clinician is on an APM Entity's Participation 
List until March 31 of the performance period. Therefore if an APM 
Entity group terminates its participation in the APM prior to March 31, 
the MIPS eligible clinicians would not be considered part of an APM 
Entity group for purposes of the APM scoring standard.
    If an APM Entity's participation in the APM is terminated on or 
after March 31 of a performance period, the MIPS eligible clinicians in 
the APM Entity group would still be considered an APM Entity group in a 
MIPS APM for the year, and would report and be scored under the APM 
scoring standard.
(6) Shared Savings Program--Quality Performance Category Scoring Under 
the APM Scoring Standard
    We proposed that beginning with the first MIPS performance period 
Shared Savings Program ACOs would only need to submit their quality 
measures to CMS once using the CMS Web Interface through the same 
process that they use to report to the Shared Savings Program to report 
quality measures to MIPS. These data would be submitted once but used 
for both the Shared Savings Program and for MIPS. 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. 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 level. The Shared Savings Program quality performance data that 
is not submitted to the CMS Web Interface, for example the CAHPS survey 
and claims-based measures, would not be included in the MIPS APM 
quality performance category score. The MIPS quality 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 stated that we believe this would 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.
    In the proposed rule, we explained that we believe that no waivers 
are necessary to adopt this approach because the quality measures 
submitted via the CMS Web Interface under the Shared Savings Program 
are also MIPS quality measures and would be scored under MIPS 
performance standards. In the event that Shared Savings Program quality 
measures depart from MIPS measures in the future, we would address such 
changes including whether further waivers are necessary at such a time 
in future rulemaking.
    The following is a summary of the comments we received regarding 
our proposal to have Shared Savings Program ACOs report quality 
measures to MIPS using the CMS Web Interface as

[[Page 77256]]

they normally would under Shared Savings Program rules and our proposal 
to calculate the MIPS quality performance category score at the APM 
Entity group level based on the data reported by the ACO to the CMS Web 
Interface and using MIPS performance benchmarks.
    Comment: A commenter wanted to know which set of APM scoring 
standard rules would apply to CPC+ practices that participate in both 
CPC+ and the Shared Savings Program. The commenter noted that if the 
reporting and scoring under the APM scoring standard for other MIPS 
APMs applies to the CPC+ practice, the quality performance category 
would be reweighted to zero. The commenter recommended that MIPS 
eligible clinicians who participate in both the CPC+ and the Shared 
Savings Program use the Shared Savings Program rules for reporting and 
scoring under the APM scoring standard.
    Response: In May 2016, CMS announced that practices may participate 
in both a CPC+ model and in an ACO participating in the Shared Savings 
Program. More information about dual participation may be found in the 
CPC+ FAQs or RFA at https://innovation.cms.gov/Files/x/cpcplus-practiceapplicationfaq.pdf or https://innovation.cms.gov/Files/x/cpcplus-rfa.pdf. For purposes of the APM scoring standard, MIPS 
eligible clinicians in CPC+ practices that are also participating in a 
Shared Savings Program ACO will be considered part of a Shared Savings 
Program ACO. CPC+ practices that are part of a Shared Savings Program 
ACO will report quality to CPC+ as required by the CPC+ model but will 
not receive the CPC+ performance-based incentive payment. As part of a 
Shared Savings Program ACO, CPC+ practices, along with the other ACO 
participants, will be subject to the payment incentives for cost and 
quality under the Shared Savings Program. Because CPC+ practices that 
participate in both the CPC+ model and the Shared Savings Program are 
not eligible to receive the performance-based incentive payment under 
the CPC+ model, responsibility for cost and quality is assessed more 
comprehensively under the Shared Savings Program. Therefore, we believe 
that the Shared Savings Program participation of these ``dual 
participants'' should determine the manner in which we assess them 
under the APM scoring standard.
    Comment: A commenter agreed with the proposed approach of not 
including CAHPS or other non-CMS Web Interface quality data measures in 
the MIPS APM quality performance category score for ACOs in the Shared 
Savings Program. Alternately, a commenter recommended that CAHPS 
measures be included in Shared Savings Program ACO quality performance 
category scores.
    Response: Because CAHPS survey responses are not submitted to the 
CMS Web Interface and may not be available in time for inclusion in the 
MIPS quality performance category scoring, we are not including these 
measures in the MIPS quality performance category score for the ACOs in 
the Shared Savings Program and the Next Generation ACO Model.
    Comment: One commenter requested clarification as to which quality 
measures, specifically whether MIPS population health measures, would 
be included in the APM scoring standard for Shared Savings Program 
ACOs.
    Response: The MIPS population health measures will not be included 
in the quality performance category score for eligible clinicians 
participating in the Shared Savings Program, the Next Generation ACO 
Model or other MIPS APMs under the APM scoring standard.
    Comment: A commenter requested that CMS ensure that all the MIPS 
eligible clinicians billing under the TIN of an ACO participant in a 
Shared Savings Program ACO receive the APM Entity group final score 
even though most ACO quality measures are for primary care physicians.
    Response: All eligible clinicians that bill through the TIN of a 
Shared Savings Program ACO participant and are included on the 
Participant List on at least one of the three Participation List 
snapshot dates will receive the APM Entity group final score.
    Comment: A commenter requested that all ACOs be exempt from the 
MIPS quality performance category because they are already being 
assessed for quality under the APM and also requested that Shared 
Savings Program Track 1 participants have the option to be exempt from 
MIPS.
    Response: All MIPS eligible clinicians participating in the Shared 
Savings Program are subject to MIPS unless they are determined to be a 
QP or a Partial QP whose APM Entity elects not to report under MIPS. 
This includes MIPS eligible clinicians who are not participating in 
Advanced APMs. Under the APM scoring standard, MIPS eligible clinicians 
participating in Shared Savings Program ACOs do not have to do any 
additional reporting to satisfy MIPS quality performance category 
reporting requirements.
    We are finalizing our proposal that a Shared Savings Program ACO's 
quality data reported to the CMS Web Interface as required by Shared 
Savings Program rules will also be used for purposes of scoring the 
MIPS quality performance category using MIPS performance benchmarks. We 
note that for purposes of the Shared Savings Program quality reporting 
requirement and the APM scoring standard, any ``partial'' reporting of 
quality measures through the CMS Web Interface that does not satisfy 
the requirements under the Shared Savings Program will be considered a 
failure to report, triggering the exception finalized above in which we 
will separately assess each ACO participant TIN under the APM scoring 
standard.
(7) Shared Savings Program--Cost Performance Category Scoring Under the 
APM Scoring Standard
    We proposed that for the first MIPS performance period, we would 
not assess MIPS eligible clinicians participating in the Shared Savings 
Program (the MIPS APM) under the cost performance category. We proposed 
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 cost 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 cost 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 cost under the Shared Savings Program and 
MIPS differ, leading to an unpredictable degree of overlap (for 
eligible clinicians and for us) 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 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 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

[[Page 77257]]

reflect the total cost of care, and the objective versus relative 
assessment factors listed above--creates uncertainty for MIPS 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 cost measures focus on spending for particular episodes of care or 
clinical conditions. 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 cost performance category under 
MIPS. Thus, we proposed to reduce the MIPS cost 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 proposed 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 cost performance category. 
With the proposed reduction of the cost performance category weight to 
zero, we believed it would be unnecessary to specify and use cost 
measures in determining the MIPS final score for these MIPS eligible 
clinicians. Therefore, under section 1899(f) of the Act, we proposed 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, cost 
measures in calculating the MIPS final score 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 
cost performance category to zero, we also needed to specify how that 
weight would be redistributed among the remaining performance 
categories in order to maintain a total weight of 100 percent. We 
proposed to redistribute the cost performance category weight to both 
the improvement activities and advancing care information performance 
categories as specified in Table 11 of this final rule with comment 
period. The MIPS cost 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 in accordance with section 
1848(q)(5)(E)(i)(I) and (II) of the Act, the weight for this category 
will be reduced from 50 to 30 percent as of the 2021 MIPS payment 
period, we proposed to evenly redistribute the 10 percent cost 
performance category weight to the improvement activities and advancing 
care information performance categories so that the distribution does 
not change the relative weight of the quality performance category. 
Because the MIPS quality performance category weight is required under 
the statute to be reduced to 30 percent after the first 2 years of 
MIPS, we believe that increasing the quality performance category 
weight would be incongruous in light of the eventual balance of the 
weights set forth in the statute. The redistributed cost performance 
category weight of 10 percent would result in a 5 percentage point 
increase (from 15 to 20 percent) for the improvement activities 
performance category and a 5 percentage point increase (from 25 to 30 
percent) for the advancing care information performance category. We 
invited comments on the proposed weights and specifically whether we 
should increase the MIPS quality performance category weight.
    In the proposed rule we explained that as the MIPS cost performance 
category evolves over time, there might be greater potential for 
alignment and less potential duplication or conflict with MIPS cost 
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 cost performance 
category into the APM scoring standard for MIPS eligible clinicians 
participating in the Shared Savings Program. We also understand that 
reducing the cost performance category weight to zero and 
redistributing the weight to the improvement activities and advancing 
care information performance categories could, to the extent that 
improvement activities and advancing care information scores are higher 
than the scores these MIPS eligible clinicians would have received 
under the cost performance category, would result in higher final 
scores on average for MIPS eligible clinicians participating in the 
Shared Savings Program. We solicited comment on the possibility of 
assigning a neutral score to the Shared Savings Program APM Entity 
groups for the cost performance category to moderate MIPS final scores 
for APM Entities participating in the Shared Savings Program. We also 
generally solicited comment on our proposed policy, and on whether and 
how we should incorporate the cost performance category into the APM 
scoring standard under MIPS for eligible clinicians participating in 
the Shared Savings Program for future years.
    The following is a summary of the comments we received regarding 
our proposal to reduce the MIPS cost performance category weight to 
zero for APM Entity groups participating in the Shared Savings Program.
    Comment: Several commenters supported our proposal not to assess 
cost for MIPS APMs and our efforts to reduce duplicative measurement. 
One commenter suggested we give a full score for the cost performance 
category instead of redistributing the 10 percent weight to other MIPS 
performance categories. A few commenters recommended the 10 percent 
weight for the cost performance category be redistributed entirely to 
the improvement activities performance category.
    One commenter recommended that MIPS eligible clinicians in Shared 
Savings Program ACOs receive extra credit in the cost performance 
category if their ACO achieved expenditures below its benchmark. The 
commenter suggested that CMS consider having a sliding scale of cost 
category points awarded to MIPS eligible clinicians that participate in 
Shared Savings Program ACOs with benchmarks of less than $10,000 per 
beneficiary per year. One commenter proposed that CMS reward Shared 
Savings Program ACOs that score at or above the average on cost 
measures, and hold harmless Shared Savings Program ACOs scoring below 
average. One commenter was opposed to reducing the cost performance 
category weight to zero.
    Response: We appreciate commenters' widespread support for this 
proposal to reduce the weight of the MIPS cost performance category to 
zero under the APM scoring standard for eligible clinicians 
participating in the Shared Savings Program. While we will continue to 
monitor and consider how we might in future years incorporate the MIPS 
cost performance category into the APM scoring standard for eligible 
clinicians participating in the Shared Savings Program, we believe that 
assessment in this category would conflict with the assessment of the 
financial performance of ACOs

[[Page 77258]]

participating in the Shared Savings Program at this time. Because ACOs 
in the Shared Savings Program are assessed through particular 
attribution and benchmarking methodologies for purposes of earning 
shared savings payments, we believe that adding additional and separate 
MIPS incentives around cost would be redundant, potentially confusing, 
and could undermine the incentives built into the Shared Savings 
Program.
    We are finalizing our proposal to reduce the cost performance 
category to zero percent for APM Entity groups in the Shared Savings 
Program and to evenly redistribute the 10 percent cost performance 
category weight to the improvement activities and advancing care 
information performance categories. We note that this policy may seem 
unnecessary given that the MIPS policy for the initial performance year 
reduces the cost performance category weight to zero for all MIPS 
eligible clinicians. However, the zero weight for the cost performance 
category for APM Entity groups in the Shared Savings Program will 
remain in place for subsequent years unless we modify it through future 
notice and comment rulemaking, whereas the zero weight given to the 
cost performance category under the generally applicable MIPS scoring 
standard is limited to the first performance period, will increase to 
10 percent in the second performance period, and will increase to 30 
percent in the third performance period. We believe that setting this 
foundation from the outset of the Quality Payment Program will 
contribute to consistency and minimize uncertainty for MIPS APM 
participants at least until such a time as we might identify a means to 
consider performance in the MIPS cost performance category that is 
congruent with cost evaluation under the Shared Savings Program.
    We further note that although we proposed to use our authority 
under section 1899(f) of the Act to waive the requirement under section 
1848(q)(5)(E)(i)(II) of the Act to specify the scoring weight for the 
cost performance category because it was necessary to waive this 
requirement in order to ensure that the Shared Savings Program retains 
the ability to structure its own measurement and payment for 
performance on total cost of care independent of other incentive 
programs, we believe we could also use our authority under section 
1899(b)(3)(D) of the Act to accomplish this result. Section 
1899(b)(3)(D) of the Act allows us to incorporate reporting 
requirements under section 1848 into the reporting requirements for the 
Shared Savings Program, as we determine appropriate, and to use 
alternative criteria than would otherwise apply. Thus, we believe that 
section 1899(b)(3)(D) of the Act also provides authority to reduce the 
weight of the cost performance category to zero percent for eligible 
clinicians participating in Shared Savings Program ACOs and to 
redistribute the 10 percent weight to the improvement categories and 
advancing care information categories.
(8) Shared Savings Program--Improvement Activities and Advancing Care 
Information Performance Category Scoring Under the APM Scoring Standard
    We proposed that MIPS eligible clinicians participating in the 
Shared Savings Program would submit data for the MIPS improvement 
activities and advancing care information performance categories 
through their respective ACO participant billing TINs independent of 
the Shared Savings Program ACO. Under 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 improvement activities 
performance category. Additionally, under 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 improvement activities performance 
category. The improvement activities and advancing care information 
scores from all the ACO participant billing TINs would be averaged to a 
weighted mean MIPS APM Entity group level score. We proposed to use a 
weighted mean in computing the overall improvement activities and 
advancing care information quality performance category score 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 improvement 
activities 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 level).
    In the proposed rule, we recognized 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 solicited comment on a possible alternative approach in 
which improvement activities 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. We also indicated that 
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 final rule with comment, at 
the TIN level. We proposed 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 
explained that 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 improvement activities and 
advancing care information performance categories at the level of the 
group billing TIN rather than the ACO (APM Entity level).
    We solicited 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 improvement activities and advancing care 
information performance categories.
    The following is a summary of the comments we received regarding 
our proposals for how to score and weight the improvement activities 
and

[[Page 77259]]

advancing care information performance categories for the Shared 
Savings Program under the APM scoring standard and on whether to score 
these two MIPS performance categories at the APM Entity or the ACO 
participant TIN level.
    Comment: Several commenters suggested that all APM Entities should 
receive full credit for improvement activities because they are already 
performing these activities as a result of being a participant in an 
APM. A few commenters stated that all APM participants should get at 
least 80 percent of the maximum score for improvement activities. Some 
commenters suggested that ACOs are involved in many of the improvement 
activities on a daily basis in order to meet the stringent requirements 
of the Shared Savings Program and the Next Generation ACO Model and 
requested that CMS provide a simple and straightforward way for ACOs to 
attest that their eligible clinicians have been involved in improvement 
activities for at least 90 days in the performance year by being a part 
of an ACO initiative.
    Response: We agree with the comments that eligible clinicians 
participating in the Shared Savings Program and other MIPS APMs are 
actively engaged in improvement activities by virtue of participating 
in an APM. In an effort to further reduce reporting burden for eligible 
clinicians in MIPS APMs and to better recognize improvement activities 
work performed through participation in MIPS APMs, we are modifying our 
proposal with respect to scoring for the improvement activities 
performance category under the APM scoring standard. Specifically, for 
APM Entity groups in the Shared Savings Program, Next Generation ACO 
Model and other MIPS APMs, we will assign a baseline score for the 
improvement activities performance category based on the improvement 
activity requirements under the terms of the particular MIPS APM. CMS 
will review the MIPS APM requirements as they relate to activities 
specified under the generally applicable MIPS improvement activities 
performance category and assign an improvement activities score for 
each MIPS APM that is applicable to all APM Entity groups participating 
in the MIPS APM. To develop the improvement activities score assigned 
to a MIPS APM and applicable to all APM Entity groups in the APM, CMS 
will compare the requirements of the MIPS APM with the list of 
improvement activities measures in section II.E.5.f. of this final rule 
with comment period and score those measures in the same manner that 
they are otherwise scored for MIPS eligible clinicians according to 
section II.E.5.f. of this final rule with comment period. Thus, points 
assigned to an APM Entity group in a MIPS APM under the improvement 
activities performance category will relate to documented requirements 
under the terms and conditions of the MIPS APM, such as in a 
participation agreement or regulation. We will apply this improvement 
activities score for the MIPS APM to each APM Entity group within the 
MIPS APM. For example, points assigned in the improvement activities 
performance category for participation in the Next Generation ACO Model 
will relate to documented requirements under the terms of the model, as 
set forth in the model's participation agreement. In the event that a 
MIPS APM incorporates sufficient improvement activities to receive the 
maximum score, APM Entity groups or their constituent MIPS eligible 
clinicians (or TINs) participating in the MIPS APM will not need to 
submit data for the improvement activities performance category in 
order to receive that maximum improvement activities score. In the 
event that a MIPS APM does not incorporate sufficient improvement 
activities to receive the maximum potential score, APM Entities will 
have the opportunity to report and add points to the baseline MIPS APM-
level score on behalf of all MIPS eligible clinicians in the APM Entity 
group for additional improvement activities that would apply to the APM 
Entity level improvement activities performance category score. The 
improvement activities performance category score we assign to the MIPS 
APM based on improvement activity requirements under the terms of the 
APM will be published in advance of the MIPS performance period on the 
CMS Web site.
    Comment: A commenter generally agreed with the proposed reweighting 
of performance categories for MIPS APMs under the APM scoring standard 
but recommended the 10 percent for the cost performance category be 
reallocated to improvement activities instead of both improvement 
activities and advancing care information. Another commenter also 
agreed with the scoring and supported the weight for the improvement 
activities performance category. One commenter recommended that MIPS 
APM participants have the option of having the APM Entity report 
improvement activities in order to achieve group scores higher than the 
initial 50 percent. A few commenters requested that the MIPS APMs only 
be scored on the quality and improvement activities performance 
categories.
    Response: After considering comments, we believe the reweighting of 
the improvement activities and the advancing care information 
performance categories should be finalized as proposed. We believe the 
proposed weights represent an appropriate balance between improvement 
activities and advancing care information, both of which are important 
goals of the MIPS program. Moreover, because the quality performance 
category weight will be reduced over time we believe that increasing 
the quality performance category weight in the first performance period 
would be incongruent the balance of the weights set forth in the 
statute.
    For the Shared Savings Program we are finalizing the weights 
assigned to each of the MIPS performance categories as proposed for 
Shared Savings Program ACOs: Quality 50 percent; cost 0 percent; 
improvement activities 20 percent; and advancing care information 30 
percent for purposes of the APM scoring standard. We are finalizing the 
proposal that for the advancing care information performance category, 
ACO participant TINs will report the category to MIPS, and the TIN 
scores will be aggregated and weighted in order to calculate one APM 
Entity score for the category. In the event a Shared Savings Program 
ACO fails to satisfy quality reporting requirements for measures 
reported through the CMS Web Interface, advancing care information 
group TIN scores will not be aggregated to the APM Entity level. 
Instead, each ACO participant TIN will be scored separately based on 
its TIN-level group reporting for the advancing care information 
performance category.
    We are revising our proposal with respect to the scoring of the 
improvement activities performance category for the Shared Savings 
Program. We will assign an improvement activities score for the Shared 
Savings Program based on the improvement activities required under the 
Shared Savings Program. We consider all Shared Savings Program tracks 
together for purposes of assigning an improvement activities 
performance category score because the tracks all require the same 
activities of their participants. All APM Entity groups in the Shared 
Savings Program will receive that baseline improvement activities 
score. To develop the improvement activities score for the Shared 
Savings Program, we will compare the requirements of the Shared Savings 
Program with the list of improvement activities measures in section 
II.E.5.f. of

[[Page 77260]]

this final rule with comment period and score those measures in the 
same manner that they would otherwise be scored for MIPS eligible 
clinicians according to section II.E.5.f. of this final rule with 
comment period. We will assign points for improvement activities toward 
the score for the Shared Savings Program based on documented 
requirements for improvement activities under the terms of the Shared 
Savings Program. We will publish the assigned scores for Shared Savings 
Program on the CMS Web site before the beginning of the MIPS 
performance period. In the event that the assigned score represents the 
maximum improvement activities score, APM Entity groups will not need 
to report additional improvement activities. In the event that the 
assigned score does not represent the maximum improvement activities 
score, APM Entities will have the opportunity to report additional 
improvement activities that would apply to the APM Entity group score. 
Table 11 summarizes the finalized APM scoring standard rules for the 
Shared Savings Program.

   Table 11--APM Scoring Standard for the Shared Savings Program--2017 Performance Period for the 2019 Payment
                                                   Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                                                    Performance
  MIPS  performance  category        APM entity submission              Performance score            category
                                          requirement                                                weight %
----------------------------------------------------------------------------------------------------------------
Quality.......................  Shared Savings Program ACOs      The MIPS quality performance                 50
                                 submit quality measures to the   category requirements and
                                 CMS Web Interface on behalf of   benchmarks will be used to
                                 their participating MIPS         determine the MIPS quality
                                 eligible clinicians.             performance category score at
                                                                  the ACO level.
Cost..........................  MIPS eligible clinicians will    N/A............................               0
                                 not be assessed on cost.
Improvement Activities........  ACOs only need to report if the  CMS will assign the same                     20
                                 CMS-assigned improvement         improvement activities score
                                 activities scores is below the   to each APM Entity group based
                                 maximum improvement activities   on the activities required of
                                 score.                           participants in the Shared
                                                                  Savings Program. The minimum
                                                                  score is one half of the total
                                                                  possible points. If the
                                                                  assigned score does not
                                                                  represent the maximum
                                                                  improvement activities score,
                                                                  ACOs will have the opportunity
                                                                  to report additional
                                                                  improvement activities to add
                                                                  points to the APM Entity group
                                                                  score.
Advancing Care Information....  All ACO participant TINs in the  All of the ACO participant TIN               30
                                 ACO submit under this category   scores will be aggregated as a
                                 according to the MIPS group      weighted average based on the
                                 reporting requirements.          number of MIPS eligible
                                                                  clinicians in each TIN to
                                                                  yield one APM Entity group
                                                                  score.
----------------------------------------------------------------------------------------------------------------

(9) Next Generation ACO Model--Quality Performance Category Scoring 
Under the APM Scoring Standard
    We proposed that beginning with the first MIPS performance period, 
Next Generation ACOs would only need to submit their quality measures 
to CMS once using the CMS Web Interface through the same process that 
they use to report to the Next Generation ACO Model. These data would 
be submitted once but used for purposes of both the Next Generation ACO 
Model and MIPS. Next Generation ACO Model ACOs 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. 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 are not submitted to the CMS Web Interface, for 
example the CAHPS survey and claims-based measures, would not be 
included in the APM Entity group quality performance score. The APM 
Entity group quality performance category score would be calculated 
using only quality measure data submitted through the CMS Web Interface 
and scored using the MIPS benchmarks, whereas the quality reporting 
requirements and performance benchmarks calculated for the Next 
Generation ACO Model would continue to be used to assess the ACO under 
the APM-specific requirements. We stated in the proposed rule that we 
believe this approach would reduce the reporting burden for 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.
    In the proposed rule, we indicated that 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 would be scored under MIPS performance standards. In the 
event that Next Generation ACO Model quality measures depart from MIPS 
measures in the future, we stated that we would address such changes, 
including whether further waivers are necessary, at such a time in 
future rulemaking.
    The following is a summary of the comments we received regarding 
our proposal to have Next Generation ACOs report quality measures to 
MIPS using the CMS Web Interface as they normally would under Next 
Generation ACO Model rules and our proposal for CMS to calculate the 
MIPS quality performance category score at the APM Entity group level 
based on the data reported to the CMS Web Interface and using the MIPS 
performance standards.
    Comment: A commenter requested clarification regarding whether the 
population-based quality measures and CAHPS would be included in the 
Next Generation ACO quality performance category score.
    Response: The population-based quality measures and CAHPS will not 
be included in the quality scoring under the APM scoring standard. This 
final rule with comment period does not affect APM-specific measurement 
and incentives.

[[Page 77261]]

    We are finalizing the scoring policy for the quality performance 
category for the Next Generation ACO Model as proposed. We will use 
Next Generation ACO Model quality measures submitted by the ACO to the 
CMS Web Interface and MIPS benchmarks to score quality for MIPS 
eligible clinicians in a Next Generation ACO at the APM Entity level. 
An ACO's failure to report quality as required by the Next Generation 
ACO Model will result in a quality score of zero for the APM Entity 
group.
(10) Next Generation ACO Model--Cost Performance Category Scoring Under 
the APM Scoring Standard
    We proposed that for the first MIPS performance period, we would 
not assess MIPS eligible clinicians in the Next Generation ACO Model 
participating in the MIPS APM under the cost performance category. We 
proposed 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 cost 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 cost 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 cost under the Next Generation 
ACO Model and MIPS differ, leading to an unpredictable degree of 
overlap (for eligible clinicians and for us) 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 cost 
measures focus on spending for particular episodes of care or clinical 
conditions. Therefore, we proposed to reduce the MIPS cost 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 proposed 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 cost performance category. With 
the proposed reduction of the cost performance category weight to zero, 
we believe it would be unnecessary to specify and use cost measures in 
determining the MIPS final score for these MIPS eligible clinicians. 
Therefore, under section 1115A(d)(1) of the Act, we proposed 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, cost 
measures in calculating the MIPS final score for such eligible 
clinicians.
    Given the proposal to waive requirements under section 
1848(q)(5)(E) of the Act to reduce the weight of the cost performance 
category to zero, we must subsequently specify how that weight would be 
redistributed among the remaining performance categories to maintain a 
total weight of 100 percent. We proposed to redistribute the cost 
performance category weight to both the improvement activities and 
advancing care information performance categories as specified in Table 
13 of the proposed rule. The MIPS cost 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 the weight for this category will be reduced 
from 50 to 30 percent as of the 2021 payment year, we proposed to 
evenly redistribute the 10 percent cost weight to the improvement 
activities and advancing care information performance categories so 
that the distribution does not change the relative weight of the 
quality performance category in the opposite of the direction it will 
change in the future. Because the quality performance category weight 
is required under the statute to be reduced to 30 percent after the 
first 2 years of MIPS we believe that increasing the quality 
performance category weight is incongruous with the eventual balance of 
the weights set forth in the statute. The redistributed cost 
performance category weight of 10 percent would result in a 5 
percentage point increase (from 15 to 20 percent) for the improvement 
activities performance category and a 5 percentage point increase (from 
25 to 30 percent) for the advancing care information performance 
category. We invited comments on the proposed redistributed weights and 
specifically on whether we should also increase the MIPS quality 
performance category weight.
    In the proposed rule, we explained that we understand that as the 
MIPS cost performance category evolves over time, there might be 
greater potential for alignment and less potential duplication or 
conflict with MIPS cost measurement for MIPS eligible clinicians 
participating in MIPS APMs such as the Next Generation ACO Model. We 
stated that we would continue to monitor and consider how we might 
incorporate an assessment in the MIPS cost performance category into 
the APM scoring standard for the Next Generation ACO Model. We also 
understand that reducing the cost weight to zero and redistributing the 
weight to the improvement activities and advancing care information 
performance categories could, to the extent that improvement activities 
and advancing care information performance category scores are higher 
than the scores MIPS eligible clinicians would have received under the 
cost performance category, result in higher final scores on average for 
MIPS eligible clinicians in APM Entity groups participating in the Next 
Generation ACO Model. We solicited comment on the possible alternative 
of assigning a neutral score to APM Entity groups participating in the 
Next Generation ACO model for the cost performance category in order to 
moderate APM Entity scores. We also generally sought comment on our 
proposed policy, and on whether and how we should incorporate the cost 
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 77262]]

    The following is a summary of the comments we received regarding 
our proposal to reduce the MIPS cost performance category weight to 
zero for APM Entity groups in the Next Generation ACO Model.
    Comment: Many commenters supported our proposal to not assess cost 
for MIPS APMs, including the Next Generation ACO Model.
    Response: We appreciate commenters' widespread support for this 
proposal. While we will continue to monitor and consider how we might 
in future years incorporate the MIPS cost performance category into the 
APM scoring standard for participants in the Next Generation ACO Model, 
we believe that assessment in this category would conflict with Next 
Generation ACO Model assessment at this time. Participants in the Next 
Generation ACO Model are assessed through particular attribution and 
benchmarking methodologies for purposes of earning shared savings 
payments; adding additional and separate MIPS incentives around cost 
would be redundant, potentially confusing, and could undermine the 
incentives built into the Next Generation ACO Model.
    We are finalizing our proposal to reduce the cost performance 
category weight to zero for MIPS eligible clinicians in APM Entity 
groups participating in the Next Generation ACO Model and to evenly 
redistribute the 10 percent cost weight to the improvement activities 
and advancing care information performance categories without changes.
(11) Next Generation ACO Model--Improvement Activities and Advancing 
Care Information Performance Category Scoring Under the APM Scoring 
Standard
    We proposed that all MIPS eligible clinicians participating in the 
Next Generation ACO Model would submit data for the improvement 
activities and advancing care information performance categories. MIPS 
eligible clinicians participating in the Next Generation ACO Model may 
bill through a TIN that includes other MIPS eligible clinicians not 
participating in the APM. Therefore for both the improvement activities 
and advancing care information performance categories, we proposed that 
MIPS eligible clinicians participating in the Next Generation ACO Model 
would submit individual level data to MIPS and not group level data.
    For both the improvement activities 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 for purposes of the improvement 
activities performance category or the 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.
    Because the MIPS quality performance category bears a relatively 
higher weight than the other three MIPS performance categories, we 
proposed to evenly redistribute the 10 percent cost performance 
category weight to the improvement activities 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, for a performance period 
shall be given the highest potential score for the improvement 
activities 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 will receive the 
highest potential improvement activities 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 improvement activities.
    For the APM scoring standard for the first MIPS performance period, 
we proposed to weight the improvement activities and advancing care 
information performance categories for the Next Generation ACO Model in 
the same way that we proposed to weight those categories for the Shared 
Savings Program: 20 percent and 30 percent for improvement activities 
and advancing care information, respectively. We solicited comment on 
our proposals for reporting and scoring the improvement activities and 
advancing care information performance categories under the APM scoring 
standard. In particular, we solicited comment on the appropriate weight 
distributions in the first performance year.
    The following is a summary of the comments we received regarding 
our proposals to score and weight the improvement activities and 
advancing care information performance categories for APM Entity groups 
in the Next Generation ACO under the APM scoring standard.
    Comment: Several commenters suggested that all APM Entities 
including ACOs in the Next Generation ACO Model should receive full 
credit for improvement activities because they are already performing 
these activities as a result of being a participant in an APM. Some 
commenters also indicated that improvement activities should be 
reported at the APM Entity level rather than at the individual level 
then averaged. A few commenters believed that CMS should allow 
reporting at the APM Entity level for all performance categories. Some 
commenters also believed that the advancing care information 
performance category should not be part of the APM scoring standard but 
rather incorporated into APM design through CEHRT requirements. One 
commenter indicated that the activities that lead to success in the 
Next Generation ACO Model directly overlap with the proposed 
improvement activities.
    Response: We agree that we can streamline reporting and scoring for 
the improvement activities and advancing care information performance 
categories while recognizing the work Next Generation ACO Model 
participants do in pursuit of the APM goals. Therefore, as described 
below, for purposes of the APM scoring standard we will assign an 
improvement activities score to the Next Generation ACO Model based on 
the improvement activities required under the Model.
    Regarding the advancing care information performance category, we 
do not believe that there is a compelling reason to exclude assessment 
in this performance category from the APM scoring standard in the same 
way that we are reducing the weight of the cost performance category. 
We do not see advancing care information measurement as duplicative or 
in conflict with Next Generation ACO Model goals and requirements. 
Participation in the Next Generation ACO Model is aligned with many 
MIPS improvement activities measures. This is why we are finalizing a 
policy that further reduces MIPS reporting burdens for Next Generation 
ACO Model participants and recognizes the similarities between MIPS 
improvement activities and the requirements of participating in the 
Next Generation ACO Model.
    Comment: A commenter requested clarification of our proposal that 
MIPS eligible clinicians participating in the Next Generation ACO would 
submit data for the improvement activities

[[Page 77263]]

performance category to MIPS individually, and not as a group.
    Response: The proposed policy involved individual reporting of 
improvement activities, which would be averaged across the ACO for one 
APM Entity group score. The finalized policy, described below, no 
longer requires individual reporting for purposes of the improvement 
activities performance category.
    Comment: A commenter noted that Next Generation ACO participants 
who are determined to be Partial QPs for a year may be disadvantaged 
given the reweighting of MIPS categories under the APM scoring 
standard.
    Response: We do not believe there is a disadvantage for Partial QPs 
who achieve that status through participation in any Advanced APM, 
including the Next Generation ACO Model to the extent it is determined 
to be an Advanced APM. As discussed in section II.F.5., the eligible 
clinicians who are Partial QPs can decide at the APM Entity group level 
to be subject to the MIPS reporting requirements and payment 
adjustment, in which case the eligible clinicians in the group would be 
scored under the APM scoring standard, or to be excluded from MIPS for 
the year.
    In response to comments, we are revising our proposal with respect 
to the scoring of the improvement activities performance category for 
the Next Generation ACO Model. CMS will assign all APM Entity groups in 
the Next Generation ACO Model the same improvement activities score 
based on the improvement activities required by the Next Generation ACO 
Model. To develop the improvement activities score assigned to all APM 
Entity groups in the Next Generation ACO Model, CMS will compare the 
requirements under the Next Generation ACO Model with the list of 
improvement activities measures in section II.E.5.f. of this final rule 
with comment period and score those measures in the same manner that 
they are otherwise scored for MIPS eligible clinicians according to 
section II.E.5.f. of this final rule with comment period. Thus, points 
assigned for participation in the Next Generation ACO Model will relate 
to documented requirements under the terms of the Next Generation ACO 
Model. We will publish the assigned improvement activities performance 
category score for the Next Generation ACO Model, based on the APM's 
improvement activity requirements, prior to the start of the 
performance period. In the event that the assigned score does not 
represent the maximum improvement activities score, APM Entities will 
have the opportunity to report additional improvement activities that 
would be applied to the baseline APM Entity group score. In the event 
that the baseline assigned score represents the maximum improvement 
activities score, APM Entities will not need to report additional 
improvement activities.
    In order to further reduce reporting burden and align with the 
generally applicable MIPS group reporting option, we are revising the 
advancing care information scoring policy for the Next Generation ACO 
Model. A MIPS eligible clinician may receive a score for the advancing 
care information performance category either through individual 
reporting or through group reporting based on a TIN according to the 
generally applicable MIPS reporting and scoring rules for the advancing 
care information performance category, described in section II.E.5.g of 
this final rule with comment period. We will attribute one advancing 
care information score to each MIPS eligible clinician in an APM Entity 
by looking at both individual and group data submitted for a MIPS 
eligible clinician and using the highest reported score. Thus, instead 
of only using individual scores to derive an APM Entity-level advancing 
care information score as proposed, we will use the highest score 
attributable to each MIPS eligible clinician in an APM Entity group in 
order to determine the APM Entity group score based on the average of 
the highest scores for all MIPS eligible clinicians in the APM Entity 
group.
    Like the proposed policy, each MIPS eligible clinician in the APM 
Entity group will receive one score, weighted equally with that of the 
other clinicians in the group, and CMS will calculate a single APM 
Entity-level advancing care information performance category score. 
Also like the proposed policy, for a MIPS eligible clinician who has no 
advancing care information performance category score--if the 
individual's TIN did not report as a group and the individual did not 
report--that MIPS eligible clinician will contribute a score of zero to 
the aggregate APM Entity group score.
    In summary, we will attribute one advancing care information 
performance category score to each MIPS eligible clinician in an APM 
Entity group, which will be averaged with the scores of all other MIPS 
eligible clinicians in the APM Entity group to derive a single APM 
Entity score. In attributing a score to an individual, we will use the 
highest score attributable to the TIN/NPI combination of a MIPS 
eligible clinician. Finally, if there is no group or individual score, 
we will attribute a zero to the MIPS eligible clinician, which will be 
included in the aggregate APM Entity score.
    We have revised this policy for the advancing care information 
performance category for Next Generation ACOs under the APM scoring 
standard because we recognize that individual reporting in the 
advancing care information performance category for all MIPS eligible 
clinicians in an APM Entity group may be more burdensome than allowing 
some degree of group reporting where applicable, and we believe that 
requiring individual reporting on advancing care information in the 
Next Generation ACO Model context will not supply a meaningfully 
greater amount of information regarding the use of EHR technology as 
prescribed by the advancing care information performance category. We 
believe that this revised policy maintains the alignment with the 
generally applicable MIPS reporting and scoring requirements under the 
advancing care information performance category while responding to 
commenters' desires for reduced reporting requirements for MIPS APM 
participants. Therefore, we believe that the revised policy, relative 
to the proposed policy, has the potential to substantially reduce 
reporting burden with little to no reduction in our ability to 
accurately evaluate the adoption and use of EHR technology. We also 
believe this final policy balances the simplicity of TIN-level group 
reporting, which can reduce burden, with the flexibility needed to 
address partial TIN scenarios common among Next Generation ACOs in 
which a TIN may have some MIPS eligible clinicians participating in the 
ACO and some MIPS eligible clinicians not in the ACO. Table 12 
summarizes the final APM scoring standard rules for the Next Generation 
ACO Model.

[[Page 77264]]



 Table 12--APM Scoring Standard for the Next Generation ACO Model--2017 Performance Period for the 2019 Payment
                                                   Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                                                    Performance
    MIPS  Performance category       APM Entity submission             Performance score             category
                                          requirement                                                weight %
----------------------------------------------------------------------------------------------------------------
Quality..........................  ACOs submit quality        The MIPS quality performance                    50
                                    measures to the CMS Web    category requirements and
                                    Interface on behalf of     benchmarks will be used to
                                    their participating MIPS   determine the MIPS quality
                                    eligible clinicians.       performance category score at the
                                                               ACO level.
Cost.............................  MIPS eligible clinicians   N/A...............................               0
                                    will not assessed on
                                    cost.
Improvement Activities...........  ACOs only need to report   CMS will assign the same                        20
                                    improvement activities     improvement activities score to
                                    data if the CMS-assigned   each APM Entity group based on
                                    improvement activities     the activities required of
                                    scores is below the        participants in the Next
                                    maximum improvement        Generation ACO Model.
                                    activities score.         This minimum score is one half of
                                                               the total possible points. If the
                                                               assigned score does not represent
                                                               the maximum improvement
                                                               activities score, ACOs will have
                                                               the opportunity to report
                                                               additional improvement activities
                                                               to add points to the APM Entity
                                                               group score.
Advancing Care Information.......  Each MIPS eligible         CMS will attribute one score to                 30
                                    clinician in the APM       each MIPS eligible clinician in
                                    Entity group reports       the APM Entity group. This score
                                    advancing care             will be the highest score
                                    information to MIPS        attributable to the TIN/NPI
                                    through either group       combination of each MIPS eligible
                                    reporting at the TIN       clinician, which may be derived
                                    level or individual        from either group or individual
                                    reporting.                 reporting. The scores attributed
                                                               to each MIPS eligible clinicians
                                                               will be averaged to yield a
                                                               single APM Entity group score.
----------------------------------------------------------------------------------------------------------------

(12) 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 proposed 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 for the first 
performance period. 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 us. 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 
in the proposed rule, our goal is to reduce MIPS eligible clinician 
reporting burden by not requiring APM participants to report quality 
data twice to us, and to avoid misaligned performance incentives. 
Therefore, we proposed 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. As we explained in the proposed rule, we 
believe it is necessary to do this because we require additional time 
to make adjustments in systems and processes related to the submission 
and collection of APM quality measures to align APM quality measures 
with MIPS and ensure APM quality measure data can be submitted in a 
time and 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 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 proposed 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.
    Accordingly, under section 1115A(d)(1) of the Act, we proposed 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

[[Page 77265]]

and use quality measures in determining the MIPS final score for these 
MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the 
Act, we proposed 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 
final score, for these MIPS eligible clinicians.
    We anticipated that beginning in the second MIPS performance 
period, the APM quality measure data submitted to us during the MIPS 
performance period 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 also anticipated 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 indicated that 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 to adjust quality measure data submission 
timelines. Therefore, beginning with the second MIPS performance 
period, we anticipated 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 solicited comment on this transitional 
approach to use of APM quality measures for the MIPS quality 
performance category for purposes of the APM scoring standard under 
MIPS in future years.
    The following is a summary of the comments we received regarding 
our proposal to, for the first MIPS performance period, reweight the 
quality performance category to zero for APM Entity groups in MIPS APMs 
other than the Shared Savings Program or the Next Generation ACO Model.
    Comment: A commenter supported exempting MIPS APMs that are not 
using the CMS Web Interface to report quality from reporting for 
purposes of the MIPS quality performance category in the first 
performance year. One commenter was concerned that these MIPS APMs will 
not receive a quality score for the first performance year and another 
commenter recommended revising the performance category weights so that 
quality is included.
    Response: We agree that it would be ideal to include performance on 
quality for all MIPS APMs in the first MIPS performance year. As noted, 
we are only reweighting the quality performance category to zero for 
the first performance year due to operational limitations. APM Entities 
in MIPS APMs are, under the policies adopted in this final rule with 
comment period, required to base payment incentives on cost/utilization 
and quality measure performance. As such they will continue to report 
quality as required under the APM, and are not truly exempt from 
quality assessment for the year. We are finalizing the inclusion of a 
MIPS quality performance category score under the APM scoring standard 
for the 2018 performance year at Sec.  414.1370(f), and will develop 
additional scoring policies for that year through future notice-and-
comment rulemaking.
    We are finalizing as proposed the policy to reweight the MIPS 
quality performance category to zero percent for APM Entity groups in 
MIPS APMs other than the Shared Savings Program or the Next Generation 
ACO Model for the first performance year.
(13) MIPS APMs Other Than the Shared Savings Program and Next 
Generation ACO--Cost Performance Category Scoring Under the APM Scoring 
Standard
    For the first MIPS performance period, we proposed that, for MIPS 
eligible clinicians participating in MIPS APMs other than the Shared 
Savings Program or the Next Generation ACO Model, to reduce the weight 
of the cost performance category to zero. We proposed this approach 
because: (1) APM Entity groups are already subject to cost and 
utilization performance assessments under MIPS APMs; (2) MIPS APMs 
usually measure cost in terms of total cost of care, which is a broader 
accountability standard that inherently encompasses the purpose of the 
claims-based measures that have relatively narrow clinical scopes, and 
MIPS APMs that do not measure cost in terms of total cost of care may 
depart entirely from MIPS measures; and (3) the beneficiary attribution 
methodologies differ for measuring cost 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 proposed 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 cost performance category.
    With the proposed reduction of the cost performance category weight 
to zero, we believed it would be unnecessary to specify and use cost 
measures in determining the MIPS final score for these MIPS eligible 
clinicians. Therefore, under section 1115A(d)(1) of the Act, we 
proposed 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, cost 
measures in calculating the MIPS final score 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 cost performance categories 
to zero, we also needed to specify how those weights would be 
redistributed among the remaining improvement activities and advancing 
care information categories in order to maintain a total weight of 100 
percent. We proposed to redistribute the quality and the cost 
performance category weights as specified in Table 14 of the proposed 
rule.
    We understand that as the cost performance category evolves, the 
rationale we discussed in the proposed rule for establishing a weight 
of zero for this performance category might not be applicable in future 
years. We solicited comment on whether and how we should incorporate 
the cost performance category into the APM scoring standard

[[Page 77266]]

under MIPS. We also understand that reducing the quality and cost 
performance category weight to zero and redistributing the weight to 
the improvement activities and advancing care information performance 
categories could, to the extent that improvement activities and 
advancing care information scores are higher than the scores MIPS 
eligible clinicians would have received under the cost performance 
category, would result in higher final scores on average for MIPS 
eligible clinicians in APM Entity groups participating in MIPS APMs. We 
solicited 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 cost performance categories in order to 
moderate APM Entity scores.
    The following is a summary of the comments we received regarding 
our proposal to establish a MIPS cost performance category weight of 
zero for all MIPS eligible clinicians in APM Entities participating in 
the MIPS APMs other than the Shared Savings Program and the Next 
Generation ACO model.
    Comment: The majority of commenters supported not assessing cost 
for MIPS APMs by reducing the weight for the cost performance category 
to zero.
    Response: We appreciate commenters' widespread support for this 
proposal. While we will continue to monitor and consider how we might 
in future years incorporate the MIPS cost performance category into the 
APM scoring standard for all MIPS APMs, we believe that inclusion of 
this category would conflict with the assessment of cost made within 
MIPS APMs at this time. Participants in MIPS APMs are assessed through 
particular attribution and benchmarking methodologies for purposes of 
incentives and penalties; adding additional and separate MIPS 
incentives around cost would be redundant, potentially confusing, and 
could undermine the incentives built into these MIPS APMs.
    We are finalizing the proposal to reduce the cost performance 
category weight to zero percent for APM Entity groups in MIPS APMs 
other than the Shared Savings Program or the Next Generation ACO Model.
(14) MIPS APMs Other Than the Shared Savings Program and Next 
Generation ACO Model--Improvement Activities and Advancing Care 
Information Performance Category Scoring Under the APM Scoring Standard
    We proposed that all MIPS eligible clinicians participating in a 
MIPS APM other than the Shared Savings Program or the Next Generation 
ACO Model would submit data for the improvement activities and 
advancing care information performance categories as individual MIPS 
eligible clinicians. MIPS eligible clinicians in these other APMs may 
bill through a TIN that includes MIPs eligible clinicians that do not 
participate in the APM. Therefore for both the improvement activities 
and the advancing care information performance categories, we proposed 
that these MIPS eligible clinicians submit individual level data to 
MIPS and not group level data. For both the improvement activities 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 improvement activities performance category or the 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, for a performance period shall be given the highest 
potential score for the improvement activities 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 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 improvement activities. We 
acknowledged that using this increased weight for improvement 
activities may make it easier in the first performance period for 
eligible clinicians in a MIPS APM to attain a higher MIPS score. We do 
not have historical data to assess the range of scores under 
improvement activities because this is the first time such activities 
are being assessed in such a manner.
    For the advancing care information performance category, we 
explained our belief 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. In the proposed rule, we indicated that we want to ensure 
that where we proposed 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 proposed that 
the weights for the improvement activities and advancing care 
information performance categories would be 25 percent and 75 percent, 
respectively. We solicited comment on our proposals for reporting and 
scoring the improvement activities and advancing care information 
performance categories under the APM scoring standard. In particular, 
we solicited comment on the appropriate weight distributions in the 
first performance year and subsequent years when we anticipate 
incorporating assessment in the quality performance category for all 
MIPS eligible clinicians participating in MIPS APMs.
    The following is a summary of the comments we received regarding 
our proposals to score and weight the improvement activities and 
advancing care information performance categories for MIPS eligible 
clinicians participating in APM Entity groups in MIPS APMs other than 
the Shared Savings Program and the Next Generation ACO Model under the 
APM scoring standard.
    Comment: Some commenters were concerned that if eligible clinicians 
in MIPS APMs would be scored only on the advancing care information and 
improvement activities performance categories, clinicians in those MIPS 
APMs could disproportionately receive upward MIPS payment adjustments 
because they would not be assessed in the quality or cost performance 
categories. Commenters believed that it may be easier for clinicians to 
perform well in the improvement activities and advancing care 
information performance categories than in the quality and cost 
performance categories. Although a few commenters supported the 
proposed performance category weights, other commenters suggested 
alternatives. Two commenters were concerned about the performance 
category scoring weights

[[Page 77267]]

for MIPS APMs under the APM scoring standard and suggested that the 
weights for the advancing care information and improvement activities 
performance categories should be similar to the ones proposed for the 
Shared Savings Program and Next Generation ACO Model. Two other 
commenters suggested assigning greater weight to the improvement 
activities performance category instead of redistributing so much of 
the weight to the advancing care information performance category. A 
few commenters suggested redistributing the weights from the quality 
and cost performance categories to the improvement activities and 
advancing care information performance categories differently--for 
example, 50 percent for improvement activities and 50 percent for 
advancing care information. One commenter indicated they understood the 
need to reweight the improvement activities and advancing care 
information for MIPS APMs other than the Shared Savings Program and the 
Next Generation ACO Model but requested that, in making reweighting 
decisions, CMS give consideration to ensuring a ``level playing 
field.'' A few commenters expressed concern that the proposed APM 
scoring standard for MIPS APMs increases the advancing care information 
category weight to 75 percent, and a commenter stated that performance 
in this category could be challenging for many clinicians, particularly 
those with little control over the IT choices and decisions made by 
their employers. A commenter recommended basing performance in this 
category on the adoption and use of EHR technology tailored to a 
specialty-appropriate assessment of meaningful use and urged CMS to 
work closely with physician societies.
    Response: We understand that an APM Entity group's final score 
under the proposed weights for the APM scoring standard could differ 
from the final score such APM Entity groups could receive if they were 
subject to both the quality and cost performance categories. However, 
for reasons discussed above, reweighting the quality performance 
category to zero percent is necessary for operational and programmatic 
reasons only for the first performance year, and we anticipate being 
able to incorporate performance under MIPS APM quality measures 
beginning in the second year of the Quality Payment Program, subject to 
future rulemaking. Also, in light of the MIPS scoring policies we are 
finalizing for the first performance year, we do not believe that this 
will cause a material adverse impact on MIPS scoring because the impact 
on MIPS payment adjustments for an eligible clinician will be affected 
more by meeting the minimum reporting requirements than by the 
weighting of performance categories. In subsequent years, we intend to 
incorporate assessments in the quality performance category into the 
APM scoring standard for all MIPS APMs, and the performance category 
weights will no longer so heavily emphasize advancing care information. 
For the first performance year, we believe that the proposed balance 
between improvement activities and advancing care information is 
appropriate, especially given the possibility that MIPS APM 
participants may be assigned the maximum improvement activities score 
under our final policy, as described below.
    Comment: A commenter stated that improvement activities reporting 
should be done by the APM Entity and that advancing care information 
should not be part of the APM scoring standard. Several commenters 
suggested that all APM Entities should receive full credit for 
improvement activities because they are already performing these 
activities as a result of being a participant in an APM. Other 
commenters suggested that both advancing care information and 
improvement activities be reported and scored at the individual level 
instead of being aggregated to the APM Entity level. A few commenters 
believed that CMS should allow reporting at the APM Entity level for 
all performance categories.
    Response: In contrast to the cost performance category, we do not 
find a compelling reason to reduce the weight of the advancing care 
information performance category because we do not believe it would 
potentially conflict with or duplicate assessments that are made within 
the MIPS APM.
    We agree with commenters that reporting in the improvement 
activities performance category could be more efficient if done by an 
APM Entity on behalf of the APM Entity group. In order to further 
reduce reporting burden on all parties and to better recognize 
improvement activities work performed through participation in MIPS 
APMs, we are modifying our proposal with respect to scoring for the 
improvement activities performance category under the MIPS APM scoring 
standard. As described above, we will assign an improvement activities 
performance category score at the MIPS APM level based on the 
requirements of participating in the particular MIPS APM. The baseline 
score will be applied to each APM Entity group in the MIPS APM. In the 
event that the assigned score is less than the maximum score, we would 
allow the APM Entity to report additional activities to add points to 
the APM Entity group score. With regards to the comment suggesting 
scoring improvement activities at the individual level, we believe that 
reporting and scoring improvement activities at the APM Entity level 
support the goals of APM participation, which focus on collective 
responsibility for the cost and quality of care for beneficiaries. 
Similarly, we agree with the comments pointing out that eligible 
clinicians participating in MIPS APMs are actively engaged in 
improvement activities by virtue of participating in the APM.
    Comment: A commenter sought clarification regarding how a subgroup 
of MIPS eligible clinicians that is not participating in a MIPS APM 
will be treated when other MIPS eligible clinicians in the same large 
multispecialty practice participate in a MIPS APM.
    Response: We maintain lists of participants that are in the MIPS 
APM using the APM participant identifier, and those MIPS eligible 
clinicians will be scored as an APM Entity group under the APM scoring 
standard. The non-APM participants in the practice will report to MIPS 
under the generally applicable MIPS requirements for reporting as an 
individual or group. If the practice decides to report to MIPS as a 
group under its TIN, then its reporting may include some data from the 
MIPS APM participants, even though those TIN/NPI combinations will 
receive their MIPS final score based on the APM Entity group according 
to the scoring hierarchy in section II.E.6. of this final rule with 
comment period.
    We are revising the proposed improvement activities scoring policy 
for MIPS APMs other than the Shared Savings Program or the Next 
Generation ACO Model. CMS will assign a score for the improvement 
activities performance category to each MIPS APM, and that score will 
be applied to each APM Entity group in the MIPS APM. To develop the 
improvement activities score for a MIPS APM, CMS will compare the 
requirements of the MIPS APM with the list of improvement activities 
measures in section II.E.5.f. of this final rule with comment period 
and score those measures in the same manner that they are otherwise 
scored for MIPS eligible clinicians according to section II.E.5.f. of 
this final rule with comment period. Thus, points assigned to an APM 
Entity group in a MIPS APM under the improvement activities performance 
category will relate to

[[Page 77268]]

documented requirements under the terms and conditions of the MIPS APM. 
We will publish the assigned improvement activities scores for each 
MIPS APM on the CMS Web site prior to the beginning of the MIPS 
performance period. In the event that the assigned score does not 
represent the maximum improvement activities score, APM Entities will 
have the opportunity to report additional improvement activities that 
would apply to the APM Entity group score. In the event that the 
assigned score represents the maximum improvement activities score, APM 
Entity groups will not need to report additional improvement 
activities.
    In order to further reduce reporting burden and align with the 
generally applicable MIPS group reporting option, we are also revising 
the proposed advancing care information scoring policy for MIPS APMs 
other than the Shared Savings Program and the Next Generation ACO 
Model.
    A MIPS eligible clinician may receive a score for the advancing 
care information performance category either through individual 
reporting or through group reporting based on a TIN according to the 
generally applicable MIPS reporting and scoring rules for the advancing 
care information performance category, described in section II.E.5.g. 
of this final rule with comment period. We will attribute one score to 
each MIPS eligible clinician in an APM Entity group by looking for both 
individual and group data submitted for a MIPS eligible clinician and 
using the highest score. Thus, instead of only using individual scores 
to derive an APM Entity-level advancing care information score as 
proposed, we will use the highest score attributable to each MIPS 
eligible clinician in an APM Entity group in order to create the APM 
Entity group score based on the average of the highest scores for all 
MIPS eligible clinicians in the APM Entity group.
    Like the proposed policy, each MIPS eligible clinician in the APM 
Entity group will receive one score, weighted equally with that of the 
other clinicians in the group, and we will calculate a single APM 
Entity-level advancing care information score. Also like the proposed 
policy, for a MIPS eligible clinician who has no advancing care 
information score attributable to the individual--the individual's TIN 
did not report as a group and the individual did not report--that MIPS 
eligible clinician will contribute a score of zero to the aggregate APM 
Entity group score.
    In summary, we will attribute one advancing care information score 
to each MIPS eligible clinician in an APM Entity group, which will be 
averaged with the scores of all other MIPS eligible clinicians in the 
APM Entity group to derive a single APM Entity score. In attributing a 
score to an individual, we will use the highest score attributable to 
the TIN/NPI combination of a MIPS eligible clinician. Finally, if there 
is no group or individual score, we will attribute a zero to the MIPS 
eligible clinician, which will be included in the aggregate APM Entity 
score.
    We have revised the proposed policy for the advancing care 
information performance category for MIPS APM participants under the 
APM scoring standard because we recognize that individual reporting in 
the advancing care information performance category for all MIPS 
eligible clinicians in an APM Entity group may be more burdensome than 
allowing some degree of group reporting where applicable, and we 
believe that requiring individual reporting on advancing care 
information in the MIPS APM context will not supply a meaningfully 
greater amount of information regarding the use of EHR technology as 
prescribed by the advancing care information performance category. We 
believe that this revised policy maintains the alignment with the 
generally applicable MIPS reporting and scoring requirements under the 
advancing care information performance category while responding to 
commenters' desires for reduced reporting requirements for MIPS APM 
participants. Therefore, we believe that the revised policy, relative 
to the proposed policy, has the potential to substantially reduce 
reporting burden with little to no reduction in our ability to 
accurately evaluate the adoption and use of EHR technology. We also 
believe this final policy balances the simplicity of TIN-level group 
reporting, which can reduce burden, with the flexibility needed to 
address partial TIN scenarios common among APM Entities in MIPS APMs in 
which a TIN may have some MIPS eligible clinicians participating in the 
APM Entity and some MIPS eligible clinicians not in the APM Entity. 
Table 13 summarizes the finalized APM scoring standard rules for MIPS 
APMs other than the Shared Savings Program and Next Generation ACO 
Model.

   Table 13--APMs Scoring Standard for MIPS APMs Other Than the Shared Savings Program and Next Generation ACO
                         Model--2017 Performance Period for the 2019 Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                                                    Performance
  MIPS  Performance  category         APM Entity submisson              Performance score            category
                                          requirement                                                weight %
----------------------------------------------------------------------------------------------------------------
Quality.......................  The APM Entity group will not    N/A............................               0
                                 be assessed on quality under
                                 MIPS in the first performance
                                 period. The APM Entity will
                                 submit quality measures to CMS
                                 as required by the APM.
Cost..........................  MIPS eligible clinicians will    N/A............................               0
                                 not be assessed on cost.
Improvement Activities........  APM Entities only need to        CMS will assign the same                     25
                                 report improvement activities    improvement activities score
                                 data if the CMS-assigned         to each APM Entity group based
                                 improvement activities scores    on the activities required of
                                 is below the maximum             participants in the MIPS APM.
                                 improvement activities score.    The minimum score if one half
                                                                  of the total possible points.
                                                                  If the assigned score does not
                                                                  represent the maximum
                                                                  improvement activities score,
                                                                  APM Entities will have the
                                                                  opportunity to report
                                                                  additional improvement
                                                                  activities to add points to
                                                                  the APM Entity group score.

[[Page 77269]]

 
Advancing Care Information....  Each MIPS eligible clinician in  CMS will attribute one score to              75
                                 the APM Entity group reports     each MIPS eligible clinician
                                 advancing care information to    in the APM Entity group. This
                                 MIPS through either group        score will be the highest
                                 reporting at the TIN level or    score attributable to the TIN/
                                 individual reporting.            NPI combination of each MIPS
                                                                  eligible clinician, which may
                                                                  be derived from either group
                                                                  or individual reporting. The
                                                                  scores attributed to each MIPS
                                                                  eligible clinician will be
                                                                  averaged to yield a single APM
                                                                  Entity group score.
----------------------------------------------------------------------------------------------------------------

(15) APM Entity Data Submission Method
    Presently, we require APM Entities in 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 quality measure data to CMS. Therefore, we expect that APM 
Entities like the Shared Savings Program ACOs will continue to submit 
their data on quality measures using the CMS Web Interface data 
submission mechanism. Similarly, in the event that the Comprehensive 
ESRD Care (CEC) Initiative is determined to be a MIPS APM, APM Entities 
in the CEC 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. We proposed that all MIPS 
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 advancing care information performance category.
    The following is a summary of the comments we received regarding 
the method used by APM Entities to submit quality data for purposes of 
MIPS.
    Comment: One commenter requested that all APM Entities be required 
to use the QRDA III data submission method because many EHRs now 
support this standard. Another commenter supported retaining the CMS 
Web Interface as the submission method for quality data for APM 
Entities participating in the Shared Savings Program. One commenter 
suggested that the improvement activities information could be 
collected via the CMS Web Interface. Another commenter suggested that 
all MIPS performance categories be submitted via web-based reporting. 
Some commenters communicated that MIPS eligible clinicians 
participating in APMs should not have to report quality data separately 
to both APMs and MIPS and another commenter suggested that MIPS APM 
participants only be required to submit data for the quality and 
improvement activities performance categories.
    Response: We appreciate the commenter's support and suggestions. We 
believe the policies that we are adopting in this final rule regarding 
data submission minimize reporting burden and disruption to APM 
participants and we will continue to consider new reporting methods in 
the future.
    Comment: A commenter recommended that the data collection processes 
be standardized and data submission be minimized to the extent that 
data can be used for various purposes within the Medicare program 
because rural practices often have human and IT infrastructure resource 
limitations.
    Response: We thank the commenters for their input and believe that 
the finalized policies for the APM scoring standard represent further 
reductions in reporting burden and reflect our commitment to streamline 
submissions wherever possible. We will continue to look for ways to 
reduce reporting burdens without compromising the robustness of our 
assessments.
    We are finalizing without changes our proposal regarding APM Entity 
data submission for the quality performance category in all MIPS APMs 
and the advancing care information performance category in the Shared 
Savings Program. APM Entity groups will not submit data for the 
improvement activities performance category unless the improvement 
activities performance category score we assign at the MIPS APM level 
is less than the maximum score. In this instance, the APM Entities in 
the MIPS APM would use one of the MIPS data submission mechanisms if 
they opt to report additional improvement activities in order to 
increase their score for the improvement activities performance 
category. MIPS eligible clinicians in APM Entity groups participating 
in MIPS APMs other than the Shared Savings Program may report advancing 
care information performance category to MIPS using a MIPS data 
submission mechanism for either group reporting at the TIN level or 
individual reporting. Table 14 describes data submission methods for 
the MIPS performance categories under the APM scoring standard.

    Table 14--APM Entity Submission Method for Each MIPS Performance
                                Category
------------------------------------------------------------------------
                                        APM Entity eligible clinician
     MIPS performance category                submission method
------------------------------------------------------------------------
Quality...........................  The APM Entity group submits quality
                                     measure data to CMS as required
                                     under the APM.
Cost..............................  No data submitted by APM Entity
                                     group to MIPS.
Improvement Activities............  No data submitted by APM Entity
                                     group to MIPS unless the assigned
                                     score at the MIPS APM level does
                                     not represent the maximum
                                     improvement activities score, in
                                     which case the APM Entity may
                                     report additional improvement
                                     activities using a MIPS data
                                     submission mechanism.
Advancing Care Information........  Shared Savings Program ACO
                                     participant TINs submit data using
                                     a MIPS data submission mechanism.
                                     Next Generation ACO Model and other
                                     MIPS APM eligible clinicians submit
                                     data at either the individual level
                                     or at the TIN level using a MIPS
                                     data submission mechanism.
------------------------------------------------------------------------


[[Page 77270]]

(16) 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 proposed 
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 
proposed 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, improvement 
activities, and advancing care information performance categories for 
the 2017 performance period. Because these MIPS eligible clinicians 
would not be assessed for the cost performance category, information on 
MIPS performance scores for the cost performance category would not be 
applicable to these MIPS eligible clinicians.
    We also proposed 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 proposed that the 
performance feedback would be available to all MIPS eligible clinicians 
participating in the MIPS APM Entity.
    We proposed 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 improvement activities and advancing care 
information performance categories only, as they would not be assessed 
under the quality or cost performance categories. The information such 
as MIPS measure score comparisons for the quality and cost performance 
categories would not be applicable to these MIPS eligible clinicians 
because no such comparative data would exist. We proposed the 
performance feedback for MIPS eligible clinicians participating in 
these other APMs would be available for each MIPS eligible clinician 
that submitted MIPS data for these performance categories under their 
respective APM Entities. We invited comment on these proposals.
    The following is a summary of the comments we received regarding 
our proposals to provide the same historical information as those 
participating in MIPS, provide feedback on scores for applicable 
performance categories to the APM Entity group for the specific MIPS 
performance period, and provide feedback for those participating in the 
Shared Savings Program at the group TIN level and feedback for those 
participating in the Next Generation ACO Model and all other MIPS APMs 
at the individual level.
    Comment: One commenter recommended that CMS deliver feedback to 
clinicians or organizations by no later than October 1 of the reporting 
year to allow the organization to make appropriate changes in care 
improvement. One commenter stated that eligible clinicians 
participating in APMs need timely feedback to provide a clear 
understanding of patient attribution and performance measurement, and 
several commenters requested that CMS give feedback more frequently 
than annually during the first few years of the program.
    Response: We appreciate that MIPS eligible clinicians participating 
in MIPS APMs would prefer to receive feedback as early and often as 
possible in order to succeed in the Quality Payment Program and 
continue to improve, and we will continue to explore opportunities to 
provide more frequent feedback in the future.
    We are revising the proposed policy in order to maintain alignment 
with the generally applicable MIPS performance feedback policies. As 
noted in section II.E.8.a. of this final rule with comment period, the 
September 2016 QRUR will be used to satisfy the requirement under 
section 1848(q)(12)(A)(i) of the Act to provide MIPS eligible 
clinicians performance feedback on the quality and cost performance 
categories beginning July 1, 2017. We are finalizing a policy that all 
MIPS eligible clinicians scored under the APM scoring standard will 
also receive this performance feedback to the extent applicable, unless 
they did not have data included in the September 2016 QRUR. MIPS 
eligible clinicians without data included in the September 2016 QRUR 
will not receive performance feedback until CMS is able to use data 
acquired through the Quality Payment Program for performance feedback.
6. MIPS Final Score Methodology
    By incentivizing quality and value for all MIPS eligible 
clinicians, MIPS creates a new mechanism for calculating MIPS eligible 
clinician payments. To implement this vision, we proposed a scoring 
methodology that allows for accountability and alignment across the 
performance categories and minimizes burden on MIPS eligible 
clinicians. Further, we proposed a scoring methodology that is 
meaningful, understandable and flexible for all MIPS eligible 
clinicians. Our proposed methodology would allow for multiple pathways 
to success with flexibility for the variety of practice types and 
reporting options. First, we proposed multiple ways that MIPS eligible 
clinicians may submit data to MIPS for the quality performance 
category. Second, we provided greater flexibility in the reporting 
requirements and scoring for MIPS. Third, we proposed that 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 outlined proposals which we believed are operationally feasible 
for us to implement in the transition year, while maintaining our 
longer-term 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 final score for each 
MIPS eligible clinician for each performance period; and (3) use the 
final score of the MIPS eligible clinician for a performance period to 
determine and apply a MIPS payment adjustment factor (and, as 
applicable, an additional MIPS payment adjustment factor) to the MIPS 
eligible clinician for the MIPS payment year. In section II.E.5 of the 
proposed rule (81 FR 28181), we proposed the measures and activities 
for each of the four MIPS performance categories: Quality, cost, 
improvement activities, and advancing care information. This section of 
the final rule with comment period discusses our proposals of 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 final score under section 1848(q)(5) of 
the Act based on the scores determined for each of the four performance 
categories. We proposed to

[[Page 77271]]

define the performance category score in section II.E.6 of the proposed 
rule (81 FR 28247) 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. In section II.E.7 of the proposed 
rule (81 FR 28271), we included proposals for determining the MIPS 
adjustments factors based on the final score.
    As noted in section II.E.2 of the proposed rule (81 FR 28176), we 
proposed 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 APM Entity participating in a MIPS APM). Further, 
in section II.E.5.a.(2) of the proposed rule (81 FR 28182), we proposed 
that data for all four MIPS performance categories would be submitted 
using the same identifier (either individual or group) and that the 
final score would be calculated using the same identifier. Section 
II.E.5.h of the final rule with comment period describes our policies 
in the event that an APM Entity scored through the APM scoring standard 
fails reporting. The scoring proposals in section II.E.6 of the 
proposed rule (81 FR 28247), 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 on scoring, the term ``MIPS eligible 
clinician'' will refer to clinicians that are reporting and are scored 
at either the individual or group level, but will not refer to 
clinicians participating in an APM Entity scored through the APM 
scoring standard.
    Comments related to APM Entity group reporting and scoring for MIPS 
eligible clinicians participating in MIPS APMs are summarized in 
section II.E.5.h of this final rule with comment period. 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 are excluded from 
MIPS, or unless another MIPS exclusion applies. We finalize at Sec.  
414.1380(d) that MIPS eligible clinicians in APM Entities that are 
subject to the APM scoring standard are scored using the methodology 
under Sec.  414.1370, as described in II.E.5.h of this final rule with 
comment period.
    MIPS eligible clinicians who participate in APMs that are not MIPS 
APMs as defined in section II.E.5.h of the proposed rule (81 FR 28234) 
would report to MIPS as an individual MIPS eligible clinician or group. 
Unless otherwise specified, the proposals in section II.E.6.a of the 
proposed rule (81 FR 28247) 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 has many components and 
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 or is not 
allowed.
    We have heard from stakeholders about our MIPS proposals. There are 
some major concerns, particularly for the transition year (MIPS payment 
year 2019), about program complexity, not having sufficient time to 
understand the program before being measured, and potentially receiving 
negative adjustments. Based on stakeholder feedback discussed in this 
section, we are adjusting multiple parts of our proposed scoring 
approach to enhance the likelihood MIPS eligible clinicians who may 
have not had time to prepare can succeed under the program. We believe 
that these adjustments will enable more robust and thorough engagement 
with the program over time. Specifically, we have modified performance 
standards for the performance categories used to evaluate the measures 
and activities as well as the methodology to create a final score, and 
we lowered the performance threshold. Thus, we have created a 
transition year scoring methodology that does the following:
     Provides a negative 4 percent payment adjustment to MIPS 
eligible clinicians who do not submit any data to MIPS;
     Ensures that MIPS eligible clinicians who submit data and 
meet program requirements under any of the three performance categories 
for which data must be submitted (quality, improvement activities, and 
advancing care information) for at least a 90-day period,\20\ and have 
low overall performance in the performance category or categories on 
which they choose to report may receive a final score at or slightly 
above the performance threshold and thus a neutral to small positive 
adjustment, and
---------------------------------------------------------------------------

    \20\ We note there are special circumstances in which MIPS 
eligible clinicians may submit data for a period of less than 90 
days and avoid a negative MIPS payment adjustment. For example, in 
some circumstances, MIPS eligible clinicians may meet data 
completeness criteria for certain quality measures in less than the 
90-day period. Also, in instances where MIPS eligible clinicians do 
not meet the data completeness criteria for quality measures 
submitted, we will provide partial credit for submission of these 
measures.
---------------------------------------------------------------------------

     Ensures that MIPS eligible clinicians who submit data and 
meet program requirements under each of the three performance 
categories for which data must be submitted (quality, improvement 
activities, and advancing care information) for at least a 90-day 
period, and have average to high overall performance across the three 
categories may receive a final score above the performance threshold 
and thus a higher positive adjustment, and, for those MIPS eligible 
clinicians who receive a final score at or above the additional 
performance threshold, an additional positive adjustment.
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 section II.E.6.a of the proposed rule (81 FR 28248). 
However, as the four performance categories collectively create a 
single MIPS final score, there are some cross-cutting policies that we 
proposed 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 proposed 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 defined the term, MIPS payment year, at 
Sec.  414.1305 as the calendar year in which MIPS payment adjustments 
are applied. Performance

[[Page 77272]]

standards for each performance category were proposed in more detail in 
section II.E.6 of the proposed rule (81 FR 28247). 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 of the proposed rule (81 FR 
28249), summarizes the proposed performance standards.
    The following is a summary of the comments we received regarding 
our performance standard proposals.
    Comment: Multiple commenters were concerned that the performance 
standards may not be available in advance of the performance period, or 
that the performance standards methodologies would only be available 
``when possible''. Commenters requested that CMS publish the 
performance standards with as much advance notice as possible so that 
MIPS eligible clinicians will be able to plan and know the standards 
against which they will be measured.
    Response: The performance standard methodology will be known in 
advance so that MIPS eligible clinicians can understand how they will 
be measured. For improvement activities and advancing care information, 
the performance standards are known prior to the performance period and 
are delineated in this final rule with comment period. For the quality 
performance category, benchmarks are known prior to the performance 
period when benchmarks are based on the baseline period. For new 
measures in the quality performance category, for quality measures 
where there is no historical baseline data to build the benchmarks, and 
for measures in the cost performance category, the benchmarks will be 
based on performance period data and therefore, will not be known prior 
to the performance period.
    When performance standards for certain quality measures are not 
known prior to the performance period, we are implementing protections 
for MIPS eligible clinicians who ultimately perform poorly on these 
measures. For example, as discussed in section II.E.6.a.(2)(b) of this 
final rule with comment period, we have added quality performance 
floors for the transition year to protect MIPS eligible clinicians 
against unexpectedly low performance scores. For cost measures, the 
benchmarks will be based on performance period data and cannot be 
published in advance. However, we do plan to provide feedback on 
performance so that MIPS eligible clinicians can understand their 
performance and improve in subsequent years. We will provide feedback 
before the performance period based on prior period data, illustrating 
how MIPS eligible clinicians might perform on these measures and we 
will provide feedback after the performance period based on performance 
period data, illustrating how MIPS eligible clinicians actually 
performed on these measures.
    In addition, as discussed in section II.E.5.e.(2) of this final 
rule with comment period, we are also lowering the weight of the cost 
performance category to 0 percent of the final score for the transition 
year.
    Finally, as discussed in section II.E.7.c of this final rule with 
comment period, we are lowering the performance threshold for this 
transition year.
    Comment: One commenter stated that the government should not decide 
on definitions of quality and financial rewards or penalties for 
meeting such standards.
    Response: 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, including quality, and section 
1848(q)(1)(A) of the Act generally requires us to develop a scoring 
methodology for assessing the total performance of each MIPS eligible 
clinician according to those standards and to use such scores to 
determine and apply MIPS payment adjustment factors and, as applicable, 
additional MIPS adjustments. We believe our proposals are consistent 
with these statutory requirements.
    After consideration of the comments, we are finalizing 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 are finalizing at Sec.  414.1380(a) 
that MIPS eligible clinicians are scored under MIPS based on their 
performance on measures and activities in four performance categories. 
MIPS eligible clinicians are scored against performance standards for 
each performance category and receive a final score, composed of their 
scores on individual measures and activities, and calculated according 
to the final score methodology. We are also finalizing at Sec.  
414.1380(a)(1) that measures and activities in the four performance 
categories are scored against performance standards.
    MIPS eligible clinicians will know, in advance of the performance 
period, the methodology for determining the performance standards and 
the methodology that will be used to score their performance. MIPS 
eligible clinicians will know the numerical performance standards in 
the quality performance category in advance of the performance period, 
when possible. A summary of the performance standards per performance 
category is provided in Table 15. As discussed in section II.E.6.a.(2) 
of this final rule with comment period, we are finalizing at Sec.  
414.1380(a)(1)(i) that for the quality performance category, measures 
are scored between zero and 10 points. Performance is measured against 
benchmarks. Bonus points are available for both submitting specific 
types of measures and submitting measures using end-to-end electronic 
reporting. As discussed in section II.E.6.a.(3) of this final rule with 
comment period, we are finalizing at Sec.  414.1380(a)(1)(ii) that for 
the cost performance category, that measures are scored between one and 
10 points. Performance is also measured against benchmarks. As 
discussed in section II.E.6.a.(4), we are also finalizing at Sec.  
414.1380(a)(1)(iii) that for the improvement activities performance 
category each improvement activity is worth a certain number of points. 
The points for each reported activity are summed and scored against a 
total potential performance category score of 40 points as discussed in 
section. As discussed in section II.E.6.a.(5) of this final rule with 
comment period, we are finalizing at Sec.  414.1380(a)(1)(iv), that for 
the advancing care information performance category, the performance 
category score is the sum of a base score, performance score, and bonus 
score.
    As discussed in section II.E.6.a.(2) of this final rule with 
comment period, we are making changes to the quality performance 
category in response to comments received and are providing a minimum 
floor for all submitted measures to provide additional safeguards in 
the transition year. As discussed in section II.E.6.a.(4) of this final 
rule with comment period, we are making a minor modification to the 
improvement activities standard to provide additional clarification on 
improvement activities scoring and to align with comments received. 
Further, as discussed in section II.E.5.f of this final rule with 
comment period, we are making additional changes to the advancing care 
information performance category to align with comments

[[Page 77273]]

received. We are also finalizing our definition of performance category 
score as defined in 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. 
Additionally, we are finalizing the definition of the term, MIPS 
payment year with a modification for further consistency with the 
statute. Specifically, MIPS payment year is defined at Sec.  414.1305 
as a calendar year in which the MIPS payment adjustment factor, and if 
applicable the additional MIPS payment adjustment factor, are applied 
to Medicare Part B payments.

    Table 15--Performance Category Performance Standards for the 2017
                           Performance Period
------------------------------------------------------------------------
                              Proposed performance    Final performance
    Performance category            standard              standard
------------------------------------------------------------------------
Quality.....................  Measure benchmarks    Measure benchmarks
                               to assign points,     to assign points,
                               plus bonus points.    plus bonus points
                                                     with a minimum
                                                     floor for all
                                                     measures.
Cost........................  Measure benchmarks    Measure benchmarks
                               to assign points.     to assign points.
Improvement Activities......  Based on              Based on
                               participation in      participation in
                               activities that       activities listed
                               align with the        in Table H of the
                               patient-centered      Appendix final rule
                               medical home.         with comment
                                                     period.
                              Number of points      Based on
                               from reported         participation as a
                               activities compared   patient-centered
                               against a highest     medical home or
                               potential score of    comparable
                               60 points.            specialty practice.
                              Based on              Based on
                               participation in      participation as an
                               the CMS study on      APM.
                               improvement
                               activities and
                               measurement;.
                              Number of points
                               from reported
                               activities or
                               credit from
                               participation in an
                               APM compared
                               against a highest
                               potential score of
                               40 points.
Advancing Care Information..  Based on              Based on
                               participation (base   participation (base
                               score) and            score) and
                               performance           performance
                               (performance score).  (performance
                                                     score).
                              Base score: Achieved  Base score: Achieved
                               by meeting the        by meeting the
                               Protect Patient       Protect Patient
                               Health Information    Health Information
                               objective and         objective and
                               reporting the         reporting the
                               numerator (of at      numerator (of at
                               least one) and        least one) and
                               denominator or yes/   denominator or yes/
                               no statement as       no statement as
                               applicable (only a    applicable (only a
                               yes statement would   yes statement would
                               qualify for credit    qualify for credit
                               under the base        under the base
                               score) for each       score) for each
                               required measure.     required measure.
                              Performance score:    Performance score:
                               Decile scale for      Between zero and 10
                               additional            or 20 percent per
                               achievement on        measure (as
                               measures above the    designated by CMS)
                               base score            based upon measure
                               requirements, plus    reporting rate,
                               1 bonus point.        plus up to 15
                                                     percent bonus
                                                     score.
------------------------------------------------------------------------

(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 proposed 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 proposed to 
incorporate the following characteristics into the scoring 
methodologies for each of the four MIPS performance categories:
     For the quality and cost 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. We noted that a similar 
point framework has been successfully implemented in several other CMS 
quality programs including the Hospital VBP Program.
     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 proposed 
that 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 of the 
proposed rule (81 FR 28181 through 28247) and this section of the final 
rule with comment period. 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 the 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.
    We noted that we anticipated scoring in future years would continue 
to align and simplify. We requested comment on the characteristics of 
the proposed unified scoring system.
    We also proposed 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

[[Page 77274]]

submission mechanism per performance category. For example, a MIPS 
eligible clinician could use one submission mechanism for sending 
quality measures and another for sending improvement activities 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 did 
intend to allow flexibility, for example, in rare 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 (such as scoring the quality performance category 
with data from a registry, and also scoring the quality performance 
category with data from a QCDR) and use the highest performance 
category score for the MIPS eligible clinician final score. We would 
not however, combine the submission mechanisms to calculate an 
aggregated performance category score.
    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 proposed opportunities for QCDRs to report new and 
innovative quality measures. In addition, several improvement 
activities emphasize QCDR participation. Finally, we proposed under 
section II.E.5.a of the proposed rule (81 FR 28181) 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 final score. We further believe these 
flexibilities encourage use of end-to-end electronic data extraction 
and submission where feasible today, and foster further development of 
methods that avoid manual data collection where automation is a valid, 
reliable option and that promote the goal of capturing data once and 
re-using it for multiple appropriate purposes.
    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 relative to 
performance standards, 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 transition year of 
MIPS, but we solicited comment on how best to incorporate improvement 
scoring for all performance categories.
    The following is a summary of the comments we received regarding 
our proposal for a unified scoring system.
    Comment: Some commenters expressed support for the unified scoring 
system and agreed with having a unified and simplified scoring system, 
but some believed the proposed scoring methodology for MIPS is 
confusing and requires more alignment across performance categories. 
Commenters noted that physicians will not be able to understand how CMS 
calculated their score and would not know if appeals to CMS would be 
needed in order to correct information or plan for the future. Several 
commenters requested one single score, or fewer than four separate 
performance category scores, rather than aggregating individual scores 
for the four performance categories. Others noted the need for feedback 
prior to scoring. Others recommended simplifying the scoring system by 
aligning it across performance categories, and one commenter expressed 
concern about the total number of measures and activities across the 
four performance categories adding complexity to the scoring.
    Response: Despite our efforts to create a transparent and 
standardized scoring system, we understand that some stakeholders may 
be concerned about the scoring complexity and may want more alignment 
across categories. We also understand stakeholders' requests for 
feedback prior to scoring. Several of our core objectives for MIPS are 
to promote program understanding and participation through customized 
communication, education, outreach and support, and to improve data and 
information sharing to provide accurate, timely, and actionable 
feedback to MIPS eligible clinicians. Prior to receiving a payment 
adjustment, MIPS eligible clinicians will receive timely confidential 
feedback on their program performance as discussed in section II.E.8.a 
of this final rule with comment period.
    We have simplified the overall scoring approach for MIPS eligible 
clinicians in the transition year. Under this scoring approach, MIPS 
eligible clinicians who report measures/activities with minimal levels 
of performance will not be subject to negative payment adjustments if 
their final score is at or above the performance threshold. We believe 
having scores for individual performance categories aligns with the 
statute; however, we have provided numerous examples within section 
II.E.6.a.(2)(g) of this final rule with comment period to provide 
transparency as to how we will calculate MIPS eligible clinicians' 
scores and help MIPS eligible clinicians to understand how to succeed 
in the program. Further, we will continue to provide additional 
materials to create a transparent and standardized scoring system.
    Comment: Commenters expressed concern that the unified scoring 
system may not allow consumers and payers to make meaningful 
comparisons across MIPS eligible clinicians. The commenters' reasons 
for concern include the varied reporting options and different score 
denominators.
    Response: We have taken a patient-centered approach toward 
implementing our unified scoring system, which does allow for special 
circumstances for certain types of practices such as non-patient facing 
professionals, as well as small practices, rural practices and those in 
HPSA geographic areas. We believe our approach balances the interests 
of patients and payers while also providing flexibility for the variety 
of MIPS eligible clinician practices and encourages more collaboration 
across practice types.
    Comment: Multiple commenters requested clarification on evaluating 
group performance within each of the four performance categories; 
specifically, whether it is CMS's intent to evaluate each individual 
within a group and somehow aggregate that performance into a composite 
group score or to evaluate the group as a single entity.
    Response: Evaluation of group practices and individual practices is 
discussed under each performance category in sections II.E.5.b., 
II.E.5.e., II.E.5.f., and II.E.5.g. of this final rule with comment 
period.
    Comment: One commenter requested that CMS explain the benefit of

[[Page 77275]]

reporting via QCDR and why this method is emphasized in the proposed 
rule.
    Response: QCDRs have more flexibility to collect data from 
different data sources and to rapidly develop innovative measures that 
can be incorporated into MIPS. Therefore, we believe that QCDRs provide 
an opportunity for innovative measurement that is both relevant to MIPS 
eligible clinicians and beneficial to Medicare beneficiaries. In 
addition, section 1848(q)(1)(E) of the Act requires us to encourage the 
use of QCDRs.
    Comment: Some commenters supported the removal of ``all-or-
nothing'' scoring. One commenter encouraged CMS to create more partial-
scoring opportunities.
    Response: We appreciate the comment on the removal of ``all-or-
nothing'' scoring. We will take these comments into consideration when 
considering additional recommendations for partial credit in future 
rulemaking
    Comment: One commenter expressed concern that CMS cannot measure 
physician ``performance'' accurately. The commenter cited multiple 
sources that supported this statement.
    Response: We recognize the challenges in measuring clinician 
performance and continue to work with stakeholders to address concerns.
    After consideration of these comments, we are finalizing all of our 
policies related to unified scoring as proposed, except we are 
modifying our proposed policy on scoring quality measures.
    We list below all policies we are finalizing related to our 
proposed unified scoring system.
     For the quality and cost performance categories, all 
measures will 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.
     The measure and activity performance standards will be 
published, where feasible, before the performance period begins, so 
that MIPS eligible clinicians can track their performance during the 
performance period.
     MIPS eligible clinicians who 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 policies 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.
    We also are finalizing 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 improvement activities 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 did intend to allow 
flexibility, for example, in rare 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 will score all 
the options (such as scoring the quality performance category with data 
from a registry, and also scoring the quality performance category with 
data from a QCDR) and use the highest performance category score for 
the MIPS eligible clinician final score. We will not however, combine 
the submission mechanisms to calculate an aggregated performance 
category score. The one exception to this policy is CAHPS for MIPS, 
which is submitted using a CMS-approved survey vendor. CAHPS for MIPS 
can be scored in conjunction with other submission mechanisms.
    With regard to the above policy, we note that some submission 
mechanisms allow for multiple measure types, such as a QCDR could 
submit data on behalf of an eligible clinician for a mixture of MIPS 
eCQMs and non-MIPS measures. However, we recognize that the scoring of 
only one submission mechanism in the transition year may influence 
which measures a MIPS eligible clinician selects to submit for the 
performance period. For example, a MIPS eligible clinician or group may 
only be able to report a limited number of measures relevant to their 
practice through a given submission mechanism, and therefore they may 
elect to choose a different submission mechanism through which a more 
robust set of measures relevant to their practice is available. We are 
seeking comment on whether we should modify this policy to allow 
combined scoring on all measures submitted across multiple submission 
mechanisms within a performance category. Specifically, we are seeking 
comment on the following questions:
     Would offering a combined performance category score 
across submissions mechanisms encourage electronic reporting and the 
development of more measures that effectively use highly reliable, 
accurate clinical data routinely captured by CEHRT in the normal course 
of delivering safe and effective care? If so, are there particular 
approaches to the performance category score combination that would 
provide more encouragement than others?
     What approach should be used to combine the scores for 
quality measures from multiple submission mechanisms into a single 
aggregate score for the quality performance category? For example, 
should CMS offer a weighted average score on quality measures submitted 
through two or more different mechanisms? Or take the highest scores 
for any submitted measure regardless of how the measure is submitted?
     What steps should CMS and ONC consider taking to increase 
clinician and consumer confidence in the reliability of the technology 
used to extract, aggregate, and submit electronic quality measurement 
data to CMS?
     What enhancements to submission mechanisms or scoring 
methodologies for future years might reinforce incentives to encourage 
electronic reporting and improve reliability and comparability of CQMs 
reported by different electronic mechanisms?
    We are modifying our proposed policy on scoring quality measures. 
Specifically, as discussed in section II.E.6.a.(2)(b) of this final 
rule with comment period, for the transition year, we are providing a 
global minimum floor of 3 points for all quality measures submitted. As 
discussed in section II.E.6.a.(2)(c) of the final rule with comment 
period, we are also modifying our proposed policy in which we would 
only score the measures that meet certain standards (such as required 
case minimum). For the transition year, we are automatically providing 
3 points for quality measures that are submitted, regardless of whether 
they lack a benchmark or do not meet the case minimum or data 
completeness requirements. Finally, as discussed in section II.E.6.h of 
this final rule with comment period, we intend to propose options for 
scoring based on improvement through future rulemaking.

[[Page 77276]]

    Various policies related to scoring the four performance categories 
are finalized at Sec.  414.1380(b) and described in more detail in 
sections II.E.6.a.(2), II.E.6.a.(3), II.E.6.a.(4), and II.E.5.g.(6) of 
this final rule with comment period.
(c) Baseline Period
    In other Medicare quality programs, such as the Hospital VBP 
Program, 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 Hospital VBP Program, we intend to adopt one 
baseline period for each MIPS payment year that is 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 proposed at section 
II.E.6.a.(1)(c) of the proposed rule (81 FR 28250) that the baseline 
period would be the 12-month calendar year that is 2 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 proposed that the baseline period would be CY 
2015 which is 2 years prior to the proposed CY 2017 performance period. 
As discussed in section II.E.6.a.(2)(a) of the proposed rule (81 FR 
28251), we proposed 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 and an exception for CMS Web Interface 
reporters, which will use the benchmarks associated with Shared Savings 
Program. For the cost performance category, we proposed to set the 
benchmarks using performance in the performance period and not the 
baseline period, as discussed in section II.E.6.a.(3) of the proposed 
rule (81 FR 28259). For the cost performance category, we also made an 
alternative proposal to set the benchmarks using performance in the 
baseline period. We proposed to define the term ``measure benchmark'' 
for the quality and cost performance categories (81 FR 28250) as the 
level of performance that the MIPS eligible clinician will be assessed 
on for a performance period at the measures and activities level.
    The following is a summary of the comments we received regarding 
our proposal to define the baseline period.
    Comment: One commenter expressed concern that baseline scoring may 
be misaligned when using benchmarks from 1 year for the cost 
performance category and a different year for measures in the quality 
performance category. Multiple commenters believe all categories should 
use the same year to determine benchmarks. Some commenters requested 
that CMS measure MIPS eligible clinicians as close as possible to the 
performance period, ideally, less than 2 years from the performance 
period. Others noted concern about the ability of a clinician to 
correct actions with 2-year old data.
    Response: Ideally, we would like to have data sources for our 
benchmarks aligned across the quality and cost performance categories. 
However, we have purposefully chosen different periods for the quality 
and cost performance categories. We proposed to use the baseline period 
for benchmarks for the quality performance category so that MIPS 
eligible clinicians can know quality performance category benchmarks in 
advance; however, we believe there are disadvantages to benchmarking 
cost measures to a previous year. For example, development of a new 
technology or a change in payment policy could result in a significant 
change in typical cost from year to year. Therefore, for more accurate 
data, it is better to build cost benchmarks from performance period 
data than the baseline period. We believe there is more value in the 
advance notice for quality performance measures so that MIPS eligible 
clinicians can benchmark themselves for quality measures when 
historical data is available. In contrast, for the cost performance 
category, we believe it is more beneficial to base benchmarks on the 
performance period. After considering comments, we are finalizing that 
the baseline period will be the 12-month calendar year that is 2 years 
prior to the performance period for the MIPS payment year. We believe 
that 2 years is the most recent data we can use to develop benchmarks 
prior to the performance period.
    We will use performance in the baseline period to set benchmarks 
for the quality performance category, with the exception of new quality 
measures, or quality measures that lack historical data, for which we 
would set the benchmarks using performance in the performance period, 
and an exception for CMS Web Interface reporters which we will use the 
benchmarks associated with the Shared Savings Program. For the cost 
performance category, we will set the benchmarks using performance in 
the performance period and not the baseline period. We are defining the 
term ``measure benchmark'' for the quality and cost performance 
categories at Sec.  414.1305 as the level of performance that the MIPS 
eligible clinician is assessed on for a specific performance period at 
the measures and activities level.
(2) Scoring the Quality Performance Category
    In section II.E.5.b.(3) of the proposed rule, we proposed multiple 
ways that MIPS eligible clinicians may submit data for the quality 
performance category to MIPS; however, we proposed that the scoring 
methodology would be consistent regardless of how the data is 
submitted. In summary, we proposed 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. We proposed that 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. We proposed that 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) of the proposed rule (81 FR 28188) but is unable to be 
scored for any of the reasons listed in section II.E.6.a.(2) of the 
proposed rule (81 FR 28250), such as not meeting the required case 
minimum or a measure lacks a benchmark. We described in section 
II.E.6.a.(2)(d) of the proposed rule (81 FR 28254), 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) of the proposed rule (81 FR 
28256), 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

[[Page 77277]]

to the cap) divided by the sum of total possible points. Examples of 
the calculations were provided in the proposed rule (81 FR 28256).
    In section II.E.6.b of the proposed rule (81 FR 28269), we 
discussed 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 proposed at section 
II.E.6.a.(2)(a) of the proposed rule (81 FR 28251) 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 proposed to 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 proposed to 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 proposed to create separate benchmarks for 
submission mechanisms that do not have comparable measure 
specifications. For example, several eCQMs have specifications that are 
different than the corresponding measure from registries. We proposed 
to develop separate benchmarks for EHR submission mechanisms, claims 
submission mechanisms, and QCDRs and qualified registry submission 
mechanisms.
    For CMS Web Interface reporting, we proposed 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, which were finalized in previous 
rulemaking.\21\ We proposed to adopt the Shared Savings Program 
performance year benchmarks for measures that are reported through the 
CMS Web Interface for the MIPS performance period, but proposed to 
apply the MIPS method of assigning 1 to 10 points to each measure as an 
alternative to calculating separate MIPS benchmarks. Because the Shared 
Savings Program does not publicly post or use benchmarks below the 30th 
percentile, we proposed to assign all scores below the 30th percentile 
a value of 2 points, which is consistent with the mid-cluster approach 
we proposed for topped out measures. We believed 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 the 
proposed rule (81 FR 28237 through 28243), we proposed to use the MIPS 
benchmarks to score MIPS eligible clinicians in 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.
---------------------------------------------------------------------------

    \21\ Shared Saving Program quality performance benchmarks and 
scoring methodology regulations: Medicare Program; Medicare Shared 
Savings Program: Accountable Care Organizations; Final Rule, 76 FR 
67802 (Nov. 2, 2011). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2014; Final Rule, 78 FR 
74230 (Dec. 10, 2013). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2015; Final Rule, 79 FR 
67907 (Nov. 13, 2014). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2016; Final Rule, 80 FR 
71263 (Nov. 16, 2015).
---------------------------------------------------------------------------

    As an alternative approach, we considered creating CMS Web 
Interface specific benchmarks for MIPS instead of using the Shared 
Savings Program benchmarks. This alternative approach for MIPS 
benchmarks would be restricted to CMS Web Interface reporters and would 
not include other MIPS data submission methods or other data sources 
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 requested 
comments on building CMS Web Interface specific benchmarks.
    We proposed that 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 proposed 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 through 69322). We would also include data 
from APM Entity submissions in the benchmark but would not score APM 
Entities using the MIPS scoring methodology. For APM scoring, we refer 
to section II.E.5.h. of the proposed rule (81 FR 28234).
    To ensure that we have robust benchmarks, we proposed 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) of the proposed rule (81 FR 28185), as well as 
meeting the required case minimum criteria for scoring that is defined 
later in this section. We proposed 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 proposed 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 were concerned that the 0 percent performance rate represents 
clinicians who are not actively engaging in that measurement activity. 
We did not want to inappropriately skew the distribution. We solicited 
comment on whether or not to include 0 percent performance in the 
benchmark.
    We proposed at Sec.  414.1380(b)(1)(i) to base the benchmarks on 
performance in the baseline period when possible. We

[[Page 77278]]

proposed 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 proposed 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, we proposed that the actual 
numerical benchmarks would not be published until after the performance 
period for quality measures that do not have comparable data from the 
baseline period. The methodology for creating the benchmarks was 
discussed in the proposed rule (81 FR 28251).
    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, in the proposed rule (81 FR 28252), we expressed 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 believed 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 did not propose the 
alternatives we considered, because we wanted to encourage adoption and 
measured performance of new measures, however, we did 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 sought 
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 clarified 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 proposed to have more robust 
data submissions, as described in section II.E.5.b.(3) of the proposed 
rule (81 FR 28188). We recognized that comparing all-payer performance 
to a benchmark that is built, in part, on Medicare data is a limitation 
and noted we would monitor the benchmarks to see if we need to develop 
separate benchmarks. We also noted that this data issue would resolve 
in a year or two, as new MIPS data becomes the historical benchmark 
data in future years.
    The following is a summary of the comments we received regarding 
our proposals for quality measure benchmarks.
    Comment: Commenters generally supported our proposed approach: some 
commenters supported the establishment of separate benchmarks for 
submission mechanisms that do not have comparable measure 
specifications, and another supported using national benchmarks and 
linear-based scoring in the MIPS performance scoring methodology.
    Response: We agree with commenters and are finalizing at Sec.  
414.1380(b)(1)(iii) the establishment of separate benchmarks for the 
following submission mechanisms: EHR submission options; QCDR and 
qualified registry submission options; claims submission options; CMS 
Web Interface submission options; CMS-approved survey vendor for CAHPS 
for MIPS submission options; and administrative claims submission 
options. We note that the administrative claims benchmarks are for 
measures derived from claims data, such as the readmission measure. As 
discussed below, the CMS Web Interface submission benchmarks will be 
the same as the Shared Savings Program benchmarks for the corresponding 
Shared Savings Program performance period. We note that assigning 
separate benchmarks in this manner creates opportunities for clinicians 
to achieve higher quality scores by selectively choosing submission 
mechanisms; as discussed in section II.E.5.a.(2) in this final rule 
with comment period, we intend to monitor for such activity and to 
report back on any findings from our monitoring in future rulemaking.
    Comment: Commenters requested that CMS provide each measure's 
benchmarks in advance, with one recommending that CMS do so in the 
final rule and in future proposed rules so that MIPS eligible 
clinicians know their target goals or, alternatively, that CMS hold a 
listening session for input on benchmarks for each measure. The 
commenters stated that they did not want to be held accountable for 
performance if benchmarks cannot be provided in advance. One commenter 
noted that it would be difficult to gauge performance and areas for 
improvement since benchmarks would not be released in time and real 
time feedback is needed.
    Response: We agree with commenters that quality benchmarks should 
be made public and should be known in advance when possible so that 
MIPS eligible clinicians can understand how they will be measured. We 
are finalizing that measure benchmarks are based on historical 
performance for the measures based on a baseline period. Those 
benchmarks will be known in advance of the performance period. We 
finalize this approach with one exception. The CMS Web Interface will 
use benchmarks from the corresponding performance year of the Shared 
Savings Program and not the baseline year. Those benchmarks are also 
known in advance of the performance period.
    When no comparable data exists from the baseline period, then we 
finalize that we will use information from the performance period (CY 
2017 for the transition year, during which MIPS eligible clinicians may 
report for a minimum of any continuous 90-day period, as discussed in 
section II.E.4 of this final rule with comment period) to assess 
measure benchmarks. In this case, while the benchmark methodology is 
being finalized in this final rule with comment period, the numerical 
benchmarks will not be known in advance of the performance period. 
However, as discussed throughout this final rule with comment period, 
we have added protections to protect MIPS eligible clinicians from poor 
performance, particularly in the transition year.
    Comment: Some commenters did not support the use of 2015 data or 
other historical data to set the 2017 benchmarks, with one commenter 
stating that CMS would be using data from periods during which MIPS did 
not exist and requesting that CMS establish an adequate foundation for

[[Page 77279]]

benchmarks based on MIPS data. One commenter recommended that CMS not 
set benchmarks or hold clinicians accountable for performance until it 
has established an adequate foundation based on MIPS data. Another 
emphasized using reliable and valid patient sample sizes or adequate 
foundation of data to determine benchmarks even if only for limited 
number of measures.
    Response: In establishing the performance standards, we had to 
choose between two feasible alternatives: Either develop benchmarks 
based on historical data and provide the numerical benchmarks in 
advance of the performance period; or use more current data for 
benchmarks and not provide the numerical benchmarks in advance of the 
performance period. We believe there is more value in providing advance 
notice for quality performance category measures so that MIPS eligible 
clinicians can set a clear performance goal for these measures, 
provided that historical data is available. In many cases, MIPS quality 
measures are the same as those available under PQRS, so we believe that 
using PQRS data is appropriate for a MIPS benchmark. In contrast, we do 
not believe there is more value in providing advance notice for cost 
performance category measures since the claims data for the cost 
performance category can vary due to payment policies, payment rate 
adjustment and other factors. Therefore, we believe having the cost 
performance category measures based on performance period data will be 
more beneficial to MIPS eligible clinicians given that it is based on 
more current data. For the cost performance category, we believe it is 
more beneficial to base performance on the performance period.
    Comment: A few commenters opposed our benchmarking approach, with 
some opposing our proposal to separate benchmarks solely by submission 
mechanism given that medical groups vary by size, location, specialty 
and other factors which should be built into developing the benchmarks. 
Commenters recommended specialty-specific benchmarks, benchmarking by 
region, and benchmarks based on group size (for example, groups with 
10-50 clinicians, 51-100 clinicians, 101-500 clinicians, 501-1,000 
clinicians, and >1,000 clinicians). In other words, commenters did not 
believe in one overall benchmark but rather that groups should be 
compared only to other similar groups (for example, APM entities to APM 
entities, individuals to individuals, clinicians by specialty and 
groups to groups, small practices to small practices, or region by 
region).
    Response: We want the benchmarks to be as broad and inclusive as 
possible and to establish a single performance standard whenever the 
measure specifications are comparable. We finalized separate benchmarks 
by submission mechanism only when the differences in specifications 
make comparisons less valid. We do not believe differences in 
specialty, group size, and region create an inherent need for separate 
benchmarks as the specifications are comparable across each of these 
categories. Furthermore, we do not expect differences in location, 
practice size, and other characteristics to impact the quality of care 
provided. We also want to keep robust sample sizes in each benchmark, 
and stratifying a benchmark by different characteristics would risk 
fragmenting the sample size in such a manner that we do not have a 
valid benchmark for some measures.
    We estimated quality performance scores by practice size based on 
historical data and did not see a systematic difference in performance 
by practice among MIPS eligible clinicians that submitted complete and 
reliable data to require a need for separate benchmarks. However, as we 
monitor the MIPS program, we will continue to evaluate whether we need 
to further refine and stratify the benchmarks.
    Comment: One commenter recommended that CMS should analyze the 
quality performance data by looking at Medicare and non[hyphen]Medicare 
populations separately, and should also examine whether stratifying the 
performance data by specialty code, site[hyphen]of[hyphen]service code, 
or both will result in more accurate measurement and fair adjustments 
for physicians who treat the sickest patients.
    Response: We want accurate and fair measurement in the MIPS 
program. We have incorporated measures that have gone through public 
review. In many cases, we believe the measure developers have 
considered scenarios where risk adjustment is required to consider mix 
of patient population and site-of-service and do not believe we need a 
separate universal policy to further stratify performance by patient 
mix, specialty, or site of service for all measures. As we move through 
the transition year, however, we will continue to evaluate the need for 
additional adjustments or stratification for informational purposes and 
would make any proposed adjustments through future rulemaking.
    Comment: One commenter expressed their belief that integrating data 
from MIPS eligible clinicians participating in MIPS APMs with data from 
MIPS eligible clinicians who do not participate in APMs will skew the 
universe of reported data toward better performance, as MIPS APM 
participants tend to be more advanced and well resourced, putting MIPS 
eligible clinicians who do not participate in APMs at a disadvantage in 
scoring. The commenter recommended segregating such data for purposes 
of setting MIPS benchmarks for 2019 payment adjustments.
    Response: As discussed above, we believe in having inclusive and 
robust datasets as possible for benchmarks. We note that we are 
building benchmarks by comparable submission mechanism and not all 
submission mechanisms will have APM data; however, we believe it is 
important to include APM participants when comparable information is 
available because the benchmark represents the true distribution of 
performance. We do not want to establish separate, potentially lower, 
standards of care for clinicians who are not in APMs. In addition, as 
more MIPS eligible clinicians transition to APMs, we may not have 
sufficient volume to create benchmark based on MIPS eligible clinicians 
alone.
    Comment: A few commenters believed CMS should not allow a ``new'' 
physician's quality measure performance to count against the practice 
under Quality Payment Program if they have not been with that practice 
greater than 6 months. Another commenter recommended that CMS allow 
physicians who practice less than 12 months to self-identify so that 
their scoring can take into account the physician's limited data.
    Response: We appreciate the commenter's feedback and will restrict 
the data for the benchmarks to MIPS eligible clinicians and, as 
discussed above, the benchmarks will include comparable APM data, 
including data from QPs and Partial QPs. We believe these steps will 
help ensure that the validity and completeness of the benchmark data.
    Comment: Some commenters expressed concern regarding the 
comparability of measures from different EHR vendor systems. One 
commenter noted that data submitted from different EHR vendor systems 
may use different methodologies, as well as inconsistent numerators and 
denominators, and will therefore not be comparable across systems and 
clinicians. This commenter recommended that CMS work with ONC to 
standardize data submitted to Medicare across a number of vendor 
systems. Another commenter requested

[[Page 77280]]

that CMS incorporate work by medical societies to implement guides to 
ensure eCQM calculations and benchmarks are accurate and that different 
EHRs are accurately capturing eCQMs. Another commenter cautioned that 
in the case of EHRs, eCQMs are also not uniformly calculated across 
EHRs, as several different administrative code sets are used. This 
commenter recommended that CMS create standards and mapping tools to 
facilitate working across these different codes, ensure consistency 
when EHR data is exchanged, and ensure eCQM calculations and benchmarks 
are accurate. The commenter also noted that different EHRs are more 
accurate at capturing eCQMs.
    Response: To date, there have been issues with EHR data accuracy 
and consistency. We have worked with ONC to address these issues 
through public feedback mechanisms, the availability of tools to 
support eCQM testing and value set uploads, and by encouraging vendors 
to consume the health quality measure format (HQMF) measure 
specifications directly. As these improvements penetrate to all systems 
in use by providers, we expect to see improvements in eCQM consistency. 
We will continue to work with ONC to continue considering the 
elimination of transitional code systems to further improve alignment 
of the eCQM data elements, and we will continue to engage with sites 
and stakeholder organizations to identify methods to further ensure 
consistency across sites and systems.
    Comment: Commenters generally supported our proposal to use the 
Shared Savings benchmarks for CMS Web Interface. One commenter 
supported our alternative approach of building our own benchmarks for 
CMS Web Interface measures.
    Response: We appreciate the commenters support and are finalizing 
our proposal to use the Shared Savings benchmarks for the CMS Web 
Interface. However, as we discuss in more detail below, we are adding a 
floor of 3 points for each measure for the transition year. Therefore, 
any values that are below the 30th percentile will receive a score of 3 
points.
    Comment: Some commenters agreed that 0 percent performance rates 
should be excluded from benchmark calculations. One commenter suggested 
including 0 percent performance rates in benchmark calculations but 
distinguishing the data that was intentionally submitted from data that 
was unintentionally submitted from EHR reporting. Another commenter 
suggested rewarding clinicians that reported on a measure if more than 
50 percent of MIPS eligible clinicians reported zero on that measure 
and removing zeroes would artificially increase the benchmark for any 
given measure.
    Response: We appreciate that in some circumstances a 0 performance 
rate may be a valid score; however, we are also concerned about skewing 
the distribution with potentially inaccurate scores. We are finalizing 
the policy to exclude 0 percent scores from the benchmarks for the 
transition year. We will continue to evaluate the impact of 0 percent 
scores on benchmarks. However, as described below, we are adding a 
floor for the transition year of MIPS, which will limit the effect of 
this adjustment on MIPS eligible clinicians' scores.
    Comment: One commenter did not agree with our proposal to use the 
Value Modifier approach to weight the performance of individuals and 
groups by the number of beneficiaries to create a single set of 
benchmarks. The commenter was concerned about combining both 
individuals and groups into one set of benchmarks. The commenter 
recommended simplifying the performance standards and incorporating 
aspects of the Shared Savings Program and VM into this MIPS category.
    Response: As discussed above, we believe that both individuals and 
groups reporting through the same submission mechanism are comparable, 
as the measure specifications are similar. In the proposed rule, we 
proposed to combine the group and individual data into a single 
benchmark by using the VM approach of patient weighting. However, after 
further analysis, we do not believe this approach is appropriate for 
the MIPS program.
    The VM defines relative performance as statistical difference from 
the mean for a measure, and weights each clinician's performance rate 
by the number of beneficiaries to identify the average score for a 
measure, a single unit. However, unlike the VM, in MIPS, we are not 
defining relative performance by using a single point, but rather a 
percentile distribution of the reliable clinician summary performance 
scores. We have taken steps to ensure that each clinician or group 
score meets certain standards to promote reliability at the group or 
individual clinician level. For example, the group or individual 
reporter must meet certain case volume and data completeness standards 
to be included in the MIPS benchmark. In MIPS, weighting individual or 
group values by the number of patients is similar to cloning or 
replicating that individual or group score in the percentile 
distribution. In a distribution benchmark, weighting will not have an 
impact in the following cases: When the distribution of scores is 
highly compressed (low variance); the distribution of cases is highly 
compressed (such as, all practices have fairly similar numbers of 
cases); or when the number of practices is large relative to the 
typical number of eligible cases for any practice for the measure. 
However, the difference between unweighted and weighted benchmarks is 
more likely to have an impact is when the number of eligible cases and 
corresponding performance scores vary widely across practices. The 
difference will be exacerbated if there are relatively few practices 
and/or if practices with especially high or low scores also have a 
disproportionately large number of cases. For example, assume a given 
benchmark has one large group and several smaller groups and individual 
reporters. The large group cares for 20 percent of the beneficiaries 
represented in the benchmark. If we weight the benchmark by patient 
weight, then another MIPS eligible clinician with a score just above or 
just below that performance rate will have a score that is different by 
a point or two, not because of differences in performance but because 
of differences in the number of beneficiaries cared for by the group or 
individual MIPS eligible clinician.
    Therefore, we are not finalizing our proposal to patient weight the 
benchmarks. Instead, we will count each submission, either by 
individual or group, as a single data point for the benchmark. We 
believe this data is reliable and the revision simplifies the 
combination of group and individual performance.
    Comment: Some commenters did not agree with our proposal to use 
performance period data to set benchmarks in instances where the 
measure is a new measure or there is a change to an existing measure. 
Instead, the commenter recommended just giving credit for reporting the 
measure. Another commenter recommended that new measures receive a 
score equal to the 90th percentile if the reporting rates are met. 
Another commenter supported not scoring new quality measures until 2 
years after introduction. Another commenter recommended that MIPS 
eligible clinicians reporting new measures be held harmless from 
negative scoring.
    Response: To encourage meaningful measurement, we want to score all 
available measures for performance, including new measures. However,

[[Page 77281]]

because new measures would not have a benchmark available prior to the 
start of the performance period; we are creating a 3-point new measure 
floor specifically for new measures and measures without a benchmark 
based on baseline period data. This floor would be available annually 
to any measure without a published benchmark. Generally, we would 
expect new measures to have the 3-point floor for the first 2 years 
until we get baseline data for that measure. This approach helps to 
ensure that the MIPS eligible clinicians are protected from a poor 
performance score that they would not be able to anticipate. As we 
discussed in section II.E.6.a.(2)(b) below, we are also setting a 
global 3-point floor for all submitted measures during the transition 
year. We would like to note that the global 3-point floor for all 
measures is a policy for the transition year of MIPS. In contrast, the 
new measure 3-point floor for measures without a previously published 
benchmark, such as new measures, would be available in future years of 
MIPS and not just the transition year. We also note that the new 
measure 3-point floor for measures without a previously published 
benchmark, is different than class 2 measures, as defined later in 
section II.E.6.a.(2)(c) of this rule and summarized in Table 17, that 
lack a benchmark because we do not have a minimum of 20 MIPS eligible 
clinicians who reported the measure meeting the case minimum and data 
completeness requirements. The new measure 3-point floor allows MIPS 
eligible clinicians to be scored on performance in which the lowest 
score possible for a measure will be 3 points, and the highest possible 
score is 10 points assuming the new measure has a benchmark and the 
MIPS eligible clinician has met the case minimum and data completeness 
criteria. However, the class 2 measures, as defined in Table 17, is not 
a floor but rather an automatic score of 3 points, in which MIPS 
eligible clinicians are not scored on performance and would only 
receive 3 points for that measure.
    We considered giving a set number of points for submitting a new 
measure, rather than measuring performance. We do not think it is 
equitable to give the maximum performance score (a score equal to the 
90th percentile or the top decile) when other eligible clinicians may 
receive fewer points based on performance.
    Comment: Many commenters expressed support for our alternative 
approach that if a MIPS eligible clinician reports a new measure under 
the quality performance category, the MIPS eligible clinician will not 
score lower than 3 points for that measure. One commenter agreed with 
the assessment that this would encourage clinicians to report new 
measures, prevent clinicians from gaming the system by reporting only 
on new measures to avoid being compared to a benchmark, and still 
incentivize better performance on the new measure. This commenter also 
expressed support for the alternative to weight new measures less than 
measures with existing benchmark data, stating that this will also 
accomplish the above goals. Two commenters recommended that CMS apply 
this minimum floor proposal both to the transition year in which the 
measure is available in MIPS and to the first time the eligible 
clinician reports on the measure. One commenter noted that this will 
encourage reporting on new measures and help mitigate potential 
unintended consequences.
    Response: We are finalizing the alternative approach for the 
scoring of new measures, or measures without a comparable historical 
benchmark, to have a floor of 3 points until baseline data can be 
utilized. We note that the floor only applies when the new measure does 
not have a benchmark based on baseline data and not the first time the 
eligible clinician reports on the measure in subsequent years.
    In addition, for the transition year (first year) only, we are also 
implementing a global floor of 3 points for all submitted quality 
measures, not only new measures. This floor, along with changes in the 
performance threshold, affords MIPS eligible clinicians the ability to 
learn about MIPS and be protected from a negative adjustment in the 
transition year for any level of performance.
    Comment: One commenter noted that, while ensuring that an eligible 
clinician reporting a new measure would not receive a score lower than 
three points may incentivize reporting of new measures, the commenter 
was concerned that doing so may artificially inflate the measure's 
benchmark, and adversely affect clinicians reporting the measure in 
year 2, during which time scoring would no longer be based on an 
inflated benchmark. This commenter recommended that CMS establish 
measure benchmarks based only on true measure performance instead of 
potentially inflated, incentivized performance.
    Response: We would like to note that the benchmarks are based on 
the performance rates for the measures, not on the assigned points. 
Therefore, the floor for new measures should not affect future 
benchmarks. Table 16 has an example of how the floor would work.

      Table 16--Example of Using Benchmarks for a Single Measure To Assign Points With a Floor of 3 Points
----------------------------------------------------------------------------------------------------------------
                                                                Sample quality  Possible points  Possible points
                       Benchmark decile                            measure        with 3-point   without 3-point
                                                                benchmarks (%)       floor            floor
----------------------------------------------------------------------------------------------------------------
Benchmark Decile 1...........................................          0.0-9.5              3.0          1.0-1.9
Benchmark Decile 2...........................................         9.6-15.7              3.0          2.0-2.9
Benchmark Decile 3...........................................        15.8-22.9          3.0-3.9          3.0-3.9
Benchmark Decile 4...........................................        23.0-35.9          4.0-4.9          4.0-4.9
Benchmark Decile 5...........................................        36.0-40.9          5.0-5.9          5.0-5.9
Benchmark Decile 6...........................................        41.0-61.9          6.0-6.9          6.0-6.9
Benchmark Decile 7...........................................        62.0-68.9          7.0-7.9          7.0-7.9
Benchmark Decile 8...........................................        69.0-78.9          8.0-8.9          8.0-8.9
Benchmark Decile 9...........................................        79.0-84.9          9.0-9.9          9.0-9.9
Benchmark Decile 10..........................................         85.0-100               10               10
----------------------------------------------------------------------------------------------------------------

    In this example, we still create an array of percentile 
distributions for benchmarks and decile breaks. However, where we would 
normally assign between 1.0-2.9 points for MIPS eligible clinicians 
with performance in the first or second deciles (in this example, 
performance between 0 and 15.7 percent), we will now assign 3.0

[[Page 77282]]

points. In future years, however, as baseline data becomes available 
for new measures, we would remove the floor and assign points less than 
3, as illustrated above. For example, a performance rate of 9.6 percent 
(start of the 2nd decile), would receive 3.0 points with the floor and 
only 2.0 points without the floor. This methodology will not affect the 
scoring for MIPS eligible clinicians with performance in the third 
decile or higher. In addition, this methodology will not affect the 
calculation of future benchmarks. We do note, however, that if a MIPS 
eligible clinician consistently has poor performance, then by the time 
the baseline data can be used, the MIPS eligible clinician may receive 
fewer points because the floor has been removed.
    After consideration of the comments on quality measure benchmarks, 
we are finalizing many policies as proposed. Specifically:
     For quality measures for which baseline period data is 
available, we are establishing at Sec.  414.1380(b)(1)(i) measure 
benchmarks are based on historical performance for the measure based on 
a baseline period. Each benchmark must have a minimum of 20 individual 
clinicians or groups who reported the measure meeting the data 
completeness requirement and minimum case size criteria and performance 
greater than zero. We will restrict the benchmarks to data from MIPS 
eligible clinicians, and, as discussed above, comparable APM data, 
including data from QPs and Partial QPs.
    We will publish the numerical baseline period benchmarks prior to 
the start of the performance period (or as soon as possible 
thereafter).
     For quality measures for which there is no comparable data 
from the baseline period, we are establishing at Sec.  
414.1380(b)(1)(ii) that CMS will use information from the performance 
period to create measure benchmarks. We will publish the numerical 
performance period benchmarks after the end of the performance period. 
In section II.E.4 of this final rule with comment period, we are 
finalizing that for the transition year, the performance period will be 
a minimum of any continuous 90-day period within CY 2017. Therefore, 
for MIPS payment year 2019, we will use data submitted for performance 
in CY 2017, during which MIPS eligible clinicians may report for a 
minimum of any continuous 90-day period.
     We are establishing at Sec.  414.1380(b)(1)(iii) separate 
benchmarks are used for the following submission mechanisms: EHR 
submission options; QCDR and qualified registry submission options; 
claims submission options; CMS Web Interface submission options; CMS-
approved survey vendor for CAHPS for MIPS submission options, and 
administrative claims submission options. As discussed above, we are 
not stratifying benchmarks by other practice characteristics, such as 
practice size. For the reasons discussed above, we do not believe that 
there is a compelling rationale for such an approach, and we believe 
that stratifying could have unintended negative consequences for the 
stability of the benchmarks, equity across practices, and quality of 
care for beneficiaries. However, we continue to receive feedback that 
small practices should have a different benchmark, so we seek comment 
on any rationales for or against stratifying by practice size we may 
not have considered.
     We are establishing at Sec.  414.1380(b)(1)(ii)(A) that 
the CMS Web Interface submission will use benchmarks from the 
corresponding reporting year of the Shared Savings Program. We will 
post the MIPS CMS Web Interface benchmarks in the same manner as the 
other MIPS benchmarks. We are not building CMS Web Interface-specific 
benchmarks for the MIPS. We will apply the MIPS scoring methodology to 
each measure. Measures below the 30th percentile will be assigned a 
value of 3 points during the transition year to be consistent with the 
global floor established in this rule for other measures. We will 
revisit this global floor for future years.
    We are modifying our proposed policy with regards to patient 
weighting. Based on public comments, we are not finalizing our proposal 
to weight 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. Instead, we will 
count each submission, either by an individual or group, as a single 
data point for the benchmark. We believe the original proposal could 
create potential unintended distortions in the benchmark. Therefore we 
believe it is more appropriate to use a distribution of each individual 
or group submission that meets our criteria to ensure reliable and 
valid data.
    We are also modifying our proposed policy for scoring new measures. 
Based on public comments, for the transition year and subsequent years 
of MIPS, we are adding protection against being unfairly penalized for 
poor performance on measures without benchmarks by finalizing a 3-point 
floor for new measures and measures without a benchmark. As discussed 
in more detail in the next section, for the transition year of MIPS we 
are also finalizing a 3-point floor for all submitted measures. We will 
revisit this policy in future years.
(b) Assigning Points Based on Achievement
    We proposed in Sec.  414.1380(b)(1)(x) of the proposed rule (81 FR 
28251) to establish benchmarks using a percentile distribution, 
separated into deciles, 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 
proposed to calculate the decile breaks for measure performance and 
assign points for a measure based on the benchmark decile range in 
which the MIPS eligible clinician's performance rate on the measure 
falls. 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 
proposed 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 of the proposed rule (81 FR 28252) illustrated an example 
of using decile points along with partial points to assign achievement 
points for a sample quality measure. We noted in the proposed rule (81 
FR 28252) that 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.
    We did not propose to base scoring on decile distributions for the 
same measure ranges as described in Table 17 of the proposed rule 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 may elect to submit 
measures on which they expect to perform well. For MIPS eligible 
clinicians electing to report on measures where they expect to perform 
well, we anticipated many measures would have performance distributions 
clustered near the top. We proposed to identify ``topped out'' measures 
by using a definition similar to the definition used in the Hospital 
VBP Program: Truncated

[[Page 77283]]

Coefficient of Variation \22\ is less than 0.10 and the 75th and 90th 
percentiles are within 2 standard errors; \23\ or median value for a 
process measure that is 95 percent or greater (80 FR 49550).\24\
---------------------------------------------------------------------------

    \22\ The 5 percent of MIPS eligible clinicians with the highest 
scores, and the 5 percent with lowest scores are removed before 
calculating the Coefficient of Variation.
    \23\ This is a test of whether the range of scores in the upper 
quartile is statistically meaningful.
    \24\ 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 did 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. of the proposed rule 
(81 FR 28184), 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 believed 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 did 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 did 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 proposed to modify the benchmark methodology for 
topped out measures. Rather than assigning up to 10 points per measure, 
we proposed to limit the maximum number of points a topped out measure 
can achieve based on how clustered the scores are. We proposed 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 proposed to 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 proposed to 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 proposed to notify 
MIPS eligible clinicians when those benchmarks are published with 
regard to which measures are topped out.
    We proposed this approach because we wanted to encourage MIPS 
eligible clinicians not to report topped out measures, but to instead 
choose other measures that are more meaningful. We also sought 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 requested 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 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 
noted 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 requested feedback on these proposals.
    The following is a summary of the comments we received regarding 
our proposal to assign points based on achievement.
    Comment: Many commenters supported the use of the decile scoring 
method for non-topped-out measures, including the partial point 
allocation, but some cautioned that without stronger clarification, the 
scoring complexity would create considerable confusion among MIPS 
eligible clinicians. One commenter wanted to know how CMS would capture 
partial credit in the quality performance category. The commenter also 
wanted to know if there is a standardized grading scale used to 
determine where a clinician/practice might fall between 0-10 points.
    Response: We appreciate the support for the decile scoring. We are 
finalizing the decile scoring method for assigning points, but for the 
transition year, we are also adding a 3-point floor for all submitted 
measures, as well as for the readmission measure (if the readmission 
measure is applicable). This means that MIPS eligible clinicians will 
receive between 3 and 10 points per reported measure. We note that this 
scoring method allows partial credit because the MIPS eligible 
clinician can still achieve points even if the MIPS eligible clinician 
does not submit all the required measures. For example, if the MIPS 
eligible clinician has six applicable measures yet only submits two 
measures, then we will score the two submitted measures. However, the 
MIPS eligible clinician will receive a 0 for every required measure 
that is not submitted.
    Comment: A few commenters requested that CMS not use quality-
tiering in MIPS given that regardless of the investment in quality, 
most MIPS eligible clinicians will receive an average score.
    Response: We are not using the quality-tiering methodology in MIPS. 
We are shifting to the decile scoring system, and, unlike quality 
tiering, we expect performance to be along a continuum.
    Comment: Other commenters were concerned about the scoring 
criteria, which they believed would not offer guaranteed success just 
for reporting. Commenters stated that benchmarks and performance 
standards remain undefined and return on investment is uncertain and 
requested that CMS revise the quality scoring so that half of the 
quality score is granted to any practice that just attempts to report.
    Response: We would like to note that MACRA requires us to measure 
performance, not reporting. During this transition year, though, we 
believe it is important for MIPS eligible clinicians to

[[Page 77284]]

learn to participate in MIPS, be rewarded for good performance, and be 
protected from being unfairly subjected to negative payment 
adjustments. Therefore, in addition to scoring measures on performance, 
we will give at least 3 points for each quality measure that is 
submitted under MIPS, as well as for the readmission measure (if the 
readmission measure is applicable). With the lowered performance 
threshold described in section II.E.7.c. of this final rule with 
comment period, this will ensure that MIPS eligible clinicians that 
submit quality data will receive at least a neutral payment adjustment 
or a small positive payment adjustment.
    Comment: A few commenters did not support the decile approach. One 
commenter proposed that CMS model quality scoring on the advancing care 
information performance category scoring with a target point total and 
the ability to exceed that total, and another commenter recommended 
using flat percentages. One commenter opposed using percentiles, 
deciles or any other rank-based statistics for performance ranking used 
for payment adjustments because it does not generate information on 
statistically significant performance at either end of the performance 
spectrum and hides real differences that could lead to effective 
quality improvement. The commenter also believed the proposed approach 
will always penalize a certain proportion of clinicians. This commenter 
recommended a methodology which uses some basis of statistical 
significance or classification based on the underlying spread of the 
distribution.
    Response: All scoring systems have limitations, but we believe the 
proposed scoring system is appropriate for MIPS. For measures for which 
there is baseline data, our scoring system bases the benchmarks on this 
data. This structure aligns with the HVBP and creates benchmarks that 
are achievable. In addition, we were striving for simplicity, and we 
believe that comparison to these benchmarks is well aligned. This 
approach brings attention to measure performance and focuses on quality 
improvement. We did not propose the flat percentage option as not all 
measures are structured as a percentage. Finally, we elected not to 
base the benchmark distribution on statistical significance because 
those methods can be more difficult to explain, monitor and track. We 
note also that relative performance is embedded in the MIPS payment 
adjustment, which is applied to the final score on a linear scale. We 
are finalizing at Sec.  414.1380(b)(1)(ix) to score performance using a 
percentile distribution, separated by decile categories.
    Comment: One commenter encouraged CMS to incorporate health equity 
into a clinician's quality achievement score in future years.
    Response: We will consider this feedback in future rulemaking.
    Comment: On commenter requested clarification on how the CAHPS for 
MIPS survey would be scored. The commenter asked if CMS intended to 
create a single CAHPS for MIPS overall mean score roll[hyphen]up or if 
CMS would score each summary survey measure (SSM) individually to 
create a CAHPS for MIPS average score.
    Response: Each SSM will have an individual benchmark. We will score 
each SSM individually and compare it against the benchmark to establish 
the number of points. The CAHPS score will be the average number of 
points across SSMs.
    Comment: Many commenters supported retaining topped out measures 
and allowing topped out measures to be awarded the maximum number of 
points. Commenters emphasized that topped out measures allow more 
specialties to report and that the proposed lower point assignment to 
topped out measures put clinicians that have limited ability to report 
and track performance over time at a distinct disadvantage. For this 
reason, commenters recommended awarding equal points for topped out and 
non-topped out measures by maintaining the 10-point maximum value, at 
least in the transition year. Commenters also cited a lack of 
transparency in how topped out measures are identified, the existing 
complexity in the quality scoring approach, the fact that measures that 
are recognized as topped out nationally might not be topped out 
regionally or locally, and a belief that topped out measures are only 
reported by a small percentage of eligible physicians for any 
particular measure. Commenters recommend not removing topped out 
measures for at least 3 years since it takes that timeframe for new 
measures to be developed to replace topped out measures and because 
some topped out measures are critical to clinical care; however, other 
commenters recommended removing topped out measures since such measures 
will not appropriately reward high performance. Another commenter 
requested a year's notice prior to removal.
    Response: We agree that MIPS eligible clinicians should understand 
which measures are topped out. Therefore, we are not going to modify 
scoring for topped out measures until the second year the measure has 
been identified as topped out. The first year that any measure can be 
identified as topped out is the transition year, that is, the CY 2017 
performance period. Thus, we will not modify the benchmark methodology 
for any topped out measures for the CY 2017 performance period. We will 
modify the benchmark methodology for topped out measures beginning with 
the CY 2018 performance period, provided that it is the second year the 
measure has been identified as topped out. We seek comment on whether, 
for the second year a measure is topped out, to use a mid-cluster 
scoring approach, flat rate percentage approach or to remove topped out 
measures at this time.
    Comment: Some commenters recommended that if topped out measures 
are to be scored differently, we should use the Shared Savings Program 
approach, not the Hospital VBP approach. One commenter suggested that 
CMS review these measures after the first performance period to re-
evaluate topped out designations. One commenter noted that the 
methodology for distinguishing topped out measures is flawed since a 
narrow performance gap only means that performance is high for the 
cohort of reporting providers and does not reflect the performance of 
the rest of the population to whom the measure may be applicable. This 
commenter stated that many of the measures CMS that had deemed topped 
out were not implemented in PQRS long enough for robust data to have 
been collected to confirm that designation and thus requested that CMS 
remove the topped out designation.
    Response: As noted above, we are not creating a separate scoring 
system for topped out measures until the second year that the measure 
has been identified as topped out based on the baseline quality scores 
(for example, 2015 performance for the 2017 performance year). Our 
methodology for selecting topped out measures uses all information 
available to us. Because we offer the flexibility for most MIPS 
eligible clinicians to select the measures most relevant to their 
practice, we generally cannot assess the performance of clinicians on 
measures that the clinicians do not elect to submit. However, we can 
assess the performance of clinicians for the readmission measure which 
is not submitted but which is calculated from administrative claims 
data. We note that we are not removing topped out measures and that the 
designation can change if data collection practices and results change. 
We recognize that the MIPS scoring algorithm may not work as

[[Page 77285]]

well for topped out measures; however, for the transition year, we have 
added protections in place to ensure that MIPS eligible clinicians who 
report at least one quality measure are protected from being unfairly 
subjected to a negative adjustment. We also intend to reduce the number 
of topped out measures in MIPS in future years.
    Comment: Commenters requested more transparency in how topped out 
measures were identified and stressed the importance of identifying 
topped out measures and the benchmarks for each of before finalizing a 
separate scoring system for such measures. Some commenters recommended 
listing them in the final rule with comment period, defining the 
rationale for maintaining them, and that if advance notice is not 
possible, topped out measure points should not be reduced. One 
commenter recommended that we allow the public to provide feedback 
before designating a measure as topped out to explain why it might 
appear as such. Another commenter noted that insufficient data is 
available to determine whether a measure is truly topped out or whether 
only high performers might have chosen to report a given measure.
    Response: We agree that MIPS eligible clinicians should understand 
which measures are topped out. We will take these comments into 
consideration for future rulemaking. As discussed above, we are not 
going to modify scoring for topped out measures until the second year 
the measure has been identified as topped out.
    We plan to identify topped out measures for benchmarks based on the 
baseline period when we post the detailed measures specifications and 
the measure benchmarks prior to the start of the performance period. 
This will count as the first year a measure is identified as topped 
out. The second year the same measure is topped out, we will apply a 
topped out measure scoring standard beginning in performance periods 
occurring in 2018. We note as reflected above we are seeking comment on 
the topped out measure scoring standard. We also plan to identify 
topped out measures for benchmarks based on the performance period.
    Comment: Most commenters recommended not limiting the number of 
topped out measures clinicians can submit, with one commenter asking 
for clarification on whether reporting additional topped out measures 
would allow a clinician to reach the maximum quality performance 
category score. Another commenter supported limiting MIPS eligible 
clinicians to reporting no more than two topped out measures to avoid 
potential ``gaming''.
    Response: For the transition year of MIPS, we are not going to 
limit the number of topped out measures a clinician can submit. Thus, 
reporting topped out measures could potentially allow a clinician to 
reach the maximum quality performance category score since the MIPS 
eligible clinician could receive 10 points for each topped out measure 
submitted. We will continue to monitor and evaluate the impact of 
topped out measures and should we deem it necessary, we would propose a 
limitation of how many topped out measures could be reported through 
future rulemaking.
    Comment: One commenter recommended that CMS reweight topped out 
measures so as not to impose an unavoidable penalty on specialists. 
Another commenter suggested CMS re-evaluate and consider expanding its 
criteria for topped out measures to ensure clinicians' relative quality 
performance is fairly and accurately tied to payment, while still 
ensuring that specialists have a sufficient number of measures to 
select from under MIPS.
    Response: We share the concerns that topped out measures may 
disproportionately affect different specialties. We plan to publicly 
post which measures are topped out so that commenters will be able to 
plan accordingly. In addition, for the transition year of MIPS, we are 
not modifying the scoring for topped out measures. Instead, scoring for 
topped out measures will be the same as scoring for all other measures. 
We will continue to monitor and evaluate the impact of topped out 
measures by various MIPS eligible clinician practice characteristics. 
We will propose any additional policy changes through future 
rulemaking. Further, we encourage stakeholders to create new measures 
that can be used in the MIPS program to replace any topped out 
measures.
    Comment: One commenter recommended removing topped out measures 
from the CMS Web Interface measures.
    Response: We are not proposing to remove topped out measures for 
MIPS in the transition year, and we do not believe it would be 
appropriate to remove topped out measures from the CMS Web Interface. 
The CMS Web Interface measures are used in MIPS and in APMs such as the 
Shared Savings Program. We have aligned policies where possible, 
including using the Shared Savings Program benchmarks for the CMS Web 
Interface measures. We believe any modifications to the CMS Web 
Interface measures should be coordinated with Shared Savings Program 
and go through rulemaking.
    Comment: One commenter was concerned about our comment in the 
proposed rule that approximately half of the MIPS quality measures are 
topped out and that several have a median score of 100 percent.
    Response: We share the commenter's concerns that so many measures 
are topped out and show little variation in performance. It is unclear 
if this result is truly due to lack of variation in performance or 
clinicians are only submitting measures for which they have a good 
performance. We believe that MIPS eligible clinicians generally should 
have the flexibility to select measures most relevant to their 
practice, but one trade-off is not all MIPS eligible clinicians are 
reporting the same measure. Because removing such a large volume of 
measures would make it difficult for some specialties to have enough 
applicable measures to submit, we are not removing these measures from 
MIPS. As discussed above, we will identify these measures for year 1, 
but we will not modify the scoring of topped out measures until the 
second year they have been identified.
    Comment: One commenter recommended that CMS identify topped out 
measures as measures with a median performance rate over 95 percent 
because the definition is easier to understand. Another commenter 
requested further clarification on the definition of topped out 
measures.
    Response: We agree that, for process measures that are scored 
between 0 and 100 percent, using a median greater than 95 percent is a 
simple way to identify topped out measures. For process measures, we 
are modifying our proposal to identify topped out measures as those 
with a median performance rate of 95 percent or higher. For other 
measures, we are finalizing our proposal to identify topped out 
measures by using a definition similar to the definition used in the 
Hospital VBP Program: Truncated Coefficient of Variation is less than 
0.10 and the 75th and 90th percentiles are within 2 standard errors.
    Comment: One commenter recommended that CMS use historical data to 
analyze whether allowing clinicians to choose an unrestricted 
combination of six quality measures out of hundreds of measures would 
lead to a topped out effect among final scores, and to devise an 
alternative MIPS measure selection methodology should it find that 
average final scores are universally inflated. Commenter also 
recommended that CMS remove topped out measures from the list of 
quality

[[Page 77286]]

measures that MIPS eligible clinicians have to choose from, as measures 
that generate universally high performance scores fail to appropriately 
reward performance with higher payment.
    Response: We plan to continue evaluating the impact of topped out 
measures in the MIPS program. Because removing such a large volume of 
measures would make it difficult for some specialties to have enough 
applicable measures to report, we are not removing these measures from 
MIPS in year 1. As discussed above, we will identify these measures for 
year 1, but we will not modify the scoring of topped out measures until 
the second year they have been identified.
    After consideration of the comments, we are not finalizing all of 
our policies as proposed.
    We are establishing that the performance standard with respect to 
the quality performance category is measure-specific benchmarks. 
Specifically, we are finalizing at Sec.  414.1380(b)(1) that, for the 
2017 performance period, MIPS eligible clinicians receive three to ten 
achievement points for each scored quality measure in the quality 
performance category based on the MIPS eligible clinician's performance 
compared to measure benchmarks. A MIPS quality measure must have a 
measure benchmark to be scored based on performance. MIPS quality 
measures that do not have a benchmark will not be scored based on 
performance. Instead, these measures will receive 3 points for the 2017 
performance period.
    We are finalizing at Sec.  414.1380(b)(1)(ix), that measures 
submitted by MIPS eligible clinicians are scored using a percentile 
distribution, separated by decile categories. As discussed below, for 
MIPS payment year 2019, topped out quality measures are not scored 
differently than quality measures that are not considered topped out. 
At Sec.  414.1380(b)(1)(x), we finalize that for each set of 
benchmarks, CMS calculates the decile breaks for measure performance 
and assigns points based on which benchmark decile range the MIPS 
eligible clinician's measure rate is between. At Sec.  
414.1380(b)(1)(xi) we assign partial points based on the percentile 
distribution. In Sec.  414.1380(b)(1)(xii) MIPS eligible clinicians are 
required to submit measures consistent with Sec.  414.1335.
    Based on public comments, we are finalizing a modification to our 
proposal for the benchmark methodology for topped out measures. 
Specifically, we will not modify the benchmark methodology for topped 
out measures for the first year that the measure has been identified as 
topped out. Rather, for the first year the measure has been identified 
as topped out we will score topped out measures in the same manner as 
other measures until the second year the measure has been identified as 
topped out. The first year that any measure can be identified as topped 
out is the transition year, that is, the CY 2017 performance period. 
Thus, we will not modify the benchmark methodology for any topped out 
measures for the CY 2017 performance period. We will modify the 
benchmark methodology for topped out measures beginning with the CY 
2018 performance period, provided that it is the second year the 
measure has been identified as topped out. We seek comment on how 
topped out measures would be scored provided that it is the second year 
the measure has been identified as topped out. One option would be to 
score the measures using a mid-cluster approach. Under this approach, 
beginning with the CY 2018 performance period, we would limit the 
maximum number of points a topped out measure can achieve based on how 
clustered the scores are. We would identify clusters within topped out 
measures and assign all MIPS eligible clinicians within the cluster the 
same value, which will 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 were not 
topped out and the values were not clustered. We would only apply this 
methodology for measures with 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. Another approach would be to remove topped out measures in the CY 
2018 performance period, provided that it is the second year the 
measure has been identified as topped out. In this instance, we would 
not score these measures. Finally, a third approach would be to apply a 
flat percentage in building the benchmarks for topped out measures, 
similar to the Shared Savings Program, where MIPS eligible clinicians 
are scored on the performance rate rather than their place in the 
performance rate distribution. We 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 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 seek 
comment on each of these three options. Finally, 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 seek comment on at what point in time should measures 
that are topped out be removed from the MIPS.
    We are modifying our proposed approach to identify topped out 
measures. We had proposed to identify all topped out measures by using 
a definition similar to the definition used in the Hospital VBP 
Program: Truncated Coefficient of Variation \25\ is less than 0.10 and 
the 75th and 90th percentiles are within 2 standard errors; \26\ or 
median value for a process measure that is 95 percent or greater (80 FR 
49550).\27\ However, for process measures, we are defining at Sec.  
414.1305 topped out process measures as those with a median performance 
rate of 95 percent or higher. For other measures, we are defining at 
Sec.  414.1305 topped out non-process measures using a definition 
similar to the definition used in the Hospital VBP Program: Truncated 
Coefficient of Variation is less than 0.10 and the 75th and 90th 
percentiles are within 2 standard errors.
---------------------------------------------------------------------------

    \25\ The 5 percent of MIPS eligible clinicians with the highest 
scores, and the 5 percent with lowest scores are removed before 
calculating the Coefficient of Variation.
    \26\ This is a test of whether the range of scores in the upper 
quartile is statistically meaningful.
    \27\ This last criterion is in addition to the HVBP definition.
---------------------------------------------------------------------------

    In addition, as discussed in section II.E.6.a.(2)(a) of this final 
rule with comment period, we will add a global 3-point floor for all 
submitted measures for the transition year by assigning the decile 
breaks for measure performance between 3 and 10 points. We will revisit

[[Page 77287]]

this policy in future years. Adding this floor responds to public 
comments for protections against being unfairly penalized for low 
performance. Table 16 in section II.E.6.a.(2)(a) illustrates an example 
of using decile points along with the addition of the 3-point floor 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, assuming the measures meet the case minimum 
requirements and have a benchmark. We will continue to apply the new 
measure 3-point floor for measures without baseline period benchmarks 
for performance years after the first transition year. As discussed in 
section II.E.6.a.(2)(g)(ii) of this final rule with comment period, CMS 
Web Interface measures below the 30th percentile will be assigned a 
value of 3 points during the transition year to be consistent with 
other submission mechanisms. For the transition year, the 3-point floor 
will apply for all submitted measures regardless of whether they meet 
the case minimum requirements or have a benchmark, with the exception 
of measures submitted through the CMS Web Interface, which must still 
meet the case minimum requirements and have a benchmark in order to be 
scored. All submitted measures, regardless of submission mechanism, 
must meet the case minimum requirements, data completeness 
requirements, and have a benchmark in order to be awarded more than 3 
points. We will revisit this policy in future years.
    We provide some examples below of the total possible points that 
MIPS eligible clinicians could receive under the quality performance 
category under our revised methodology. As described in section 
II.E.5.b. of this rule, MIPS eligible clinicians are required to submit 
six measures or measures from a specialty measure set, and we would 
also score MIPS eligible clinicians on the all-cause hospital 
readmission measure for groups of 16 or more with sufficient case 
volume (200 cases). The total possible points for the quality 
performance category would be 70 points for groups of 16 or more 
clinicians (6 submitted measures x 10 points + 1 all-cause hospital 
readmission measure x 10 points = 70). Further, the total possible 
points for small practices of 15 or fewer clinicians and solo 
practitioners and MIPS individual reporters (or for groups with less 
than 200 cases for the readmission measure) would be 60 points (6 
submitted measures x 10 points = 60) because the all-cause hospital 
readmissions measure would not be applicable.
    However, for groups reporting via CMS Web Interface and that have 
sufficient case volume for the readmission measure, the total possible 
points for the quality performance category would vary between 120-150 
points as discussed in Table 24 in section II.E.6.a.(2)(g)(ii) of this 
rule. If all measures are reported, then the total possible points is 
120 points: (11 measures x 10 points) + (1 all-cause hospital 
readmission measures x 10 points) = 120; for those groups with 
sufficient case volume (200 cases) to be measured on readmissions. We 
discuss in section II.E.6.a.(2)(g)(ii) why the total possible points 
vary based on whether measures without a benchmark are reported. For 
other CMS Web Interface groups without sufficient volume for the 
readmissions measure, the readmission measure will not be scored, and 
the total possible points for the quality performance category would 
vary between 110-140 points, instead of 120-150 as discussed in section 
II.E.6.a.(2)(g)(ii).
(c) Case Minimum Requirements and Measure Reliability and Validity
    We seek to ensure that MIPS eligible clinicians are measured 
reliably; therefore, we proposed at Sec.  414.1380(b)(1)(iv) 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 
referred 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 proposed 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 proposed 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 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.
    The following is a summary of the comments we received regarding 
our proposal to score measures with minimum case volume and validity.
    Comment: Several commenters were generally supportive of the 20 
case minimum requirement.
    Response: We appreciate the support from these commenters and are 
finalizing our proposed approach of the 20 case minimum requirement for 
all measures except the all-cause hospital readmission measure. We are 
keeping the 200 case minimum for the all-cause readmission measure; 
however, as we are defining small groups as those with 15 or fewer 
clinicians, we are revising our proposal to not apply the readmission 
measure to solo practices or to groups with 2-9 clinicians. Rather, for 
consistency, we will not apply the readmission measure to solo 
practices or small groups (groups with 15 or fewer clinicians) or MIPS 
individual reporters.
    Comment: One commenter noted that clinicians attempting to 
participate, even if they are unable to meet the minimum case 
requirements, should still be acknowledged for making the attempt, 
especially if they are showing year-over-year improvement.
    Response: We agree that MIPS eligible clinicians should receive 
acknowledgement for participating; however, we also have to balance 
this with the ability to accurately measure performance. For the 
transition year, we are modifying our proposed approach on how we will 
score submitted measures that are unreliable because, for example, they 
are below the case minimum requirements. These measures will not be 
scored based on performance against a benchmark, but will receive an 
automatic score of three points. We believe this policy will simplify 
quality scoring in that it ensures that every clinician that submits 
quality data will receive a quality score.

[[Page 77288]]

This is particularly important in the transition year because with a 
minimum 90-day performance period, we anticipate more MIPS eligible 
clinicians will submit measures below the case minimum requirements. We 
selected three points because we did not want to provide more credit 
for reporting a measure that cannot be reliably scored against a 
benchmark than for measures for which we can measure performance 
against a benchmark. In Table 17, we summarize two classes of measures: 
``class 1'' are those measures for which performance can be reliably 
scored against a benchmark, and ``class 2'' are measures for which 
performance cannot be reliably scored against a benchmark. 
Additionally, we seek comment on whether we should remove non-outcomes 
measures for which performance cannot reliably be scored against a 
benchmark (for example, measures that do not have 20 reporters with 20 
cases that meet the data completeness standard) for 3 years in a row. 
We believe it would be appropriate to remove outcomes measures under a 
separate timeline as we expect reporting of such measures to increase 
more slowly; further, we want to encourage the availability of outcomes 
measures.
    Comment: One commenter wanted to know whether a MIPS eligible 
clinician will receive credit for reporting a measure even if the MIPS 
eligible clinician's measure data indicates that the measure activity 
was never performed. Another commenter supported the proposal to allow 
MIPS eligible clinicians to receive credit for any measures that they 
report, regardless of whether the MIPS eligible clinician meets the 
quality performance category submission criteria.
    Response: As summarized in Table 17, for the transition year, 
measures that are submitted with a 0 percent performance rate 
(indicating that the measure activity was never performed) will receive 
3 points. Measures that are below the case minimum requirement, or lack 
a benchmark (as discussed in section II.E.6.a (2)(a) or do not meet the 
data completeness requirements will also receive 3 points. However, we 
acknowledge that these policies do not reflect our goals for MIPS 
eligible clinicians' performance under this program. Rather, we aim for 
complete and accurate reporting that reflects meaningful efforts to 
improve the quality of care patients receive; we do not believe that a 
0 percent performance rate or reporting of measures that do not meet 
data completeness requirements achieves that aim. As such, we intend to 
revisit these policies and apply more rigorous standards moving 
forward. We will revisit these policies in future years.
    Comment: One commenter requested that CMS ensure that all claims 
measures meet a reliability threshold of 0.80 at the individual 
physician level.
    Response: We believe that measures with a reliability of 0.4 with a 
minimum attributed case size of 20 meet the standards for being 
included as quality measures within the MIPS program. We aim to measure 
quality performance for as many clinicians as possible, and limiting 
measures to reliability of 0.7 or 0.8 would result in fewer individual 
clinicians with quality performance category measures. In addition, a 
0.4 reliability threshold ensures moderate reliability for most MIPS 
eligible clinicians or group practices that are being measured on 
quality.
    Comment: One commenter also opposed limiting the number of measures 
that MIPS eligible clinicians can submit that are not able to be scored 
due to not meeting the required case minimum, since certain specialties 
may not have sufficient measures to report due to the few that are 
applicable and available to them.
    Response: We will not be limiting the number of measures that MIPS 
eligible clinicians can submit that are below the case minimum 
requirement in the transition year. We may revisit this approach in 
future years.
    Comment: One commenter recommended that CMS finalize the proposal 
whereby physicians are not penalized in scoring when they report 
measures but do not have the required case minimum.
    Response: We are modifying our proposed approach. Under our 
proposed approach, measures that were below the case minimum 
requirement, would have not been scored. Our revised approach is that, 
for the transition year, measures that do not meet the case minimum 
requirement, lack a benchmark or do not meet the data completeness 
criteria will not be scored and instead, MIPS eligible clinicians will 
receive 3 points for submitting the measure.
    After consideration of the comments, we are finalizing case minimum 
policies for measures at Sec.  414.1380(b)(1)(iv) and (v). For the 
quality performance category measures, we will use the following case 
minimum requirements: 20 cases for all quality measures, with the 
exception of the all-cause hospital readmissions measure, which has a 
minimum of 200 cases. We reiterate that we will only apply the all-
cause readmission measure to groups of 16 or more MIPS eligible 
clinicians that meet the case minimum requirement.
    Based on public comments, we are revising our proposed policy for 
all measures, except CMS Web Interface measures and administrative 
claims-based measures, that are submitted but for which performance 
cannot be reliably measured because the measures do not meet the 
required case minimum, do not have a benchmark, or do not meet the data 
completeness requirement, benchmark or is below the data completeness 
requirement, it will receive a floor of 3 points. At Sec.  
414.1380(b)(1)(vii), for the transition year, we finalize that if the 
measure is submitted but is unable to be scored because it does not 
meet the required case minimum, does not have a benchmark, or does not 
meet the data completeness requirement, the measure will receive a 
score of 3 points.
    We are finalizing our proposed policy for CMS Web Interface 
measures that are submitted but for which performance cannot be 
reliably measured because the measures do not meet the required case 
minimum or do not have a benchmark. At Sec.  414.1380(b)(1)(viii), we 
are finalizing that the MIPS eligible clinician will receive 
recognition for submitting such measures, but the measure will not be 
included for MIPS quality performance category scoring. CMS Web 
Interface measures that do not meet the data completeness requirement 
will receive a score of 0. We are also finalizing our proposed policy 
for administrative claims-based measures for which performance cannot 
be reliably measured because the measures do not meet the required case 
minimum or do not have a benchmark. For the transition year, this 
policy would only apply to the readmission measure since the only 
administrative claims-based quality measure is the readmission measure. 
However, this policy will apply to additional administrative claims-
based measures that are added in future years. At Sec.  
414.1380(b)(1)(viii), we are finalizing that such measures will not be 
included in the MIPS eligible clinician's quality performance category 
score. We note that the data completeness requirement does not apply to 
administrative claims-based measures. Overall, at Sec.  414.1380, we 
will provide points for all submitted

[[Page 77289]]

measures, but only a subset of measures receive points based on 
performance against a benchmark. Table 17 summarizes our scoring rules 
and identifies two classes of measures for scoring purposes.\28\
---------------------------------------------------------------------------

    \28\ We classified the measures for simplicity in discussing 
results. Name of classification subject to change.

    Table 17--Quality Performance Category: Scoring Measures Based on
                 Performance for Performance Period 2017
------------------------------------------------------------------------
    Measure type               Description              Scoring rules
------------------------------------------------------------------------
Class 1--Measure can  Measures that were submitted    Receive 3
 be scored based on    or calculated that met the     to 10 points based
 performance           following criteria:            on performance
                      (1) The measure has a           compared to the
                       benchmark; \29\                benchmark.
                      (2) Has at least 20 cases;
                       and
                      (3) Meets the data
                       completeness standard
                       (generally 50 percent.)
Class 2--Measure      Measures that were submitted,   Receive 3
 cannot be scored      but fail to meet one of the    points.
 based on              class 1 criteria. Measures     Note: This
 performance and is    either                         Class 2 measure
 instead assigned a   (1) Do not have a benchmark,    policy does not
 3-point score.       (2) Do not have at least 20     apply to CMS Web
                       cases, or                      Interface measures
                      (3) Measure does not meet       and administrative
                       data completeness criteria.    claims-based
                                                      measures.
------------------------------------------------------------------------

    Generally, if we identify issues or circumstances that impact the 
reliability or validity of a class 1 measure score, we will recognize 
that the measure was submitted, but exclude that measure from scoring. 
Instead, MIPS eligible clinicians will receive a flat 3 points for 
submitting the measure. However, if we identify issues or circumstances 
that impact the reliability or validity of a class 1 measure that is a 
CMS Web Interface or administrative claims-based measure, we will 
exclude the measure from scoring. For Web Interface measures, we will 
recognize that the measure had been submitted. For Web Interface 
measures, as discussed in section II.E.6.a.(2)(g)(ii) of the final rule 
with comment period, and administrative claims-based measures, we will 
not score these measures. For the transition year, we note that the 
readmission measure is the only administrative claims-based quality 
measure. However, this policy will apply to additional administrative 
claims-based measures that are added in future years.
---------------------------------------------------------------------------

    \29\ Benchmarks needed 20 reporters with at least 20 cases meet 
data completeness and performance greater than 0 percent.
---------------------------------------------------------------------------

    We provide below examples of our new scoring approach. For 
simplicity, the examples not only explain how the to calculate the 
quality performance category score, but also how the quality 
performance category score contributes to the final score as described 
in section II.E.6.b of this final rule with comment period, assuming a 
quality performance category weight of 60 percent. We use the term 
weighted score to represent a performance category score that is 
adjusted for the performance category weight.
    If the MIPS eligible clinician, as a solo practitioner, scored 10 
out of 10 on each of five measures submitted, one of which was an 
outcome measure, and had one measure that was below the required case 
minimum, the MIPS eligible clinician would receive the following 
weighted score for the quality performance category: (5 measures x 10 
points) + (1 measure x 3 points) or 53 out of 60 possible points x 60 
(weight of quality performance category) = 53 points toward the final 
score. Similarly, if the MIPS eligible clinician, as a solo 
practitioner, scored 10 out of 10 on each of five measures submitted, 
one of which was an outcome measure, but failed to submit a sixth 
measure even though there were applicable measures that could have been 
submitted, the MIPS eligible clinician would receive the following 
weighted score in the quality performance category: (5 measures x 10 
points) + (1 measure x 0 points) or 50 out of 60 possible points x 60 
(weight of quality performance category) = 50 points toward the final 
score.
    We also provide examples of instances where MIPS eligible 
clinicians either do not have 6 applicable measures or the applicable 
specialty set has less than six measures.
    For example, if a specialty set only has 3 measures or if a MIPS 
eligible clinician only has 3 applicable measures, then, in both 
instances, the total possible points for the MIPS eligible clinician is 
30 points (3 measures x 10 points). If the MIPS eligible clinician 
scored 8 points on each of the 3 applicable measures submitted, one of 
which was an outcome measure, then the MIPS eligible clinician would 
receive the following weighted score in the quality performance 
category: (3 measures x 8 points) or 24 out of 30 possible points x 60 
(weight of quality performance category) = 48 points toward the final 
score.
(d) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality 
Performance Category Criteria
    Section II.E.5.b. of the proposed rule outlined our proposed 
quality performance category criteria for the different reporting 
mechanisms. The criteria vary by reporting mechanism, but generally we 
proposed to include a minimum of six measures with at least one cross-
cutting measure (for patient facing MIPS eligible clinicians) (Table C 
of the proposed rule at 81 FR 28447) and an outcome measure if 
available. If an outcome measure is not available, then we proposed 
that 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. We proposed that MIPS eligible clinicians and groups would 
have to select their measures from either the list of all MIPS Measures 
in Table A of the Appendix in the proposed rule (81 FR 28399) or a set 
of specialty specific measures in Table E of the Appendix in the 
proposed rule (81 FR 28460). As discussed in section II.E.5.b.(3) of 
this final rule with comment period, we are not finalizing the 
requirement for a cross-cutting measure. As discussed in II.E.5.b.(6) 
of this final rule with comment period, we are also not including two 
of the three population measures in the scoring.
    We noted that there are some special scenarios for those MIPS 
eligible clinicians who select their measures from the Specialty Sets 
(Table E of the

[[Page 77290]]

Appendix in the proposed rule at 81 FR 28460) as discussed in section 
II.E.5.b. of the proposed rule (81 FR 28186).
    For groups using the CMS Web Interface and MIPS APMs, we proposed 
to have different quality performance category criteria described in 
sections II.E.5.b. and II.E.5.h. of the proposed rule (81 FR 28187 and 
81 FR 28234). Additionally, as described in section II.E.5.b of the 
proposed rule, we also proposed 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. However, we proposed 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 proposed 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. 
However, we proposed that 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.
    We also noted 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 
meet the required case minimum. We sought 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 sought comment on whether we should require 
these MIPS eligible clinicians to submit different measures with 
sufficient cases for the next performance period (to the extent other 
measures are applicable and available to them).
    We proposed that 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
    We stated our intent 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. of the 
proposed rule. 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 requested 
comments on these proposals.
    The following is a summary of the comments we received regarding 
our proposal to score MIPS eligible clinicians that do not meet quality 
performance category criteria.
    Comment: Commenters recommended that we clarify the proposed 
process to identify whether groups have fewer than 6 applicable 
measures to report and wanted real time notification of whether they 
passed. One commenter requested clarification on how proposed specialty 
sets will be scored, given that many have less than the required number 
of measures and do not include a required outcome or high priority 
measure. A few commenters recommended reinstating the MAV process. A 
few commenters recommended that CMS should engage the public in 
developing the MAV process and provide the public with a formal 
opportunity to provide input into proposed clusters and the overall MAV 
algorithm. One commenter recommended that CMS consider both the 
availability of measures based on subspecialty or patient condition and 
also submission mechanism. The commenter was concerned that due to the 
requirement to use only one submission mechanism per performance 
category, a MIPS eligible clinician or group may be prevented from 
achieving all measure requirements. The commenter believed CMS should 
not penalize a clinician for failing to report a measure because it is 
unavailable via the submission mechanism selected. Another commenter 
requested that CMS compare the scores of primary care and specialty 
care clinicians and assess whether the difference is due to a lack of 
available measures.
    Response: The MIPS validation process will vary by submission 
mechanism. For claims and registry submissions, we plan to use the 
cluster algorithms from the current MAV process under PQRS to identify 
which measures an MIPS eligible clinician is able to report. For QCDRs, 
we do not intend to establish a validation process. We expect MIPS 
eligible clinicians that enroll in QCDRs have sufficient meaningful 
measures that the MIPS eligible clinician is able to report. For the 
EHR submissions, we know that MIPS eligible clinicians may not have six 
measures relevant within their EHR. If there are not sufficient EHR 
measures to meet the full specialty set requirements or meet the 
requirement to submit 6 measures, the MIPS eligible clinician should 
select a different submission mechanism in order to meet the quality 
performance category requirements of submitting measures in a specialty 
set or six applicable measures. MIPS eligible clinicians should work 
with their EHR vendors to incorporate applicable measures as feasible. 
As discussed in section II.E.6.a.(1) of this final rule with comment 
period, if a MIPS eligible clinician submits via multiple mechanisms we 
would calculate two quality performance category scores and take the 
highest score. For the CMS Web Interface, MIPS eligible clinicians are 
attributed beneficiaries on a defined population that is appropriate 
for the measures, so there is no need for additional validation. Given 
the number of choices for submitting quality data, we anticipate MIPS 
eligible clinicians will be able to find a submission mechanism that 
meets the MIPS

[[Page 77291]]

submission requirements. We strongly encourage MIPS eligible clinicians 
to select the submission mechanism that has 6 measures that are 
available and appropriate to their specialty and practice type.
    Comment: Several commenters made recommendations on our request for 
comments on preventing gaming. Some commenters recommended an 
attestation or statement of explanation when a practice or provider 
chooses to submit a quality measure that does not meet the required 
case minimum. One commenter recommended that CMS require attestation 
from physicians who claim they are unable to report on quality 
performance requirements and that CMS provide very clear directions 
about the requirements in order to prevent confusion and inadvertent 
wrongdoing. Another commenter encouraged CMS to implement a strict 
validation and review process and to establish safeguards, such as a 
limit on the amount of measures that can be reported below the case 
minimum. One commenter requested clarification on whether CMS will 
allow clinicians to remain within their applicable measure set in such 
a scenario (that is, not force clinicians to report measures outside of 
their applicable measure set just to meet case minimum thresholds) and 
was concerned about the idea of prohibiting subsequent reporting on 
measures that did not meet case minimums. One commenter objected to our 
request for comments on how to prevent `gaming' stating that for CMS to 
give such time and consideration to potential gaming of the system is 
insulting to America's physicians. The commenter believed that such 
focus on gaming leads to unnecessarily complicated programs. The 
commenter recommended that CMS acknowledge in the final rule with 
comment period that the vast majority of Medicare physicians are not 
intending to ``game'' the system or avoid meeting CMS program 
requirements and are instead attempting to learn about a new payment 
system that could go into effect in less than 6 months. The commenter 
also recommended that the resources currently earmarked for the purpose 
of identifying potential gaming should be directed towards helping MIPS 
eligible clinicians, from both large and small practices, understand 
the regulatory requirements, correctly report data, and identify areas 
and methods in which they can improve their scores.
    Response: For the transition year, we are encouraging participation 
in MIPS and will not be finalizing any policies to prevent gaming. We 
agree with the commenter in that we believe the vast majority of MIPS 
eligible clinicians do not intend to game the system. Rather, we 
believe that clinicians are interested in working with us to learn the 
details of the new payment system established under the Quality Payment 
Program and to provide high quality care to Medicare beneficiaries. We 
must ensure, however, that payment under this new system is based on 
valid and accurate measurement and scoring, and identify ways to 
prevent any potential gaming that could occur in the program. We will 
continue to monitor MIPS eligible clinician submissions and may propose 
additional policies through future rulemaking as appropriate.
    Comment: Commenters recommended that we hold EHR vendors 
accountable for EHR certification and measure availability and take 
this into account when scoring a MIPS eligible clinician on low case 
volume.
    Response: We do currently require that EHR vendors be certified to 
a minimum of 9 eCQMs as is required for reporting under the current 
PQRS and EHR Incentive Programs. In the 2015 EHR Incentive Programs 
final rule, CMS required EPs, eligible hospitals, and CAHs to use the 
most recent version of an eCQM for electronic reporting beginning in 
2017 (80 FR 62893). We are maintaining this policy for the electronic 
reporting bonus under MIPS and encourage MIPS eligible clinicians to 
work with their EHR vendors to ensure they have the most recent version 
of the eCQM. CMS will not accept an older version of an eCQM for a 
submission for the MIPS program for the quality category or the end-to-
end electronic reporting bonus within that category. Additionally, 
measures that are submitted below the required case minimum will 
receive 3 points but will not be scored on performance for the 2017 
performance period
    After consideration of the comments, we are finalizing at Sec.  
414.1380(b)(1)(vi) that MIPS eligible clinicians who fail to report a 
measure that is required to satisfy the quality performance category 
submission criteria will receive zero points for that measure. Further, 
we are finalizing implementation of a validation process for claims and 
registry submissions to validate whether MIPS eligible clinicians have 
six applicable and available measures, whether an outcome measure is 
available or another other high priority measure if an outcome measure 
is not available.
    However, we are not finalizing our proposal that MIPS eligible 
clinicians who report a measure that does not meet the required case 
minimum, the data completeness criteria, or for which there is no 
benchmark due to less than 20 MIPS eligible clinicians reporting the 
measure, would not receive any points for submission and would not be 
scored on performance against a benchmark. Rather, as discussed in 
section II.E.6.a.(2)(c) of this final rule with comment period, for 
``class 2'' measure, as defined in Table 17, that are submitted, but 
unable to be scored, we will add a 3-point floor for all submitted 
measures for the transition year. That is, if a MIPS eligible clinician 
submits a ``class 2'' measure, as defined in Table 17 we will assign 3 
points to the MIPS eligible clinician for submitting that measure 
regardless of whether the measure meets the data completeness 
requirement or required case minimum requirement or whether the measure 
has a benchmark for the transition year. For example, a MIPS eligible 
clinician who is a solo practitioner could submit 6 measures as 
follows: 2 measures (one of which is an outcome measure) with high 
performance, scoring 10 out of 10 on each of these measures, 1 measure 
that lacks minimum case size, 1 measure that lacks a benchmark, 1 
measure that does not meet the data completeness requirement and 1 
measure with low performance. In this case, the MIPS eligible clinician 
would receive 32 out of 60 possible points in the quality performance 
category (2 measures x 10 points plus 4 measures x 3 points). We will 
revisit this policy in future years.
(e) Incentives To Report High Priority Measures
    Consistent with other CMS value-based payment programs, we proposed 
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 through 
D of the Appendix in the proposed rule (81 FR 28399-28460) for these 
measures. We proposed 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 through D and provided

[[Page 77292]]

criteria for how we identified these measures in section II.E.5.b. of 
the proposed rule. For non-MIPS measures reported through QCDRs, we 
proposed to classify which measures are high priority during the 
measure review process.
    We proposed scoring adjustments to create incentives for MIPS 
eligible clinicians to submit high priority measures and to allow these 
measures to have more impact on the total quality performance category 
score.
    We proposed to create an incentive for MIPS eligible clinicians to 
voluntarily report additional high priority measures. We proposed to 
provide 2 bonus points for each outcome and patient experience measure 
and 1 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 2 outcome measures, and 
two patient safety measures, the MIPS eligible clinician would receive 
2 bonus points for the second outcome measure reported and 2 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 2 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 
2 bonus points for patient experience measures given the importance of 
patient experience measures to our measurement goals. We selected 1 
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 performance receives only 3 points for 
performance for a particular high priority measure. The bonus points 
would increase the MIPS eligible clinician's points to 4 (or 5 if the 
measure is an outcome measure or patient experience measure), but that 
amount is far less than the 10 points a top performer would receive. We 
noted that population-based measures would not receive bonus points.
    We noted 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. MIPS 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.
    Groups submitting data through the CMS Web Interface, including 
MIPS APMs that report through the CMS Web Interface, are required to 
submit a set of predetermined measures and are unable to submit 
additional measures (other than the CAHPS for MIPS survey). For that 
submission mechanism, we proposed 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 this final rule with comment 
period, we will publish how many bonus points the CMS Web Interface 
measure set would have available based on the final list of measures 
(See Table 21).
    We proposed 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 
of the proposed rule (81 FR 28257-28258) illustrated examples of how to 
calculate the bonus cap. We also proposed 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 percent cap was 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 high priority measures in order to obtain bonus 
points; however, we were also concerned that 5 percent may not be 
enough incentive to encourage reporting. We requested comment on the 
appropriate threshold for this bonus cap.
    The following is a summary of the comments we received regarding 
our proposal to provide bonus points for high priority quality 
measures.
    Comment: Several commenters supported our proposal to award two 
bonus points for reporting additional outcome or patient experience 
measures and one bonus point for reporting any other high priority 
measure, indicating that rewarding bonus points would provide an 
additional incentive to report on measures which were of higher value 
to patients.
    Response: We appreciate the support of the commenters for our 
proposals. We are finalizing the proposal to assign two bonus points 
for reporting additional outcome or patient experience measures and one 
bonus point for reporting any other high priority measure.
    Comment: Some commenters recommended that outcome, patient 
experience, and other high priority measures not be required for 
reporting but should be awarded bonus points if they are reported, 
including the first high priority measure reported.
    Response: Our long term goal for the Quality Payment Program is to 
move reporting towards high priority measures. We believe that our 
proposal to require an outcome measure or another high priority measure 
if an outcome measure is not available presents a balanced approach 
that will encourage more reporting of these measures. We are concerned 
that the use of these measures would be much more limited and selective 
if reporting of one of these measures were not required.
    Comment: A number of commenters expressed concern with the proposal 
to award bonus points for the reporting of additional high priority 
measures because many specialties do not have sufficient outcome, 
patient experience or other high priority measures to receive bonus 
points. Some commenters expressed concern about the future development 
of outcome measures due to lack of available clinical evidence and poor 
risk adjustment.
    Response: By awarding bonus points for the reporting of additional 
high priority measures, we are encouraging a movement towards stronger 
development of measures that are aligned with our measurement goals. We 
encourage stakeholders who are concerned about a lack of high priority 
measures to consider development of these measures and submit them for 
future use within the program. In addition, our strategy for 
identifying and developing meaningful outcome measures are in the MACRA 
quality measure development plan, authorized by section 102 of the 
MACRA (https://

[[Page 77293]]

www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). 
The plan references how we plan to consider evidence-based research, 
risk adjustment, and other factors to develop better outcome measures.
    Comment: A commenter recommended that CMS identify a small number 
of high priority measures including patient-reported outcome measures 
that would be tested on a regional scale before being implemented 
nationally. This commenter recommended that these proposed high 
priority measures should be vetted with other stakeholders.
    Response: We believe that our proposed measure set provides 
flexibility for clinicians in determining which measures to report. All 
measures go through a review process that includes public comment as 
part of the rulemaking process, and most measures are reviewed by the 
NQF-convened MAP as part of CMS' pre-rulemaking process.
    Comment: A commenter recommended that CMS move toward establishing 
core sets of high priority measures by specialty or subspecialty. This 
would enable consumers and purchasers to make direct comparisons of 
similar clinicians with assurance that they are all being assessed 
against a consistent and standardized set of important quality 
indicators.
    Response: As part of this rule, we have finalized specialty measure 
sets that may simplify the measure selection process. We continue to 
encourage the development of outcome and other high priority measures 
that may be reported and relevant to all specialties of medicine.
    Comment: A commenter supported the concept of incentivizing 
clinicians to submit high priority measures given that they can be more 
challenging; however, this commenter sought clarification on which 
measures submitted by QCDRs would be considered high priority. This 
same commenter indicated that QCDRs should be allowed to determine the 
most appropriate classification for each of its measures, including 
which measures should be considered high priority, subject to the QCDR 
measure approval process.
    Response: We define high priority to measures as those based on the 
following criteria: outcome, appropriate use, patient safety, 
efficiency, patient experience and care coordination measures. For non-
MIPS measures reported through QCDRs, we proposed to classify which 
measures are high priority during the measure review process (81 FR 
28186). If the measure is endorsed by NQF as an outcome measure, we 
will take that designation into consideration. If we decide to assign 
these domains to QCDR measures, we will add the high priority 
designation to QCDR measures accordingly. Although we may enlist the 
assistance and consultation of the QCDR in assessing high priority 
measures, we would still make the final high priority designation.
    Comment: One commenter requested clarity on measures which are 
identified as a high priority and noted that, based on past reporting 
statistics, certain high-priority measures may be classified as topped 
out. The commenter requested clarification on what this means for the 
MIPS eligible clinician's score.
    Response: Any high priority measure that is topped out will still 
be eligible for bonus points. We think incentives should remain to 
report high priority measures, even topped out measures, as additional 
reporting makes for a more comprehensive benchmark and can help confirm 
that the measure is truly topped out. Also, as discussed in section 
II.E.6.a.(2)(c) of this final rule with comment period, we are not 
implementing any special scoring for topped out measures in year 1 of 
MIPS. Thus, the score for that measure will not be reduced by our 
proposed mid-cluster approach for topped out measures in CY 2017. We 
will not modify the benchmark methodology for any topped out measures 
for the CY 2017 performance period. We will modify the benchmark 
methodology for topped out measures beginning with the CY 2018 
performance period, provided that it is the second year the measure has 
been identified as topped out. We will propose options for scoring 
topped out measures through future rulemaking.
    Comment: One commenter supported our proposal to award 2 bonus 
points for outcome measures but recommended that only 1 bonus point be 
awarded for the reporting of patient experience measures.
    Response: We believe that patient experience measures align with 
our measurement goals and for that reason should be awarded the same 
number of bonus points as outcome measures.
    Comment: One commenter requested clarification as to whether a MIPS 
eligible clinician can earn bonus points if the MIPS eligible clinician 
does not report all 6 measures due to lack of available measures.
    Response: The MIPS eligible clinician can receive bonus points on 
all high priority measures submitted, after the first required high 
priority measure submitted, assuming these measures meet the minimum 
case size and data completeness requirements even if the MIPS eligible 
clinician did not report all 6 required measures due to lack of 
available measures.
    Comment: One commenter recommended that CMS pursue additional 
approaches to the quality performance category to advance health equity 
and reward MIPS eligible clinicians who promote health equity 
including: adding measures stratified by race and ethnicity or other 
disparity variable, and developing and adding a stand-alone health 
equity measure as a high priority measure for which clinicians can 
receive a bonus point.
    Response: Eliminating racial and ethnic disparities to achieve an 
equitable health care system is one of the four foundational principles 
listed in the CMS Quality Strategy. We refer readers to the MACRA 
quality measure development plan, authorized by section 102 of the 
MACRA (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf). The plan outlines the many ways we look to identify, measure 
and reduce disparities. We will consider in future rulemaking the 
commenter's proposed options to advance health equity and reward MIPS 
eligible clinicians who promote health equity.
    After consideration of the comments, we are finalizing at Sec.  
414.1380(b)(1)(xiii) our proposal to award 2 bonus points for each 
outcome or patient experience measure and 1 bonus point for each other 
high priority measure that is reported in addition to the 1 high 
priority measure that is already required to be reported under the 
quality performance category submission criteria. We will revisit this 
policy in future years. High priority measures are defined as outcome, 
appropriate use, patient safety, efficiency, patient experience and 
care coordination measures, as identified in Tables A through D in the 
Appendix of this final rule with comment period. For the CMS Web 
Interface, we will apply bonus points based on the finalized set of 
measures reportable through that submission mechanism. MIPS eligible 
clinicians will only receive bonus points if they submit a high 
priority measure with a performance rate that is greater than zero, 
provided that the measure meets the case minimum and data completeness 
requirements. We believe that this will encourage stronger reporting of 
those measures that are

[[Page 77294]]

more closely aligned to our measurement goals.
    The following is a summary of the comments we received regarding 
our proposal for establishing a cap on bonus points awarded for the 
reporting of additional high priority measures:
    Comment: Some commenters opposed our proposal to cap bonus points 
for high priority measures. Others recommended that the cap be 
increased from 5 percent of the denominator as proposed to 10 percent 
of the denominator as in our alternative option. Those who opposed the 
cap on bonus points at 5 percent of the denominator believe that the 5 
percent cap was too low to encourage the reporting of high-priority 
measures. One commenter requested that CMS share a data analysis 
demonstrating the necessity for a cap. Others cautioned that quality 
measures and the available bonus points may be selected, not for the 
benefit of the clinician or patient, but only to obtain the bonus 
points, and that this defeats the purpose of true quality measurement 
for quality patient care.
    Response: After consideration of the comments, we believe 
increasing the cap on bonus points to 10 percent of the quality score 
denominator for high priority measures provides a strong incentive to 
report these measures while still providing a necessary safeguard to 
avoid masking poor performance. While our long term goals for the 
program are to move towards the use of outcome and other high priority 
measures as much as possible, we also acknowledge the important role 
that other measures play at this time. We remain concerned, however, 
that without a cap in place, or with a cap that is too high, we could 
incentivize the reporting of additional measures over a focus on 
performance in relevant clinical areas, and mask poor performance with 
higher bonus points. We understand commenters' concern that quality 
measures and the available bonus points may be selected, not for the 
benefit of the clinician or patient, but only to obtain the bonus 
points. We have identified high priority measures to encourage 
meaningful measurement in each of the high priority areas and believe 
MIPS eligible clinicians who report on these measures will continue to 
work to improve their performance in these areas accordingly. At the 
same time, we will continue to monitor reporting trends and revisit our 
policies on bonus points for high priority measures as the program 
develops in future years.
    Comment: Some commenters were concerned that at a 5 percent cap, 
CMS may be incentivizing the reporting of a high priority measure over 
high performance on another measure. Some commenters recommended that 
CMS defer awarding bonus points for high priority measures to reduce 
the complexity of the scoring methodology within the quality 
performance category.
    Response: We do not believe that raising the bonus cap of 10 
percent will mask poor performance. Instead, we believe it will 
encourage additional reporting of these outcome and high priority 
measures. We note that we will not assign bonus points if an additional 
high priority measure is reported with a zero performance rate or if 
the reported measure does not meet the case minimum or data 
completeness requirements. We believe that this approach will avoid the 
issue that the commenters have identified. We will closely monitor 
reporting trends to ensure that this balance is maintained.
    Comment: One commenter recommended that we cap the bonus points 
that CMS Web Interface users can earn as the CMS Web Interface includes 
several high priority measures.
    Response: We believe the bonus points should be applied 
consistently across all submission mechanisms. Groups who report via 
the CMS Web Interface submit data on a pre-defined set of measures and 
do not have the ability to report on additional measures through 
another submission mechanism (other than the CAHPS for MIPS survey). We 
note that CMS Web Interface users are subject to the same 10 percent 
cap that all other MIPS eligible clinicians have, so CMS Web Interface 
users will not receive any additional credit compared to other MIPS 
eligible clinicians. We will closely monitor reporting trends to 
address commenter's concern that Web Interface users do not receive an 
unfair advantage by having more high priority measures available to 
them than other MIPS eligible clinicians.
    After consideration of the comments, we are finalizing at Sec.  
414.1380(b)(1)(xiii) a modification to the proposed high priority 
measure cap. Specifically, we are increasing the cap for high priority 
measures from 5 percent to 10 percent of the denominator (total 
possible points the MIPS eligible clinician could receive in the 
quality performance category) \30\ of the quality performance category 
for the first 2 years. We believe that this cap protects against 
rewarding reporting over performance while still encouraging reporting 
of the types of measures which will form the foundation of the future 
of the program. In future years, we plan to decrease this cap over 
time.
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    \30\ For example, the denominator for a MIPS eligible clinician 
who is a solo practitioner would be 60 points if the clinician has 
six applicable measures (6 measures x 10 points). If the MIPS 
eligible clinician, who is a solo practitioner, only has 5 
applicable measures, then the denominator would be 50 points (5 
measures x 10 points). A group of 16 or more would have a 
denominator of 70 points assuming the group had 6 applicable 
measures and enough cases to be scored on the readmission measure (7 
measures x 10 points).
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(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: (1) Encourage MIPS eligible clinicians 
to report on applicable measures under the quality performance category 
through the use of CEHRT and QCDRs; and (2) for 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 CQMs 
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 
proposed a scoring incentive to MIPS eligible clinicians who use their 
CEHRT systems to capture and report quality information.
    We proposed to allow one bonus point for each measure 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 Sec.  414.1305;
     The MIPS eligible clinician exports and transmits measure 
data electronically to a third party using relevant standards or 
directly to us 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 us using a submission method as defined at Sec.  
414.1325.

[[Page 77295]]

    These requirements are referred to as ``end-to-end electronic 
reporting.''
    We note that this bonus would be in addition to the bonus points 
for reporting high priority measures. 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 proposed 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 was 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; however, we were also concerned that 5 percent may not 
be enough incentive to encourage end-to-end electronic reporting. We 
sought comment on the appropriate threshold for this bonus cap. We 
proposed 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 (except 
in cases where measures are entered manually into the CMS Web 
Interface). Specifically, MIPS eligible clinicians who report via 
qualified registries, QCDRs, EHR submission mechanisms, and CMS Web 
Interface in a manner that meets the end-to-end reporting requirements 
may receive one bonus point for each reported measure with a cap as 
described. We did 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 requested comment on this proposed approach.
    The following is a summary of the comments we received regarding 
our proposal to award CEHRT bonus points for end-to-end electronic 
submissions.
    Comment: Commenters questioned whether the 5 percent cap would 
provide a worthwhile incentive. One commenter noted that the potential 
bonus points are so diluted that physicians will not be motivated to 
navigate the additional complexity of earning a bonus point. Others 
supported the higher cap.
    Response: We agree with commenters that capping the bonus available 
at 5 percent would not provide a sufficient incentive to utilize CEHRT 
for reporting in the initial years of the program; Accordingly, we are 
finalizing our alternative option that a provider may receive bonus 
points up to 10 percent of the denominator of the quality performance 
category score for the first 2 years of the program. We intend to 
decrease these cap in future years through future notice and comment 
rulemaking.
    Comment: One commenter recommended giving 2 points, not 1, for the 
CEHRT incentive.
    Response: We agree with the commenter that the proposed bonus would 
not provide a sufficient incentive for MIPS eligible clinicians. 
Although we are not increasing the points per-measure that a clinician 
can earn by conducting electronic end-to-end reporting, we are 
finalizing our alternate option which would cap the bonus a clinician 
may earn at 10 percent instead of 5 percent of the denominator of the 
quality performance category score.
    Comment: A few commenters wanted bonus incentives for use of QCDRs. 
Currently, many QCDRs, including specialty registries, cannot obtain 
data from CEHRT or support the standards for data submission. The 
commenters believed that clinicians should still receive bonus points 
if they transfer data from an EHR into their own registry. One 
commenter recommended that CMS encourage EHRs to embrace 
interoperability so that data transfer can occur between EHR and QCDRs. 
Another commenter stated that CMS should also offer bonus points to 
clinicians who use a QCDR (regardless of its ties to CEHRT) since QCDRs 
in and of themselves represent robust electronic data submission for a 
growing number of clinicians.
    Response: We appreciate commenters' support for the use of QCDRs. 
Under the policy we are finalizing, MIPS eligible clinicians who 
capture their data using CEHRT and electronically export and transmit 
this data to a QCDR which uses automated software to aggregate measure 
data, calculate measures, perform any filtering of measurement data, 
and submit the data electronically via a submission method defined at 
Sec.  414.1325, would be able to earn a bonus point. Any submission 
pathway that involves manual abstraction and re-entry of data elements 
that are captured and managed using certified health IT is not end-to-
end electronic quality reporting and is not consistent with the goal of 
the bonus. It is, however, important to note that end-to-end electronic 
submission is a goal for which bonus points are available, and not a 
requirement to achieve maximum performance in the quality performance 
category.
    Comment: Some commenters supported the proposed bonus points for 
the use of certified EHR technology. One commenter agreed with the 
inclusion of bonus points to encourage reporting via QCDR and CEHRT, 
but was concerned that giving bonus points for reporting via the CMS 
Web Interface and via Qualified Registry would not encourage use of 
QCDRs and CEHRT, and that giving bonuses for all of these methods would 
function as a penalty for those who submit via claims. This commenter 
encouraged either only giving bonus points to CEHRT or QCDR-based 
submissions or attaching more bonus points to these mechanisms. Another 
commenter recommended that CMS encourage the continued uptake of CEHRT 
and QCDRs by awarding bonus points for use of those technologies and 
not by unfairly penalizing MIPS eligible clinicians that have not yet 
adopted them. One commenter appreciated the optional bonus points that 
can be awarded for the use of CEHRT, as this is foundational to the 
functionality needed for a quality program of this magnitude.
    Response: We appreciate commenters' support for the proposed bonus 
for use of CEHRT. We want to encourage increased usage of CEHRT and 
believe this functionality should be available for qualified registries 
and CMS Web Interface as well as EHR and QCDR submission.
    Comment: Commenters wanted clarification on how to determine which 
measures qualify for end-to-end electronic reporting, as measures 
reported through the CMS Web Interface and QCDR may or may not involve 
``end-to-end'' electronic reporting. Commenters requested that CMS 
consider any measures coming from an electronic source to an electronic 
source, following relevant standards, as eligible for the electronic 
reporting bonus points. One commenter proposed clarifying our 
requirement for ``end-to-end reporting'' as follows: ``in conformance 
to the standards relevant for the measure and submission pathway allows 
the manner in which

[[Page 77296]]

the specific registry requires the data submission, such as data 
derived from an electronic source, which might not be CEHRT, and the 
destination is electronic. One commenter noted that many clinicians 
will not have end-to-end electronic capability by 2018 for reasons 
outside of their control.
    Response: The end-to-end electronic reporting bonus point is not 
specific to certain CQMs, but would apply in any case where the 
submission pathway maintains fully electronic management and movement 
of patient demographic and clinical data once it is initially captured 
in the eligible clinician's certified health IT. Where a registry is 
calculating and submitting the Quality Payment Program-accepted 
measures on the MIPS eligible clinician's behalf, this means that: (1) 
The MIPS eligible clinician uses certified health IT to capture and 
electronically provide to the registry clinical data for the measures, 
using appropriate electronic means (for example, through secure access 
via API or by electronic submission of QRDA documents); and (2) the 
registry uses verifiable software to process the data, calculate, and 
report measure results to CMS (in CMS-specified electronic submission 
format). In order to qualify for a bonus point, submission via a QCDR 
or the CMS Web Interface would need to adhere to these principles. Any 
submission pathway that involves manual abstraction and re-entry of 
data elements that are captured and managed using certified health IT 
is not end-to-end electronic quality reporting and is not consistent 
with the goal of the bonus. We understand that not all clinicians may 
have end-to-end electronic capabilities immediately, and note that end-
to-end electronic submission is a goal for which bonus points are 
available, and not a requirement to successfully participate in MIPS. 
We are finalizing policies that offer MIPS eligible clinicians 
substantial flexibility and sustain proven pathways for successful 
participation across all of the performance categories. As noted by the 
commenter, we have, included some pathways to which the end-to-end 
electronic reporting bonus points may not apply in 2017. For example, 
if a MIPS eligible clinicians submits electronic data to a registry, 
but the electronic data is not captured from certified health IT or if 
a MIPS eligible clinician uses CEHRT to capture data, but then 
calculates measures using chart abstraction and submits the resulting 
measures to CMS, then the MIPS eligible clinician would not be eligible 
for the end-to-end electronic reporting bonus points. Those MIPS 
eligible clinicians who are already successfully reporting quality 
measures meaningful to their practice via one of these pathways may 
continue to do so, or may of course choose a different pathway, if they 
believe the different pathway will offer them a better avenue for 
success in MIPS.
    Comment: Several commenters requested that CMS create incentives to 
make CEHRT more flexible because many registries rely on both automated 
and manual data entries. Commenters were concerned that most EHRs do 
not support all the necessary data elements for advanced quality 
measures or analytics and require hybrid approaches to data collection, 
but that other electronic submissions have that data. The commenters 
believed that CMS should reward eligible clinicians for utilizing 
registries, leveraging electronic capture, reporting where it is 
feasible, and using alternative methods including manual data entry. 
One commenter wanted to incorporate use of an EHR with a registry 
system to minimize double reporting and documentation.
    Response: We are finalizing policies that offer MIPS eligible 
clinicians substantial flexibility and sustain proven pathways for 
successful participation. For purposes of the end-to-end electronic 
reporting bonus point, the pathway should maintain fully electronic 
management and movement of data once it is initially captured in the 
MIPS eligible clinician's health IT. Standards-based, interoperable 
methods for managing quality measurement data are essential for 
improving the value of measures to MIPS eligible clinicians while 
reducing these clinicians' data-handling burdens. We would expect the 
elements of a hybrid measure that use essential patient demographic and 
clinical data normally managed in CEHRT or other certified health IT 
for care delivery and documentation (for example, Common Clinical Data 
Set elements) could be made available to the registry using electronic 
means. Electronic means would include transmission in any Clinical 
Document Architecture format supported by the CEHRT, or an 
appropriately secure API.
    We recommend and encourage all registries to pursue standards-
based, fully electronic methods for accurately extracting and importing 
data from other electronic sources, in addition to data supported by 
CEHRT and other ONC-Certified Health IT, as appropriate to their 
measures. However, we recognize that for some types of measures some 
supplementation of the data normally recorded in EHRs in the course of 
care may in the near future still require registries to continue 
alternate, including manual, means of harvesting the data elements not 
yet practically available using electronic means. In future years, we 
anticipate evolving data standards and data aggregation and management 
services infrastructure, including robust registries capable of 
seamlessly aggregating and analyzing data across multiple electronic 
types and sources, will eventually eliminate the burden of manual 
processes including abstraction.
    Comment: One commenter noted that utilizing the CMS Web Interface 
would involve abstraction and therefore not truly be completely 
electronic, and recommended that the bonus point for ``end to end'' 
quality measure submission be applied only when data is submitted from 
the CEHRT to CMS. Another commenter noted the proposed rule does not 
address whether data scrubbing is allowed when the MIPS eligible 
clinician is receiving bonus points for using these methods. The 
commenter believed data scrubbing is necessary to improve the accuracy 
of quality measures and recommends that CMS clarify that data scrubbing 
does not nullify bonus points for data submission.
    Response: We are finalizing our proposed policy that the CEHRT 
bonus would be available for groups using CMS Web Interface for 
measures submitted in a manner that meets the end-to-end reporting 
requirements. CMS Web Interface users may receive one bonus point for 
each reported measure with a cap of 10 percent of the denominator of 
the quality performance category. For CMS Web Interface users, we 
define end-to-end electronic reporting as cases where users upload data 
that has been electronically exported or extracted from EHRs, 
electronically calculated, and electronically formatted into a CMS-
specified file that is then electronically uploaded via the Web 
Interface as opposed to cases where measures are entered manually into 
the CMS Web Interface.
    Any submission pathway that involves manual abstraction and re-
entry of data elements that are captured and managed using certified 
health IT is not end-to-end electronic quality reporting and is not 
consistent with the goal of bonus. Thus, the bonus points would not 
apply to measures entered manually into the CMS Web Interface, though 
those measurements would be included in the MIPS eligible clinician's 
scoring for the performance category.
    We do not believe limiting the bonus points to the relatively small 
number of measures that we will be able to accept directly from CEHRT 
for the 2017

[[Page 77297]]

performance period would be the best way to recognize and encourage 
development of other standards-based, interoperable methods for 
managing quality measurement data. If a MIPS eligible clinician finds 
the measures most meaningful to their practice in a registry, and makes 
patient clinical and demographic data captured and managed using 
certified health IT available to the registry for use in calculating a 
measure, that is consistent with the goals of end-to-end electronic 
reporting, stimulating innovation in the use of standards to re-use 
data captured in the course of care to advance more timely and 
affordable availability of meaningful measure measurements to help 
drive continuous improvement.
    Comment: Others were concerned that limiting data sources to CEHRT 
alone would eliminate the potential for obtaining bonus points for many 
specialties and practice types. Commenters expressed concern that their 
electronic data sources cannot be certified or that financial 
constraints make these resources unavailable.
    Response: Bonus points apply both to measures that can be captured, 
calculated, and reported only using CEHRT and to measures for which 
only some of the data elements needed for the measure are currently 
supported by CEHRT. For purposes of the end-to-end electronic reporting 
bonus points, the pathways for those patient demographic and clinical 
data that are initially captured in the eligible clinician's certified 
health IT (including but not necessarily limited to those modules 
required to meet the CEHRT definition for MIPS) should maintain fully 
electronic management and movement from the clinician through measure 
submission to CMS. For example, where a registry is calculating and 
submitting MIPS-accepted measures that each use one or more data 
elements captured and managed for care delivery and documentation using 
certified health IT (such as, but not limited to, elements included in 
the Common Clinical Data Set), this means that: (1) The eligible 
clinician uses certified health IT to capture and electronically 
provide to the registry those clinical data using appropriate 
electronic means; and (2) the registry uses verifiable software to 
process the data, calculate, and report measure results to CMS using 
appropriate electronic means. Appropriate electronic means for getting 
data from the certified health IT to the registry would include secure 
access via API or by electronic submission of QRDA or other Clinical 
Document Architecture documents, and appropriate electronic means of 
measure submission from the registry to CMS would be the CMS-specified 
electronic submission format.
    Comment: One commenter disagreed with the decision to award bonus 
points to MIPS eligible clinicians who report using their CEHRT since 
their EHR vendor is charging a high fee by compiling the data and 
reporting the measures themselves instead of directly from the EHR.
    Response: We appreciate the commenter's concerns. We believe the 
awarding of bonus points for use of CEHRT is important to incentivize 
solutions, which ultimately reduces cost and burden to MIPS eligible 
clinicians. Our approach also encourages clinicians to consider a range 
of options to determine which health IT systems and submission 
mechanisms will provide the best value to their practice. We expect 
that over time, as the technology to support electronic reporting 
evolves and more options become available, the cost and administrative 
burden on participants leveraging these technologies will continue to 
decrease.
    Comment: One commenter wanted the CEHRT bonus for claims based 
reporting.
    Response: The CEHRT bonus is designed for submission of data 
captured utilizing CEHRT. We did not propose to allow this option for 
claims submission because there is no mechanism for MIPS eligible 
clinicians to identify the information included in the claims 
submission was pulled using CEHRT.
    Comment: One commenter was concerned that there are fewer EHR 
products available that can provide the reporting functionality 
necessary to carry out the MIPS requirements. One commenter noted that 
CEHRT standards fall short of providing QRDA or appropriate 
functionality without errors.
    Response: ONC's 2014 Edition and 2015 Edition Health IT 
Certification criteria \31\ do align with the Quality Payment Program 
requirements. Specifically, the 2015 Edition, while not required for 
2017, offers rigorous testing for more features and functionality than 
have prior editions of certification. Each developer will need to 
decide how best to support the needs of its users, but we expect that 
between now and 2018, when the MIPS requirements to use technology 
certified to the 2015 Edition will be in full effect, that more 
products will be certified to the 2015 Edition in order to support 
their users' needs for MIPS program participation. As CMS and ONC 
assess the impact of our policies and learn from the transition year of 
the Quality Payment Program (along with health IT vendors and MIPS 
eligible clinicians and groups) we will continue advancing health IT 
certification infrastructure and support in parallel to the needs of 
developers, clinicians, and other care providers to encourage the 
continued development, adoption and use of certified health IT 
including quality measurement standards to increase the availability of 
standards-based, interoperable data management and aggregation 
technology.
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    \31\ 45 CFR 170.314(c)(1) through (3) and 170.315(c)(1) through 
(3) and optionally (c)(4).
---------------------------------------------------------------------------

    After consideration of the comments, we are finalizing at Sec.  
414.1380(b)(1)(xiv) one bonus point is available for each measure 
submitted with end-to-end electronic reporting for a quality measure 
under certain criteria described in this section. We are modifying the 
CEHRT bonus cap. Specifically, we are increasing the cap for using 
CEHRT for end-to-end reporting from 5 percent to 10 percent of the 
denominator of the quality performance category (total possible points 
for the quality performance category) for the first 2 years. We intend 
to decrease this cap in future years through future notice and comment 
rulemaking. MIPS eligible clinicians will be eligible for both the 
CEHRT bonus option and the high priority bonus option with separate 
bonus caps for each option. The CEHRT bonus will be available to all 
submission mechanisms except claims submissions.
    We are finalizing that the CEHRT bonus would be available to all 
submission mechanisms except claims submissions. Specifically, MIPS 
eligible clinicians who report via qualified registries, QCDRs, EHR 
submission mechanisms, and CMS Web Interface in a manner that meets the 
end-to-end reporting requirements may receive one bonus point for each 
reported measure with a cap as described. For Web Interface users, we 
define end-to-end electronic reporting as cases where users upload data 
that has been electronically exported or extracted from EHRs, 
electronically calculated, and electronically formatted into a CMS-
specified file that is then electronically uploaded via the Web 
Interface as opposed to cases where measures are entered manually into 
the CMS Web Interface.
    Due to requests from many commenters that we provide more clarity 
around the various options for a MIPS eligible clinician to satisfy the 
``end-to-end electronic'' requirements and to earn the CEHRT bonus 
points, we are providing additional explanation regarding the final 
policy.

[[Page 77298]]

    There are several key steps common across all of the submission 
pathways for end-to-end electronic reporting: (1) The collection of 
data at the point of care; (2) calculation of CQM performance as a 
numerator/denominator ratio; and (3) submission of the data to CMS 
using a standard format. ONC's certification regulations (45 CFR 
170.315(c)(1) through (3) in the 2015 edition) have established several 
independent but complementary quality measurement capability criteria 
to which health IT modules can be certified because some health IT may 
not support all of the steps in the measurement process. For example, 
one application may support capturing the clinical data at the point of 
care (step 1), but not the calculation of measure results (step 2) or 
reporting of them to payers like CMS (step 3). Instead, that 
application may be built to export the measurement data in standard 
format to another application that performs the calculation and 
reporting functions but may not support initial data capture provide 
that feature. Some health IT applications are capable of performing 
each step necessary from data capture to CMS submission.
    Although certification for each of these steps helps to ensure 
accurate calculation and reporting measures, our final policy seeks to 
offer MIPS eligible clinicians the opportunity to earn bonus points for 
a wider array of measurement pathways rather than the EHR submission 
method currently available only for eCQMs for which a health IT 
product, service, or registry could be certified under ONC's Health IT 
Certification Program as being in conformance with CMS-published 
specifications. At this time, we believe it is important to ensure 
incentives are tied to a wider array of submission pathways that 
facilitate automated, electronic reporting.
    However, we continue to believe that standards-based, interoperable 
methods for managing quality measurement data are essential for both 
improving the value of measures to eligible clinicians while reducing 
these clinicians' data-handling burdens.
    In a 2014 concept paper, Connecting Health and Care for the Nation: 
A 10-Year Vision to Achieve an Interoperable Health IT 
Infrastructure,\32\ ONC described how interoperability is necessary for 
a ``learning health system'' in which health information flows 
seamlessly and is available to the right people, at the right place, at 
the right time to better inform decision making to improve individual 
health, community health, and population health. The vision that ONC 
and CMS share for health IT in the learning health system is that it 
will integrate seamlessly with efficient, clinical care processes, 
while sustaining strong protections for the security and integrity of 
the data. Within that infrastructure, quality improvement support 
functions are increasingly expected to enable and rely upon the 
seamless aggregation, routine analysis, and automated electronic 
management of data needed to deliver meaningful, actionable feedback on 
clinician performance and treatment efficacy while minimizing data-
related burdens on clinicians. As we implement, observe, and learn from 
the transition year of the Quality Payment Program, CMS and ONC will 
continue working in close partnership to enable ONC to continue 
advancing health IT certification infrastructure in parallel to the 
needs of clinicians, other providers, consumers, purchasers, and payers 
who will increasingly rely on standards-based, interoperable data 
management and aggregation technology to better measure and 
continuously improve safety, quality, and value of care.
---------------------------------------------------------------------------

    \32\ https://www.healthit.gov/sites/default/files/ONC10yearInteroperabilityConceptPaper.pdf.
---------------------------------------------------------------------------

    Table 18, summarizes at a high level several pathways we expect to 
be widely available to MIPS eligible clinicians in 2017 and 2018 for 
quality performance reporting and which of these pathways would earn 
bonus points for use of CEHRT to report quality measures electronically 
from capture to CMS (``end-to-end'').

   Table 18--Examples Illustrating How End-to-End Electronic Reporting
                            Requirements Work
------------------------------------------------------------------------
                                                      Then meets end-to-
MIPS Eligible clinician scenario     Actions taken       end reporting
                                                             bonus
------------------------------------------------------------------------
(1) Uses health IT certified to   MIPS eligible       Yes.
 Sec.   170.314 or Sec.            clinician uses
 170.315(c)(1) through (3)--that   their e-measure-
 is, the MIPS eligible             certified health
 clinician's system is certified   IT to submit MIPS
 capable of capturing,             eCQM to CMS via
 calculating, and reporting MIPS   EHR data
 eCQMs.                            submission
                                   mechanism
                                   (described at 42
                                   CFR 414.1325).
(2) Uses health IT certified to   The third-party     Yes.
 Sec.   170.314 or Sec.            intermediary is
 170.315(c)(1) to capture data     certified to be
 and export MIPS eCQM data         in conformance
 electronically to a third-party   with Sec.
 intermediary.                     170.415(c)(2-3)
                                   (import data/
                                   calculate, report
                                   results) for each
                                   measure; and
                                   calculates and
                                   submits MIPS
                                   eCQMs.
(3) Uses health IT certified to   QCDR uses           Yes.
 Sec.   170.314 or Sec.            automated,
 170.315(c)(1) to capture data     verifiable
 and export a MIPS eCQM            software to
 electronically to a QCDR.         process data,
                                   calculate and
                                   electronically
                                   report to a MIPS
                                   eCQM to CMS
                                   consistent with
                                   CMS-vetted
                                   protocols.
(4) Uses certified health IT,     QCDR uses           Yes.
 including but not necessarily     automated,
 limited to that needed to         verifiable
 satisfy the definition of CEHRT   software to
 at Sec.   414.1305, to capture    process data,
 demographic and clinical data     calculate and
 and transmit it to a QCDR using   electronically
 appropriate Clinical Document     report to MIPS
 Architecture standard (such as    approved non-MIPS
 QRDA or C-CDA).                   measures
                                   consistent with
                                   CMS-vetted
                                   protocols.
(5) Uses certified health IT,     The third-party     Yes.
 including but not necessarily     intermediary uses
 limited to that needed to         automated,
 satisfy the definition of CEHRT   verifiable
 at Sec.   414.1305, to capture    software to
 demographic and clinical data.    process data,
 Makes data available to a third-  calculate and
 party intermediary via secure     electronically
 application programming           report to MIPS
 interface (API).                  approved non-MIPS
                                   measures
                                   consistent with
                                   CMS-vetted
                                   protocols.

[[Page 77299]]

 
(6) Uses certified health IT,     The eligible        No; manual entry
 including but not necessarily     clinician or        interrupted data
 limited to that needed to         group, or a third-  flow and
 satisfy the definition of CEHRT   party               electronic
 at Sec.   414.1305, to capture    intermediary uses   calculation is
 demographic and clinical data     automated,          not verified.
 and transmit it to the third-     verifiable
 party intermediary using          software to
 appropriate standard or method    process data,
 (QRDA, C-CDA, API).               calculate and
                                   reports to MIPS
                                   approved measures
                                   through manual
                                   entry, or manual
                                   manipulation of
                                   an uploaded file,
                                   into a CMS web
                                   portal.
(7) Uses certified health IT to   The third-party     No; manual
 support patient care and          intermediary uses   abstraction
 capture data but abstracts it     automated,          interrupted data
 manually into a web portal or     verifiable          flow.
 abstraction-input app.            software to
                                   process data,
                                   calculate and
                                   report measure.
------------------------------------------------------------------------

    In the first example in Table 18, for MIPS eCQMs, when a MIPS 
eligible clinician wishes to use CEHRT for the entire process of data 
capture to CMS submission, the health IT solution must be certified to 
Sec.  170.315(c)(1) through (3) in order to achieve the bonus point.
    In the second and third examples, the MIPS eligible clinician has 
chosen to participate in a registry or QCDR and report eCQMs. This MIPS 
eligible clinician sends quality data electronically from CEHRT to the 
registry, and the registry calculates the measure results and 
eventually submits the eCQMs data to CMS on the eligible clinician's 
behalf. In the second case, the registry uses health IT that is 
certified to Sec.  170.315(c)(2) through (3) in order for the MIPS 
eligible clinician to earn the bonus points for end-to-end electronic 
reporting. In the third case, the QCDR does not use health IT that is 
certified to a particular standard, but uses automated, verifiable 
software to process data, calculate and electronically report a MIPS 
eCQM to MIPS consistent with CMS-vetted protocols. In both of these 
cases, a MIPS eligible clinician or group would earn a bonus point for 
each measure submitted in this manner, up to a 10 percent cap.
    In both the fourth and fifth examples, the MIPS eligible clinician 
has chosen to participate in a QCDR and report on the MIPS-accepted 
non-MIPS (registry) measures. The MIPS eligible clinician uses CEHRT, 
and perhaps some additional certified health IT modules, in the normal 
course of clinical documentation and this certified health IT captures 
clinical data needed for the MIPS eligible clinician's selected 
registry measures. In both the fourth and fifth examples, the QCDR has 
satisfied the MIPS criteria, including obtaining CMS' approval of the 
non-MIPS measures this MIPS eligible clinician is using. In these 
cases, the QCDR processes the clinical data to calculate measure 
results and reports the MIPS-approved non-MIPS measures consistent with 
CMS-vetted protocols. The only difference between these two examples is 
how the data gets from the MIPS eligible clinician's certified health 
IT to the QCDR. In the fourth example, the MIPS eligible clinician's 
certified health IT transmits quality data documents to the registry in 
QRDA or other Clinical Document Architecture standard format. In the 
fifth example, the MIPS eligible clinician has made appropriate 
arrangements to grant the registry access to the quality measurement 
information via a secure application programming interface (API). We 
have presented both examples to emphasize that the MIPS eligible 
clinician would receive the bonus point under each scenario. Either the 
secure transmission of data within CDA documents or a secure API is an 
electronic method of managing and moving the quality measurement data 
to where it is needed.
    In the sixth example, the group, or a third party submitting data 
on their behalf, may use the CMS Web Interface to submit electronic 
data for quality measure submissions. However, such a submission would 
only be awarded the bonus for end-to-end reporting if the submission 
included uploading an electronic file without modification. This is to 
preserve the electronic flow of data end-to-end and provide a 
verifiable method to ensure that manual abstraction, manual 
calculation, or subsequent manual correction or manipulation of the 
measures using abstraction did not occur.
    Finally, in the last example, the MIPS eligible clinician initially 
captures data electronically, but manually abstracts the data for 
analysis and keys it into a web portal used by a registry. The registry 
then calculates and submits the measure results to CMS electronically. 
In this case, no bonus point would be given as the manual abstraction 
process interrupted the complete end-to-end electronic data flow.
(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 
finalized policies.
(i) Calculating the Quality Performance Category Score for Non-APM 
Entity, Non-CMS Web Interface Reporters
    To calculate the quality performance category score, we proposed 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. (81 FR 28256)
    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. In the proposed rule (81 FR 
28257), we provided an example for how this logic would work. The 
quality performance category score would be capped at 100 percent.
    We proposed that 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) of the proposed rule, then a quality performance 
category score would not be calculated. Refer to section II.E.6.a.2.d. 
of the proposed rule (81 FR 28254) for details on how we proposed to 
address scenarios where a quality performance category score is not 
calculated for a MIPS eligible clinician. We requested comment on our 
proposals to calculate the quality performance category score.
    The following is summary of the comments we received on our 
proposals to calculate the quality performance category score.
    Comment: Several commenters expressed concern about the complexity 
of the scoring approach. One commenter

[[Page 77300]]

recommended taking an average of the performance percentages as an 
alternative.
    Response: We have simplified our methodology for scoring the 
quality performance category. For example, during the transition year, 
we are adding a floor of 3 points for any submitted measure (class 1 or 
class 2 measures as defined in Table 17, as discussed in section 
II.E.6.a.(2)(c) of this final rule with comment period). This 
adjustment will minimize the number of measures that are not scored and 
stabilize the denominator of the MIPS quality performance category 
score. This also ensures that all MIPS eligible clinicians will have a 
quality performance category score. As discussed in the Web Interface 
scoring section in section II.E.6.a.(2)(g)(ii), we are not scoring 
measures that lack a benchmark or are below case minimum if the measure 
meets data completeness criteria.
    Comment: Several commenters supported our proposal to use the top 
six scored measures.
    Response: We appreciate the support and we are finalizing the 
proposal to score the top six scored measures for all submission 
mechanisms except CMS Web Interface. The required number of measures 
for CMS Web Interface is discussed in section II.E.5.b.(3)(a)(ii) of 
this final rule with comment period.
    Comment: One commenter disagreed with the ability to report more 
than 6 measures because not all groups had the same option to report 
additional measures given the availability of measures.
    Response: With the exception of the CMS Web Interface submission 
mechanism (other than the CAHPS for MIPS survey), groups are allowed to 
report additional measures. We note that groups, outside of the MIPS 
APM scoring standard, have the option to choose whether they will 
report via the CMS Web Interface or another submission mechanism. With 
regard to the availability of measures, we will continue to monitor 
trends to identify areas where further measure development is needed.
    After consideration of the comments, we are finalizing our policy 
at Sec.  414.1380(b)(1)(xv) to calculate the quality performance 
category score as proposed. We will sum the 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. 
The quality performance category score cannot exceed the total possible 
points for the quality performance category. 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 will only 
include the scores for the measures with the highest number of assigned 
points, once the first outcome measure is scored, or if an outcome 
measure is not available, once another high priority measure is scored.
    We are finalizing our proposal that if a MIPS eligible clinician 
does not have any scored measures, then a quality performance category 
score will not be calculated. However, we also note that during the 
transition year, with the implementation of the 3-point floor for class 
2 measures as described in Table 17 that all MIPS eligible clinicians 
who are non-CMS Web Interface users, that submit some quality data will 
have a quality performance category score in year 1 of MIPS. The MIPS 
eligible clinician will receive:
     3 points for submitted measures that do not meet the 
minimum case size, do not have a benchmark or do not meet data 
completeness criteria, even if the measure is reported with a 0 percent 
performance rate.
     3 points or more for submitted or calculated measures that 
meet the minimum case size, have a benchmark and meet data completeness 
criteria, even if the measure is reported with a 0 percent performance 
rate.
    However, as we will illustrate below, because we have changed the 
performance standards, submission criteria, and other scoring elements, 
we believe the scoring system will be simpler to understand and that it 
will reduce burden on MIPS eligible clinicians trying to achieve a 
higher quality performance category score. Thus, based on public 
comments, we are adjusting multiple parts of our proposed scoring 
approach to ensure that we do not unfairly penalize MIPS eligible 
clinicians who have not had time to prepare adequately to succeed under 
our proposed approach while still rewarding high performers.
    For example, we are no longer requiring a cross-cutting measure for 
patient facing MIPS eligible clinicians, as discussed in section 
II.E.5.(b)(3) of this final rule with comment period. Additionally, we 
are no longer requiring two of the 3 population health measures and are 
only requiring the all-cause hospital readmission measure for groups of 
16 or more clinicians instead of our proposed approach of groups of 10 
or more, assuming the case minimum of 200 cases has been met, as 
discussed in section II.E.5.b.(6) of this final rule with comment 
period. If the case minimum of 200 cases has not been met, we will not 
score this measure. Thus, the MIPS eligible clinician will not receive 
a zero for this measure, but rather this measure will not apply to the 
MIPS eligible clinician's quality performance category score.
    We also note that if a group of 16 or more, does not report any 
quality performance category data, the group would be scored on the 
all-cause readmission measure (assuming the group meets the readmission 
measure minimum case size requirements) even if they did not submit any 
other quality performance category measures if they submitted 
information in other performance categories. If a group of 16 or more 
did not report any information in any of the performance categories, 
then the readmission measure would not be scored.
    We are now capping both the high priority bonus and the CEHRT bonus 
at 10 percent instead of 5 percent of the denominator of the quality 
performance category score. Further, all measures reported can now be 
scored with a floor of 3 points even if the measure is below the case 
minimum, lacks a benchmark or is below the completeness requirement. We 
believe that all of these modified elements, when combined, will 
significantly increase participation in the MIPS, will reduce burden 
and confusion on MIPS eligible clinicians and will allow MIPS eligible 
clinicians to gain experience under the MIPS while penalties are 
smaller in nature.
    For example, a MIPS eligible clinician who is in a group of 20 
practitioners that reports as a group, and reports 4 quality measures 
instead of the required 6 measures. Of the 4 measures submitted, which 
include an outcome measure, each measure has a performance rate that is 
low. The clinician is also scored on an additional measure, the all-
cause hospital readmission measure, but has a poor performance rate on 
this measure as well. Under this revised scoring approach, we allow all 
MIPS eligible clinicians who submit quality measures to receive a 3-
point floor per measure in the quality performance category. Under this 
scenario, the MIPS eligible clinician receives the 3-point floor for 
each of the 4 submitted measures and the all-cause hospital readmission 
measure. The MIPS eligible clinician's quality performance category 
weighted score is calculated as follows: 5 measures x 3 points each/
total possible points of 70 points x (quality performance category 
weight of 60) = 12.9 points towards the final score.
    In another example, a MIPS eligible clinician who is a solo 
practitioner reports all 6 measures, including an outcome measure, 
although all are

[[Page 77301]]

below the required case minimum. The eligible clinician receives a 
floor of 3 points for all 6 measures in the quality performance 
category even though the measures are below the 20 case size minimum. 
Under this scenario, the MIPS eligible clinician's quality performance 
category weighted score is calculated as follows: 6 measures x 3 points 
each/total possible points of 60 points x (quality performance category 
weight of 60), or 18/60 x 60 = 18 points towards the final score. We 
note that we did not include the all-cause hospital readmissions 
measure in the above quality performance category calculation since it 
is not applicable to groups of 15 or fewer clinicians and solo 
practitioners and MIPS individual reporters due to reliability 
concerns.
    In another example, a MIPS eligible clinician is in a group of 25 
that reports as a group via registry 3 process measures, 1 outcome 
measure, 1 other high priority (for example, patient safety) measure 
and 1 process measure that is below the case minimum requirement. Two 
of the process measures and one outcome measure qualify for the CEHRT 
bonus. Measures that do not meet the required case minimum or do not 
have a benchmark or fall below the data completeness requirement will 
be given 3 points. We emphasize that these measures are treated 
differently than a required measure that is not reported. Any required 
measure that is not reported would receive a score of zero points and 
be considered a scored measure. Table 19 illustrates the example.

                                Table 19--Quality Performance Category Example With High Priority and CEHRT Bonus Points
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           Quality bonus
               Measure                      Measure type        Number of    Points based  on  Total possible   Quality bonus points for    points for
                                                                  cases        performance          points           high priority             CEHRT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Measure 1...........................  Outcome Measure using             20                4.1              10  0........................               1
                                       CEHRT.                                                                  (required)...............
Measure 2...........................  Process using CEHRT....           21                9.3              10  N/A......................               1
Measure 3...........................  Process using CEHRT....           22                 10              10  N/A......................               1
Measure 4...........................  Process................           50                 10              10  N/A......................             N/A
Measure 5...........................  High Priority (Patient            43                8.5              10  1........................             N/A
                                       Safety).
Measure 6...........................  Process below case                10                  3              10  N/A......................             N/A
                                       minimum.
All-Cause Hospital Readmission......  Claims.................          205                  5              10  N/A......................             N/A
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total Points....................  All Measures...........          N/A               49.9              70  1........................               3
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total possible points for the MIPS eligible clinician is 70 
points. The eligible clinician has 49.9 points based on performance. 
The MIPS eligible clinician also qualifies for 1 bonus point for 
reporting an additional high priority patient safety measure and 3 
bonus points for end-to-end electronic reporting of quality measures. 
The bonus points for high priority measures and CEHRT reporting are 
subject to two separate caps, which are each 10 percent of 70 possible 
points or 7 points. The quality performance category score for this 
MIPS eligible clinician is (49.9 points + 4 bonus points = 53.9)/70 
total possible points x 60 (quality performance category weight) = 46.2 
points towards the final score. The quality performance category score 
would be capped at 100 percent.
    The example in Table 20 illustrates how to calculate the bonus cap 
for the high priority measure bonus and the CEHRT bonus. In this 
scenario, the MIPS eligible clinician is a solo practitioner who has 
submitted 6 measures, as an individual, all above the case minimum 
requirement. Since the MIPS eligible clinician is a solo practitioner, 
the all-cause hospital readmission measure does not apply. The MIPS 
eligible clinician below successfully submitted six 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 4 outcome 
measures (6 bonus points), a patient experience measure (2 bonus 
points) and a care coordination measure (1 bonus point) for 9 total 
high priority bonus points. The MIPS eligible clinician receives 2 
bonus points for the second, third and fourth outcome measures, given 
that no bonus points are given for the first required measure. However, 
the number of high priority measure bonus points (9 points) is over the 
cap (which is 10 percent of 60 possible points or 6 points), and the 
number of CEHRT bonus points (6 points) is at the cap (which is 10 
percent of 60 possible points or six points). The quality performance 
category score for this MIPS eligible clinician is 50.8 + 6 CEHRT bonus 
points + 6 high priority bonus points/60 points = 62.8/60 or 100 
percent since the overall number of points is capped at 60 or 100 
percent score. Note, in section II.E.5.b.(2) of this final rule with 
comment period, we proposed to weight the quality performance category 
at 60 percent of the MIPS final score, so a 100 percent quality 
performance category score would account for 60 percent of the final 
score.

                            Table 20--Quality Performance Category Bonus Cap Example
----------------------------------------------------------------------------------------------------------------
                                                   Points based                    Quality bonus   Quality bonus
            Measure               Measure type          on        Total possible    points for      points for
                                                    performance       points       high priority       CEHRT
----------------------------------------------------------------------------------------------------------------
Measure 1.....................  Outcome Measure              4.1              10             * 0               1
                                 using CEHRT.
Measure 2.....................  Outcome Measure              9.3              10               2               1
                                 using CEHRT.
Measure 3.....................  Patient                       10              10               2               1
                                 Experience
                                 using CEHRT.

[[Page 77302]]

 
Measure 4.....................  High Priority                 10              10               1               1
                                 (Care
                                 Coordination)
                                 measure using
                                 CEHRT.
Measure 5.....................  Outcome measure                9              10               2               1
                                 using CEHRT.
Measure 6.....................  Outcome measure              8.4              10               2               1
                                 using CEHRT.
                                                 ---------------------------------------------------------------
    Total.....................  ................            50.8              60               9               6
-------------------------------------------------
Cap applied to Bonus Categories 10% x total       ..............  ..............               6               6
 possible points to calculate the high priority
 bonus cap and 10% x total possible points to
 calculate the CEHRT bonus cap.
----------------------------------------------------------------------------------------------------------------
Total with high priority and    ** 60...........
 CEHRT Bonus.
----------------------------------------------------------------------------------------------------------------
* Required.
** Given we cap the quality performance category score at 60.

(ii) Calculating the Quality Performance Category for CMS Web Interface 
Reporters
    CMS Web Interface reporters have different quality performance 
category submission criteria; therefore, we proposed 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 proposed to score all measures. If a group does not meet 
the reporting requirements for one of the measures, then the group 
would receive 0 points for that measure. We note that since groups 
reporting through the CMS 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 CMS Web Interface measures, in 
which case the group would receive zeroes 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) of the proposed rule, 
including bonus points, would still apply for CMS Web Interface. We 
requested comment on this proposal.
    The following is a summary of the comments we received regarding 
our proposal to score CMS Web Interface.
    Comment: Some commenters requested that we apply the policy of 
scoring only the six highest scoring measures to the CMS Web Interface.
    Response: For other submission mechanisms, MIPS eligible clinicians 
are required to report 6 measures; therefore, we are scoring 6 required 
measures. In contrast, in the transition year, the CMS Web Interface 
reporters are required to report 13 individual measures, and a 2-
component diabetes composite measure. We believe it would be 
appropriate to score all the required measures. However, we note that 3 
measures do not have a benchmark in the Shared Saving Program; 
therefore, we will only score those measures with a benchmark. For the 
transition year, measures with a benchmark include 10 individual 
measures and the 2-component diabetes composite measure for a total of 
11 measures with benchmarks. CMS Web Interface reporters are required 
to report on more than 6 measures; they are required to report on 13 
individual measures and the 2-component diabetes composite measure, but 
are only scored in the transition year on 11 (10 individual measures 
and the 2-component diabetes composite measure) of the total 14 
required measures given that only 11 measures have a benchmark. 
Therefore, we believe we have a comparable number of measures scored in 
CMS Web Interface (11measures with benchmarks) compared to other 
reporting mechanisms (6 measures). In addition, we think this policy to 
not score measures without a benchmark is consistent with Shared 
Savings Program and NextGen ACO programs which do not measure 
performance on selected measures. Table 21 shows the number of CMS Web 
Interface measures and indicates which have benchmarks and which are 
high priority measures that would be eligible for bonus points. The 
first required outcome measure would not receive bonus points. For the 
two-component diabetes composite measure, both components of the 
measure would need to be submitted to qualify as a high priority 
measure.

                                 Table 21--Finalized Quality Measures Available for MIPS Web Interface Reporting in 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    2017 Shared  savings
          Count                     NQF/Q #                     ACO #             Measure title & description      High priority     program benchmark
                                                                                                                    designation           (yes/no)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........................  0059/001.................  ACO-27..................  2- Component Diabetes Composite                *   Yes, diabetes
                                                                                 Measure: Diabetes: Hemoglobin                      composite benchmark
                                                                                 A1c (HbA1c) Poor Control                           only.
                                                                                 (>9%): Percentage of patients
                                                                                 18-75 years of age with
                                                                                 diabetes who had hemoglobin
                                                                                 A1c > 9.0% during the
                                                                                 measurement period.

[[Page 77303]]

 
                           0055/117.................  ACO-41..................  Diabetes: Eye Exam: Percentage
                                                                                 of patients 18-75 years of age
                                                                                 with diabetes who had a
                                                                                 retinal or dilated eye exam by
                                                                                 an eye care professional
                                                                                 during the measurement period
                                                                                 or a negative retinal or
                                                                                 dilated eye exam (no evidence
                                                                                 of retinopathy) in the 12
                                                                                 months prior to the
                                                                                 measurement period.
2........................  0097/046.................  ACO-12..................  Medication Reconciliation Post-                *   No.
                                                                                 Discharge: The percentage of
                                                                                 discharges from any inpatient
                                                                                 facility (e.g. hospital,
                                                                                 skilled nursing facility, or
                                                                                 rehabilitation facility) for
                                                                                 patients 18 years and older of
                                                                                 age seen within 30 days
                                                                                 following discharge in the
                                                                                 office by the physician,
                                                                                 prescribing practitioner,
                                                                                 registered nurse, or clinical
                                                                                 pharmacist providing on-going
                                                                                 care for whom the discharge
                                                                                 medication list was reconciled
                                                                                 with the current medication
                                                                                 list in the outpatient medical
                                                                                 record.
                                                                                This measure is reported as
                                                                                 three rates stratified by age
                                                                                 group:.
                                                                                 Reporting Criteria 1:
                                                                                 18-64 years of age.
                                                                                 Reporting Criteria 2:
                                                                                 65 years and older.
                                                                                 Total Rate: All
                                                                                 patients 18 years of age and
                                                                                 older..
3........................  0041/110.................  ACO-14..................  Preventive Care and Screening:   ................  Yes.
                                                                                 Influenza Immunization:
                                                                                 Percentage of patients aged 6
                                                                                 months and older seen for a
                                                                                 visit between October 1 and
                                                                                 March 31 who received an
                                                                                 influenza immunization OR who
                                                                                 reported previous receipt of
                                                                                 an influenza immunization.
4........................  0043/111.................  ACO-15..................  Pneumonia Vaccination Status     ................  Yes.
                                                                                 for Older Adults: Percentage
                                                                                 of patients 65 years of age
                                                                                 and older who have ever
                                                                                 received a pneumococcal
                                                                                 vaccine.
5........................  2372/112.................  ACO-20..................  Breast Cancer Screening:         ................  Yes.
                                                                                 Percentage of women 50 through
                                                                                 74 years of age who had a
                                                                                 mammogram to screen for breast
                                                                                 cancer.
6........................  0034/113.................  ACO-19..................  Colorectal Cancer Screening:     ................  Yes.
                                                                                 Percentage of patients 50--75
                                                                                 years of age who had
                                                                                 appropriate screening for
                                                                                 colorectal cancer.
7........................  0421/128.................  ACO-16..................  Preventive Care and Screening:   ................  Yes.
                                                                                 Body Mass Index (BMI)
                                                                                 Screening and Follow-Up Plan:
                                                                                 Percentage of patients aged 18
                                                                                 years and older with a BMI
                                                                                 documented during the current
                                                                                 encounter or during the
                                                                                 previous six months AND with a
                                                                                 BMI outside of normal
                                                                                 parameters, a follow-up plan
                                                                                 is documented during the
                                                                                 encounter or during the
                                                                                 previous six months of the
                                                                                 current encounter.
                                                                                Normal Parameters: Age 18-64
                                                                                 years BMI >= 18.5 and < 25 kg/
                                                                                 m\2\..
8........................  0418/134.................  ACO-18..................  Preventive Care and Screening:   ................  Yes.
                                                                                 Screening for Depression and
                                                                                 Follow-Up Plan: Percentage of
                                                                                 patients aged 12 years and
                                                                                 older screened for depression
                                                                                 on the date of the encounter
                                                                                 using an age appropriate
                                                                                 standardized depression
                                                                                 screening tool AND if
                                                                                 positive, a follow-up plan is
                                                                                 documented on the date of the
                                                                                 positive screen.

[[Page 77304]]

 
9........................  0068/204.................  ACO-30..................  Ischemic (IVD): Use of Aspirin   ................  Yes.
                                                                                 or Another Antiplatelet:
                                                                                 Percentage of patients 18
                                                                                 years of age and older who
                                                                                 were diagnosed with acute
                                                                                 myocardial infarction (AMI),
                                                                                 coronary artery bypass graft
                                                                                 (CABG) or percutaneous
                                                                                 coronary interventions (PCI)
                                                                                 in the 12 months prior to the
                                                                                 measurement period, or who had
                                                                                 an active diagnosis of
                                                                                 ischemic vascular disease
                                                                                 (IVD) during the measurement
                                                                                 period and who had
                                                                                 documentation of use of
                                                                                 aspirin or another
                                                                                 antiplatelet during the
                                                                                 measurement period.
10.......................  0028/226.................  ACO-17..................  Preventive Care and Screening:   ................  Yes.
                                                                                 Tobacco Use: Screening and
                                                                                 Cessation Intervention:
                                                                                 Percentage of patients aged 18
                                                                                 years and older who were
                                                                                 screened for tobacco use one
                                                                                 or more times within 24 months
                                                                                 AND who received cessation
                                                                                 counseling intervention if
                                                                                 identified as a tobacco user.
11.......................  0018/236.................  ACO-28..................  Controlling High Blood                         *   Yes.
                                                                                 Pressure: Percentage of
                                                                                 patients 18-85 years of age
                                                                                 who had a diagnosis of
                                                                                 hypertension and whose blood
                                                                                 pressure was adequately
                                                                                 controlled (<140/90 mmHg)
                                                                                 during the measurement period.
12.......................  0101/318.................  ACO-13..................  Falls: Screening for Fall Risk:                *   Yes.
                                                                                 Percentage of patients 65
                                                                                 years of age and older who
                                                                                 were screened for future fall
                                                                                 risk at least once during the
                                                                                 measurement period.
13.......................  0710/370.................  ACO-40..................  Depression Remission at Twelve                 *   No.
                                                                                 Months: Patients age 18 and
                                                                                 older with major depression or
                                                                                 dysthymia and an initial
                                                                                 Patient Health Questionnaire
                                                                                 (PHQ-9) score greater than
                                                                                 nine who demonstrate remission
                                                                                 at twelve months (+/- 30 days)
                                                                                 after an index visit defined
                                                                                 as a PHQ-9 score less than
                                                                                 five. This measure applies to
                                                                                 both patients with newly
                                                                                 diagnosed and existing
                                                                                 depression whose current PHQ-9
                                                                                 score indicates a need for
                                                                                 treatment.
14.......................  N/A/438..................  ACO-42..................  Statin Therapy for the           ................  No.
                                                                                 Prevention and Treatment of
                                                                                 Cardiovascular Disease:
                                                                                 Percentage of the following
                                                                                 patients--all considered at
                                                                                 high risk of cardiovascular
                                                                                 events--who were prescribed or
                                                                                 were on statin therapy during
                                                                                 the measurement period:.
                                                                                 Adults aged >= 21
                                                                                 years who were previously
                                                                                 diagnosed with or currently
                                                                                 have an active diagnosis of
                                                                                 clinical atherosclerotic
                                                                                 cardiovascular disease
                                                                                 (ASCVD); OR.
                                                                                 Adults aged >= 21
                                                                                 years with a fasting or direct
                                                                                 low-density lipoprotein
                                                                                 cholesterol (LDL-C) level >=
                                                                                 190 mg/dL; OR.
                                                                                 Adults aged 40-75
                                                                                 years with a diagnosis of
                                                                                 diabetes with a fasting or
                                                                                 direct LDL-C level of 70-189
                                                                                 mg/dL.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: High priority measures are noted with an asterisk (*).

    Comment: One commenter opposed the approach in which groups not 
able to report on all measures would receive a score of zero for 
omitting measures, as it limits the use of this technology.
    Response: Section 1848(q)(5)(B)(i) of the Act requires us to give 
the lowest possible score to a MIPS eligible clinician that fails to 
report a required measure or activity. As all measures in the CMS Web 
Interface are required to be submitted, we have to score zeros for 
those who do not report.
    Comment: Commenter recommended that CMS give extra points when 
specialists utilizing the CMS Web Interface participate in specialty 
registries.
    Response: We offer CMS Web Interface users the ability to receive 
bonus points for reporting more than one high priority measure and for 
end-to-end electronic reporting. We did not propose to offer bonuses 
for participation in specialty registries. We do not think it is 
appropriate to offer a special bonus for one particular submission 
mechanism; however, if we revisit the issue of new bonus point 
categories in the future, we would do so through proposed rulemaking in 
future years.
    After considering all comments, we are finalizing our policy as 
proposed with regard to scoring CMS Web

[[Page 77305]]

Interface measures for all elements except for the following scenarios.
    We also highlight that unless otherwise noted, this section on CMS 
Web Interface scoring will not apply to clinicians participating in an 
APM Entity scored through the APM scoring standard. APM Entity group 
reporting and scoring for MIPS eligible clinicians participating in 
MIPS APMs are summarized in section II.E.5.h. of this final rule with 
comment period. 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 are excluded from MIPS, or unless another MIPS 
exclusion applies.
    We are finalizing the following modifications for our CMS Web 
Interface scoring policies. First, we will be providing a global floor 
of 3 points for all CMS Web Interface measures submitted in the 
transition year, even with measures at 0 percent performance rate, 
assuming that these measures have met the data completeness criteria, 
have a benchmark and meet the case minimum requirements. However, 
measures with performance below the 30th percentile will be assigned a 
value of 3 points during the transition year to be consistent with the 
floor established in this rule for other measures and because the 
Shared Savings Program does not publish benchmarks below the 30th 
percentile. We will reassess scoring for measures below the 30th 
percentile in future years. Table 22 illustrates how the decile score 
works for Shared Saving Program benchmarks. For example, a performance 
rate of 9.6 percent (below 30th percentile), would receive 3.0 points. 
This methodology will not affect the scoring for MIPS eligible 
clinicians with performance in the third decile or higher. In addition, 
this methodology will not affect the calculation of future benchmarks.

   Table 22--Example of Using Shared Saving Program Benchmarks * for a
     Single Measure To Assign Points With a Global Floor of 3 Points
------------------------------------------------------------------------
                                 Sample quality
                               measure benchmarks      Possible points
      Benchmark decile          for web interface    with 3-point floor
                                       (%)
------------------------------------------------------------------------
Benchmark Deciles 1-3                          N/A                   3.0
 (starts at 0 and ends
 before the 30th percentile)
Benchmark Decile 4 (starts               23.0-35.9               4.0-4.9
 at the 30th percentile)....
Benchmark Decile 5..........             36.0-40.9               5.0-5.9
Benchmark Decile 6..........             41.0-61.9               6.0-6.9
Benchmark Decile 7..........             62.0-68.9               7.0-7.9
Benchmark Decile 8..........             69.0-78.9               8.0-8.9
Benchmark Decile 9..........             79.0-84.9               9.0-9.9
Benchmark Decile 10.........              85.0-100                    10
------------------------------------------------------------------------
* Data is illustrative and does not represent an actual Shared Savings
  Program Benchmark.

    We will not score CMS Web Interface measures that do not meet the 
case minimum requirement or lack a benchmark unless that measure is not 
submitted. We believe that this policy is appropriate since, unlike 
with non-CMS Web Interface users where MIPS eligible clinicians can 
report additional measures beyond the required six to ensure that there 
are sufficient measures to be scored on performance, CMS Web Interface 
users are limited to reporting the 14 measures (13 individual measures 
and the 2-component diabetes composite measure) listed in Table 21. 
Given that these CMS Web Interface users cannot report additional 
measures in instances where a measure does not have a benchmark or is 
below the case minimum, we have decided not to score these measures.
    However, measures that are not reported and measures reported below 
the data completeness requirements will receive a 0 score. We have 
decided to give a zero to measures that are below the data completeness 
requirements for CMS Web Interface users because we believe that these 
users generally have more experience in reporting measures than the 
non-CMS Web Interface users and therefore should not have any 
challenges in meeting the data completeness criteria. Table 23 
summarizes the scoring approach for Web Interface and Non-Interface 
Measures.

  Table 23--Comparison of Scoring Approach of Web Interface and Non-Web
                           Interface Measures
------------------------------------------------------------------------
                                                         Range possible
Data completeness, with/without    Range of possible       scores per
   case minimum criteria met/     scores per measure    measure for CMS
           benchmark                for non-CMS web      web interface
                                    interface users          users
------------------------------------------------------------------------
No measures reported regardless                     0  0
 of case minimum criteria met.
No measures reported regardless                     0  0
 of whether there is a
 benchmark.
Partial data (below data                            3  0
 completeness criteria
 requirement) without case
 minimum criteria met,
 regardless of whether the
 measure is at 0% performance
 rate or not.
Partial data (below data                            3  0
 completeness criteria
 requirement) without a
 benchmark, regardless of
 whether the measure is at 0%
 performance rate or not.
Complete data (data                                 3  Null: The
 completeness criteria met)                             measures will
 without case minimum criteria                          not be scored.
 met, regardless of whether the
 measure is at 0% performance
 rate or not.
Complete data (data                                 3  Null: The measure
 completeness criteria met)                             will not be
 without a benchmark,                                   scored.
 regardless of whether the
 measure is at 0% performance
 rate or not.
Complete data (data                                 3  3
 completeness criteria met)
 with case minimum criteria
 met, the measure has a
 benchmark, and the measure is
 at 0% performance rate.

[[Page 77306]]

 
Complete data (data                              3-10  3-10 *
 completeness criteria met)
 with case minimum criteria
 met, the measure has a
 benchmark, and the performance
 rate is greater than 0%
 performance rate**.
------------------------------------------------------------------------
* SSP benchmark's start at the 30th percentile
** Given the global 3-point floor for low performance, a measure that
  would have received 1 point or 2 points will now receive a score of 3
  points.

    We provide in Table 24 examples of this scoring approach. For 
example, for each measure that lacks a benchmark that is not reported, 
a zero will be added to the numerator and 10 points will be added to 
the denominator. This is because normally these measures are not scored 
but since these measures were not reported, the group will be penalized 
with a lower quality performance category score accordingly. For each 
measure that does not lack a benchmark that is not reported, then a 
zero will be added to the numerator but no points will be added to the 
denominator since these measures are normally scored so the denominator 
is static. We are finalizing the policy to score measures with 
benchmarks because CMS Web Interface reporters have to report on more 
than 6 measures, so we believe we have a comparable number of measures 
compared to other reporting mechanisms. In addition, we believe this 
policy to not score measures without a benchmark is consistent with 
Shared Savings Program and NextGen ACO programs which do not measure 
performance on selected measures.

          Table 24--Scoring Examples: Groups Reporting via Web Interface With the Readmission Measure *
----------------------------------------------------------------------------------------------------------------
                                                                                    Quality
                                                                                  performance
                                                                                    category         Quality
                                                                                   numerator/      performance
                                                                                  denominator     category score
                                                                                  (assume all       numerator/
                                Reported 14       Number of        Number of        measures      denominator x
          Examples            measures yes/no    measures not    measures not       reported        (weight of
                                                   reported        scored **      received 10        quality
                                                                                 points and the    performance
                                                                                 score for the   category of 60)
                                                                                  readmission    = points toward
                                                                                 measure* is 3   the final score
                                                                                    points)
----------------------------------------------------------------------------------------------------------------
Reported 14 measures........  Yes............  N/A............               3  11 measures x    113/120 x 60 =
                                                                                 10 points + 1    56.5.
                                                                                 measures x 3
                                                                                 points/120.
Reported 11 measures, did     No.............  3 measures                    0  11 measures x    113/150 x 60 =
 not report 3 measures                          lacking a                        10 points + 1    45.2.
 without a benchmark.                           benchmark.                       measure x 3
                                                                                 points/150.
Reported 13 measures, did     No.............  1 measure with                3  10 measures x    103/120 x 60 =
 not report measure with a                      a benchmark.                     10 points + 1    51.5.
 benchmark.                                                                      measure x 3
                                                                                 points/120.
----------------------------------------------------------------------------------------------------------------
Note: * For CMS Web Interface groups without sufficient volume for the readmissions measure (below the 200 case
  minimum), as well as Shared Saving Program and NextGen ACOs, the readmission measure will not be scored.
** Measures are not scored if the measure is reported but the case minimum criteria is not met or if the measure
  lacks a benchmark.

(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 final score methodology shall take into account 
improvement of the MIPS eligible clinician in calculating the 
performance score for the quality and cost performance categories and 
may take into account improvement for the improvement activities and 
advancing care information performance categories.
    We solicited public comments on potential ways to incorporate 
improvement into the scoring methodology moving forward. We were 
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 were 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 sought feedback on whether to score improvement 
where MIPS eligible clinicians do not have the required case minimum 
for measures to be scored.
    Option 1: In the proposed rule, we presented an option in which 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

[[Page 77307]]

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 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 Hospital VBP Program methodology, we refer readers 
to Sec. Sec.  412.160 and 412.165.
    Option 2: In the proposed rule, we presented an option where we 
could adopt the approach for assessing improvement currently used in 
the Shared Savings Program, where MIPS 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 4 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 4 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 period (79 FR 67928--
67931) for a discussion of how CMS will determine whether the 
improvement or decline is significant.
    Option 3: In the proposed rule, we presented an option where 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 apply the following rule, which is similar to how the 
Medicare Advantage 5-star rating methodology treats highly rated plans 
within the Medicare Star Quality Rating System, 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 requested comments on these 
proposals.
    Comment: Numerous commenters wrote in support of Options 1, 2, and 
3, with the majority supporting Option 1. Those who supported Option 1 
recognized that this approach presented challenges if the clinician 
changes measures from year to year or changes between group and 
individual reporting. One commenter was concerned about improvement 
points for year 2, where a clinic performing highly would not be able 
to receive as many points as another lower performing clinic even 
though both had improved. One commenter expressed concern with how CMS 
intends to measure and score quality improvement in the years following 
the first performance period. In particular, this commenter sought 
clarity on scoring process measures versus outcome measures. The 
commenter requested that specific examples of how each measure will be 
scored be included in the final rule with comment period. One commenter 
requested that CMS release an RFI outlining the three options in detail 
before finalizing any proposal. Another commenter recommended 
postponing measuring improvement and instead focusing on a successful 
MIPS launch. Another commenter cautioned that no methodology should be 
finalized without testing and significant outreach to, and input from 
the medical community to ensure clinicians understand and trust what 
they are being scored on. One commenter recommended that CMS determine 
the feasibility for each of the 3 proposed strategies. The concern is 
that due to fluidity of physician groups, payment adjustment applied 2 
years later may never reach the physicians that earned it. This is due 
to the physician leaving their group. Also if a physician achieves 
success and moves to a lower performing group they will be penalized. 
This commenter recommended not committing to a single approach in 
incorporating improvements into MIPS scores.
    Response: We thank commenters for their feedback. We are not 
finalizing any policies related to improvement in this rule, but will 
consider comments for future rulemaking.
    Comment: One commenter recommended measuring improvement in 
advancing care information and cost. One commenter suggested that all 
Shared Savings Program participants for which CY 2015 was their first 
year of ACO participation be able to choose the timeline that becomes 
the baseline for their performance improvement score as

[[Page 77308]]

these providers were only being evaluated on reporting and not 
performance, and to use CY 2015 for the baseline would be misleading. 
Commenter strongly believed that CMS should work on securing a 
successful launch of the program and encouraging participation before 
it begins to evaluate future improvement. One commenter supported CMS' 
proposals to reward improvement.
    Response: We are open to measuring improvement for all performance 
categories. We are not finalizing any policies related to improvement 
in this rule, but will consider comments for future rulemaking.
    Comment: One commenter expressed concern that practices that are 
high performers may be penalized because they do not have the 
opportunity for large increases in performance.
    Response: We note that we are required to measure achievement, and 
in addition to measuring achievement, may measure improvement in Year 
2, if data sufficient to measure improvement is available. MIPS 
eligible clinicians will not be penalized if they are high performers.
    We appreciate the comments regarding the three proposed options to 
score improvement; however, we are not proposing an approach for 
scoring improvement at this time. We will consider these comments and 
outline a proposal in future rulemaking.
(3) Scoring the Cost Performance Category
    As we described in the proposed rule (81 FR 28259), we proposed to 
align scoring across the MIPS performance categories. For the cost 
performance category, we proposed to score the cost measures similarly 
to the quality performance category. Specifically, we proposed at Sec.  
414.1380(b)(2) to assign one to ten points to each cost measure based 
on a MIPS eligible clinician's performance compared to a benchmark (81 
FR 28260). However, we proposed that for the cost performance category 
(unlike the quality performance category), the benchmark would be based 
on the performance period, rather than the baseline period. The details 
of the scoring for cost measures are described below.
(a) Cost Measure Benchmarks
    For the cost performance category, we proposed at Sec.  
414.1380(b)(2) that the performance standard is measure-specific 
benchmarks (81 FR 28259). We would calculate an array of measure 
benchmarks based on performance. Then, a MIPS eligible clinician's 
actual performance on the cost measure during the performance period 
would be evaluated to determine the number of points that should be 
assigned based on where the clinician's actual performance falls within 
these benchmarks.
    We proposed at Sec.  414.1380(b)(2) to create benchmarks for the 
cost measures based on the performance period (81 FR 28260). 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 performance on cost measures in a performance 
period with a historical baseline period. In addition, for the Hospital 
VBP Program and the VM, we use the performance period to establish the 
benchmarks for scoring Hospital VBP Program's efficiency measures and 
the VM's cost measures (80 FR 49562, 80 FR 71280). We proposed that 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 
stated we believe that it is important for MIPS eligible clinicians to 
know in advance how they might be scored 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 cost performance category 
measure benchmarks on the baseline period proposed rather than the 
performance period (81 FR 28259). This option would further align the 
cost 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 cost 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 other adjustments to the measures. We believe the 
relative performance that we provide through performance feedback 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 the cost 
of care for patients treated by MIPS eligible clinicians. 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 proposed to create a single set of benchmarks for each measure 
specified for the cost performance category. We proposed that all MIPS 
eligible clinicians that are attributed sufficient cases for the 
measure would be included in the same benchmark. In addition, we 
proposed that a minimum of 20 MIPS eligible clinicians or groups must 
be attributed the case minimum in order to develop the benchmark. If a 
measure does not have enough MIPS eligible clinicians or groups that 
are attributed enough cases to create a benchmark, then we proposed not 
including that measure in the scoring for the cost performance 
category.
    We requested comment on the proposal to establish cost measure 
benchmarks based on the performance period as well as the alternative 
proposal.
    The following is a summary of the comments we received regarding 
our proposals on the benchmarking of cost measures:
    Comment: Several commenters supported our proposal to benchmark 
cost measures on the performance period, noting that clinicians do not 
have control of the payment rate for individual services and could be 
subject to inappropriate adjustments to payments if a previous year was 
used as a benchmark.
    Response: We agree with commenters and will be finalizing our 
proposal at Sec.  414.1380(b)(2)(i) to establish cost measure 
benchmarks based on the performance period. As discussed further below, 
cost measures must have a benchmark to be scored.
    Comment: A number of commenters opposed our proposal to benchmark 
cost measures on the basis of the performance period and instead 
supported our alternative proposal to benchmark cost measures on the 
basis of a previous year. These commenters supported the alternative 
benchmarking proposal because they believed it would support alignment 
with the benchmarking period used for quality scoring, allow clinicians 
to be aware of

[[Page 77309]]

cost targets in advance, and be more consistent with the approach used 
in the Medicare Shared Savings Program. A few commenters recommended 
using regional trend factors, similar to the Shared Savings Program, to 
update historical data. Some commenters suggested a benchmark period 
that was less than a year.
    Response: For quality measurement, we believe that providing a 
benchmark from previous years provides a helpful target that can 
support the overall goal of improvement. However, we believe that cost 
measures have important differences that make using a previous year as 
a benchmark period problematic, such as changes in Medicare payment 
policies over time and the development of new therapies and technology. 
We will continue to provide feedback to clinicians on the cost of care 
associated with cost measures to which they would have patients 
attributed and believe that this will be helpful information as they 
address potential improvements to make in future years. Because we are 
using performance period data, not historical data, we do not require a 
trend factor to update the benchmark. We believe that benchmarking to a 
period of less than 1 year could reduce the reliability of our 
measures. By benchmarking to the current performance period, we are not 
making clinicians responsible for differences in costs of care that 
occur as a result of changes in payment policy over time.
    Comment: Some commenters opposed our proposal to establish a single 
national benchmark for each cost measure and instead recommended that 
clinicians only be compared to those that practice in the same 
specialty, subspecialty, or region of the country, or which have a 
similar practice sizes or mix of patients.
    Response: The measures used within the cost performance category 
are constructed to identify the differences in patients as much as 
possible as opposed to the different specialties of the individual 
clinicians. We considered the option of peer compatibility grouping 
during the development of the VM. At that time, we found that there 
were difficulties in defining which groups were similar enough to be 
considered peers. We believe that this difficulty is increased by 
attributing patients to individual clinicians as identified by TIN/NPI 
rather than TINs as in the VM. We will continue to use a specialty 
adjustment for the total per capita cost measure to accommodate the 
different circumstances by which patients are often treated by 
specialists but will not otherwise adjust or limit comparison based on 
the specialty of the clinician. In section II.E.5.e.(3) of this final 
rule with comment period, we provide additional responses on comparing 
cost measures based on other characteristics based on practice size or 
the types of patients served.
    We also believe that it is appropriate to have a national versus 
regional benchmark. The cost measures are price standardized to remove 
geographic adjustments such as wage indices and cost of living 
adjustments, so that measures would reflect the same payment rate for a 
particular service regardless of the region in which it is provided. 
Other CMS performance programs such as VM and HVBP use national 
benchmarks and we believe it is appropriate to continue that policy for 
MIPS. After considering the comments, we are finalizing our proposals 
at Sec.  414.1380(b)(2) to establish a single benchmark for each cost 
measure and to base those benchmarks on the performance period. We are 
finalizing the methodology proposed at Sec.  414.1380(b)(2) to assign 
one to ten points to each cost measure attributed to the MIPS eligible 
clinician based on the MIPS eligible clinician's performance compared 
to the measure benchmark. Because we are basing the benchmarks on the 
performance period, we will not be able to publish the actual numerical 
benchmarks in advance of the performance period, as indicated in the 
proposed rule (81 FR 28259).
    While we understand there are some opportunities associated with 
benchmarking to a previous year, we believe they are overwhelmed by the 
disadvantages. This is particularly true as we continue to develop 
episode-based measures in which the development of a new technology or 
a change in payment policy could result in a significant change in 
typical cost of care from year to year. This could potentially result 
in the majority of clinicians being found to perform well above or well 
below the benchmark, even if they did not change their practice 
patterns in relation to their peers. While we did not receive any 
comments on our proposal to only develop a benchmark for a measure if a 
minimum 20 MIPS eligible clinicians or groups are attributed the case 
minimum, we are finalizing that proposal incorporating the changes made 
to the attribution methodology used for cost measures discussed in 
II.E.5.e.(3) of this final rule with comment period. We will develop a 
benchmark for a measure only if at least 20 groups (for those MIPS 
eligible clinicians participating in MIPS as a group practice) or TIN/
NPI combinations (for those MIPS eligible clinicians participating in 
MIPS as an individual) can be attributed the case minimum for the 
measure. We are also finalizing our proposal that if a benchmark is not 
developed, the measure is not scored or included in the performance 
category.
(b) Assigning Points Based on Achievement
    For each set of benchmarks, we proposed 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 
proposed that for cost measures, lower costs represent better 
performance. In other words, MIPS-eligible clinicians in the top decile 
would have the lowest cost of care. We proposed to use a methodology 
generally consistent with the methodology proposed for the quality 
performance category. We refer readers to Tables 21 and 22 of the 
proposed rule (81 FR 28260 through 28261), for details on assigning 
points based on decile distribution. We requested comments on the 
methodology for assigning points based on performance period deciles 
for the cost performance category and solicited comments on alternative 
methodologies for assigning points for performance under this 
performance category for future rulemaking.
    For clarity, we have reproduced Table 21 from the proposed rule in 
Table 25. Table 25 illustrates an example of using decile points along 
with partial points to assign achievement points for a sample cost 
measure.

 Table 25--Example of Using Benchmarks for One Sample Measure To Assign
                                 Points
------------------------------------------------------------------------
                                                             Possible
           Decile                    Average cost             points
------------------------------------------------------------------------
Benchmark Decile 1..........  $100,000 or more..........         1.0-1.9
Benchmark Decile 2..........  $75,893-$99,999...........         2.0-2.9

[[Page 77310]]

 
Benchmark Decile 3..........  $69,003-$75,892...........         3.0-3.9
Benchmark Decile 4..........  $56,009-$69,002...........         4.0-4.9
Benchmark Decile 5..........  $50,300-$56,008...........         5.0-5.9
Benchmark Decile 6..........  $34,544-$50,299...........         6.0-6.9
Benchmark Decile 7..........  $27,900-$34,543...........         7.0-7.9
Benchmark Decile 8..........  $21,656-$27,899...........         8.0-8.9
Benchmark Decile 9..........  $15,001-$21,655...........         9.0-9.9
Benchmark Decile 10.........  $1,000-$15,000............              10
------------------------------------------------------------------------
Note: The numbers provided in this table are for illustrative purposes
  only.

    The following is summary of the comments we received regarding our 
proposal to assign points for a measure based on performance period 
deciles for the cost performance category.
    Comment: A commenter expressed concern with the use of the decile 
scoring system for the cost performance category, noting that the wide 
variation in spending demonstrated in Table 21 of the proposed rule 
indicated that the cost measures are not properly risk adjusted. 
Another commenter expressed concern that the decile approach was not 
reliable.
    Response: We noted that Table 21 in the proposed rule was provided 
for illustrative purposes only and was not created on the basis of any 
particular data analysis. We believe that the decile approach is 
appropriate to measure relative performance for the cost performance 
category and is consistent with the approach taken for the quality 
performance category of MIPS.
    Comment: Some commenters recommended that the cost performance 
category be scored on both achievement and improvement. Commenters 
indicated that MACRA requires improvement to be considered in 
calculating this performance category.
    Response: Section 1848(q)(5)(D) of the Act requires us to consider 
both achievement and improvement in assessing the cost performance 
category beginning with the second year of MIPS if data sufficient to 
measure improvement is available. We will discuss how to incorporate 
improvement in future rulemaking.
    After considering the comments, we are finalizing our proposal to 
assign 1 to 10 achievement points for each measure based on which 
benchmark decile range the MIPS eligible clinician's performance on the 
measure is between.
(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) (81 FR 28198) 
of the proposed rule, to establish a 20 case minimum for each cost 
measure. We noted that this would include the 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 through 71296). 
As discussed further in section II.E.5.e.(3)(a)(ii) of this final rule 
with comment period, after considering the comments and reviewing 
additional data sources, we finalized a higher case minimum of 35 for a 
MIPS eligible clinician or group to be attributed the MSPB cost 
measure. This newly established case minimum of 35 will ensure that the 
measure meets our reliability threshold for both groups and individual 
clinicians. We finalized a case minimum of 20 for all other cost 
measures and finalized at Sec.  414.1380(b)(2)(ii) that MIPS eligible 
clinicians and groups must meet the minimum case volume specified by 
CMS to be scored on a cost measure for the cost performance category 
for the clinician or group.
(d) Calculating the Cost Performance Category Score
    To calculate the cost performance category score, we proposed at 
Sec.  414.1380(b)(2)(iii) to average all the scores of all the cost 
measures attributed to the MIPS eligible clinician. All measures in the 
cost performance category as described in section II.E.5.e. of the 
proposed rule would be weighted equally. If a MIPS eligible clinician 
has only one cost measure with a required case minimum to be scored, we 
proposed to score that measure accordingly, and the MIPS eligible 
clinician's cost performance category score would consist of the score 
for that one measure. We noted that MIPS eligible clinicians cannot 
receive a zero score for any cost measure for failure to submit the 
measure since none of the cost 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 cost 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 cost 
performance category score would not be calculated. Refer to section 
II.E.6.b.(2) of this final rule with comment period for details on how 
we address scenarios where a performance category score is not 
calculated for a MIPS eligible clinician. MIPS eligible clinicians 
would receive performance feedback as required under section 
1848(q)(12) of the Act and discussed in section II.E.8.a. of this final 
rule with comment period. Over time, performance feedback may include a 
list of attributed cases for each measure by MIPS eligible clinician. 
We requested comment on our proposals to calculate the cost performance 
category score.
    Table 22 of the proposed rule illustrated a sample scoring 
methodology for a limited set of measures (81 FR 28261). Measures that 
do not meet the required case minimum are not used for scoring. Unlike 
the quality performance category score, we did not propose bonus points 
as part of the cost performance category score. The following is 
summary of the comments we received regarding our proposed calculation 
of the cost performance category score:
    Comment: One commenter opposed our proposal to weigh all cost 
measures equally, indicating that the total per capita cost measure 
should be weighed more heavily due to a lack of experience with other 
measures. Some commenters suggested that cost measures be weighted on 
the basis of the volume of attributed patients for each of the 
individual measures that are scored, rather than weighted equally 
regardless of patient volume.
    Response: We are making two important changes to the cost 
performance category that are relevant to these comments. First, we are 
reducing the number of cost measures

[[Page 77311]]

from the proposed rule to only include those which have previously been 
used in the VM or the 2014 sQRUR. Secondly, we are reducing the weight 
of the cost performance category to zero in the MIPS final score for 
the 2019 MIPS payment year to allow clinicians and groups to better 
understand the different attribution and scoring approach used in this 
category as compared with the approach to cost measures for the VM. 
Given that we are reducing the weight of the category to zero, we do 
not believe it is necessary for the 2019 MIPS payment year to create 
differential weighting for individual measures, whether it is by 
weighting measures based on an individual clinician or group patient 
volume, charges, or establishing a static weight that always weights a 
particular measure higher or lower for all clinicians or groups. We 
encourage clinicians to review performance feedback to become more 
familiar with the measures and the scoring for this category. We will 
continue to review the cost performance category and consider changes 
as we develop and include additional cost measures in the future.
    Comment: Some commenters opposed our proposal to include all 
measures for which a clinician or group meets the case minimum in 
calculating a cost performance score and recommended that scoring be 
limited to a certain number of measures. Some commenters expressed 
concern that cost for a particular patient could be captured within 
multiple measures and encouraged CMS to only use the measures with the 
highest scores.
    Response: Our goal in the cost performance category of MIPS is to 
include as broad a collection of measures as possible to measure costs 
for many different patients. Some clinicians or groups may have a 
larger number of cost measures attributed to them, particularly as we 
continue to develop new episode-based measures, but we believe that 
this larger number of attributed measures reflects a breadth of care 
provided by a clinician or group. Given that there is no additional 
reporting burden associated with cost measures, we do not believe it is 
appropriate to limit the number of measures that apply once the case 
minimums are met.
    We also understand that there are cases in which an individual 
clinician or group might have the same individual patient costs 
attributed for multiple cost measures. However, we do not believe that 
this justifies limiting the number of measures in the cost performance 
category score for a particular clinician or group. In the quality 
performance category, if a clinician submits more measures than 
required, we will only include those with the highest score in the 
performance category score. We do this in part to encourage quality 
reporting on new and diverse measures. Because cost measures do not 
require reporting, we do not believe this rationale applies for the 
cost performance category. We will use all cost measures that meet the 
case minimums in calculating the cost performance category score, as 
long as those measures have also met our standards for the minimum 
number of attributed clinicians or groups needed to calculate a 
benchmark.
    After consideration of the comments, we are finalizing our proposal 
at Sec.  414.1380(b)(2)(iii) that a MIPS eligible clinician's cost 
performance category score is the equally-weighted average of all 
scored costs measures. We are also finalizing our proposal to not 
calculate a cost performance category score if a clinician or group is 
not attributed any cost measures, because the clinician or group has 
not met the case minimum requirements for any of the cost measures or a 
benchmark has not been created for any of the cost measures that would 
otherwise be attributed to the clinician or group. As described in 
section II.E.5.e.(2) of this final rule with comment period, we are 
finalizing a 0 percent weight for the cost performance category for the 
transition year of MIPS, a 10 percent weight for MIPS payment year 
2020. For MIPS payment year 2021 and beyond, the cost performance 
category will be 30 percent. This reduced weighting provides an 
opportunity for MIPS eligible clinicians to become familiar with the 
scoring in the cost performance category of MIPS.
(4) Scoring the Improvement Activities Performance Category
    Section 1848(q)(5)(C) of the Act outlines specific scoring rules 
for the improvement activities performance category. Section 
1848(q)(5)(C)(i) of the Act provides that a MIPS eligible clinician who 
is in a practice that is a certified patient-centered medical home or 
comparable specialty practice for a performance period shall receive 
the highest potential score for the improvement activities performance 
category for such period. Section 1848(q)(5)(C)(ii) of the Act provides 
that MIPS eligible clinicians participating in an APM for a performance 
period shall earn a minimum score of one-half of the highest potential 
score for the improvement activities performance category for such 
period. We refer readers to section II.E.5.h. of this final rule with 
comment period for a description of the APM scoring standard for MIPS 
APMs. 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 to receive the highest possible score for the 
improvement activities performance category. Based on these criteria, 
we proposed a scoring methodology that assigns points for the 
improvement activities performance category (based on certified 
patient-centered medical home participation and the improvement 
activities reported by the MIPS eligible clinician). A MIPS eligible 
clinician's performance would be evaluated by comparing the reported 
improvement activities to the highest possible score.
(a) Assigning Points to Reported Improvement Activities
    Improvement activities is a new performance category that has not 
been implemented in our previous programs. Therefore, in the transition 
year, 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 improvement activities 
performance category. Therefore, we proposed at Sec.  414.1380(b)(3) to 
assign points for each reported activity within two categories: Medium-
weighted and high-weighted activities (81 FR 28261). Medium-weighted 
activities are worth 10 points. High-weighted activities are worth 20 
points. Table 26 under section II.E.6.a(4)(a) of this final rule with 
comment period lists all of the improvement activities that are high-
weighted. All other activities not listed as high-weighted activities 
are considered medium activities. Table H in the Appendix of this final 
rule with comment period provides the Improvement Activities 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 improvement activity.
    Activities are proposed to be weighted as high based on the extent 
to which they align with activities that support the certified patient-
centered medical home, since that is the standard under section 
1848(q)(5)(C)(i) of the Act for achieving the highest potential score 
for the improvement activities performance category, as well as with 
our priorities for transforming clinical practice. Additionally, 
activities that require

[[Page 77312]]

performance of multiple actions, such as participation in the 
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 solicited 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 
improvement activities. We solicited comment on a multi-tier weighting 
approach such as low, medium and high activity categories for future 
years of MIPS.
    The following is a summary of the comments we received regarding 
our proposal on the assigning of points to reported improvement 
activities.
    Comment: A number of commenters requested a reduction in the number 
of activities or a reduction in the reporting threshold from 60 to 30 
points to meet 100 percent of scoring for this performance category, 
citing reporting burden and the limited amount of time that clinicians 
will have to prepare to begin reporting improvement activities for this 
new performance category. Some commenters requested a requirement of a 
maximum of three activities and other commenters suggested four 
activities.
    Response: After consideration of the comments, we are modifying our 
proposal to reduce the number of activities so that no more than four 
medium-weighted activities, or no more than two high-weighted 
activities, or an equivalent combination (that is, 1 high and 2 medium) 
are required in order to achieve the highest possible improvement 
activities performance category score. The comments we received support 
this modification as commenters expressed concerns about the limited 
amount of time MIPS eligible clinicians will have to start preparing 
for these activities and also the burden associated with reporting 
additional activities.
    After consideration of the comments, we are finalizing our 
proposals at Sec.  414.1380(b)(3) to assign points for improvement 
activities according to two weightings: Medium-weighted; and high-
weighted activities. Each medium-weighted activity is worth 10 points 
toward the total category score, and each high-weighted activity is 
worth 20 points toward the total category score of 40 points. These 
points are doubled for small practices, rural practices, or practices 
located in geographic health professional shortage areas (HPSAs), and 
non-patient facing MIPS eligible clinicians. We refer readers to 
section II.E.6.a.(4)(d) of this final rule with comment period for 
further detail on improvement activities scoring.
    We are finalizing Table 23 of the proposed rule (81 FR 28263) with 
modifications that include clarifying language for one of the existing 
PDMP activities that is assigned the highest points for an activity (20 
points), revising the description of one existing activity under the 
Emergency Response and Preparedness Subcategory that is also assigned 
the highest points for an activity (20 points) and changing the period 
for this activity to be performed from a minimum of 6 months to 60 
days, which is better aligned with the new overall performance period 
for the Quality Payment Program of a 90-day reporting period, and we 
are changing the weighting of one existing activity in the Population 
Management subcategory from medium-weighted and instead assigning it 
the highest points for an activity (20 points). We are changing this 
existing activity from a medium to a high-weighted activity to 
incentivize caring for these vulnerable populations. These 
modifications are reflected in Table 26, which lists the improvement 
activities that are assigned the highest points for an activity (high-
weighted activities are double-weighted to 40 points for MIPS eligible 
clinicians that are small practices, practices located in rural areas, 
geographic HPSAs, or non-patient facing MIPS eligible clinicians and 20 
points for all other MIPS eligible clinicians). Table H in the Appendix 
to this final rule with comment period provides the Improvement 
Activities Inventory of all activities, both medium-weighted and high-
weighted.

 Table 26--Finalized Improvement Activities Assigned the Highest Points
------------------------------------------------------------------------
            Subcategory                           Activity
------------------------------------------------------------------------
Expanded Practice Access..........  Provide 24/7 access to MIPS eligible
                                     clinicians, eligible groups, or
                                     care teams for advice about urgent
                                     and emergent care (e.g., eligible
                                     clinician and care team access to
                                     medical record, cross-coverage with
                                     access to medical record, or
                                     protocol-driven nurse line with
                                     access to medical record) that
                                     could include one or more of the
                                     following:
                                    Expanded hours in evenings and
                                     weekends with access to the patient
                                     medical record (for example,
                                     coordinate with small practices to
                                     provide alternate hour office
                                     visits and urgent care);
                                    Use of alternatives to increase
                                     access to care team by MIPS
                                     eligible clinicians and groups,
                                     such as e-visits, phone visits,
                                     group visits, home visits and
                                     alternate locations (for example,
                                     senior centers and assisted living
                                     centers); and/or
                                    Provision of same-day or next-day
                                     access to a consistent MIPS
                                     eligible clinician, group or care
                                     team when needed for urgent care or
                                     transition management.
Population Management.............  Participation in a systematic
                                     anticoagulation program
                                     (coagulation clinic, patient self-
                                     reporting program, patient self-
                                     management program) for 60 percent
                                     of practice patients in the
                                     transition year and 75 percent of
                                     practice patients in year 2 who
                                     receive anti-coagulation
                                     medications (warfarin or other
                                     coagulation cascade inhibitors).

[[Page 77313]]

 
Population Management.............  MIPS eligible clinicians and MIPS
                                     eligible clinician and groups who
                                     prescribe oral Vitamin K antagonist
                                     therapy (warfarin) must attest
                                     that, in the first performance
                                     period, 60 percent or more of their
                                     ambulatory care patients receiving
                                     warfarin are being managed by one
                                     or more of these improvement
                                     activities:
                                    Patients are being managed by an
                                     anticoagulant management service,
                                     that involves systematic and
                                     coordinated care, incorporating
                                     comprehensive patient education,
                                     systematic INR testing, tracking,
                                     follow-up, and patient
                                     communication of results and dosing
                                     decisions;
                                    Patients are being managed according
                                     to validated electronic decision
                                     support and clinical management
                                     tools that involve systematic and
                                     coordinated care, incorporating
                                     comprehensive patient education,
                                     systematic INR testing, tracking,
                                     follow-up, and patient
                                     communication of results and dosing
                                     decisions;
                                    For rural or remote patient,
                                     patients are managed using remote
                                     monitoring or telehealth options
                                     that involve systematic and
                                     coordinated care, incorporating
                                     comprehensive patient education,
                                     systematic INR testing, tracking,
                                     follow-up, and patient
                                     communication of results and dosing
                                     decisions; and/or
                                    For patients who demonstrate
                                     motivation, competency, and
                                     adherence, patients are managed
                                     using either a patient self-testing
                                     (PST) or patient-self-management
                                     (PSM) program.
                                    The performance threshold will
                                     increase to 75 percent for the
                                     second performance period and
                                     onward.
                                    Clinicians would attest that, 60
                                     percent for the transition year, or
                                     75 percent in future years, of
                                     their ambulatory care patients
                                     receiving warfarin participated in
                                     an anticoagulation management
                                     program for at least 90 days during
                                     the performance period.
Population Management.............  For outpatient Medicare
                                     beneficiaries with diabetes and who
                                     are prescribed antidiabetic agents
                                     (for example, insulin,
                                     sulfonylureas), MIPS eligible
                                     clinicians and MIPS eligible
                                     clinician groups must attest to
                                     having:
                                    For the first performance period, at
                                     least 60 percent of medical records
                                     with documentation of an
                                     individualized glycemic treatment
                                     goal that:
                                    (a) Takes into account patient-
                                     specific factors, including, at
                                     least age, comorbidities, and risk
                                     for hypoglycemia; and
                                    (b) Is reassessed at least annually.
                                    The performance threshold will
                                     increase to 75 percent for the
                                     second performance period and
                                     onward.
                                    Clinicians would attest that, 60
                                     percent for the transition year, or
                                     75 percent in future years, of
                                     their medical records that document
                                     individualized glycemic treatment
                                     represent patients who are being
                                     treated for at least 90 days during
                                     the performance period.
Population Management.............  Participating in a Rural Health
                                     Clinic (RHC), Indian Health Service
                                     (IHS), or Federally Qualified
                                     Health Center in ongoing engagement
                                     activities that contribute to more
                                     formal quality reporting, and that
                                     include receiving quality data back
                                     for broader quality improvement and
                                     benchmarking improvement which will
                                     ultimately benefit patients.
                                    Participation in Indian Health
                                     Service, as an improvement
                                     activity, requires MIPS eligible
                                     clinicians and groups to deliver
                                     care to federally recognized
                                     American Indian and Alaska Native
                                     populations in the U.S. and in the
                                     course of that care implement
                                     continuous clinical practice
                                     improvement including reporting
                                     data on quality of services being
                                     provided and receiving feedback to
                                     make improvements over time.
Population Management.............  Use of a Qualified Clinical Data
                                     Registry to generate regular
                                     performance feedback that
                                     summarizes local practice patterns
                                     and treatment outcomes, including
                                     for vulnerable populations.
Care Coordination.................  Participation in the CMS
                                     Transforming Clinical Practice
                                     Initiative.
Beneficiary Engagement............  Collection and follow-up on patient
                                     experience and satisfaction data on
                                     beneficiary engagement, including
                                     development of improvement plan.
Patient Safety and Practice         Clinicians would attest that, 60
 Assessment.                         percent for the transition year, or
                                     75 percent in the second year, of
                                     consultation of prescription drug
                                     monitoring program prior to the
                                     issuance of a Controlled Substance
                                     Schedule II (CSII) opioid
                                     prescription that lasts for longer
                                     than 3 days.
Patient Safety and Practice         Participation in the Consumer
 Assessment.                         Assessment of Healthcare Providers
                                     and Systems Survey or other
                                     supplemental questionnaire items
                                     (e.g., Cultural Competence or
                                     Health Information Technology
                                     supplemental item sets).
Achieving Health Equity...........  Seeing new and follow-up Medicaid
                                     patients in a timely manner,
                                     including individuals dually
                                     eligible for Medicaid and Medicare.
Emergency Response and              Participation in domestic or
 Preparedness.                       international humanitarian
                                     volunteer work. Activities that
                                     simply involve registration are not
                                     sufficient. MIPS eligible
                                     clinicians and groups attest to
                                     domestic or international
                                     humanitarian volunteer work for a
                                     period of a continuous 60 days or
                                     greater.
Integrated Behavioral and Mental    Integration facilitation, and
 Health.                             promotion of the colocation of
                                     mental health and substance use
                                     disorder services in primary and/or
                                     non-primary clinical care settings.
Integrated Behavioral and Mental    Offer integrated behavioral health
 Health.                             services to support patients with
                                     behavioral health needs, dementia,
                                     and poorly controlled chronic
                                     conditions that could include one
                                     or more of the following:
                                    Use evidence-based treatment
                                     protocols and treatment to goal
                                     where appropriate;
                                    Use evidence-based screening and
                                     case finding strategies to identify
                                     individuals at risk and in need of
                                     services;
                                    Ensure regular communication and
                                     coordinated workflows between
                                     eligible clinicians in primary care
                                     and behavioral health;
                                    Conduct regular case reviews for at-
                                     risk or unstable patients and those
                                     who are not responding to
                                     treatment;
                                    Use of a registry or other certified
                                     health information technology
                                     functionality to support active
                                     care management and outreach to
                                     patients in treatment; and/or
                                    Integrate behavioral health and
                                     medical care plans and facilitate
                                     integration through co-location of
                                     services when feasible.
------------------------------------------------------------------------


[[Page 77314]]

(b) Improvement Activities Performance Category Highest Potential Score
    Although there is likely to be variability in the level at which 
each MIPS eligible clinician may perform improvement activities, 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 improvement in performing improvement activities. Because 
we cannot measure variable performance within an improvement activity 
at this time, we proposed at Sec.  414.1380(b)(3)(v) to compare the 
points associated with the reported activities against the highest 
potential score (81 FR 28265). We proposed the highest potential score 
to be 60 points for the transition year performance period based on the 
following rationale.
    Based on discussions with several high performing organizations, we 
believed 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 six adult specialties and high-
performing in six adult specialties; \33\ 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 15-28 percent below 
regional average and significant improvement in patient surveys from 
CAHPS; \34\ and a third recognized as a leader in rural health with the 
highest award for excellence from the National Rural Primary Care 
Association.
---------------------------------------------------------------------------

    \33\ 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.
    \34\ California Association of Physicians Groups in Medicare 
Advantage (2014). Retrieved from http://www.ehcca.com/presentations/capgma1/cohen_b2.pdf.
---------------------------------------------------------------------------

    We also believed that a top performing small practice or practice 
in a rural area or geographic HPSA, 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 HPSAs or non-patient 
facing MIPS eligible clinicians, we proposed 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 believed it was reasonable to 
expect all MIPS eligible clinicians to be able to report improvement 
activities, and as such, a MIPS eligible clinician reporting no 
improvement activities would receive a zero score for the improvement 
activities performance category. We believed this proposal would allow 
us to capture variation in reporting the improvement activities 
performance category.
    Section 414.1355(a) of the proposed rule presented the CMS Study on 
Improvement Activities and Measurement (81 FR 28214). 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 proposed 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 improvement activities performance category.
    The following is a summary of the comments we received regarding 
our proposal on the methodology for achieving the highest score.
    Comment: Commenters supported considerations for small, rural, HPSA 
and non-patient facing MIPS eligible clinicians, but recommended that 
CMS allow these entities to report on two medium-weighted improvement 
activities or one high-weighted improvement activity in order to 
achieve 100 percent of the total possible score, and to report on one 
medium-weighted improvement activity to achieve 50 percent of the total 
possible score.
    Response: As discussed in section II.E.5.f.(2) of this final rule 
with comment period, we are reducing the number of activities for these 
types of clinicians. Rather than selecting any two activities, these 
practices may select either two medium-weighted activities, or one 
high-weighted activity, to achieve the highest score.
    Comment: Other commenters recommended that CMS use a uniform 
weighting for all the activities, and that scoring for this category be 
aligned with the other performance categories.
    Response: We justify the weighting of high for specific activities 
based on our priorities for specific programs/activities and alignment 
with activities that would be performed by a clinician in a certified 
patient-centered medical home or comparable specialty practice. For 
weighting of a high, we focused on areas with activities that promote 
CMS public health priorities and support the patient centered medical 
home. We are retaining the two weights, medium and high for activities.
    Comment: Commenters also requested general clarification about how 
credit for meeting improvement activities participation requirements 
will be determined, and questioned how groups will be scored.
    Response: Scoring is based on the number of different weighted 
activities selected from the broad list in Table H in the Appendix to 
this final rule with comment period. As discussed in section 
II.E.6.a.(4)(a) of this final rule with comment period, small 
practices, practices located in rural areas or geographic health 
professional shortage areas or non-patient facing MIPS eligible 
clinicians receive 20 points by selecting one medium-weighted activity 
and receive 40 points by selecting two medium-weighted activities, or 
alternatively may select one high-weighted activity to receive 40 
points. If a MIPS eligible clinician, other than a MIPS APM or APM, 
does not select any activity, they will receive zero points in the 
improvement activities performance category.
    All other MIPS eligible clinicians, other than a MIPS APM, will 
receive 10 points by selecting one medium-weighted activity (a medium-
weighted activity is double-weighted for small practices, practices 
located in rural areas and geographic HPSAs, and non-patient facing 
MIPS eligible clinicians); 20 points by selecting two medium-weighted 
activities; 30 points by selecting three medium activities; and 40 
points by selecting four medium-weighted activities. An APM, other than 
a MIPS APM, only needs to select two medium or one high-weighted 
activity to add to their automatic score of at least one-half of the 
highest score. Alternatively, these same MIPS eligible clinicians may 
receive 20 points by selecting one high-weighted activity (a high-
weighted activity is double-weighted for small practices, practices 
located in rural areas and geographic HPSAs, and non-patient facing 
MIPS eligible clinicians), or 40 points by selecting two high-weighted 
activities. With the exception of small practices, practices in rural 
areas and geographic HPSAs and non-patient facing MIPS eligible 
clinicians, a combination of one medium-weighted activity and one high-
weighted activity would achieve 30 points and two medium- and one high-
weighted activity would achieve 40 points. MIPS eligible clinicians or

[[Page 77315]]

groups, other than APMs, who do not select any activity would receive 
zero points.
    Comment: Commenters recommended that practices participating in 
APMs should receive more than 50 percent of the total possible score 
and recommended that participants receive up to 100 percent of the 
total possible score. One commenter recommended that alternatively, 
activity reporting be allowed at the APM entity level to reduce 
reporting burden.
    Response: We are finalizing our proposal that APM participants will 
receive at least one-half of the highest possible score. However, we 
recognize that participating in an APM requires significant effort from 
practices and eligible clinicians, and with that in mind, we are 
revising the improvement activities performance category scoring policy 
for MIPS APMs. To develop the improvement activities score assigned to 
all MIPS APMs, CMS will compare the requirements of the specific APM 
with the list of activities in the Improvement Activities Inventory in 
Table H in the Appendix to this final rule with comment period and 
score those activities in the same manner that they are otherwise 
scored for MIPS eligible clinicians according to section II.E.6.a.(4) 
of this final rule with comment period. For further explanation of how 
MIPS APMs scores will be calculated, we refer readers to section 
II.E.5.h of this final rule with comment period.
    After consideration of the comments, we are not finalizing our 
proposal at Sec.  414.1380(b)(3)(v) to compare the points associated 
with the reported activities against the highest potential score of 60 
points but are using 40 points instead as the total points possible to 
achieve the highest score for the transition year performance period 
(81 FR 28265). For small practices, rural and geographic HPSA practices 
and non-patient facing MIPS eligible clinicians, the weight for any 
activity selected would be doubled so that these practices only need to 
select one high- or two medium-weighted activities to achieve the 
highest score of 40 points. We are finalizing our proposal that MIPS 
eligible clinicians participating in APMs will automatically receive 
one-half of the highest score for improvement activities and in 
addition, MIPS APMs may receive a higher score based on the improvement 
activities performance category score that CMS assigns for each MIPS 
APM based on the extent to which the requirements of the specific model 
meet the list of activities in the Improvement Activities Inventory. We 
note that one-half of the highest score for improvement activities is 
the minimum amount that eligible clinicians participating in APMs could 
achieve, in accordance with the statute. We refer readers to section 
II.E.5.h of this final rule with comment period for additional 
information about how a MIPS APM can achieve the highest score.
    The following is a summary of the comments we received regarding 
our proposal to conduct the CMS Study on Improvement Activities and 
Measurement.
    Comment: One commenter agreed that improvement activities 
performance category study participants should receive full credit for 
improvement activities performance category and that those participants 
that do not meet study guidelines should be removed and be subject to 
typical improvement activities performance category requirements. This 
commenter recommended that CMS provide a final date by which it plans 
to make these exclusion determinations and that after this date, CMS 
can work with the ex-participant to help them complete the year. They 
also recommended that all participants who get excluded from the study 
not be allowed to participate in the study the following year.
    Response: We will continue to work with stakeholders to further 
define future participation requirements as this study evolves.
    After consideration of the comments, we are finalizing our proposal 
that MIPS eligible clinicians and groups that successfully participate 
and submit data to fulfill study requirements will receive the highest 
score for the improvement activities 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, for a performance period must be given the highest potential 
score for the improvement activities performance category for the 
performance period. We proposed that certified 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); \35\ or are a 
Medicaid Medical Home Model or Medical Home Model. We proposed that our 
proposed comparable specialty practices are those that include the NCQA 
Patient-Centered Specialty Recognition. We refer readers to 
II.E.5.g.(5) of this final rule with comment period for a description 
of the Medical Home Model and the Medicaid 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-
centered medical home or comparable specialty practice except for being 
recognized by one of the above organizations.
---------------------------------------------------------------------------

    \18\ The name was officially shortened to URAC in 1996.
---------------------------------------------------------------------------

    We outlined at Sec.  414.1355(b) of the proposed rule the policy 
for certified patient-centered medical homes (81 FR 28209). The 
organizations identified above maintain a list of certified patient-
centered medical homes, including the Medical Home Models and the 
Medicaid Medical Home Models, that would be used to determine whether a 
MIPS eligible clinician qualifies for the highest potential score for 
the improvement activities performance category because the MIPS 
eligible clinician is in a certified patient-centered medical home. The 
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 improvement activities performance category because the MIPS 
eligible clinician is in a comparable specialty practice.
    We proposed 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 Medical Home Model, Medicaid 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 improvement 
activities performance category (81 FR 28210).
    The following is summary of the comments we received regarding our 
proposal to provide practices defined as certified patient-centered 
medical homes with the highest score for the improvement activities 
performance category. We address comments

[[Page 77316]]

regarding the specifics of this definition in section II.E.5.f.(3)(b) 
of this final rule with comment period.
    Comment: One commenter strongly recommended a flexible approach to 
quality assessment that emphasizes outcomes of care and that favors 
continuous quality improvement methodologies rather than rigid, 
process-oriented patient-centered medical home certification models, 
believing that relying on patient-centered medical home certification 
as a means of quality assessment runs the risk of practices not 
actually realigning efforts to produce higher quality and more cost 
effective care.
    Response: Our policy on this topic is required by the statute, 
which specifically identifies MIPS eligible clinicians who practice in 
a certified patient-centered medical home or comparable specialty 
practices as receiving the highest score for the improvement activities 
performance category; this policy does not apply to the quality 
category.
    Comment: Several commenters supported certified patient-centered 
medical homes and supported MIPS eligible clinicians who practice in 
these entities receiving full credit for the improvement activities 
category. One commenter suggested that patient-centered medical homes 
stratify data by disparity variables and implement targeted 
interventions to address health disparities. These commenters believed 
that the presentation of the information in this way will allow MIPS 
eligible clinicians to better understand the patient-centered medical 
home model and decide how to best deliver care under MIPS. Additional 
commenters suggested including activities under the improvement 
activities category that are associated with actions conducted by a 
certified patient-centered medical home. The commenters recommended the 
following subcategories of activities be associated with elements of a 
patient-centered medical home: expanded practice access, population 
management, care coordination, beneficiary engagement, and patient 
safety and practice assessment.
    Response: We do not believe the commenter is suggesting these 
elements should be a requirement for being approved to receive full 
credit as a certified patient-centered medical home. Stratification of 
data to address health disparities is something we will consider 
encouraging in the future. Reorganizing and expanding the existing 
Improvement Activities Inventory is something we look forward to 
working with stakeholders on in future years.
    After consideration of these comments we are finalizing our 
proposal 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, Medical Home Model, or comparable 
specialty practice, will receive the highest potential score (in 
accordance with section 1848(q)(5)(C)(i) of the Act) for the 
improvement activities performance category (81 FR 28210). However, as 
noted in section II.E.5.f.(3)(b) of this final rule with comment 
period, we are not finalizing our proposal at Sec.  414.1380(b)(3)(v) 
to compare the points associated with the reported activities against 
the highest potential score of 60 points (81 FR 28210), but instead are 
using 40 points as the total points required to achieve the highest 
score for the transition year performance period. We also are not 
finalizing our proposal at Sec.  414.1355(b) to only define certified 
patient-centered medical home practices as those that have received 
accreditation from 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)); or comparable specialty practices as those that are a Medicaid 
Medical Home Model or Medical Home Model or from the NCQA Patient-
Centered Specialty Recognition (81 FR 26210), rather we are finalizing 
an expanded definition of these practices at section II.E.5.f.(3)(b) of 
this final rule with comment period, and we refer readers to the 
specifics of this definition in section II.E.5.f.(3)(b) of this final 
rule with comment period.
(d) Calculating the Improvement Activities Performance Category Score
    To determine the improvement activities performance category score, 
we proposed to sum the points for all of the MIPS eligible clinician's 
reported activities and divide by the proposed improvement activities 
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 improvement 
activities points, then we proposed to cap the resulting improvement 
activities performance category score at 100 percent.
    Table 24 of the proposed rule illustrated a sample scoring 
methodology for the improvement activities performance category for a 
MIPS eligible clinician that is not an APM participant (81 FR 28267). 
For example, the MIPS eligible clinician was not an APM participant and 
did 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 completed two high-weighted activities 
worth 20 points each and two medium-weighted activities for 10 points 
each to receive the maximum 60 points available in the improvement 
activities performance category score of 100 percent.
    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). 
Please refer to Table 24 of the proposed rule for the illustration of 
the proposed methodology (81 FR 28267).
    Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to 
give consideration to the circumstances of small practices and 
practices located in rural areas and in geographic 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, 
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 proposed alternative scoring 
requirements for the improvement activities 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

[[Page 77317]]

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 a 
certified patient-centered medical home or comparable specialty 
practice, a non-patient facing MIPS eligible clinician, a small 
practice, 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 
proposed that the following scoring would apply to MIPS eligible 
clinicians who are a non-patient facing MIPS eligible clinician, 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 improvement 
activities 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 section 
1848(q)(2)(C)(v)(III) of the Act provides that the intent of the 
improvement activities performance category is to demonstrate 
improvement over time and not just demonstrate same benefit from year 
to year. Specifically, the statute defines that an activity is 
expected, when effectively executed, to result in improved outcomes, 
which would be demonstrated over time. If a MIPS eligible clinician 
reports on the same activity from year to year that does not show 
improved outcomes, it would not be in line with the spirit of statute.
    For example, continuing to provide expanded practice access year 
after year would not demonstrate improved outcomes over time. Further, 
should the weighting of activities change in future years, we may also 
adjust the improvement activities performance category point target 
accordingly. We requested comment on our proposed approach to score the 
improvement activities performance category, and solicited comment on 
alternative methodologies for the improvement activities performance 
category. We sought to assure equity in scoring MIPS eligible 
clinicians while still considering activity variation, impact and 
burden.
    The following is summary of the comments we received regarding our 
proposal to calculate the improvement activities performance score.
    Comment: Commenters requested that CMS reduce the complexity in 
scoring, especially since improvement activities is a new performance 
category. One commenter disagreed with the complexity of the MIPS final 
score methodology, including for the improvement activities performance 
category, because it is difficult for physicians to understand, and to 
plan for the future.
    Response: To address confusion regarding our proposal for 
calculating the improvement activities performance category score, we 
first explain in section II.E.5.f.(3) of this final rule with comment 
period, the number of activities that a MIPS eligible clinician or 
group must select to achieve the highest score. Under this same 
section, section II.E.5.f.(3), we also explain the number of activities 
that a small practice, a practice located in a rural area or geographic 
health professional shortage area, and non-patient facing MIPS eligible 
clinicians must select in order to achieve the highest score. Under 
section II.E.6.a.(4)(a) of this final rule with comment period, we 
explain the number of points that a medium-weighted activity and a 
high-weighted activity are worth for a MIPS eligible clinician or 
group, and we also explain the number of points that a medium-weighted 
activity and a high-weighted activity are worth for a small practice, a 
practice located in a rural area or geographic health professional 
shortage area, and non-patient facing MIPS eligible clinicians. In 
section II.E.6.a.(4)(d) of this final rule with comment period, we 
explain that the total number of points achievable for the improvement 
activities performance category are now 40 points since the maximum 
number of improvement activities a MIPS eligible clinician or group 
would have to report to achieve the highest score for improvement 
activities is four. This means that 40 points is the denominator for 
the improvement activities performance category. If a medium-weighted 
activity is worth 10 points and a MIPS eligible clinician reported four 
activities that would result in a total of 40 points (4 activities x 10 
points each). A medium-weighted activity and a high-weighted activity 
are doubled for a small practice, a practice located in a rural area or 
geographic health professional shortage area, and non-patient facing 
MIPS eligible clinicians. We arrive at 40 points for a practice located 
in a rural area or geographic health professional shortage area, and 
non-patient facing MIPS eligible clinicians because the most these 
practices need to select are two medium-weighted activities that are 
double weighted (20 points x 2) which is equal to 40 points or one 
high-weighted activity that is double weighted (40 points x 1) which is 
equal to 40 points.
    Comment: Some commenters requested that CMS specify how many MIPS 
eligible clinicians in each group must participate in each project in 
order to provide the points for the entire group. Other commenters were 
confused as to whether everyone in the group or TIN had to be a 
certified patient-centered medical home to receive the highest score.
    Response: For the transition year of the MIPS program, there are no 
minimum participation thresholds established at the group level. There 
are also no thresholds for the number of practice sites within the same 
TIN that must be certified as a patient-centered medical home to 
receive the highest score. We anticipate that as we gain experience 
with the improvement activities category this may be modified in future 
years.
    Comment: One commenter requested that bonus points be applied to 
the calculated score for prior year awards.
    Response: We will not award bonus points for the improvement 
activities performance category in the transition year but will 
continue to monitor trends in the program to determine the need for a 
bonus in the future. We also clarify that we cannot give bonus points 
for an

[[Page 77318]]

activity or award given outside of the program performance.
    Comment: Several commenters supported the proposal that non-patient 
facing MIPS eligible clinicians select two activities, recognizing that 
the MIPS statute requires consideration of special circumstances for 
these types of clinicians. One commenter did not support the proposed 
policy allowing ``non-patient facing'' providers to perform a single 
activity in the improvement activities category to achieve one-half of 
the total points toward the improvement activities score and 
recommended that we hold all clinicians to the same standard.
    Response: We believe there are several subcategories such as 
beneficiary engagement and expanded practice access that may limit a 
non-patient facing MIPS eligible clinician from having access to the 
broader list of activities more than other types of practices and 
believe it is reasonable to limit the number of activities for non-
patient facing MIPS eligible clinicians.
    Comment: Commenters generally expressed their support for the 
approach of reducing improvement activities category requirements for 
non-patient facing MIPS eligible clinicians and groups, as well as 
clinicians practicing in rural areas or health professional shortage 
areas. One commenter disagreed with our proposed approach, however, 
noting that non-patient facing MIPS clinicians should be able to obtain 
the highest potential score for the improvement activities performance 
category without special modifications to improvement activities 
scoring. Another commenter suggested increasing the number of 
clinicians for small practices to 25 for purposes of the improvement 
activities category.
    Response: We agree with commenters that supported reducing the 
improvement activities category requirements for non-patient facing 
MIPS eligible clinicians to two medium-weighted activities, or one 
high-weighted activity, and this policy is consistent with the statute, 
which states that the Secretary shall give consideration to the 
circumstances of professional types who typically furnish services that 
do not involve face-to-face interaction with the patient. We are 
finalizing our proposal to allow for either two medium or one high-
weighted activity for these types of practices.
    Comment: Commenters requested clarification regarding the need to 
self-identify during attestation following the performance period as a 
MIPS eligible clinician or group participating in an APM, certified 
patient-centered medical home or comparable specialty practice.
    Response: We clarify that for MIPS eligible clinicians or groups 
participating in an APM, self-identification by attestation following 
the performance period is not necessary. For eligible clinicians or 
groups participating in a certified patient-centered medical home or 
comparable specialty practice, however, self-identification will be 
required.
    After consideration of the comments, we are not finalizing our 
proposal to require achievement of 60 points to receive the highest 
score for the improvement activities performance category. Rather, we 
are only requiring a total of 40 points to receive the highest score 
for the improvement activities performance category. In alignment with 
the reduction in total points required, we are finalizing that the 
following scoring that will apply to MIPS eligible clinicians who are a 
non-patient facing clinician, a small practice, a practice located in a 
rural area, or practice in a geographic HPSA or any combination 
thereof:
     Reporting of one medium-weighted activity would result in 
20 points or one-half of the highest score.
     Reporting of two medium-weighted activities would result 
in 40 points or the highest score.
     Reporting of one high-weighted activity would result in 40 
points or the highest score.
    In alignment with the reduction in total points required, we are 
finalizing the following scoring that will apply to MIPS eligible 
clinicians who are not a non-patient facing clinician, a small 
practice, a practice located in a rural area, or a practice in a 
geographic HPSA:
     Reporting of one medium-weighted activity would result in 
10 points which is one-fourth of the highest score.
     Reporting of two medium-weighted activities would result 
in 20 points which is one-half of the highest score.
     Reporting of three medium-weighted activities would result 
in 30 points which is three-fourths of the highest score.
     Reporting of four medium-weighted activities would result 
in 40 points which is the highest score.
     Reporting of one high-weighted activity would result in 20 
points which is one-half of the highest score.
     Reporting of two high-weighted activities would result in 
40 points which is the highest score.
     Reporting of a combination of medium-weighted and high-
weighted activities where the total number of points achieved are 
calculated based on the number of activities selected and the weighting 
assigned to that activity (number of medium-weighted activities 
selected x 10 points + number of high-weighted activities selected x 20 
points).
    The most any MIPS eligible clinician or group can achieve for the 
improvement activities performance category is 40 points, so if more 
activities are selected than, for example, 4 medium-weighted 
activities, the total points that could be achieved is still 40 points. 
We refer readers to section II.E.5.g. of this final rule with comment 
period, regarding activities in the improvement activities performance 
category that would also qualify for a bonus under the advancing care 
information performance category. This bonus would be calculated under 
the Advancing Care Information Performance Category and not under the 
improvement activities Performance Category.
    We also are not finalizing Table 24 of the proposed rule which 
provided an example of the scoring methodology based on a highest 
potential score of 60 points for the improvement activities performance 
category (81 FR 28267). We are instead finalizing Tables 27 and 28 that 
illustrate the sample scoring methodology for the improvement 
activities performance category based on a policy of a highest 
potential score of 40 points, which we are finalizing in this final 
rule with comment period. The first example in Table 27 illustrates a 
sample scoring methodology for the improvement activities category for 
a MIPS eligible clinician that is not an APM participant or certified 
patient-centered medical home or comparable specialty practice or 
Medical Home Model and does not qualify as a small practice or a 
practice located in a rural or HPSA and is not a non-patient facing 
MIPS eligible clinician.

[[Page 77319]]



                     Table 27--Improvement Activities Performance Category Scoring Example 1
----------------------------------------------------------------------------------------------------------------
                                                                            Relative
                                                                         weight  (based
                                                                          on whether a
                                                                          small, rural,
             Activity                   Subcategory      Total possible    geographic          Total score
                                                             points       HPSA or non-
                                                                         patient facing
                                                                          MIPS eligible
                                                                           clinician)
----------------------------------------------------------------------------------------------------------------
                          For Midsize Practice (not rural, HPSA or non-patient facing)
----------------------------------------------------------------------------------------------------------------
Activity 1 (Medium Weighted).....  Population                        10               1  .......................
                                    Management.
Activity 2 (High Weighted).......  Expanded Practice                 20               1  30/40 points.
                                    Access.
                                  ------------------------------------------------------------------------------
    Total........................                           30
----------------------------------------------------------------------------------------------------------------

    The next example in Table 28 illustrates two examples of the 
scoring methodology for MIPS eligible clinicians that are small, rural 
or geographic HPSA practices or are a non-patient facing MIPS eligible 
clinician.

                     Table 28--Improvement Activities Performance Category Scoring Example 2
----------------------------------------------------------------------------------------------------------------
                                                                            Relative
                                                                         weight  (based
                                                                          on whether a
                                                                          small, rural,
             Activity                   Subcategory      Total possible    geographic          Total score
                                                             points       HPSA or non-
                                                                         patient facing
                                                                          MIPS eligible
                                                                           clinician)
----------------------------------------------------------------------------------------------------------------
                         For Small, Rural, HPSA Practice or Non-Patient Facing Clinician
----------------------------------------------------------------------------------------------------------------
Clinician #1:
    Activity 1 (Medium Weighted).  Population                        10               2  20 points.
                                    Management.
    Activity 2 (Medium Weighted).  Integrated                        10               2  20 points.
                                    Behavioral and
                                    Mental Health.
                                  ------------------------------------------------------------------------------
        Total....................  ....................  ..............  ..............  40/40 points
Clinician #2:
    Activity 1 (High Weighted)...  Patient Safety and                20               2  40 points.
                                    Practice Assessment.
                                  ------------------------------------------------------------------------------
        Total....................  ....................  ..............  ..............  40/40 points
----------------------------------------------------------------------------------------------------------------

    We also finalize our proposal to calculate a score of zero points 
for any MIPS eligible clinician, except for an APM, if they do not 
report at least one activity. We further finalize that MIPS eligible 
clinicians or groups participating in APMs are not required to self-
identify as part of an APM, but all MIPS eligible clinicians will be 
required to self-identify as part of a certified patient-centered 
medical home or comparable specialty practice, a non-patient facing 
MIPS eligible clinician, a small practice, a practice located in a 
rural area, or a practice in a geographic HPSA or any combination 
thereof to self-identify as applicable during attestation following the 
performance period. We will validate these self-identifications as 
appropriate.
(5) Scoring the Advancing Care Information Performance Category
    We refer readers to section II.E.5.g.(6) of this final rule with 
comment period, for our final methodology for scoring the advancing 
care information performance category.
b. Calculating the Final Score
    Section II.E.6.a. of the proposed rule describes our proposed 
methodology for assessing and scoring MIPS eligible clinician 
performance for each of the four performance categories (81 FR 28248-
28268). In this section, we proposed the methodology to determine the 
composite performance score (now called final score) based on the 
scores for each of the four performance categories. We proposed to 
define at Sec.  414.1305 the final score 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 for the applicable measures and 
activities for each applicable performance category. The final score 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 Final Score
    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 for the applicable 
measures and activities for each performance category applicable to 
such clinician for a performance period, and using the methodology, 
provide for a final score (using a scoring scale of 0 to 100) for

[[Page 77320]]

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 final score.
    To create a final score from 0-100 based on the individual 
performance category scores, we proposed to multiply the score for each 
performance category by the assigned weight for the performance 
category. We provided in Table 25 of the proposed rule (81 FR 28269), 
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 final score. As described in section 
II.E.2. of the proposed rule (81 FR 28176-28177), we proposed that the 
identifier for MIPS performance would be the same for all four 
performance categories, and therefore, the methodology to calculate a 
final score would be the same for both individual and group 
performance.
    The following equation summarizes the proposed final score 
calculation at Sec.  414.1380(c): Final score = [(quality performance 
category score x quality performance category weight) + (cost 
performance category score x cost performance category weight) + 
(improvement activities performance category score x improvement 
activities performance category weight) + (advancing care information 
performance category score x advancing care information performance 
category weight)] x 100.
    We did not receive comments on our proposal to define at Sec.  
414.1305 the final score as a composite assessment (using a scoring 
scale of 0 to 100) for each MIPS eligible clinician for a specific 
performance period.
    We did receive several comments on our proposal to define at Sec.  
414.1380(c) the MIPS final score calculation.
    Comment: A few commenters stated the proposed scoring standards are 
confusing and complex and suggested that CMS revise the standards to 
produce a scoring formula that is streamlined and easier to understand. 
Several commenters simply believe the final score scoring approach is 
``too complex''. Several commenters noted that the scoring formula for 
the MIPS final score should be streamlined and scoring across the 
performance categories should be more integrated. Commenters raised 
concern that due to the complexity of the formulas, there would be an 
increased risk that scoring would lack accuracy and not reflect the 
philosophy behind this rule.
    Response: We address performance category scoring standards in 
section II.E.6.a.(2), II.E.6.a.(3), II.E.6.a.(4), and II.E.6.a.(5) of 
this final rule with comment period. We address our approach to a 
unified scoring system in MIPS at II.E.6.a.(1)(b) of this final rule 
with comment period. The weights of the MIPS performance categories to 
determine the final score are specified in section 1848(q)(5)(E) of the 
Act. Therefore, we must establish a formula for calculating the final 
score based upon the differing category weights as prescribed by the 
statute. To properly calculate a weighted score for each performance 
category, we must first calculate the performance category scores and 
then apply the statutory weights before adding the weighted scores 
together to determine the final score. The approach we have proposed 
meets the statutory requirements and will accurately reflect an 
eligible clinician's performance.
    We have aligned the approach to scoring across the performance 
categories. Measures in the quality, cost, and the advancing care 
information performance categories are scored based on a point scale 
between 0 and 10. The measures and activities within each performance 
category are designed to measure performance on different aspects of 
high value healthcare within each performance category, therefore the 
performance requirements and scoring calculations within the 
performance categories are differentiated as appropriate.
    Comment: Other commenters believed that there is no standard for 
quality care to form the basis for a MIPS final score. The commenters 
also stated that the quality care standards should be specific within a 
specialty.
    Response: We believe the performance standards we are adopting 
represent appropriate standards of quality care for MIPS eligible 
clinicians to strive to meet. We will take the commenter's views on 
MIPS scoring methodology under advisement as we continue its 
development.
    After consideration of the comments, we are codifying our final 
score definition and final score formula with minor changes for 
accuracy and to change the labeling of composite performance score to 
final score. At Sec.  414.1305, final score means a composite 
assessment (using a scoring scale of 0 to 100) for each MIPS eligible 
clinician for a performance period determined using the methodology for 
assessing the total performance of a MIPS eligible clinician according 
to performance standards for applicable measures and activities for 
each performance category. The final score is the sum of each of the 
products of each performance category score and each performance 
category's assigned weight, multiplied by 100. At Sec.  414.1380(c), we 
finalize that each MIPS eligible clinician receives a final score of 0 
to 100 points equal to the sum of each of the products of each 
performance category score and each performance category's assigned 
weight, multiplied by 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, 
cost measures and other measures used under MIPS and assess and 
implement appropriate adjustments to payment adjustments, final scores, 
scores for performance categories or scores for measures or activities 
under the MIPS. In doing this, the Secretary is required to take into 
account the relevant studies conducted under section 2(d) of the IMPACT 
Act of 2014 and, as appropriate, other information, including 
information collected before completion of such studies and 
recommendations. ASPE is conducting studies on the issue of risk 
adjustment for socioeconomic status on quality measures and cost 
measures as required by section 2(d) of the IMPACT Act and expects to 
issue a report to Congress in October 2016. We will closely examine the 
ASPE studies when they are available and incorporate findings 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 cost 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 cost measures have different risk adjustments that are specific 
to the individual measure. For the transition year of MIPS (MIPS 
payment year 2019), for the quality and cost performance categories, we 
proposed to use the measure-specific

[[Page 77321]]

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 invited public comments on this proposal. For discussion of 
comments specific to risk adjustment for sociodemographic and/or 
socioeconomic factors we refer readers to section II.E.5.b.(6) of this 
final rule with comment period.
    The following is summary of the comments we received regarding our 
proposal 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.
    Comment: Several commenters suggested that CMS undertake additional 
specialty adjustments to compare specialists and similarly situated 
eligible clinicians. These commenters believe CMS should group and 
compare MIPS eligible clinicians by patient profile rather than 
comparing all eligible clinicians to one another.
    Response: We have previously reviewed the option to segment 
eligible clinicians' measurement and scoring across geography, 
specialty, patient mix and other criteria. Such an approach may provide 
an advantage to certain eligible clinician types who historically have 
scored lower on performance measures. However, we are promoting and 
incentivizing high performance and identified the scoring approach as 
best suited for this purpose. Additionally, because we have aimed to 
make MIPS scoring simple to understand, we decided not to implement a 
complex system with multiple benchmarks for sub-groups.
    Comment: Many commenters expressed concern that under MIPS, 
eligible clinicians caring for poor and/or clinically complex patients 
will be unfairly penalized when compared with physicians caring for 
healthier patients. As with socioeconomic status, commenters believe 
MIPS eligible clinicians with higher risk patients should not be 
penalized for poor outcomes due to factors outside of their control. 
These commenters recommended that CMS risk adjust for clinical severity 
and complex patients.
    Response: We have incorporated specialty adjustment into the total 
per capita cost measure under the cost performance category, which will 
account for specialties focused on high-cost procedures. While we agree 
certain patients with additional comorbidities often require additional 
care, we are concerned additional adjustment for clinical severity may 
have a tendency to mask poor performance. We will closely examine the 
ASPE studies when they are available and incorporate findings, along 
with additional sources of valid information, and incorporate them as 
feasible and appropriate through future rulemaking.
    Comment: Several commenters recommended that CMS adjust for 
specifically rural-relevant socio-demographic factors. One commenter 
referenced the 2014 Update of Rural-Urban Chartbook that provides data 
on rural areas and riskier behaviors and pointed out that the Congress 
provides cost based reimbursement in rural settings in recognition of 
the additional costs of providing low volume services.
    Response: We appreciate commenter feedback on the role of rural 
relevant socio-demographic factors and will consider this information 
for future rulemaking. MIPS is intended to support the larger objective 
of ensuring excellent care for patients regardless of their geographic 
area. We will engage in further study to gauge the appropriateness of 
risk adjusting for sociodemographic factors, including those specific 
to rural populations, by reviewing the findings of the ASPE studies 
when they are available, along with other sources of information. In 
addition, we will actively monitor MIPS scoring outcomes to provide 
fair treatment for MIPS eligible clinicians serving rural areas.
    Comment: One commenter believes CMS should release the actual 
variables, coefficients and equations used for risk adjustment.
    Response: We have and will continue to publicly release information 
regarding our approach to risk adjustment for measures. However; as the 
variables and coefficients are frequently revised to improve system 
accuracy and efficiency, it would not be practical to provide this 
information of this type in a regulation.
    Comment: One commenter recommended that CMS require reporting 
mechanisms that allow stratification by demographic characteristics; 
and also add age to the list of demographic factors.
    Response: Calculation of performance by subgroup may be one way to 
identify and measure disparities, and could potentially help meet the 
objectives under the improvement activities subcategory ``Achieving 
Health Equity''. We may consider such an approach in future rulemaking 
as we review approaches and recommendations, such as those from ASPE, 
for including sociodemographic evaluation in CMS programs.
    After consideration of the comments, we are finalizing our proposal 
for the quality and cost performance categories 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 
measure. Cost measures in the cost performance category are risk 
adjusted as previously discussed in detail at 77 FR 69317 through 69318 
and referenced in section II.E.5.e.(3). Measures finalized for MIPS 
(see Tables A through D in the Appendix) may be risk adjusted as 
described in the measure specification using statistical processes to 
identify and adjust for extraneous variables not associated with care. 
However, many quality measures are process measures for which the 
measure outcome is not subject to influence by factors outside the 
eligible clinicians' control.
(2) Final Score 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 final score: in general, 30 
percent for the quality performance category, 30 percent for the cost 
performance category, 25 percent for the advancing care information 
performance category, and 15 percent for the improvement activities 
performance category. However, that section also specifies different 
weightings for the quality and cost 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 final score will be based on the cost 
performance category and for year 2, not more than 15 percent will be 
based on cost 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 2 years will increase by the 
difference of 30 percent minus the weight specified for the cost 
performance category for the year.
    We have proposed the performance category weights for the first 
MIPS payment year of 2019. In section II.E.5.e.(2) of the proposed rule 
(81 FR 28198), we proposed to set the cost 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 proposed to 
set the quality performance category weight to 50 percent for the 2019 
payment year and 45 percent for the 2020 payment (81 FR

[[Page 77322]]

28185). 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 cost 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 improvement 
activities 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 EPs (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 final score, but not below 15 percent, and adjust the 
weighting of the other performance categories. We refer readers to our 
policies concerning section 1848(q)(5)(E)(ii) of the Act in section 
II.E.5.g.(6)(e) of this final rule with comment period.
    We received comments on the proposed weights of the MIPS 
performance categories which are addressed in section II.E.5.b.(2) for 
quality, section II.E.5.e.(2) for cost, section II.E.5.f.(2) for 
improvement activities and section II.E.5.g.(2) for advancing care 
information. As noted in those sections, many commenters expressed 
concern regarding the proposed weight for the cost performance 
category. After consideration of the comments and for the reasons 
stated in those sections, we are adjusting our proposed category 
weights for the first 2 years of MIPS. We are finalizing that for the 
first MIPS payment year (2019), the quality performance category will 
account for 60 percent of the final score and the cost performance 
category will account for 0 percent of the final score. We are also 
finalizing that for the second MIPS payment year (2020), the quality 
performance category will account for 50 percent of the final score and 
the cost performance category will account for 10 percent of the final 
score. The final score weights for the improvement activities and 
advancing care information performance categories are specified in 
section 1848(q)(5)(E)(i) of the Act, and we did not propose to deviate 
from those values.
    Table 29 summarizes the weights specified for each performance 
category under section 1848(q)(5)(E)(i) of the Act and in accordance 
with our final policies which are summarized at Sec.  414.1380(c)(1) 
and detailed at Sec. Sec.  414.1330(b), 414.1350(b), 414.1355(b), and 
414.1375(a).

                                 Table 29--Final Weights by Performance Category
----------------------------------------------------------------------------------------------------------------
                                                                                                     2021 MIPS
                                                                     2019 MIPS       2020 MIPS     payment year
                      Performance category                         payment year    payment year     and beyond
                                                                        (%)             (%)             (%)
----------------------------------------------------------------------------------------------------------------
Quality.........................................................              60              50              30
Cost............................................................               0              10              30
Improvement Activities..........................................              15              15              15
Advancing Care Information*.....................................              25              25              25
----------------------------------------------------------------------------------------------------------------
* The weight for advancing care information could decrease (not below 15 percent) if the Secretary estimates
  that the proportion of physicians who are meaningful EHR users is 75 percent or greater. The remaining weight
  would then be reallocated to one or more of the other performance categories.

(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 MIPS 
eligible clinician involved, the Secretary shall assign different 
scoring weights (including a weight of zero) for each performance 
category based on the extent to which the category is applicable and 
for each measure and activity based on the extent to which the measure 
or activity is applicable and available to the type of MIPS eligible 
clinician involved.
    In section II.E.6.a (81 FR 28248-28268) and section II.E.5.g.(8) 
(81 FR 28230-28234) of the proposed rule, we describe scenarios where 
certain MIPS eligible clinicians might not receive a performance 
category score in the quality, cost, or advancing care information 
performance categories. We proposed 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.
    Below we summarize these scenarios from the proposed rule. However, 
our transition year policies and modifications in this final rule to 
simplify scoring affect many of these scenarios, so we describe both 
the proposed scenario and how our final policies have impacted that 
scenario.
    For the quality and cost performance categories, in the proposed 
rule (81 FR 28269-28270), we stated our belief that having sufficient 
measures applicable and available meant 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 cost performance categories, we proposed in sections 
II.E.6.a.(2)(d) (81 FR 28254-28255), II.E.6.a.(3)(a) (81 FR 28259-
28260), and II.E.6.a.(3)(d) (81 FR 28260-28261) of the proposed rule 
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. We had proposed that 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 
cost 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.) In our segment II.E.6.a.(2). of the final rule with comment 
period, we noted that this policy has changed for the quality 
performance category. We established a policy to assign 3 points for 
scenarios where a MIPS eligible clinician has quality measures that do 
not meet case minimum thresholds, do not meet data completeness 
criteria, or do not have a benchmark. As we noted in those sections we 
believe that in the initial

[[Page 77323]]

years of MIPS providing a set number of points for these types of 
measures rather than not scoring these measures will further 
incentivize clinicians' participation in the MIPS. We continue to 
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; 
however, with the new measure scoring policy in the quality performance 
category, we do not anticipate as many MIPS eligible clinicians not 
having scored measures. Therefore, in almost all cases, we anticipate a 
MIPS eligible clinician would receive a quality performance category 
score. The only exception would be the rare circumstance that a MIPS 
eligible clinician does not have any measures that are relevant to the 
clinician's practice.
    In the proposed rule, we anticipated that most MIPS eligible 
clinicians would select the measures for the quality performance 
category that are most relevant to their practice and that in most 
cases, the measures they select would meet the required case minimum. 
We planned to monitor measure selection trends under the performance 
category and would 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. With 
the new 3-point policy, we do not believe MIPS eligible clinicians 
would purposefully select measures with low case volume in order to 
avoid a score. Rather, we believe that the overwhelming majority of 
MIPS eligible clinicians aim to meet our performance criteria in the 
most straightforward manner possible. As described in 
II.E.5.b.(3)(a)(i) and II.E.6.a.(2)(d) of this final rule with comment 
period, we will continue to monitor the selection of measures and may 
adjust policies if we determine MIPS eligible clinicians are not 
reporting measures for which they can be scored.
    In the cost 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 finalized in 
section II.E.5.e. of this final rule with comment period, the measures 
for the cost performance category; however, if a MIPS eligible 
clinician is not attributed a sufficient number of cases for a measure 
(in other words, has not met the required case minimum for the measure) 
or if a measure does not have a benchmark, then the measure will not be 
scored for that clinician in accordance with the final policy in 
section II.E.6.(a)(3) of this final rule with comment period. However, 
while we are scoring cost measures in the transition year of MIPS (MIPS 
payment year 2019), they are not contributing to transition year final 
scores as we have set the cost performance category weight to 0 percent 
in the transition year.
    We refer readers to section II.E.5.g.(8) of this final rule with 
comment period 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 improvement activities performance category, however, we 
envision that all MIPS eligible clinicians would have sufficient 
activities applicable and available and did not propose any scenario 
where a MIPS eligible clinician would not receive an improvement 
activities performance category score.
    In addition to scenarios where a MIPS eligible clinician would have 
no scored measures for a performance category, we stated in the 
proposed rule that 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 final score for the 
2019 MIPS payment year. We proposed 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, we stated in the proposed rule that 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 final score 
for the 2019 MIPS payment year. In addition, as described in the next 
section, for MIPS eligible clinicians that are not scored on the cost 
or advancing care information performance category, we proposed to 
increase the weight of the quality performance category. For these 
reasons, we proposed that for the transition year of MIPS (MIPS payment 
year 2019), the quality performance category requires a sufficient 
number of measures to justify its weight in the final score. We noted 
we would reconsider this policy in future years as the weights for the 
performance categories change. We proposed that we would consider 
implementing a similar policy for the cost performance category for 
future years, but not for the transition year of MIPS based upon the 
lower weighting of the cost performance category.
    In the proposed rule (81 FR 28186), we proposed for the quality 
performance category, generally, that MIPS eligible clinicians submit a 
minimum of six measures for scoring in MIPS. In addition, we proposed 
to include up to three population-based measures derived from claims 
data. As described in section II.E.6.a.(2) of the proposed rule (81 FR 
28250-28259), 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 reiterated 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. In section II.E.5.b.(6), we have modified our final policies 
to reflect that only one of the three population-based measures is 
being finalized. Additionally, in section II.E.6.a.(2)(d), we have 
modified our approach for quality measures that fall below case minimum 
requirements, data completeness thresholds and measures without a 
benchmark to include a 3-point measure floor.
    We stated in the proposed rule that 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 
final score because the quality performance category score is worth 30 
to 50 percent (depending on the year) of the final score under section 
1848(q)(5)(E)(i) of the Act. We did not believe a score for one or two 
quality measures can capture all the elements of quality performance 
during a performance period. We believed the lack of a sufficient 
number of measures for scoring limits the value of quality performance 
measurement toward the final score. Therefore, we

[[Page 77324]]

proposed 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 proposed 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 requested comment on these proposals to identify MIPS eligible 
clinicians without sufficient measures and activities applicable and 
available and our proposals to reweight those performance categories. 
We also sought 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.
    The following is summary of the comments we received regarding our 
proposal to consider MIPS eligible clinicians with fewer than three 
scored quality measures as having insufficient measures applicable and 
available for the 2019 MIPS payment year quality performance category 
and to, therefore, lower the weight of the quality performance 
category.
    Comment: Several commenters were opposed to our proposal to reduce 
the weight of the quality performance category because they were 
concerned how this might impact specialty clinicians with only one or 
two measures available to report. For example, these commenters were 
concerned that continuous shifts in the weights for calculating their 
final score will make it more difficult to determine goals as they 
transition to subsequent reporting periods.
    Response: We understand the commenters' concerns with reducing the 
weight of the quality category for those MIPS eligible clinicians who 
may lack a sufficient number of applicable and available quality 
measures. Our proposal considered the potential downside of basing at 
least half of the final score on less than three measures when other 
performance categories with additional measures were applicable to 
these MIPS eligible clinicians. After consideration of these comments 
and other final policies in this final rule with comment period, we are 
seeking to simplify our approach in the initial years of MIPS to ensure 
clarity and to encourage eligible clinicians to participate in MIPS and 
report their quality data. As a result, we intend to maintain a 
consistent weight for the quality performance category and will score 
all measures that are submitted or calculated for the MIPS eligible 
clinician. Required measures that are not submitted will receive a 
score of zero points.
    We will not finalize our proposed policy to reduce and redistribute 
the weight of the quality performance category if only one or two 
measures are scored. We will finalize with modification our proposed 
policy to reduce and redistribute the quality performance category 
weight if a MIPS eligible clinician has no scored measures for the 
quality performance category for the transition year (MIPS payment year 
2019), although we believe this scenario will be unlikely. We have 
modified our approach because, under our policies for the quality 
performance category for the transition year, we believe it is less 
likely that a MIPS eligible clinician will have only 1 or 2 scored 
measures. As discussed in section II.E.6.a.(2), all quality performance 
category measures that are submitted receive at least 3 points. In 
addition, any required measure that is not submitted receives a score 
of 0 points. Therefore, a MIPS eligible clinician submitting data as an 
individual, who has at least 6 measures applicable and available, who 
submits one measure is still scored on six measures. One measure 
receives a score of at least 3 points and the other five measures 
receive zero points. With this adjustment in the quality scoring, we 
believe the number of instances where a MIPS eligible clinician has 
fewer than 3 scored measures will be reduced. Eliminating the proposed 
reduction and redistribution of the weight of the quality performance 
category if only one or two measures are scored further simplifies 
scoring for the transition year. We refer readers to section 
II.E.6.b.(2)(c) of this final rule with comment period for discussion 
of how the quality performance category weight will be redistributed in 
instances where a MIPS eligible clinician is not scored on any quality 
measures and receives a null score in the quality performance category.
    In Table 17 in section II.E.6.a.(2)(c), we summarize two classes of 
quality measures for the quality performance category: ``Class 1'' are 
those measures for which performance can be reliably scored against a 
benchmark and ``class 2'' are measures for which performance cannot be 
reliably scored against a benchmark. For the transition year (MIPS 
payment year 2019), we have modified our proposed approach on how we 
will score measures submitted that are unreliable because they are 
below the case minimum requirements, or lack a benchmark or do not meet 
data completeness criteria. These measures will not be scored based on 
performance against a benchmark, but will receive an automatic three 
points. We believe this policy will simplify quality performance 
category scoring. We want to ensure that every clinician that submits 
quality data will receive a quality performance category score, even if 
the quality data submitted is class 2 measures. This is particularly 
important in the transition year because with a minimum 90-day 
performance period, we anticipate more MIPS eligible clinicians will 
submit measures below the case minimum requirements. We selected three 
points because we did not want to provide more credit for reporting a 
measure than cannot be reliably scored against a benchmark than for 
measures for which we can measure performance against a benchmark. 
Again, any measure that was not submitted would also receive a zero 
score.
    As noted in this final rule with comment period, we have decided 
not to finalize our proposed approach to reduce the weight of the 
quality performance category in the final score if only one or two 
measures are scored for the following reasons. First, we want to create 
an opportunity for all MIPS eligible clinicians to participate and 
succeed in MIPS through minimal quality performance category measure 
submission during the transition year. Second, we want to create a 
thoughtful ``ramp'' into the program for participants that is sensitive 
to stakeholder concerns. Many commenters in section II.E.6.a.(2)(c) 
requested that we provide ``credit'' for measures that were submitted 
that did not meet the quality submission criteria.

[[Page 77325]]

In addition to scoring measures on performance, we will give at least 3 
points for each measure that is submitted to MIPS, even if these 
measures are class 2 measures. Measures that are not submitted receive 
a score of zero. As a result of this policy, we think the number of 
MIPS eligible clinicians with only one or two scored measures will 
decrease and that removing the proposed reduction and redistribution of 
the weight of the quality performance category if only one or two 
measures are scored further simplifies the MIPS scoring for the 
transition year. As we gain experience with the MIPS, we will revisit 
these approaches in future rulemaking. For clarity we refer readers 
once again to section II.E.6.b.(2)(c) of this final rule with comment 
period for discussion of how the quality performance category weight 
will be redistributed in instances where a MIPS eligible clinician is 
not scored on any quality measures and receives a null score in the 
quality performance category.
    Comment: Commenters requested clarification on how we plan to 
identify MIPS eligible clinicians without sufficient measures and 
activities and whether reweighting will still allow for a maximum final 
score.
    Response: We note that the reweighting policies ensure that all 
MIPS eligible clinicians will receive a final score between 0 and 100 
points. The only difference is how much the individual performance 
category scores contribute to the final score.
    In response to the request for clarification on how we would 
identify clinicians without sufficient measures and activities, we 
refer readers to section II.E.5.b.(3)(a)(i) and II.E.6.a.(2)(d) of this 
rule for a discussion of our validation process to assess whether 
measures for the quality performance category are applicable and 
available, section II.E.5.g.(8) of this rule for a discussion of when 
measures for the advancing care information performance category may 
not be applicable and available, and section II.E.6.a.(3) of this rule 
for a discussion of when measures for the cost performance category may 
not be are applicable and available. As we stated in the proposed rule, 
we believe the activities specified for the improvement activities 
performance category will always be applicable and available to all 
MIPS eligible clinicians.
    Comment: A commenter stated they did not believe the quality 
category should be reweighted when a MIPS eligible clinician has fewer 
than three quality measures because the commenter believes that all 
MIPS eligible clinicians should be required to report six measures and 
that specialists could find at least six quality measures by using 
cross-cutting measures.
    Response: We share the commenter's goal to have MIPS eligible 
clinicians report at least six measures. However, we also recognize 
that not every MIPS eligible clinician may have six measures relevant 
to their practice. We note that if a MIPS eligible clinician is able to 
report six measures, yet submits fewer measures, then the MIPS eligible 
clinicians would receive a zero for the measures that were not 
submitted.
    Comment: Multiple commenters supported our proposal for lowering 
the weight of the quality performance category for MIPS eligible 
clinicians with fewer than three applicable and available scored 
measures.
    Response: We appreciate the support from commenters; however, as 
discussed in this final rule with comment period, in a desire to 
simplify the scoring process, we are not finalizing the proposal to 
reduce and redistribute the quality performance category weight for 
MIPS eligible clinicians with only one or two scored measures. As 
discussed in section II.E.6.b.(2)(c) of this final rule with comment 
period, we will only reduce and redistribute the weight of the quality 
performance category when a MIPS eligible clinician has no scored 
quality measures, which we believe will be rare.
    Comment: Other commenters disagreed with our proposal to 
redistribute weight from the quality performance category to other 
performance categories when fewer than three scored measures are 
available because these commenters believed that the intent of the 
MACRA was to limit the weight given to cost and that any redistribution 
should not include an increase in the weight of cost in the final 
score.
    Response: As a result of other final policies, the cost category is 
weighted to zero percent in the final score for the transition year as 
detailed in section II.E.6.a.(3)(d), therefore its weight is not 
eligible for redistribution to the other performance categories. We 
also believe section 1848(q)(5)(F) of the Act gives the Secretary 
discretion to redistribute weight to the cost performance category and 
thus disagree with commenters that weight should never be redistributed 
to that category.
    After consideration of the comments, and for the reasons explained 
in our responses above, we are not finalizing our proposal to reduce 
and redistribute the weight of the quality performance category when a 
MIPS eligible clinician has only one or two scored quality measures. 
Maintaining a consistent quality performance category weight whenever 
at least one measure can be scored will increase simplicity and 
predictability of scoring for MIPS eligible clinicians. We may revisit 
this policy at a future date through rulemaking. See section 
II.E.6.b.(2)(c) of this final rule with comment period for discussion 
of how we will reduce and redistribute the weight of the quality 
performance category to other performance categories when a MIPS 
eligible clinician has no scored measures in the quality performance 
category.
(c) Redistributing Performance Category Weights
    We proposed at Sec.  414.1380(c)(2) to redistribute the weights of 
the performance categories for MIPS eligible clinicians when there are 
not sufficient measures and activities applicable and available to 
them. We proposed to redistribute the weights of the performance 
categories in the following situations.
    If the MIPS eligible clinician does not receive a cost 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 
proposed to reassign the weights of the performance categories without 
a score to the quality performance category. We believed this policy 
was appropriate for several reasons. First, section 
1848(q)(5)(E)(i)(I)(bb) of the Act redistributes weight from the cost 
performance category to the quality performance category in the first 2 
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 final 
score. 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 stated that we may revisit this policy 
in future years as the weight for the cost performance category 
increases and the weight for the quality performance category 
decreases.
    We also proposed an alternative that does not reassign all the 
weight to the quality performance category, but rather

[[Page 77326]]

reassigns the weight proportionately to each of the other performance 
categories for which the MIPS eligible clinician has received a 
performance category score.
    We requested 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 clinician has fewer than three scored measures 
in the quality performance category score, then we proposed 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 
requested comment on this proposal.
    Finally, because the final score is a composite score, we stated in 
the proposed rule that 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 final score on a single 
performance category, even a robust and familiar performance category 
like quality, would frustrate that intent. In our proposals, 
improvement activities is the only performance category which would 
always have a performance category score. We were 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, cost, and advancing care 
information performance categories, and would only receive a score for 
the improvement activities performance category. The improvement 
activities performance category is based on activities that are 
reported by attestation, not on measured performance. In addition, 
because the improvement activities performance category is not as 
mature as the other performance categories, each of which include 
certain aspects of existing CMS programs, we were unsure how much 
variation we will have in the improvement activities performance 
category. We did not believe it would be equitable to allow MIPS 
eligible clinicians that attest to receive the maximum points for that 
performance category and then base the final score solely on the 
improvement activities performance category. Such a scenario may result 
in higher final score and MIPS adjustment factors for some MIPS 
eligible clinicians based solely on the improvement activities 
performance category, while other MIPS eligible clinicians are measured 
based on their performance under the other performance categories. 
Therefore, we proposed that if a MIPS eligible clinician receives a 
score for only one performance category, we would assign the MIPS 
eligible clinician a final score that is equal to the performance 
threshold described in section II.E.7.c of the proposed rule (81 FR 
28273), which means the eligible clinician would receive a MIPS payment 
adjustment factor of 0 percent for the year. We anticipated 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 requested public comment on this proposal.
    The following is summary of the comments we received regarding our 
proposal to reassign performance category weights to the quality 
performance category when an eligible clinician cannot be scored in a 
category and has at least three scored measures in the quality 
performance category.
    Comment: Multiple commenters supported CMS' proposal to distribute 
the weights for the advancing care information and cost performance 
categories to the quality performance category in cases where the 
category is not scored for an eligible clinician.
    Response: We agree with the commenters. By redistributing weight to 
the quality performance category, we are providing a clear scoring 
approach for eligible clinicians who do not receive a score in another 
performance category. This approach is also in line with section 
1848(q)(5)(E)(i) of the Act, which requires that we redistribute weight 
from the cost category to the quality category during the first 2 years 
of MIPS. We would like to note, that the cost performance category is 
weighted at 0 percent for the transition year (MIPS payment year 2019), 
so the cost performance category weight will not need to be 
redistributed.
    Comment: Several commenters recommended that CMS implement the 
alternate reweighting proposal (the proportional reassignment of 
weights to the remaining performance categories) for MIPS eligible 
clinicians that receive a zero weight in the advancing care information 
and cost performance categories and have at least three scored quality 
measures. Commenters who supported this approach did so because they 
were concerned about disproportionate weighting in the quality 
performance category.
    Response: MIPS eligible clinicians have prior experience with 
quality reporting through PQRS and VM. Also, as discussed in section 
II.E.6.a.(3)(d) of this final rule with comment period, we are 
weighting the cost performance category at zero percent for the 
transition year of MIPS (MIPS payment year 2019) and assigning its 
weight to the quality performance category. As a result, for the 
transition year, there will be no need to redistribute the weight of 
the cost performance category if there are not sufficient measures 
applicable and available under that category. In the event that an 
eligible clinician does not receive a score for advancing care 
information, it would not be appropriate to allocate substantial 
additional weight to improvement activities in the transition year of 
MIPS before we have gained additional experience with the improvement 
activities performance category. While we understand commenter concerns 
about placing additional weight in the quality category, section 
1848(q)(5)(E)(i) of the Act seems to favor an approach where quality is 
given substantial weight in the final score during the first 2 years of 
MIPS.
    Comment: Several commenters expressed concern that both options for 
reweighting the remaining performance categories would increase the 
importance of the quality performance category in determining the final 
score. These commenters were concerned that allocating additional 
weight within the final score to the quality performance category could 
become detrimental to eligible clinicians who do not have a sufficient 
number of quality measures applicable to their practice.
    Response: While we understand commenter concerns about allocating 
additional weight to the quality category, we believe our approach of 
redistributing the weight to quality is consistent with section 
1848(q)(5)(E)(i) of the Act, which gives quality substantial weight in 
the final score during the first 2 years of MIPS. In addition, many 
eligible clinicians will have prior experience reporting quality 
measures to PQRS; while, on the other hand, improvement activities is a 
new performance category without any reporting history. With our 
transition year policies, we anticipate that the advancing care 
information performance category will be the one performance category 
that may need to be reweighted if there are not sufficient measures 
applicable and available to some MIPS eligible clinicians, as discussed 
in section II.E.5.g.(8) of this final rule with comment period. 
Therefore, reallocating additional weight to the quality performance 
category presents a clear option for rebalancing the final score when 
the advancing care information

[[Page 77327]]

performance category is weighted at zero percent.
    Comment: Several commenters suggested that CMS work with affected 
physicians who have insufficient measures and activities and with 
physician organizations to determine the best method of reweighting to 
accommodate the unique needs of various practices.
    Response: We appreciate that developing a single reweighting 
approach may not satisfy all stakeholders. However, we are not prepared 
to develop specialty-specific reweighting schema at this time, and 
doing so prematurely would impair our ability to maintain simplicity 
and clearly articulate scoring expectations to MIPS eligible 
clinicians. We may reassess our approach in future years and do intend 
to continue our engagement with physician organizations and other 
stakeholders to incorporate their feedback as appropriate in future 
rulemaking.
    Comment: Multiple commenters recommended that MIPS eligible 
clinicians who are unable to report performance categories other than 
improvement activities should have the option to increase the weight of 
the improvement activities performance category. These commenters 
believed that this approach would provide greater flexibility for MIPS 
eligible clinicians to be measured on activities relevant to their 
practice.
    Response: The weights for the performance categories are prescribed 
by statute in section 1848(q)(5)(E) of the Act or determined by the 
Secretary in accordance with section 1848(q)(5)(F) of the Act. The 
statute, as written, would not allow for an approach such as the 
commenters suggest.
    Comment: Many commenters stated that when there are not sufficient 
measures and activities applicable and available for a MIPS eligible 
clinician in a performance category, the most appropriate action would 
be to score the physician as ``meets performance standard'', and that 
the MIPS eligible clinician should be assigned the median score for the 
performance category. These commenters believed that reweighting may 
ultimately disadvantage MIPS eligible clinician types who may tend not 
to have an advancing care information performance category score.
    Response: While we recognize the simplicity of the approach 
proposed by commenters, it would not be permissible under statute. 
Section 1848(q)(5)(F) of the Act stipulates the Secretary shall assign 
different scoring weights (including a weight of 0) if there are not 
sufficient measures and activities applicable and available to the MIPS 
eligible clinicians. We do not believe that assigning a MIPS eligible 
clinician a score of ``meets performance standard'' would be consistent 
with that statutory requirement. Redistributing final score weight to 
performance categories in which a MIPS eligible clinician has engaged 
allows us to produce a composite assessment between 0 and 100 and 
maintains and eligible clinician's ability to reach 100 percent of the 
final score even when they cannot be scored in all categories.
    Comment: We received comments from hospital-based eligible 
clinicians who did not agree with our proposal to reweight their 
advancing care information performance category to zero in their final 
score and to reallocate the performance category weight to the quality 
performance category based upon the Secretary's authority under section 
1848(q)(5)(F) of the Act. These commenters did not believe the 
resulting final score would be representative of their performance in 
MIPS. The commenters further stated that, in combination with 
reweighting the cost performance category to zero, doing so for the 
advancing care information performance category would shift a large and 
disproportionate amount of weight to the quality performance category. 
This would result in significant difference in total quality 
performance category scores for minor variances in quality measure 
performance, making it very difficult to earn a high score in the 
category and in the final score. For example, a score of 99.9 percent 
versus 100 percent for a quality measure would make a larger difference 
in the overall quality performance category score if the weight of that 
performance category is larger than for those MIPS eligible clinicians 
who also have the opportunity earn points in the advancing care 
information performance category. The commenter suggested that an 
alternate method of reweighting and redistributing the advancing care 
information performance category score be considered. For example, the 
commenter suggested that the score distribution be across multiple 
performance categories and not just quality.
    Response: As discussed in section II.E.5.g.(8)(a)(i) of this final 
rule with comment period, we believe there may not be sufficient 
measures applicable and available to hospital-based MIPS eligible 
clinicians under the advancing care information performance category of 
MIPS.
    The cost performance category is weighted at zero percent in the 
final score under our transition year policies. As discussed earlier in 
this section, we believe it would not be appropriate to allocate 
substantial additional weight to improvement activities in the 
transition year of MIPS before we have gained additional experience 
with the improvement activities performance category. Therefore, while 
we understand the commenters concerns about placing additional weight 
in the quality category, section 1848(q)(5)(E)(i) of the Act seems to 
favor an approach where quality is given substantial weight in the 
final score during the first 2 years of MIPS. We may revisit this 
policy in future years.
    After consideration of the comments, we are codifying at Sec.  
414.1380(c)(2) that we will assign different weights than the ones 
listed in Sec.  414.1380(c)(1) when we determine that there are not 
sufficient measures and activities applicable and available to MIPS 
eligible clinicians.
    For the transition year (MIPS payment year 2019), we are codifying 
with modification our proposal to redistribute the weight of the cost 
and advancing care information performance categories to the quality 
performance category when there are not sufficient measures applicable 
and available to a MIPS eligible clinician under the cost and advancing 
care information performance categories and thus the clinician does not 
receive a score for those performance categories. We are not finalizing 
the requirement that the quality performance category have a minimum of 
three scored measures in order to redistribute the weight of the cost 
and advancing care information performance categories to the quality 
performance category. Maintaining a consistent quality performance 
category weight whenever at least one measure can be scored will 
increase simplicity and predictability of scoring for MIPS eligible 
clinicians while learning the program.
    The following is a summary of the comments regarding our proposal 
to reduce the weight of the quality performance category and 
redistribute the amount by which it is reduced to the other performance 
categories, in the event a MIPS eligible clinician has fewer than three 
scored measures in the quality performance category.
    Comment: Several commenters stated that if a MIPS eligible 
clinician lacks sufficient measures to report into the quality 
performance category, then CMS should assign a neutral final score that 
meets the performance threshold and thus a 0 percent update.

[[Page 77328]]

    Response: If there are not sufficient measures applicable and 
available under the quality performance category, section 1848(q)(5)(F) 
of the Act directs the Secretary to assign different scoring weights 
for the performance categories. As stated above, we are not finalizing 
our proposal to reduce and redistribute the quality performance 
category weight to other categories if a MIPS eligible clinician has 
only one or two scored quality measures. We believe our final policies 
will reduce the instances where a MIPS eligible clinician does not 
receive any quality performance category score by applying a 3-point 
minimum score for all quality measures reported in the quality 
performance category (see section II.E.6.a.(2)(b) of this final rule 
with comment period). In event that a MIPS eligible clinician is not 
scored in the quality performance category because there are not 
sufficient measures applicable and available, for the transition year 
(MIPS payment year 2019), we will redistribute the 60 percent weight of 
the quality performance category so that the performance category 
weights are 50 percent for advancing care information and 50 percent 
for improvement activities.
    Comment: Multiple commenters recommended that CMS simplify the 
final score scoring methodology and our proposals for reweighting to 
make it easier for MIPS eligible clinicians to understand how to 
maximize their score. Commenters recommended that CMS balance the value 
of requiring MIPS eligible clinicians to understand various reweighting 
scenarios versus clearly laying out the results for MIPS eligible 
clinicians reporting the data they have available. Commenters also 
recommended that CMS maintain the weight of the quality category at 50 
percent, as MIPS eligible clinicians may be unfamiliar with the 
improvement activities and advancing care information performance 
categories. Finally, commenters believed that a streamlined weighting 
methodology will improve fairness in the absence of greater historical 
data for certain performance categories.
    Response: We understand the commenters' concerns with complexity in 
our approach to reweighting performance category weights when a MIPS 
eligible clinician cannot be scored in one or more categories. In 
response to these comments and other finalized policies, we are 
simplifying our approach in the first 2 years of MIPS to ensure clarity 
and to encourage MIPS eligible clinicians to report their quality data. 
As discussed in section II.E.5.e.(2) of this final rule with comment 
period, we are reducing the cost performance category weight to zero 
percent for the transition year (MIPS payment year 2019) only. We are 
also making adjustments to quality scoring by providing a 3-point floor 
for all reported quality measures (see II.E.6.a.(2) of this final rule 
with comment period). We are also not finalizing our proposal to reduce 
and redistribute the weight of the quality performance category if MIPS 
eligible clinicians have only one or two scored quality measures. For 
the transition year (MIPS payment year 2019), we will redistribute the 
60 percent weight of the quality performance category so that the 
performance category weights are 50 percent for advancing care 
information and 50 percent for improvement activities in the event that 
a MIPS eligible clinician is not scored in the quality performance 
category because there are not sufficient measures applicable and 
available. All of these modifications will help provide stability and 
predictability in the MIPS final score methodology.
    After consideration of the comments, and for the reasons discussed 
in our responses above, we are finalizing a modification of our 
proposal to reduce the weight of the quality performance category and 
redistribute the amount by which it is reduced to the other performance 
categories if the eligible clinician has fewer than three scored 
quality measures. MIPS eligible clinicians will receive a quality 
performance category score as long as they are scored on at least one 
quality measure. We believe it is unlikely that a MIPS eligible 
clinician will not receive a score for at least one quality measure as 
a result of our final policy for the transition year to provide a 3-
point floor for all reported quality measure in the quality performance 
category (see II.E.6.a.(2) of this final rule with comment period). In 
the event a MIPS eligible clinician is not scored on at least one 
measure in the quality performance category because there are not 
sufficient measures applicable and available, for the transition year 
(MIPS payment year 2019), we will redistribute the 60 percent weight of 
the quality performance category so that the performance category 
weights are 50 percent for advancing care information and 50 percent 
for improvement activities. We are finalizing this policy for the MIPS 
payment year 2019 and will revisit this approach for later years 
through future rulemaking. With the 3-point floor policy, we anticipate 
almost all MIPS eligible clinicians will have a quality performance 
category score. We believe that only in rare circumstances would a MIPS 
eligible clinician have no applicable and available quality measures. 
This approach is similar to our proposal but takes into account our 
final policy to weight the cost performance category at 0 percent in 
the transition year of MIPS and responds to commenter requests for 
additional simplicity in our policies for reweighting the performance 
categories. Table 30 summarizes these final policies.
    The following is summary of the comments we received regarding our 
proposal to assign MIPS eligible clinicians with only one scored 
performance category a final score that is equal to the performance 
threshold.
    Comment: Several commenters expressed agreement with CMS' proposal 
to assign a final score that is equal to the performance threshold, 
resulting in a zero percent adjustment, to MIPS eligible clinicians who 
receive a score for only one performance category.
    Response: We agree with commenters and will finalize the proposal 
to define a final score as more than one performance category and to 
assign a final score at the performance threshold to a MIPS eligible 
clinician who has only one performance category score.
    Comment: A few commenters suggested that the minimum number of 
performance categories for a final score should be based on the 
assumption that most participants will complete the improvement 
activities performance category and the advancing care information 
performance category, and will be able to report on at least one of the 
remaining cost and quality performance categories.
    Response: We agree that a large number of MIPS eligible clinicians 
will be able to participate in all performance categories. However, 
there are instances we have identified when MIPS eligible clinicians 
would not receive an advancing care information performance category 
score, or a cost performance category score; therefore, we believe it 
would be inappropriate to not have policies in place for those MIPS 
eligible clinicians that do not have measures applicable and available 
in all performance categories.
    After consideration of the comments, we are finalizing our proposal 
to assign MIPS eligible clinicians with only one scored performance 
category a final score that is equal to the performance threshold. We 
note that with the scoring changes to the quality performance category, 
we do anticipate that almost all MIPS eligible clinicians will have

[[Page 77329]]

performance category scores for both quality and improvement 
activities.
    Based upon the policies we are finalizing; we summarize in Table 30 
the potential reweighting scenarios for the transition year of MIPS 
(MIPS payment year 2019):

                 Table 30--Performance Category Redistribution Policies for the Transition Year
                                            [MIPS payment year 2019]
----------------------------------------------------------------------------------------------------------------
                                                                                     Reweight
                                                                                  scenario if no     Reweight
                                                                   Weighting for  advancing care  scenario if no
                      Performance category                           2019 MIPS      information       quality
                                                                   payment year     performance     performance
                                                                        (%)       category score  category score
                                                                                        (%)             (%)
----------------------------------------------------------------------------------------------------------------
Quality.........................................................              60              85               0
Cost............................................................               0               0               0
Improvement Activities..........................................              15              15              50
Advancing Care Information......................................              25               0              50
----------------------------------------------------------------------------------------------------------------

    We do not include a scenario where a MIPS eligible clinician does 
not receive an improvement activities performance category score. MIPS 
eligible clinicians that do not submit any improvement activities data 
receive a zero percent score for that performance category.
7. MIPS Payment Adjustments
a. MIPS Payment Adjustment Identifier and Final Score Used in the MIPS 
Payment Adjustment Calculation
i. MIPS Payment Adjustment Identifier
    As we described in section II.E.2. of the proposed rule (81 FR 
28271), we proposed 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. However, for purposes of 
the application of the MIPS payment adjustment factors to payments in 
accordance with section 1848(q)(6)(E) of the Act (referred to as the 
MIPS payment adjustment), we proposed 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 final score based on individual, group, 
or APM Entity group performance, but the MIPS payment adjustment would 
be applied at the TIN/NPI level.
    We proposed to use the single identifier, TIN/NPI, for the MIPS 
payment adjustment for several reasons. First, the final eligibility 
status of some clinicians would not be known until after the 
performance period ends. For example, the calculations determining 
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 quality measurement are not mutually 
exclusive, and using TIN/NPI to apply the MIPS 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 Entity and TIN identifiers because in this case, 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 final scores (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 final score (one based on the group TIN 
performance). Applying the MIPS 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 81 FR 28271 for a discussion of identifiers and our 
proposals related to them.
    The following is summary of the comments we received regarding our 
proposal to use the TIN/NPI combination as the MIPS payment adjustment 
identifier.
    Comment: Some commenters opposed using the TIN/NPI as the MIPS 
payment adjustment identifier. They are concerned that TIN/NPI promotes 
individual achievement and undercuts a practice's ability to 
incentivize quality improvement behaviors through group or teamwork. 
Other commenters noted the administrative burden for group practices 
because they would have to track multiple MIPS payment adjustments 
within their TIN. They recommended applying the MIPS payment adjustment 
uniformly for each TIN.
    Response: We want the MIPS to encourage teamwork and coordination. 
We have finalized measurement at the group level (TIN) and the APM 
entity level to help encourage that goal. Generally, all TIN/NPIs that 
are measured as a group or an APM entity will have the same final 
score, and therefore have the same MIPS payment adjustment. We believe 
it would be challenging to apply the MIPS payment adjustment uniformly 
at the TIN level, because as noted earlier, we need to account for 
individuals who are excluded from MIPS and to resolve scenarios where 
there are overlapping or duplicative final scores. For MIPS eligible 
clinicians that report as a group, the low-volume threshold will be 
determined based on the group as a whole--in this case, the low volume 
threshold would be determined based on considering the volume across 
all NPIs billing within that TIN regardless of MIPS eligibility. Other 
exclusions,

[[Page 77330]]

however, such as newly enrolled and QP, are applied at the NPI level. 
Therefore, some NPIs within a TIN may be excluded from MIPS individual 
reporting requirements and payment adjustments; however, if the TIN 
chooses to participate in MIPS as a group, data for those NPIs would be 
included when determining the group's performance. We refer readers to 
section II.E.3 of this final rule with comment period for the list of 
MIPS statutory exclusions. In response to concerns on administrative 
burden, we intend to work with stakeholders to develop tools to 
minimize the potential burden of tracking numerous MIPS eligible 
clinician's payment status.
    Comment: One commenter believed that applying the MIPS payment 
adjustment at the TIN level also closes potential loopholes that would 
otherwise allow avoidance of payment reductions through switching NPIs. 
Another commenter expressed significant concerns related to our 
proposal to use multiple identifiers when assessing participation and 
performance in MIPS while relying solely on an eligible clinician's 
TIN/NPI for the purpose of the MIPS payment adjustment under certain 
circumstances, and requested clarification on how MIPS eligible 
clinicians would be scored across performance categories when they are 
a part of a group, whether this score is based on individual or group 
data, and whether the process is consistent across performance 
categories.
    Response: The NPI is meant to be a lasting identifier, and is 
expected to remain unchanged even if a health care provider changes his 
or her name, address, provider taxonomy, or other information that was 
furnished as part of the original NPI application process. Assignment 
of a unique NPI to each clinician is managed by the National Plan and 
Provider Enumeration System (NPPES) which only assigns a single NPI to 
each individual clinician. We will use the individual NPI, which cannot 
be changed when the clinician reassigns payment to a different TIN.
    Eligible clinicians will be scored across the four performance 
categories either as an individual or through their group. It is our 
intent that an eligible clinician reporting through a group will be 
scored as part of that group for all performance categories, or 
conversely, that an eligible clinician reporting as an individual will 
be scored on their individual data for all performance categories.
    We would also like to note that all TIN/NPIs participating in a 
group practice or APM Entity will have the same final score and the 
same MIPS payment adjustment. The only time the TIN/NPIs will vary 
across a group practice will be when a TIN/NPI: (1) Is excluded from 
MIPS; (2) has multiple possible final score submissions (for example an 
APM Entity final score and a TIN final score); or (3) the TIN/NPI is 
new to a TIN or a TIN is new and therefore does not have historical 
data associated with the TIN/NPI.
    Comment: Several commenters supported the TIN/NPI proposal. Reasons 
for support included that the TIN/NPI: Holds MIPS eligible clinicians 
accountable for their own performance; could simplify how the MIPS 
payment adjustment is applied and creates a consistent set of rules. 
Commenters cautioned, however, that failing to ensure TIN accuracy and 
completeness and having a complicated and inaccessible process for 
rectifying errors undermines trust in the program.
    Response: We agree with commenters that TIN/NPI simplifies how the 
MIPS payment adjustment is applied. We also note that MIPS eligible 
clinicians will have an opportunity to request a targeted review of 
their MIPS payment adjustment factor(s) for a year, which is described 
in more detail in section II.E.8, and we believe that process to be 
responsive to the commenters' requests.
    After consideration of these comments, we are finalizing our 
proposal to adopt the TIN/NPI combination as the MIPS payment 
adjustment identifier.
ii. Final Score Used in MIPS Payment Adjustment Calculation
    Because we proposed 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 
final score to each TIN/NPI that is subject to MIPS for the payment 
year.
    In general, we proposed to use the final score associated with the 
TIN/NPI combination in the performance period. For groups submitting 
data using the TIN identifier, we proposed to apply the group final 
score 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 proposed to use the final score 
associated with the TIN/NPI that is used during the performance period. 
For eligible clinicians in MIPS APMs, we proposed to assign the APM 
Entity group's final score to all the APM Entity Participant 
Identifiers that are associated with the APM Entity. We refer readers 
to section II.E.5.h. of this final rule with comment period 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 proposed to assign a final score 
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 final score 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 final score 
associated with a TIN/NPI from the performance period, we proposed 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 final score associated with the NPI from the performance period, 
then we proposed to use that final score. 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 final score 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 linked the MIPS 
eligible clinician's performance during the performance period to the 
MIPS payment adjustment. It also ensured that MIPS eligible clinicians 
that qualify for a positive MIPS payment adjustment are able to keep 
it, even if they change practices. For those who have a negative MIPS 
payment adjustment, this proposal also ensured 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 proposed 
to use a weighted average final score based on total allowed charges 
associated with the NPI from the performance period. This proposal 
would provide a final score that is based on all the services the NPI 
billed to Medicare during the performance period. Table 26 of the 
proposed rule (81 FR 28272), presents an example of how the weighted 
average proposed approach would work. If an NPI did not have any 
allowed charges in the performance period, then the clinician

[[Page 77331]]

would not be included in MIPS due to the low-volume exclusion.
    We also proposed an alternative policy where in lieu of taking the 
weighted average, we take the highest final score from the performance 
period. We believe the alternative approach rewards MIPS eligible 
clinicians for their prior performance and may be easier to implement 
in the transition year of MIPS. Our concern with this approach is that 
the highest final score may represent a relatively small portion of the 
MIPS eligible clinician's practice during the performance period.
    We requested comment on the proposal to use the final score 
associated with the TIN(s) the NPI was billing under during the 
performance period when the TIN/NPI does not have a final score from 
the performance period. We also requested comment on our proposal to 
use a weighted average, and the alternative proposal to select the 
highest final score from the performance period.
    We also considered, but did not propose, 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 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 MIPS 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 MIPS payment adjustment based on their performance during the 
performance period would not retain the positive MIPS payment 
adjustment if the new TIN had a lower final score. 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 did not propose to have performance follow the 
TIN, but rather have performance follow the NPI; however, we solicited 
comment on this option.
    In some cases, a TIN/NPI could have more than one final score 
associated with it from the performance period, if the MIPS 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 final score for an APM Entity and a final 
score for a group TIN. If a MIPS eligible clinician has multiple final 
scores, we proposed a multi-pronged approach to select the final score 
that would be used to determine the MIPS payment adjustment. First, we 
proposed that if a MIPS eligible clinician is a participant in MIPS 
APM, then the APM Entity final score would be used instead of any other 
final score (such as a group TIN final score or individual final 
score). We proposed that if a MIPS eligible clinician has more than one 
APM Entity final score for the same TIN (by participating in multiple 
MIPS APMs), we would apply the highest APM Entity final score to the 
MIPS eligible clinician. Second, if a MIPS eligible clinician reports 
as a group and as an individual, we would calculate a final score for 
the group and individual identifier and use the highest final score for 
the TIN/NPI. We requested comment on this proposed approach.
    The following is summary of the comments we received regarding our 
proposals for the final score used in the MIPS payment adjustment 
calculation.
    Comment: Some commenters did not support applying MIPS payment 
adjustments based on a previous employer's performance or use of prior 
TIN/NPI combinations if there is no historical information for the 
current TIN/NPI. Commenters noted it is unfair to base payments on the 
previous TIN/NPI combinations and supported awarding a neutral score 
when a MIPS eligible clinician comes to a new practice. Commenters also 
expressed concerns about placing undue burden on the hiring entity and 
the potential to influence hiring decisions based on data that are 2 
years old. Finally, some commenters expressed concerns that a new TIN 
would be adversely affected by having to accept a negative MIPS payment 
adjustment for a MIPS eligible clinician that was hired into that TIN 
after the performance period. These commenters also imply that 
calculating the MIPS payment adjustment for the individual based on 
their performance for that corresponding payment year does not 
recognize that the clinician may learn better compliance at the new 
practice. Many of these commenters recommended having the NPI inherit 
the final score of the TIN they moved to after the performance period, 
if that TIN was an existing TIN during the performance period, even 
though that NPI was not part of that TIN during that performance 
period.
    Response: In the case where a MIPS eligible clinician starts 
working in a new practice or otherwise bills Medicare under a new TIN, 
we have no historical performance data for the TIN/NPI. We examined 
using either the TIN's historical performance or the NPI's historical 
performance. However, we do not always have a TIN's historical 
performance. For example, in cases where a TIN elected to have its MIPS 
eligible clinicians submit individual data, then we would not have a 
TIN score, only individual scores. In contrast, we would always have 
NPI historical performance if the TIN/NPI is subject to MIPS. 
Therefore, we proposed, and will finalize, using the NPI's performance 
for the TIN(s) the NPI was billing under during the performance period.
    We do not believe it would be appropriate to assign a neutral score 
when performance data for the NPI is available.
    In response to concerns that an undue burden would be placed on the 
hiring entity, we are not asking TINs to perform any of the 
calculations. We will apply the specific MIPS payment adjustment that 
needs to be applied for that specific TIN/NPI for the payment year. We 
seek feedback on ways to provide the necessary information to practices 
to minimize burden for them.
    In response to concerns about the adverse effect on a new TIN that 
hires an individual that had a lower final score in the performance 
period, we want to reiterate that the MIPS payment adjustment is only 
being applied to that individual TIN/NPI and not all NPIs in that same 
hiring TIN and that in some cases the MIPS payment adjustment is 
positive. We believe that our policy tracks accountability to the 
clinician and will actually encourage all clinicians to seek high 
performance.
    Comment: Some commenters generally supported our proposal that the 
score follows the clinician to the new practice if there is a change 
after performance period to a new practice in the payment year, 
acknowledging that this holds clinicians accountable, but questioned 
the reasonableness of tracking this for the new receiving practice. One 
commenter encouraged CMS to consider how to mitigate these problems.
    Response: We will work with stakeholders to develop strategies to 
minimize the burden of tracking adjustments for MIPS eligible 
clinicians that change practices over time.
    Comment: Some commenters supported CMS' proposal to use a weighted 
final score average of TIN/NPI combinations and apply it to a new TIN/

[[Page 77332]]

NPI that did not exist during the performance period. One of these 
commenters stated this was a straightforward approach for handling MIPS 
eligible clinicians who have changed practice mid-year. Commenters that 
supported the TIN/NPI combination also supported using the final score 
associated with each TIN/NPI combination (not weighting across each 
TIN/NPI) if the clinician was in those TIN/NPIs in the performance 
period and still in those TINs/NPIs in the payment year. Some 
commenters supported the approach to use the highest TIN score in 
instances where a clinician has multiple MIPS scores rather than a 
weighted average. One commenter supported CMS's alternative approach 
for eligible clinicians who bill under more than one TIN.
    Response: We agree that performance should follow the clinician's 
NPI. We believe that a weighted average final score would provide a 
more accurate picture of the NPI's performance. We believe it is easier 
to communicate and operationalize a methodology that selects the 
highest final score available for a MIPS eligible clinician, 
particularly for the transition year. Therefore, we are finalizing our 
alternative policy to use the highest final score associated with an 
NPI from the performance period. We may revisit this policy in future 
rulemaking and consider whether we should require a certain percentage 
of billings by an NPI under a TIN before attributing the TIN's final 
score to the NPI.
    Comment: One commenter proposed that CMS give eligible clinicians 
practicing in multiple TINs the option of being scored based on their 
performance across all TINs and did not recommend that CMS simply 
calculate a weighted average across all TINs.
    Response: We are finalizing the policy that compares scores across 
all practices and takes the highest final score.
    Comment: Some commenters did not support CMS' proposal to calculate 
a final score for both a group and individual identifier, taking the 
higher final score, in cases where a MIPS eligible clinician reported 
as both a group and as an individual. One commenter recommended CMS use 
a weighted final score average based on total allowed charges 
associated with the NPI because this approach takes into account the 
eligible clinician's entire performance during the period. One 
commenter specifically stated they did not support CMS' proposal to 
apply the highest APM entity final score to the eligible clinician in 
cases where a MIPS clinician has more than one APM entity final score 
for the same TIN.
    Response: We are unclear as to how we would calculate a weighted 
score for the same TIN/NPI during the same performance period. For 
simplicity, we have elected to take the highest final score.
    Comment: Another commenter stated the proposed process to determine 
which final score takes precedence (APM entity, group, or individual) 
for eligible clinicians is confusing and unnecessarily complicated, as 
it is currently possible for MIPS eligible clinicians to earn multiple 
final scores based on their unique reporting experience. The commenter 
suggested CMS assign only one score to each TIN/NPI.
    Response: Each TIN/NPI will receive only one final score for 
purposes of the MIPS payment adjustment determination. However, since 
we allow each MIPS eligible clinician to decide how they want to 
report, either individually, through a group, or through an APM as a 
MIPS APM participant, we cannot completely control the number of 
submissions that one TIN/NPI may have. To address these types of 
circumstances, we have established policies in this section to clearly 
articulate the hierarchy for which of the final scores will take 
precedence for the MIPS payment adjustment.
    After consideration of these comments, we are finalizing our policy 
to use the TIN/NPI's historical performance from the performance period 
associated with the MIPS payment adjustment, regardless of whether that 
NPI is billing under a new TIN after the performance period. In the 
event that an NPI bills under multiple TINs in the performance period 
and bills under a new TIN in the MIPS payment year, we are finalizing 
our alternative policy of taking the highest final score associated 
with that NPI in the performance period.
b. MIPS Payment Adjustment Factors
    Section 1848(q)(6)(A) of the Act requires the Secretary to specify 
a MIPS adjustment factor (referred to as a MIPS payment adjustment 
factor) for each MIPS eligible clinician for a year determined by 
comparing the final score 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 a final score at or 
above the performance threshold receive a zero or positive MIPS 
adjustment factor on a linear sliding scale such that a MIPS adjustment 
factor of 0 percent is assigned for a final score at the performance 
threshold and a MIPS adjustment factor of the applicable percent is 
assigned for a final score of 100. Positive MIPS adjustment factors may 
be increased or decreased by a scaling factor (not to exceed 3.0) to 
ensure the budget neutrality requirement is met.
    Section 1848(q)(6)(A)(iv) of the Act provides that MIPS eligible 
clinicians with a final score below the performance threshold receive a 
negative MIPS adjustment factor on a linear sliding scale such that a 
MIPS adjustment factor of 0 percent is assigned for a final score at 
the performance threshold and a MIPS adjustment factor of the negative 
of the applicable percent is assigned for a final score of 0; further, 
MIPS eligible clinicians with final scores that are equal to or greater 
than zero, but not greater than one-fourth of the performance 
threshold, receive a negative MIPS 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 payment adjustment factor for exceptional performance 
(referred to as an additional MIPS payment adjustment factor), for each 
of the years 2019 through 2024, for each MIPS eligible clinician with a 
final score for a year at or above the additional performance threshold 
under paragraph (D)(ii) for such year. The additional MIPS payment 
adjustment factor shall be in the form of a percent and determined in a 
manner such that MIPS eligible clinicians having higher final scores 
above the additional performance threshold receive higher additional 
MIPS payment adjustment factors.
    We are codifying these requirements as follows:
    At Sec.  414.1405(a), we are codifying that each MIPS eligible 
clinician receives a MIPS payment adjustment factor, and if applicable 
an additional MIPS payment adjustment factor for exceptional 
performance, for a MIPS payment year determined by comparing their 
final score to the performance threshold and additional performance 
threshold for the year.
    At Sec.  414.1405(b)(1), we are codifying that MIPS eligible 
clinicians with a final score at or above the performance threshold 
receive a zero or positive

[[Page 77333]]

MIPS payment adjustment factor on a linear sliding scale such that an 
adjustment factor of 0 percent is assigned for a final score at the 
performance threshold and an adjustment factor of the applicable 
percent is assigned for a final score of 100.
    At Sec.  414.1405(b)(2), we are codifying that MIPS eligible 
clinicians with a final score below the performance threshold receive a 
negative MIPS payment adjustment factor on a linear sliding scale such 
that an adjustment factor of 0 percent is assigned for a final score at 
the performance threshold and an adjustment factor of the negative of 
the applicable percent is assigned for a final score of 0; further, 
MIPS eligible clinicians with final scores that are equal to or greater 
than zero, but not greater than one-fourth of the performance 
threshold, receive a negative MIPS payment adjustment factor that is 
equal to the negative of the applicable percent.
    At Sec.  414.1405(c), we are codifying the applicable percent.
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 for which the 
final scores of MIPS eligible clinicians are compared for purposes of 
determining the MIPS payment adjustment factors under section 
1848(q)(6)(A) of the Act for a year. The performance threshold for a 
year must be either the mean or median (as selected by the Secretary, 
and which may be reassessed every 3 years) of the final scores for all 
MIPS eligible clinicians for a prior period specified by the Secretary. 
Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the 
initial 2 years of MIPS, which requires the Secretary, prior to the 
performance period for such years, to establish a performance threshold 
for purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act and an additional performance 
threshold for purposes of determining the additional MIPS payment 
adjustment factors under section 1848(q)(6)(C) of the Act, each of 
which shall be based on a period prior to the performance periods and 
take into account data available for performance on measures and 
activities that may be used under the performance categories and other 
factors determined appropriate by the Secretary.
    We are codifying the definition of the term ``performance 
threshold'' at Sec.  414.1305 as the numerical threshold for a MIPS 
payment year against which the final scores of MIPS eligible clinicians 
are compared to determine the MIPS payment adjustment factors. Final 
scores above the performance threshold receive a positive MIPS payment 
adjustment factor and final scores below the performance threshold 
receive a negative MIPS payment adjustment factor. Final scores that 
are equal to or greater than 0, but not greater than one-fourth of the 
performance threshold receive the maximum negative MIPS payment 
adjustment factor for the MIPS payment year. Final scores at the 
performance threshold receive a neutral MIPS payment adjustment factor.
    To establish the performance threshold for the 2019 MIPS payment 
year, we proposed to model 2014 and 2015 Medicare 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 
cost 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 improvement activities 
performance category, we would apply some sensitivity analyses to help 
inform where the performance threshold should be.
    For the 2019 MIPS payment year, we proposed 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 final scores 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. of the proposed rule (81 FR 
28273) 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 MIPS adjustment factor 
and potentially an additional adjustment factor for exceptional 
performance. We solicited comment on the policy options for setting the 
performance threshold.
    The following is summary of the comments we received regarding our 
proposals for setting the performance threshold for the 2019 MIPS 
payment year.
    Comment: One commenter stated that it is unreasonable to punish 
nearly half of clinicians in MIPS. Several commenters requested that 
CMS seek to establish a performance threshold that would ease the 
transition to MIPS by minimizing penalties under the program. One of 
those commenters noted that section 1848(q)(6)(D)(iii) of the Act 
provides the Secretary with a level of discretion in establishing the 
MIPS performance threshold during the first 2 years of the program and 
requested CMS adopt a threshold methodology for years 1 and 2 that 
would ease the transition to MIPS by minimizing penalties under the 
program. Several commenters recommended setting the performance 
threshold at a modest level for the initial performance year such that 
it would be readily attainable through data reporting alone (for 
example, no downward adjustment for those who report measures during 
the first 2 years). These same commenters suggested that if CMS insists 
upon setting the performance threshold such that the distribution of 
penalties and bonuses under MIPS would be expected to be roughly equal, 
then commenters recommended that CMS adopt the lower-bound estimate of 
the final score that would be needed to establish such a performance 
threshold. In other words, CMS should take the lowest possible 
performance threshold value from the different estimates it generates. 
According to one commenter, such an approach would be justified because 
(1) CMS has admitted that it is unclear how MIPS will impact small and 
solo practices and should therefore go with the threshold that is least 
likely to have negative impacts, (2) the scaling factor will help 
ensure budget neutrality in a case where the threshold is set too low, 
(3) the additional performance threshold will reward true exceptional 
performance even in cases where the threshold is too low. Other 
commenters recommended exercising caution in setting the initial 
performance threshold under MIPS.
    One commenter referred to the estimate that half of eligible 
clinicians would fall below the performance threshold and recommended 
that CMS create a structure whereby fewer clinicians are penalized 
during the

[[Page 77334]]

transition year of the program. Some commenters suggested various 
approaches to setting the performance threshold lower. One commenter 
suggests pushing a greater number of physicians into the category where 
no MIPS payment adjustment is made as one possible solution. Another 
commenter proposed identifying a threshold range, at least for 2017 
performance, to hold clinicians harmless falling in that range. And 
another commenter suggested to ``flatten the curve'' of negative MIPS 
payment adjustments and positive MIPS payment adjustments in the 
transition year so that more eligible clinicians fall in the middle of 
the curve and there will be fewer negative MIPS payment adjustments.
    Response: We heard significant concern, as summarized above, that 
MIPS eligible clinicians will not have time to prepare for MIPS, that 
there is confusion about MIPS, and that the performance threshold 
should be set low so that the majority of MIPS eligible clinicians are 
not subject to a negative MIPS payment adjustment. Given the numerous 
concerns, we agree that year 1 of MIPS should be a transition year, and 
we have determined that it would be inappropriate to set a performance 
threshold that would result in downward adjustments to payments for 
many clinicians who may not have had time to prepare adequately to 
succeed under the MIPS. By providing a pathway for many clinicians to 
succeed under MIPS, we believe that we will encourage early 
participation in the program, which would enable more robust and 
thorough engagement with the program over time. We agree with the 
commenters that setting the performance threshold at an appropriately 
low number will provide MIPS eligible clinicians an opportunity to 
achieve a minimum level of success under the program, while gaining 
experience with reporting on the measures and activities and becoming 
familiar with other program policies and requirements. By contrast, if 
we set the threshold too high, using a new formula that is unfamiliar 
and confusing to clinicians, many could be discouraged from 
participating in the first year of the program, which may lead to lower 
participation rates in future years. We believe that active 
participation of MIPS eligible clinicians in MIPS will improve the 
overall quality, cost, and care coordination of services provided to 
Medicare beneficiaries.
    Section 1848(q)(6)(D)(iii) of the Act includes a special rule to 
establish the performance threshold and the additional performance 
threshold for the first 2 years of MIPS. Specifically, the Secretary 
shall, prior to the performance period for such years, establish a 
performance threshold for purposes of determining the MIPS payment 
adjustment factors under section 1848(q)(6) (A) of the Act and an 
additional performance threshold for purposes of determining the 
additional MIPS payment adjustment factors under section 1848(q)(6)(C) 
of the Act, each of which shall be based on a period prior to the 
performance periods and take into account data available for 
performance on measures and activities that may be used under the 
performance categories and other factors determined appropriate by the 
Secretary.
    We are relying on the special rule under section 1848(q)(6)(D)(iii) 
of the Act to establish the performance threshold and the additional 
performance threshold for the 2019 MIPS payment year to create a 
transition year policy that encourages participation and provides an 
opportunity for MIPS eligible clinicians to become familiar with MIPS 
and other aspects of the Quality Payment Program.
    We considered available data regarding performance on measures and 
activities that may be used under the MIPS performance categories. With 
regard to the quality performance category, we took several steps to 
identify PQRS participation rates for MIPS eligible clinicians. First, 
we identified the TIN/NPIs who billed a Medicare Part B service in 
2015. We used clinician type and specialty information from NPPES to 
establish a subset of those clinician types who are eligible for MIPS 
as described in section II.E.1 of this rule. We then used 2015 Part B 
data to exclude those who did not exceed the low-volume threshold as 
defined in section II.E.3 of this rule. We used 2015 PQRS data to 
assess whether to apply the low-volume at the individual (TIN/NPI) or 
group (TIN) level. We assumed all Shared Savings Program participants 
would exceed the low volume threshold because the Shared Savings 
Program has a requirement that the ACOs be attributed a minimum number 
of patients.
    Due to data limitations, we had to proxy new enrollment by 
identifying NPIs who billed PFS services in 2015 and not in 2014. We 
also excluded 2015 Pioneer ACO participants and CPC participants as we 
estimated they might represent QPs in the future. We were not able to 
specifically identify the exact number of QPs or Partial QPs. We refer 
readers to the regulatory impact analysis in section V.C. of this final 
rule with comment period for more details on this analysis. We estimate 
between 592,119-642,119 MIPS eligible clinicians, but due to the model 
limitations to identify QP and Partial QPs, we included 676,722 MIPS 
eligible clinicians in our model.
    We used the 2015 PQRS data to create benchmarks for our model based 
on our final policies and assign points under the quality performance 
category based on performance. For the readmission measure we used the 
2014 VM analytic file, which was the most recent data available. We 
then estimated final scores using the quality performance category 
scores. We did not include cost measures because the cost performance 
category has 0 percent weight in the 2019 final score. We did not 
include data for improvement activities or advancing care information 
because we did not have detailed performance data available for all 
MIPS eligible clinicians. While we have some performance data for the 
Medicare EHR Incentive Program, we do not have detailed performance 
data for the Medicaid EHR Incentive Program. Having performance data 
for only a portion of MIPS eligible clinicians would have skewed the 
analysis; therefore, we restricted our analysis to the quality 
performance data only.
    Using 2015 PQRS data, we determined which of these MIPS eligible 
clinicians participated and calculated participation rates for the MIPS 
quality performance category, the performance category that accounts 
for a minimum of 60 percent of the transition year final score. For our 
participation counts, we did not include other data files because 2015 
information was either not available or would not have impacted the 
participation score. We noted that 87.2 percent of the estimated MIPS 
eligible clinicians submitted data to PQRS, but the participation rate 
is lower for solo practitioners and practices with 2-9 clinicians at 
58.2 percent. As mentioned in this final rule with comment period, we 
want to create a scenario where many MIPS eligible clinicians have the 
ability to participate while transitioning to the MIPS.
    We are setting the performance threshold at 3 points for the 2019 
MIPS payment year taking into account the data available as described 
above, but also based on other factors we believe are appropriate, such 
as encouraging participation in the first year of MIPS. We want to 
ensure that MIPS eligible clinicians are allowed time to gain 
understanding of the MIPS and pick their pace as they report on the 
MIPS performance categories. We believe that setting the performance 
threshold at 3 points will encourage more MIPS

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eligible clinicians to participate in the MIPS during the transition 
year and provide a structure for eligible clinicians to gain experience 
in order to successfully participate in the future years of the MIPS. 
With a 3 point performance threshold, an eligible clinician could meet 
or exceed the performance threshold through a minimal level of 
performance during the transition year. For example, under the quality 
performance category, the 3-point floor for any submitted quality 
measure would result in a neutral or positive MIPS payment adjustment 
for most MIPS eligible clinicians submitting a single measure. A MIPS 
eligible clinician, including solo practitioner or small practice, that 
submits one quality measure with low performance, and no improvement 
activities or measures specified for the advancing care information 
performance category (assuming advancing care information performance 
category measures are available and applicable to the MIPS eligible 
clinician) would have the following performance category scores: The 
quality performance category score is 3 points out of a possible 60 
points (the total possible points is 10 points for each of the six 
required measures) or 5 percent; improvement activities is 0 points out 
of a possible 40 points or 0 percent; and advancing care information is 
0 percent out of 100 percent. The final score would equal the 
performance category scores times the performance category weights (([5 
percent*60 percent] + [0 percent*15 percent] + [0 percent*25 percent]) 
*100), which totals 3 points. This MIPS eligible clinician would 
receive a neutral MIPS payment adjustment because the performance 
threshold is set at 3 points. Similarly, any MIPS eligible clinician 
reporting as a group of 16 or more clinicians would receive at least 
3.75 points for submitting at least one improvement activity (10 points 
out of a possible 40 points x 15 percent (improvement activities 
performance category weight)). Solo practitioner clinicians and those 
in groups of 15 or less would receive at least 7.5 points (20 points 
out of a possible 40 points x 15 percent (improvement activities 
performance category weight)). We provide further details of these 
calculations in the examples listed at the end of this section. The 
exception that should be noted is under the advancing care information 
performance category. For a MIPS eligible clinician to receive a 
neutral or positive MIPS payment adjustment based solely on the 
advancing care information performance category, the MIPS eligible 
clinician must report on all of the measures in the base score, for the 
reasons discussed in section II.E.5.g.(6)(b) of this final rule with 
comment period. Finally, we note that if a group of 16 or more, does 
not report any quality performance category data, the group would be 
scored on the all-cause readmission measure (assuming the group meets 
the readmission measure minimum case size requirements) even if they 
did not submit any other quality performance category measures if they 
submitted information in other performance categories. If a group of 16 
or more did not report any information in any of the performance 
categories, then the readmission measure would not be scored. A group 
will never have a final score based on the readmission measure alone.
    As commenters note above, the lower performance threshold will 
``flatten the curve'' in that relatively fewer MIPS eligible clinicians 
would receive a negative MIPS payment adjustment which would lower the 
scaling factor required by budget neutrality. In other words, the 
amount of the positive MIPS payment adjustment from the adjustment 
factor on a per-clinician basis will be less than under our initial 
proposal as more MIPS eligible clinicians would qualify for a positive 
MIPS payment adjustment; however, we believe this is necessary in order 
to achieve our transition year goals.
    While we have lowered the performance threshold as part of our 
transition year policies, we do not think it would be appropriate to 
lower the additional performance threshold, as the additional 
performance threshold is the point at which MIPS eligible clinicians 
can receive an additional adjustment factor for exceptional 
performance. As we discuss in the next section, we will decouple the 
performance threshold and the additional performance threshold and set 
the additional performance threshold at 70 points. The lower 
performance threshold of 3 points will meet our policy goal to increase 
participation in the first year of MIPS and transparency in the scoring 
methodology; however, we believe that MIPS eligible clinicians must 
demonstrate exceptional performance to receive an additional adjustment 
factor.
    We intend to increase the performance threshold in year 2 and 
beginning in year 3 we will use the mean or median final score from a 
prior period as required by section 1848(q)(6)(D)(i) of the Act. The 
performance threshold and other transition year policies provide an 
opportunity for MIPS eligible clinicians to pick their pace in 
participation. This encourages MIPS eligible clinicians to participate 
and become familiar with the MIPS requirements.
    Also, while we are finalizing a performance threshold of 3 and an 
additional performance threshold of 70 in this rule, in future years we 
may not publish the numerical performance threshold and additional 
performance threshold in a final rule. We would finalize our 
methodology for calculating these thresholds via notice and comment 
rulemaking and then utilize that methodology to calculate and announce 
the performance threshold and additional performance threshold for a 
MIPS payment year on a Web site prior to the performance period, rather 
than publishing the numerical thresholds within a final rule.
    Comment: Several commenters expressed support for our proposal to 
set the performance threshold as the median of all expected final 
scores. Another commenter expressed support for CMS' proposal to set 
the performance threshold for 2019 such that half of eligible 
clinicians would be below the performance threshold and half would be 
above it.
    Response: As described in this final rule with comment period, we 
are not finalizing our proposal to set the performance threshold at a 
level where approximately half of the MIPS eligible clinicians would be 
below the threshold and half would be above the performance threshold; 
rather, we are relying on the special rule under section 
1848(q)(6)(D)(iii) to set the performance threshold at 3 points for the 
2019 MIPS payment year to encourage participation by MIPS eligible 
clinicians. We will take these commenter's support into consideration 
as we monitor the MIPS scoring system over time.
    Comment: One commenter requested CMS to clarify in the final rule 
with comment period how the performance thresholds will be set each 
year. Another commenter questioned the use of the term 
``approximately'' in defining the performance threshold, asking why it 
would be approximate, rather than precise. One commenter recommended 
that CMS allow stakeholders to provide input on how the methodology is 
applied to calculate the 2019 performance threshold, since the 
description in the proposed rule on the proposed methodology, and 
alternative methodologies, is not sufficiently detailed. Another 
commenter is concerned that performance data from 2019 could yield a 
less equal distribution if CMS chooses to move towards a mean for the 
performance threshold because if half of MIPS eligible clinicians are 
above and half are

[[Page 77336]]

below the performance threshold, this could lead to MIPS eligible 
clinicians receiving a penalty in 2021 after 2 years of increases, even 
if their performance did not objectively change. One commenter advised 
the creation of a policy to mitigate instability in MIPS payment 
adjustments as the MIPS transitions to its own data. Another commenter 
expressed concern that CMS' proposal to set the performance threshold 
at the 50th percentile of national MIPS eligible clinician performance 
could have disparate impacts on different types of clinicians, 
particularly those in small practices.
    Response: To inform our policies we performed data modeling based 
on available data. Please see description of our model to assess 
participation described earlier in this section. We took into account 
this data to set the additional performance threshold, which we have 
decoupled from the performance threshold and will set at 70 points. As 
we noted in this final rule with comment period, for future MIPS 
payment years, we intend to publish the numerical performance threshold 
and additional performance threshold on a Web site prior to the 
performance period. These thresholds will be specific numbers, not 
approximations.
    Beginning with the third MIPS payment year (2021), we must set the 
performance threshold according to section 1848(q)(6)(D)(i) of the Act 
at the mean or median of the final scores for all MIPS eligible 
clinicians for a prior period.
    Comment: Several commenters opposed the use of pre-MACRA data for 
setting performance thresholds. One commenter did not favor using non-
MIPS historical data to set performance thresholds during the first 2 
years of MIPS. Another commenter did not support CMS proposal to use 
existing quality and cost data to set MIPS performance thresholds as 
this data did not align exactly with MIPS. Another commenter proposed 
withdrawing the use of 2014 data and using 2016 data in the 
establishment of the thresholds and noted that using 2016 data will 
more accurately reflect clinical practice improvements as a result of 
PQRS. A commenter requested, to the extent that CMS is using 2014 and 
2015 PQRS data submissions in setting the initial performance 
threshold, that CMS exclude data submitted via Measure Groups 
reporting, which requires only a non-random sample of 20 patients per 
measure. Additionally, one commenter suggested that thresholds should 
be determined by clinicians and clinician practices in MIPS. Another 
commenter requested that CMS devise an approach to use 2017 data to set 
thresholds for both 2017 and 2018 performance periods. One commenter 
recommended that CMS not rely only on existing data, but to apply 
lessons learned from previous legacy reporting programs and changes 
that have been incorporated into MIPS and build those into future 
performance thresholds.
    Response: We disagree with commenters on using prior data from 
PQRS, VM, and the EHR Incentive program. Section 
1848(q)(6)(D)(iii)(II)(aa) of the Act requires us to consider data 
available with respect to performance on measures and activities that 
may be used under the performance categories and we believe this data 
to be the most comparable. As described earlier in this section, we 
have used data from 2015 PQRS and the 2014 Physician Feedback Program 
and VM to inform our models, which is the most recent data available. 
We excluded the PQRS measures group submissions as that option is no 
longer available in MIPS. In addition, we have used 2015 CMS enrollment 
files and administrative claims to estimate who is a MIPS eligible 
clinician.
    Comment: One commenter recommended CMS conduct additional analyses 
assessing the differences in requirements between the preexisting 
reporting programs and the MIPS performance categories, and use this 
analysis as the basis for adjusting performance thresholds in the MIPS 
performance categories.
    Response: PQRS, VM, and EHR Incentive Program are different 
programs than MIPS; however, many of the measures used in the MIPS 
performance categories are drawn from these programs. In addition, we 
are unaware of other data sources that would be more appropriate. We 
have used the source data and tried to replicate the MIPS requirements 
to create the most informed models possible. For example, we created 
benchmarks using PQRS data based on the finalized MIPS policies. We 
created group scores for PQRS group practice reporting options and 
individual scores for individual submissions. The VM and QRUR data from 
the Physician Feedback Program data is only available at the TIN level, 
so we applied the group score to individuals when individuals were 
reporting. While this is not an exact replication of the MIPS 
methodology, we believe this is a close approximation and we used these 
data to inform our policies. The performance threshold is set at 3 
points to encourage MIPS eligible clinicians to pick their pace as they 
participate under the Quality Payment Program.
    Comment: One commenter requested that CMS clarify how it plans to 
calculate the MIPS performance threshold for the 2019 payment year by 
providing detail about the ``sensitivity analyses'' used to account for 
the improvement activities performance category. Another commenter 
recommended that CMS publish this methodology and include a public 
comment period prior to the start of MIPS.
    Response: We elected to not use sensitivity analyses for the 
creation of the performance threshold. Rather, we used PQRS data to 
estimate participation and our scoring policies to set the performance 
threshold at 3 points, and the additional performance threshold at 70 
points. As noted above we intend to finalize our methodology for 
calculating these thresholds for future years via notice and comment 
rulemaking.
    Comment: A commenter disagreed with CMS's alternative proposal that 
would require a clinician to earn a minimum number of points above the 
performance threshold before receiving a positive MIPS adjustment 
factor, and believed clinicians performing above the established 
threshold have shown a high level of performance and should be able to 
immediately begin earning incentives.
    Response: We are explaining that our alternative proposal would not 
have required a MIPS eligible clinician to earn a minimum number of 
points above the performance threshold to achieve a positive MIPS 
payment adjustment. Rather, we would set the performance threshold 
where clinicians would be required to meet a certain number of points. 
As described above, we believe it is important to set transition year 
policies that encourage participation while allowing the flexibility 
for MIPS eligible clinicians to pick their pace with the MIPS and other 
provisions of the Quality Payment Program. Therefore, we are 
establishing the performance threshold at 3 points.
    Comment: A commenter did not believe MIPS eligible clinicians 
should be rewarded or penalized for scores that do not reflect 
significant statistical differences from their peers. One commenter 
stated that given that previous CMS performance analyses were unable to 
distinguish between large majorities of clinicians, the commenter 
recommended that performance adjustments be made only the high and low 
end with clinicians in the middle areas receiving adjustments of a de 
minimis amount. The commenter understood there were statutory questions 
involved in this

[[Page 77337]]

decision by CMS, but the commenter believed that CMS can operate within 
the text of the statute and employ an adjusted linear structure that 
recognized the reality that most physicians' performance will be 
indistinguishable from one another. One commenter suggested 
incentivizing high-performers and suggested that eligible clinicians 
under the national performance threshold that improve score by a 
certain percentage would be eligible to have their penalty decreased by 
0.5 percent. Another commenter suggested that CMS apply MIPS payment 
adjustments based on aggregated MIPS scores that are one standard 
deviation above (incentive) or one standard deviation below (penalty) 
the mean or median.
    Response: We would like to emphasize that the MIPS payment 
adjustment a MIPS eligible clinician receives is determined by the 
final score and how it relates to the performance threshold. Once the 
linear sliding scale that is described in section II.E.7.b. of this 
final rule with comment period is established, we will not modify the 
amount of the MIPS payment adjustment based on factors such as 
improvement or standard deviations. In our scoring policies described 
in section II.E.6. of this final rule with comment period, we have 
discussed in detail how we are differentiating performance for the 
different performance categories and how those performance categories 
scores are combined into a final score. All MIPS eligible clinicians 
with the same final score will receive the same MIPS payment 
adjustment. We also note that with our transition policies that we 
anticipate most MIPS eligible clinicians that submit data will receive 
a neutral to small positive MIPS payment adjustment in the transition 
year. We anticipate the slope of the positive MIPS payment adjustment 
due to budget neutrality to be relatively flat, which will minimize 
differences based on the adjustment factor, although there will be more 
MIPS payment adjustments for the additional adjustment factor for 
exceptional performance.
    Comment: Numerous commenters expressed concern about the negative 
impact the Quality Payment Program would have on small and rural 
practices. One commenter recommended that small practices have lower 
reporting thresholds and adjusted scoring mechanisms throughout the 
MIPS program. Another commenter recommended that CMS set the 
performance threshold at 15 points in the transition year of 
implementation to reduce the negative impact on small practices. One 
commenter noted that CMS estimates that 87 percent of solo practices 
will face a negative MIPS payment adjustment in 2019, causing them 
disproportionate hardship as a result of this system of evaluation.
    Response: We recognize the particular challenges faced by small and 
rural practices. We agree with the commenter that a reduced performance 
threshold should ease participation burden for small practices, 
therefore as noted above we are lowering the performance threshold for 
the transition year to 3 points. We did consider creating different 
performance criteria for small practices, but determined that these 
different performance criteria levels would create additional confusion 
and additional burden for administrators to have to track towards. 
Rather we believe our approach of modifying the low volume threshold 
exclusion in combination with the modified performance threshold has 
created a path for solo and small practices to participate in MIPS. In 
addition, we will provide additional technical assistance to these 
practices.
    Comment: Several commenters disagreed with the MIPS negative MIPS 
payment adjustment proposal because they believed it will penalize 
small practices while subsidizing larger practices. Another commenter 
requested that small physician practices be exempted from negative MIPS 
payment adjustments so that they can continue to participate in 
Medicare. One commenter recommended that CMS reduce the proposed MIPS 
payment adjustments for 2019, which would result from the 2017 
performance period, especially for small practices of 2-9 clinicians. 
Another commenter hoped there was a reasonable penalty for zero percent 
compliance for small FFS practices. A few commenters expressed concern 
that the adjustment factors would exacerbate distortions between well-
resourced and less resourced practices. Another commenter requested 
that CMS take into consideration practice size and location in 
determining overall MIPS incentives or payment reductions, so that 
rural clinicians and practices are not penalized at greater levels than 
urban clinicians and practices. One commenter stated the adverse 
effects to small and solo practices of the estimated negative MIPS 
payment adjustments would jeopardize patient care.
    Response: We appreciate the commenters concerns and want MIPS to be 
an equitable program regardless of practice size. We do recognize that 
many solo and small practices did not participate in the sunsetting 
programs and therefore have less experience with the requirements under 
the MIPS. To ease the participation burden, we have reduced the 
performance threshold to 3 points for year 1, which provides a pathway 
for solo and small practices to engage in MIPS. We do not have the 
statutory authority to exempt solo practitioners and small practices 
from MIPS. We have however increased the low-volume exclusion to 
exclude groups and individuals with less than or equal to $30,000 in 
Part B charges or less than or equal to 100 beneficiaries, which will 
exclude more small groups and solo practices from being MIPS eligible 
clinicians. Lastly, we note the applicable percent for the MIPS payment 
adjustments are established in section 1848(q)(6)(B) of the Act and we 
are not able to modify that amount.
    Comment: Several commenters suggested that the scoring system may 
need special rules for IHS, Tribal, and Urban Indian health programs. 
These commenters suggested that these clinicians should have their own 
performance threshold that accounts for the government's responsibility 
to provide quality health care to AI/ANs and the chronic underfunding 
of their health care systems.
    Response: We appreciate the unique challenges that face MIPS 
eligible clinicians that are part of IHS, Tribal, and Urban Indian 
health programs. We considered creating different performance criteria 
for certain types of clinicians, however, we believe that approach 
would create more confusion and burden than a cohesive set of criteria. 
Rather, to ease the participation burden, we have reduced the 
performance threshold to 3 points for the transition year only, which 
provides a pathway for MIPS eligible clinicians to engage in MIPS. We 
are also committed to continuing to work with IHS and its partners to 
streamline and coordinate programs where possible.
    Comment: A few commenters were concerned with the proposed 
notification of the performance threshold. One commenter was concerned 
that the threshold for the MIPS final score had not been identified, 
which would make it difficult for a practice to assess what changes may 
need to occur. Another commenter was concerned clinicians will not know 
where they stand relative to the performance threshold on an annual 
basis until after the close of the reporting period. A commenter 
proposed that CMS make the MIPS adjustment information available to 
each eligible clinician at least 2 months prior to when the MIPS 
payment adjustment is applied each year.
    Response: We will publish the performance threshold in advance of

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each performance period. We also intend to provide performance feedback 
as discussed in section II.E.8.a. of the final rule with comment period 
to provide eligible clinicians with meaningful information regarding 
their performance trends. We also intend to develop toolkits and 
educational materials which will allow MIPS eligible clinicians to 
estimate their total score and the associated adjustment percentage 
they could receive.
    Comment: Another commenter believed the development of more ``real-
time'' feedback mechanisms would greatly increase the impact of the 
published performance threshold.
    Response: We appreciate the desire for ``real-time'' feedback and 
the impact it may have on eligible clinicians' performance. We refer 
readers to section II.E.8.a. of this final rule with comment period for 
detailed policies on the performance feedback. We have also established 
performance standards so that MIPS eligible clinicians will be able to 
estimate their performance throughout the performance period.
    After consideration of the public comments, we are finalizing at 
Sec.  414.1405(b) that a performance threshold will be specified for 
each MIPS payment year. Specifically, we are finalizing a performance 
threshold of 3 points for the 2019 MIPS payment year in accordance with 
the special rule set forth in section 1848(q)(6)(D)(iii) of the Act. We 
believe this approach to establishing the performance threshold will 
enable more robust and thorough engagement with the program over time 
consistent with our goal for a transition year. As noted above, 
however, we intend to increase the performance threshold in year 2, and 
beginning in year 3 we will use the mean or median final score from a 
prior period as required by section 1848(q)(6)(D)(i) of the Act.
(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 MIPS payment 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 final 
score above the performance threshold determined under section 
1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score 
that is equal to the 25th percentile of the actual final score for MIPS 
eligible clinicians with final score at or above the performance 
threshold for the prior period described in section 1848(q)(6)(D)(i) of 
the Act.
    For each year of the MIPS, we will compute an additional 
performance threshold for purposes of determining the additional MIPS 
payment adjustment factors under section 1848(q)(6)(C) of the Act. We 
proposed 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 final score above the 
performance threshold; or it shall be equal to the 25th percentile of 
the actual final score for MIPS eligible clinicians with final scores 
at or above the performance threshold for 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 2 years of MIPS. Because 2019 is the first MIPS payment 
year, we do not have any actual final score for MIPS eligible 
clinicians to use for purposes of defining an additional performance 
threshold under the methodology proposed above. Therefore, we proposed 
to establish the additional performance threshold at the 25th 
percentile of the range of possible final scores above the performance 
threshold. For example, if the performance threshold is 60, then the 
range of possible final scores above the performance threshold would be 
61-100. The 25th percentile of those possible values is 70. We intended 
to publish the additional performance threshold with the performance 
threshold prior to the performance period.
    The following is a summary of the comments we received regarding 
our proposal to establish the additional performance threshold at the 
25th percentile of the range of possible final scores above the 
performance threshold for exceptional performance.
    Comment: One commenter expressed support for CMS's proposal to set 
the additional performance threshold in 2019 at the 25th percentile of 
the range of possible scores above the performance threshold.
    Response: As we discussed in section II.E.7.c.(1) of this final 
rule with comment period, we are relying on the special rule under 
section 1848(q)(6)(D)(iii) of the Act to establish the performance 
threshold at 3 points for the transition year of MIPS (2019 MIPS 
payment year). As a result, we are not finalizing our proposal to 
establish the additional performance threshold at the 25th percentile 
of the range of possible final scores above the performance threshold. 
With a performance threshold set at 3 points, the range of total 
possible points above the performance threshold is 4 to 100 points. The 
25th percentile of that range is 27.3 points, which is less than one 
third of the possible 100 points in the MIPS final score. We do not 
believe it would be appropriate to lower the additional performance 
threshold to 27.3 points, as we do not believe a final score of 27.3 
points demonstrates exceptional performance by a MIPS eligible 
clinician. Under section 1848(q)(6)(C) of the Act, a MIPS eligible 
clinician with a final score at or above the additional performance 
threshold will receive an additional MIPS payment adjustment factor and 
may share in the $500,000,000 available for the year under section 
1848(q)(6)(F)(iv) of the Act. We believe these additional incentives 
should only be available to those clinicians with very high performance 
on the MIPS measures and activities. Therefore, we are relying on the 
special rule under section 1848(q)(6)(D)(iii) of the Act to set the 
additional performance threshold at 70 points for the transition year 
(MIPS payment year 2019), which is higher than the 25th percentile of 
the range of the possible final scores above the performance threshold 
as proposed. We took into account the data available and the modeling 
described in section II.E.7.c.(1) to estimate final scores based on 
2015 PQRS data and used the distribution of quality performance 
category scores to determine an appropriate additional performance 
threshold for the transition year (MIPS payment year 2019). In our 
model using historical 2015 PQRS participation, a final score of 70 
points was higher than the mean, but less than the median final score. 
We believe 70 points is appropriate because it requires a MIPS eligible 
clinician to submit data for and perform well on more than one 
performance category (except in the event the advancing care 
information measures are not applicable and available to a MIPS 
eligible clinician). Generally, a MIPS eligible clinician could receive 
a maximum score of 60 points for the quality performance category, 
which is below the 70-point additional performance threshold. In 
addition, 70 points is at a high enough level that MIPS eligible 
clinicians have to submit quality data in order to

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achieve this target. For example, if a MIPS eligible clinician gets a 
perfect score for the improvement activities and advancing care 
information performance categories, but does not submit quality 
measures data, then the MIPS eligible clinician will only receive 40 
points (0 points for quality + 15 points for improvement activities + 
25 points for advancing care information), which is below the 
additional performance threshold. We believe the additional performance 
threshold at 70 points maintains the incentive for excellent 
performance while keeping the focus on quality performance.
    Comment: One commenter requested clarification on how IHS/Tribally-
operated facilities can qualify for an additional positive MIPS payment 
adjustment for exceptional performance.
    Response: MIPS eligible clinicians that are part of IHS/Tribally-
operated facilities are able to earn an additional MIPS payment 
adjustment factor if their final score is at or above the additional 
performance threshold of 70 points. These clinicians are subject to the 
same rules for MIPS participation that apply to other MIPS eligible 
clinicians.
    Comment: One commenter recommended that CMS provide exceptional 
performance bonuses to MIPS eligible clinicians who demonstrate 
improvement, not just high achievement, in subsequent performance 
periods after the first performance period.
    Response: We do not have authority to distribute the $500 million 
available under section 1848(q)(6)(F)(iv) of the Act for exceptional 
performance for any reason other than for final scores at or above the 
additional performance threshold.
    After consideration of the public comments, we are codifying at 
Sec.  414.1305 the definition of additional performance threshold as 
the numerical threshold for a MIPS payment year against which the final 
scores of MIPS eligible clinicians are compared to determine the 
additional MIPS payment adjustment factors for exceptional performance. 
We are also finalizing at Sec.  414.1405(d) that an additional 
performance threshold will be specified for each of the MIPS payment 
years 2019 through 2024. Specifically, the additional performance 
threshold for the 2019 MIPS payment year is 70 points.
d. Scaling/Budget Neutrality
    Section 1848(q)(6)(F)(i) of the Act provides, for positive MIPS 
payment adjustment factors for MIPS eligible clinicians whose final 
score 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) 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 payment adjustment factors under 
section 1848(q)(6)(A) of the Act (after application of the scaling 
factor) is equal to the estimated decrease in the aggregate allowed 
charges resulting from the application of negative MIPS payment 
adjustment factors under section 1848(q)(6)(A) of the Act. Under 
section 1848(q)(6)(F)(iii) of the Act, budget neutrality requirements 
shall not apply if all MIPS eligible clinicians receive final scores 
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. We are codifying at Sec.  414.1405(b)(3) that a scaling 
factor not to exceed 3.0 may be applied to positive MIPS payment 
adjustment factors to ensure budget neutrality such that the estimated 
increase in aggregate allowed charges resulting from the application of 
the positive MIPS payment adjustment factors for the MIPS payment year 
equals the estimated decrease in aggregate allowed charges resulting 
from the application of negative MIPS payment adjustment factors for 
the MIPS payment 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 MIPS payment 
adjustment factor for each MIPS eligible clinician whose final score 
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 final scores above the additional performance threshold receive 
higher additional MIPS payment 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 Medicare 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 payment adjustment factors under 
section 1848(q)(6)(A) of the Act, we proposed to apply a linear sliding 
scale where MIPS eligible clinicians with a final score at the 
additional performance threshold would receive 0.5 percent additional 
adjustment factor and MIPS eligible clinicians with a final score 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 final scores 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 proposed the starting 
point for the additional adjustment factor at 0.5 percent for a final 
score 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 proposed to lower the starting percentage 
for a final score 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 
final score that is below the additional performance threshold would 
not be eligible for an additional adjustment factor. We requested 
comments on these proposals.
    The following is summary of the comments we received regarding the 
additional adjustment factor.
    Comment: One commenter expressed support for CMS's proposal to set 
the starting point for the additional adjustment factor at 0.5 percent;

[[Page 77340]]

however, a couple commenters did not believe this should be considered 
a large enough incentive for eligible clinicians to strive to reach the 
additional threshold, particularly for physicians without a significant 
amount of Medicare business. One of the commenters requested an 
explanation for why CMS would use a 0.5 percent adjustment factor for 
MIPS clinicians above the additional performance threshold.
    Response: We would like to note that the additional adjustment 
factor could range from 0.5 percent up to 10 percent, depending on the 
scaling factor. As the final score increases, the additional adjustment 
factor increases. We started at 0.5 percent as that is the annual 
update for the PFS for 2019 and we believed this was a reasonable 
starting point that would allow a positive slope for the additional 
adjustment factor.
    Comment: One commenter was concerned with funding bonuses for the 
Quality Payment Program given that the program needs to be budget 
neutral.
    Response: Under section 1848(q)(6)(F) of the Act, budget neutrality 
is only required with respect to the MIPS payment adjustment factors 
under section 1848(q)(6)(A), not the additional MIPS payment adjustment 
factors for exceptional performance under section 1848(q)(6)(C) of the 
Act.
    After consideration of the public comments, we are finalizing our 
proposal at Sec.  414.1405(d)(1), MIPS eligible clinicians with a final 
score at or above the additional performance threshold receive an 
additional MIPS payment adjustment factor for exceptional performance 
on a linear sliding scale such that an additional adjustment factor of 
0.5 percent is assigned for a final score at the additional performance 
threshold and an additional adjustment factor of 10 percent is assigned 
for a final score of 100, subject to the application of a scaling 
factor as determined by CMS, such that the estimated aggregate increase 
in payments resulting from the application of the additional MIPS 
payment adjustment factors for the MIPS payment year shall not exceed 
$500,000,000 for each of the MIPS payment years 2019 through 2024.
f. Application of the MIPS Payment 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 for such 
items and services and MIPS eligible clinician for such year, shall be 
multiplied by 1 plus the sum of the MIPS payment adjustment factor 
determined under section 1848(q)(6)(A) of the Act divided by 100, and 
as applicable, the additional MIPS payment adjustment factor determined 
under section 1848(q)(6)(C) of the Act divided by 100. We would apply 
the adjustment factors in accordance with section 1848(q)(6)(E) of the 
Act.
    We requested comment on our proposals.
    The following is summary of the comments we received regarding our 
proposal to apply the MIPS payment adjustment factors for items and 
services furnished by a MIPS eligible clinician during a year in 
accordance with section 1848(q)(6)(E) of the Act.
    Comment: One commenter requested clarification as to how the MIPS 
payment adjustment will be made, either in a lump sum at the end of the 
year or reflected in each claim paid. Another commenter suggested the 
payment be one lump sum.
    Response: MIPS payments will not be made in a lump sum, but applied 
as an adjustment on a per claim basis.
    Comment: A few commenters requested further clarification on 
whether the base rate factored into the MIPS adjustment calculation 
includes the MIPS adjustment rate.
    Response: The adjustment will be based upon the amount otherwise 
paid for the item or service under Part B.
    Comment: One commenter requested that CMS clarify whether Part B 
drug payments will be affected by MIPS payment adjustments. Commenter 
observed that in previous programs (PQRS, EHR Incentive Program 
(Meaningful Use), and Value-based Payment Modifier) the payment 
adjustments were only made to the services paid under the Medicare PFS, 
which included administration of Part B drugs, but not the cost of the 
actual drugs. Commenter would like verification that this policy will 
continue under the Quality Payment Program.
    Response: We appreciate the comment and note that we did not 
address this issue in the proposed rule. We will consider this issue 
and intend to provide clarification in the future.
    Comment: Commenter requested guidance on whether Medicare Advantage 
plans would build in MIPS adjustments to their payment rates to non-
contracted providers, as MA plans are currently required to pay non-
contracted providers the same rates as they receive under FFS. 
Commenter stated that if adjustments must be factored in to non-
contracted provider payment rates, it will be critical for CMS to 
provide plans with timely and complete data on adjustments to ensure 
payment accuracy.
    Response: Medicare Advantage rates are set through a separate 
process, and payment policies will be addressed in the Advance Notice 
and Rate Announcement for that program.
    After consideration of the public comments, we are finalizing our 
proposed application of the MIPS payment adjustment factors at Sec.  
414.1405(e). For each MIPS payment year, the MIPS payment adjustment 
factor, and if applicable the additional MIPS payment adjustment 
factor, are applied to Medicare Part B payments for items and services 
furnished by the MIPS eligible clinician during the year.
g. Example of Adjustment Factors
    Figure A of the proposed rule, provided an example of how various 
final scores would be converted to an adjustment factor and potentially 
an additional adjustment factor, using the statutory formula. We direct 
readers to 81 FR 28276 for an illustration of the proposed policies.
    Figure A in this final rule with comment period shows an 
illustrative picture based on the final policies. In Figure A, the 
performance threshold is 3 points. 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 final score between 0 and \1/4\ of the performance 
threshold (0 and 0.75 for the 2019 payment year). All MIPS eligible 
clinicians with a final score in this range would receive the lowest 
negative applicable percentage (negative 4 percent for 2019). Second, 
the linear sliding scale line for the positive MIPS adjustment factor 
is adjusted by the scaling factor (which is determined by the formula 
described in section II.E.7.d. of this final rule with comment 
period.). If the scaling factor is greater than 0 and less than or 
equal to 1.0, then the adjustment factor for a final score 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 final 
score of 100 would be higher than 4 percent. Only those MIPS eligible 
clinicians with a final score equal to 3 points (which is the 
performance threshold in this example) would receive a neutral MIPS 
payment adjustment. Because our final policies have set the performance 
threshold at 3 points, we anticipate that the scaling

[[Page 77341]]

factor would be less than 1.0 and the payment adjustment for MIPS 
eligible clinicians with a final score of 100 points would be less than 
4 percent.
    Figure A of this final rule with comment period illustrates an 
example slope. In this example, the scaling factor for the adjustment 
factor is 0.214, which is much lower than 1.0. MIPS eligible clinicians 
with a final score equal to 100 would have an adjustment factor of 
0.856 percent (4.0 percent x 0.214).
    The additional performance threshold is 70 points. An additional 
adjustment factor of 0.5 percent starts at the additional performance 
threshold and increases on a linear sliding scale up to 10 percent 
times a scaling factor that is greater than 0 and less than or equal to 
1.0. In Figure A of this final rule with comment period, the example 
scaling factor for the additional adjustment factor is 0.1523. 
Therefore, MIPS eligible clinicians with a final score of 100 would 
have an additional adjustment factor of 1.523 percent (10 percent x 
0.1523). The total adjustment for a MIPS eligible clinician with a 
final score equal to 100 would be 1 + 0.00856 + 0.01523 = 1.02379, for 
a total positive MIPS payment adjustment of 2.379 percent. Note that in 
calculating payment adjustments, we will not round any numbers until 
the final step of the process. After we have calculated the total 
adjustment for a MIPS eligible clinician, we will round the percentage 
upward or downward to one decimal point. Thus, a total adjustment of 
1.02379 will be rounded to a positive payment adjustment of 2.4 
percent.
[GRAPHIC] [TIFF OMITTED] TR04NO16.007


    Note:  The adjustment factor for final score values above the 
performance threshold is illustrative. For MIPS eligible clinicians 
with a final score 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. MIPS eligible clinicians at or above 
the additional performance threshold will receive the amount of the 
adjustment factor plus the additional adjustment factor.

    The final MIPS payment adjustments would be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors would decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment. More MIPS eligible clinicians below the performance 
threshold means the scaling factors would increase because more MIPS 
eligible clinicians would have negative MIPS payment adjustments and 
relatively fewer MIPS eligible clinicians receive positive MIPS payment 
adjustments.
    We requested comment on these examples, but we did not receive any 
comments on them. We have however provided in Table 31 a summary of the 
MIPS payment adjustments based on different final scores.

[[Page 77342]]



  Table 31--Illustration of Point System and Associated Adjustments in
                             Transition Year
------------------------------------------------------------------------
     Final score points                     MIPS adjustment
------------------------------------------------------------------------
0-0.75......................  Negative 4 percent
                              (Note: We anticipate that this range will
                               comprise mostly of MIPS eligible
                               clinicians with a final score of 0.)
0.76-2.9....................  Negative MIPS payment adjustment greater
                               than negative 4 percent and less than 0
                               percent on a linear sliding scale. (Note:
                               We do not anticipate many MIPS eligible
                               clinicians to fall into this range.)
3.0.........................  0 percent adjustment.
3.1-69.9....................  Positive MIPS payment adjustment ranging
                               from greater than 0 percent to 4 percent
                               x a scaling factor to preserve budget
                               neutrality, on a linear sliding scale.
70.0-100....................  Positive MIPS payment adjustment AND
                               additional MIPS payment adjustment for
                               exceptional performance. (Additional MIPS
                               payment adjustment starting at 0.5
                               percent and increasing on a linear
                               sliding scale to 10 percent multiplied by
                               a scaling factor.)
------------------------------------------------------------------------

    We have provided the following examples to demonstrate to readers 
how the MIPS calculations and performance threshold of 3 points will 
operate for various performance scenarios.
    Example 1: A solo practitioner is a low performer who reports one 
measure/activity in each performance category. For quality scoring, the 
MIPS eligible clinician submits 1 quality measure instead of the 
required 6 measures. Under our finalized scoring approach, we allow all 
MIPS eligible clinicians to receive a three-point floor per measure in 
the quality performance category. Under this scenario, the MIPS 
eligible clinician receives the three-point floor for the one measure 
submitted and the quality performance category is weighted at 60 
percent of the final score. The MIPS eligible clinician's total quality 
performance category score is 3: (1 measure x 3 points each/total 
possible points of 60 points) x 60 = 3. We note that we did not include 
the all-cause hospital readmissions measure in the above quality 
performance category calculation since it is not applicable to groups 
of 15 or fewer clinicians, nor to MIPS eligible clinicians reporting as 
individuals due to reliability concerns.
    As discussed in section II.E.6.a.(4) of this final rule with 
comment period, different improvement activities scoring rules apply to 
a solo practitioner (or small group) than apply to groups of 16 or more 
clinicians. Under these special scoring rules, a solo practitioner who 
performs one medium-weighted activity receives 20 out of 40 potential 
points in the improvement activities performance category score, and 
one who performs one high-weighted activity receives 40 out of 40 of 
the improvement activities performance category score. The improvement 
activities performance category score is weighted as 15 percent of the 
final score. In this example, the MIPS eligible clinician that is a 
solo practitioner who performs only one medium-weighted activity, which 
equals 20 out of the 40 possible points, or 50 percent, for the 
improvement activities performance category score, which has a weight 
of 15 percent of the final score. The MIPS eligible clinician's total 
improvement activities performance category score is 7.50 (50 percent x 
15 =7.50).
    For advancing care information performance category scoring, the 
eligible clinician submits the required elements of the base for 
advancing care information only which is worth 50 percent of the 
advancing care information performance category score. The advancing 
care information performance category is worth 25 percent of the final 
score. In this scenario, the eligible clinician would receive an 
advancing care information score of (50 percent x 25) =12.5.
    As a result, the total final score = 3 +7.5+12.5= 23.0 points which 
is above the performance threshold of 3 points.
    Example 2: A MIPS eligible clinician, who is a solo practitioner, 
receives a 0 for all performance categories except the quality 
performance category. The MIPS eligible clinician submits four quality 
measures, instead of the required six measures. Under the finalized 
scoring approach, we allow all MIPS eligible clinicians to receive a 
three-point floor per submitted measure in the quality performance 
category. Under this scenario, the MIPS eligible clinician receives the 
three-point floor for each of the four measures submitted and the 
quality performance category is weighted at 60 percent of the final 
score. Since the MIPS eligible clinician has received 0 in each of the 
other categories. The MIPS eligible clinician's total final score is: 
(four measures x 3 points each/total possible points of 60 points) x 60 
percent performance category weight = 12 points. The final score = 12 
points (12 points for quality + 0 points for improvement activities + 0 
points advancing care information) which is above the performance 
threshold. We note that we did not include the all-cause hospital 
readmissions measure in the above calculation since it is not 
applicable to groups 15 or fewer clinicians, nor MIPS eligible 
clinicians reporting as individuals due to reliability concerns.
    Example 3: A MIPS eligible clinician, a high performer who is a 
solo practitioner, performs two medium-weighted activities in 
improvement activities and submits five measures with high performance 
and one measure with slightly above average performance. This clinician 
does not report in the advancing care information performance category 
and receives a 0 score for the category. For quality scoring, under 
this scenario, we assume for purposes of illustration and ease of 
understanding that the MIPS eligible clinician receives 10 points for 
each of the measures submitted with high performance, and 6 points for 
the other measure submitted. The quality performance category is 
weighted at 60 percent of the final score. The MIPS eligible 
clinician's quality score is: (five measures x 10 points each + 1 
measure x 6 points each/total possible points of 60 points) x 60 = 56 
points. We note that we did not include the all-cause hospital 
readmissions measure in the above calculation since it is not 
applicable to groups with 15 or fewer clinicians and MIPS eligible 
clinicians reporting as individuals due to reliability concerns.
    As discussed in section II.E.6.a.(4) of this final rule with 
comment period, different improvement activities scoring rules apply to 
a solo practitioner (or small group) than apply to groups of 16 or more 
clinicians. Under these special scoring rules, a solo practitioner who 
performs one medium-weighted activity receives 20 out of 40 potential 
points in the improvement activities performance category score, and 
one who performs one high-weighted activity receives 40 out of 40 of 
the improvement activities performance category score. The improvement 
activities performance category score is weighted as 15 percent of the 
final score. In this example, the MIPS eligible clinician performs two 
medium-weighted activities, which

[[Page 77343]]

equals 40 out of 40 points or 100 percent for the improvement 
activities performance category score, which has a weight of 15 percent 
of the final score. The MIPS eligible clinician's total improvement 
activities performance category score is 15 (40/40 x 15=15).
    Under this scenario, the MIPS eligible clinician's final score is 
56 for the quality performance category score +15 for the improvement 
activities performance category score + 0 for advancing care 
information performance category score = 71 points which is above the 
additional performance threshold of 70.
    Example 4: A MIPS eligible clinician in a group with 20 MIPS 
eligible clinicians, reports as a group, and only submits data for the 
improvement activities performance category. This group also has 
sufficient case volume to be measured for the readmission measure and 
in our hypothetical example, has poor performance and receives 3 points 
for the readmission measure. In this scenario, the improvement 
activities special scoring rules do not apply since the MIPS eligible 
clinician is in a group of 20 MIPS eligible clinicians and is reporting 
as a group. The MIPS eligible clinician performs only one high activity 
for the improvement activities performance category. For improvement 
activities scoring for groups of more than 15 clinicians, all groups 
who perform one medium activity receive 10 out of 40 points for the 
improvement activities score, and those who perform each high activity 
receive 20 points toward the improvement activities score. The 
improvement activities score is weighted as 15 percent of the final 
score. In this example, the MIPS eligible clinician performs only one 
high activity, achieves 20 out of 40 possible points of the improvement 
activities score, which has a weight of 15 percent of the final score. 
In addition, even though the group did not submit quality measures to 
the quality performance category information, the group is measured on 
the readmission measure because the group has submitted improvement 
activities as a group. As explained above, the group achieves only 3 
points on the readmission measure and therefore has a quality score 
equal to 3 out 70 points. The group has 0 for the advancing care 
information category. The eligible clinician's total final score is (3/
70 quality performance category score x 60 percent for quality 
performance category weight) + (20/40 improvement activities 
performance category score x 15 percent improvement activities 
performance category weight) + (0 advancing care information quality 
score x 25 percent advancing care information performance category 
weight) = [(4.3 percent x 60 percent) + (50 percent x 15 percent) + (0 
percent x 25 percent)] x 100 = 10.1 points, which is above the 
performance threshold of 3.
    We cannot guarantee that establishing the performance threshold of 
3 for the transition year will always provide a positive MIPS payment 
adjustment for MIPS eligible clinicians; however, it does provide more 
opportunities for MIPS eligible clinicians to participate and become 
familiar with MIPS. In addition, the additional adjustment factor 
provides incentives for MIPS eligible clinicians to strive for good 
performance.
8. Review and Correction of MIPS Final 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 
final score 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 cost performance 
categories beginning July 1, 2017, and we have discretion to provide 
such feedback regarding the improvement activities and advancing care 
information performance categories.
    Beginning July 1, 2017, we proposed to include information on the 
quality and cost performance categories in the performance feedback. 
Within these performance categories, we proposed to use fields similar 
(that is, quality and cost) to those currently available in the Quality 
and Resource Use Reports (QRURs). Since the QRURs already provide 
information on quality and cost 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/2015-QRUR.html.
    The first performance feedback is due on July 1, 2017. As this is 
prior to us having received any MIPS data, we proposed 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 cost data. Since 2017 is the first 
MIPS performance period (as finalized in section II.E.8.a.), we do not 
anticipate receiving the first set of data for MIPS until 2018 (see 81 
FR 28181). At a minimum for the transition year, we proposed 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 solicited 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 
measures before these data are incorporated into performance feedback, 
as we want to ensure the data we are providing in the performance 
feedback is useful and actionable for our stakeholders. We requested 
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 
cost performance categories, we understand

[[Page 77344]]

that the improvement activities 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 these data are provided to 
MIPS eligible clinicians. Therefore, we may consider including feedback 
on the performance categories of improvement activities and advancing 
care information in future years. Further, before we consider adding 
improvement activities 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 actionable for MIPS 
eligible clinicians. Regarding the MIPS final score, 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 final score and each of the 
four performance categories in future performance feedback once MIPS 
data become available. In addition, we plan to explore the possibility 
of including the MIPS payment adjustment factor (and, as applicable, 
the additional MIPS payment adjustment factor) in future performance 
feedback. We solicited comment on the frequency with which this 
performance feedback should be provided, considerations for including 
improvement activities and advancing care information, and data fields 
that should be included in the performance feedback as this program 
evolves.
    The following is a summary of the comments we received regarding 
our proposal to provide annual performance feedback on the quality and 
cost performance categories starting July 1, 2017, which would be based 
on historic/baseline information and include fields similar to QRURs.
    Comment: Some commenters were not in support of providing 
performance feedback. However, the majority of commenters supported 
providing performance feedback. Some commenters agreed with the 
proposal to provide initial feedback starting on July 1, 2017 based on 
historical data for the quality and cost performance categories.
    With regard to the frequency of providing performance feedback, 
commenters' suggestions ranged from annually to 6 weeks of the 
performance period. The majority of commenters stated that annual 
feedback would not provide timely information or frequent feedback, due 
to the long look-back periods hindering the ability for improvements of 
care. Many commenters supported real-time feedback to eligible 
clinicians and groups, and suggested making feedback available during 
the performance periods so clinicians could correct errors in a timely 
fashion. The majority of comments supported quarterly feedback from 
CMS, some commenters noting this should begin in 2017. One commenter 
requested that CMS adopt a requirement that eligible clinicians be 
furnished quarterly feedback on the advancing care information 
performance category during the performance period.
    One commenter stated that 6 months is the ideal target to provide 
feedback, to allow for unavoidable claim run-out and review processes. 
While some commenters supported a monthly performance feedback so 
adjustments could be made in workflow to improve performance. Another 
commenter noted that performance feedback should be provided no later 
than 45 days following the end of a performance period. One commenter 
requested that performance feedback be available and accessible upon 
request. One commenter recommended that CMS allow eligible clinicians 
to choose if they want to receive more current feedback, such as 
quarterly.
    Another commenter recommended that performance feedback be provided 
prior to the end of the performance period. Other commenters suggested 
that the final performance feedback is provided no later than October 1 
of the reporting year. Another commenter expressed that performance 
feedback to eligible clinicians would only be effective if it would 
come in time to make meaningful changes to the practice, and that 
subsequently July 1 was too late in the year for feedback.
    Some commenters believed there is value in submitting data more 
frequently (for example, an iterative process where practices and 
vendors submit data routinely); but if CMS intends to provide feedback 
after eligible clinicians submit their data and not on a frequent 
basis, then eligible clinicians should not be required to submit data 
more frequently.
    Another commenter recommended an approach that allows for timely, 
actionable feedback, such as the Bundled Payments for Care Improvement 
(BPCI) model, which offers monthly data files and quarterly 
reconciliation reports with subsequent true-ups.
    Response: As we indicated in the proposed rule, our goal is to 
provide even more timely feedback under MIPS as the program evolves. We 
do note that there are a number of challenges with providing feedback 
more frequently than annually, namely that for the MIPS performance 
period, under our final policies in this rule data will be received on 
an annual basis for the majority of submission mechanisms. However, as 
noted in section II.E.4., we will, if technically feasible, allow for 
submissions during the performance period. In that section we note that 
having more frequent data submissions is a preliminary step on being 
able to issue more timely feedback. We will provide the first 
performance feedback on the quality and cost performance categories by 
July 1, 2017. We believe that additional steps need to be taken both 
internally by CMS and through external stakeholder outreach/engagement 
to move towards a more frequent data submission process, which will 
enable CMS to provide more timely or real-time feedback. Additionally, 
we do not currently have the ability to provide feedback more 
frequently than annually as data will be submitted to CMS by clinicians 
and their third party intermediaries on an annual basis. However we 
will take this comment into future consideration as we develop the 
processes to provide more frequent feedback, including what frequency 
requirements should be placed around the submission requirements.
    Comment: Some commenters requested clarification on whether CMS 
would provide clinician and/or TIN specific feedback about quality 
during the reporting year.
    Response: We can only provide feedback on performance as often as 
data are reported to us; for MIPS, this will be an annual basis for all 
quality submission mechanisms except for claims and administrative 
claims. As noted in section II.E.4. we will, if technically feasible, 
allow the submission of data more frequently throughout the year which 
would allow us to enable the generation of additional feedback that is 
accurate and meaningful to MIPS eligible clinicians.
    Comment: One commenter requested that CMS expand the type of data 
available to clinicians on the cost performance category. One commenter 
believed that cost data should be provided to eligible clinicians on a 
rolling quarterly basis. A few commenters requested more frequent 
performance feedback for cost, and that cost information be available 
to clinicians as soon as possible during the performance period, and to 
keep the attribution process transparent.
    One commenter noted that clinicians need real-time information, 
including attribution for cost to perform well and achieve the Quality 
Payment Program's goals. One commenter requested that

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CMS provide attributed cost beneficiary lists and other data to 
eligible clinicians that can provide timely and actionable insights to 
organizations on a quarterly basis. Another commenter recommended 
making available information about cost in local specialists in 
performance feedback to inform referral decisions which can impact the 
cost measure performance. Some commenters recommended CMS to provide 
patient-level claims data for each cost performance measure so 
clinicians can understand specific care pathways and referral patterns 
that drive unnecessary expenditures. Another commenter suggested 
allowing clinicians to drill down to the un-aggregated patient level 
for performance feedback for cost.
    Some commenters recommended that CMS provide the ability for 
eligible clinicians and organizations to run real-time cost measure 
reports on the CMS Web site, as waiting for CMS to publish mid-year or 
even quarterly reports does not provide sufficient time to design and 
implement improvement interventions.
    One commenter encouraged CMS to provide cost performance feedback 
that makes it possible for the data to be incorporated into other 
reporting and analytics tools the clinician might be using and allows 
the clinician to monitor their scores throughout the reporting period.
    Response: We do intend to provide performance feedback on cost 
measures, as further described in section II.E.5.e. of this final rule 
with comment period. As technically feasible, we will provide 
performance feedback on the measures specified for the cost performance 
category. We also plan to provide feedback on episode-based measures, 
as we believe this information will be useful to eligible clinicians, 
even though some of these episode-based measures have not been adopted 
for the cost performance category for the CY 2017 performance period, 
but could be used in future years if proposed through rulemaking (see 
II.E.5.e. of this rule). Additionally, some of these measures will be 
released in the 2015 S-QRURs that will be available in October 2016. We 
are still determining the formatting and details of that data. We will 
publish the cost measures specifications and attribution methodology on 
our Web site. We also agree the goal of performance feedback will be to 
provide as frequently-as-is-meaningful feedback to MIPS eligible 
clinicians regarding the cost performance category, and this is what we 
are working toward in the future as we build the web-based application 
for performance feedback distribution.
    Additionally, 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. We agree this 
information would be useful to eligible clinicians, and are therefore 
targeting to include this information in the performance feedback 
beginning July 1, 2018.
    Comment: One commenter indicated that CMS needs to create 
performance feedback that shows quality and cost at the measure level 
and change in performance over time in order for information to be used 
in performance improvement. Another commenter suggested that CMS 
provide transparency on quality measurement data at both the individual 
and group level.
    Response: We agree providing performance feedback that shows 
quality and cost at the measure level would be useful to MIPS eligible 
clinicians, and we plan to include this data beginning July 1, 2018. As 
technically feasible we intend to incorporate improvement information 
into the performance feedback, when available.
    Comment: One commenter requested clarification on if the QRUR would 
still be utilized under MIPS in the same way it is being utilized for 
PQRS now. Some commenters were concerned about using the QRURs as the 
template for MIPS performance feedback, expressing their belief that 
QRURs were not clear in the feedback being provided, actionable on the 
eligible clinician's behalf, or inclusive of data that would allow the 
eligible clinician to compare and improve against the performance 
thresholds. One commenter recommended improvements to the content and 
accessibility of supplemental QRURs to encourage familiarity with cost 
performance data and the clinical episodes that will be attributed to a 
clinician or group. One commenter suggested the QRUR be supplemented 
with additional information on topics such as beneficiary attribution 
characteristics. Another commenter requested that CMS encourage 
clinicians to access performance feedback to supplement the information 
they receive from CMS on their Medicare Fee for Services claims.
    One commenter requested that CMS continue to provide timely mid-
year and end-of-year QRURs to eligible clinicians in order for them to 
receive timely feedback about their performance and payment adjustments 
under MIPS. Some commenters supported quicker and broader access to 
performance scores and ``feedback reports'' such as those provided to 
clinicians as part of the Physician Feedback Program (QRURs), and the 
Medicare Shared Savings Program for ACOs for quality improvement 
purposes. One commenter suggested the QRURs be provided on a quarterly 
basis moving forward with the Quality Payment Program so the 
information is timely for performance feedback.
    One commenter noted concerns with the implementation feasibility of 
getting performance feedback out for mid-year performance given past 
experience with the PQRS and QRURs, and urged CMS to make the 
investments needed in resources and systems to ensure timely feedback.
    Response: Under section 1848(n)(11) of the Act, as added by section 
101(d)(3) of the MACRA, reports under the Physician Feedback Program 
(in other words, the QRURs) shall not be provided after December 31, 
2017, and will be succeeded by the MIPS performance feedback under 
section 1848(q)(12) of the Act. The QRURs have provided information on 
quality and cost measure performance as well as the beneficiary and 
clinician-level data underlying and driving the measures; therefore, 
while we believe this is a good starting point for performance feedback 
under the MIPS, we do not anticipate using the same format as the QRURs 
for future years of the Quality Payment Program. We will continue to 
engage in user research with front-line clinicians and other 
stakeholders to ensure we are providing the performance feedback data 
in a user-friendly format, and that we are including the data most 
relevant to clinicians.
    Comment: Many commenters suggested feedback be included on all four 
performance categories, so eligible clinicians could know how they are 
doing in each performance category. Some commenters recommended that 
CMS use its discretion to expand the performance feedback to relay 
information on improvement activities and advancing are information.
    Response: We agree that all four performance categories may be 
beneficial to include in performance feedback. For the first 
performance

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feedback, as we proposed, only quality and cost will be provided. We 
will continue to work with stakeholders on the best way to include all 
four performance categories in performance feedback. A summary of 
comments received regarding future considerations for including 
improvement activities and advancing care information, and data fields 
that should be included in the performance feedback as this program 
evolves can be found below in section II.E.8.a.(7) of this final rule 
with comment period.
    Comment: One commenter expressed support for providing more 
frequent real-time feedback to eligible clinicians on administrative 
claims-based measures. Another commenter believed that CMS should make 
claim-level data for all potential beneficiaries available to practices 
with MIPS eligible clinicians.
    Response: We will be providing performance feedback on these types 
of measures, as applicable. We also agree the goal of performance 
feedback will be to provide as frequently-as-is-meaningful feedback to 
clinicians, and this is what we are working toward in the future as we 
build the web-based application and work with registries, EHRs, and 
QCDRs for performance feedback.
    Comment: One commenter believed that CMS does not need to create a 
new feedback reporting system, but should instead focus on improving 
the current system.
    Response: We agree, and will continue working with stakeholders to 
improve the future performance feedback for the Quality Payment 
Program.
    Comment: Some commenters requested that eligible clinicians who are 
not required, but who report voluntarily, receive the same access to 
performance feedback as MIPS eligible clinicians.
    One commenter requested that CMS expedite the performance feedback 
process so that partial[hyphen]year data on performance in the 
transition year of the MIPS is available to physicians prior to July 1, 
2018--and preferably prior to January 1, 2018.
    Response: We have considered the comments received and will take 
them into consideration in the future development of performance 
feedback through separate notice-and-comment rulemaking.
    After consideration of the comments, we are finalizing that we will 
use the QRUR released on September 26, 2016 (referred to as the 2015 
Annual QRUR) as the first MIPS performance feedback provided under 
section 1848(q)(12)(A)(i) of the Act, which will contain quality and 
cost data. The September 2016 QRURs are available and can be accessed 
at https://portal.cms.gov/wps/portal/unauthportal/home/. We encourage 
physicians and physician groups to access their report and review the 
quality and cost information to prepare for the Quality Payment 
Program. To note, this report will not contain data regarding the final 
score or payment adjustment for the Quality Payment Program, that 
information is not yet available and therefore will be provided in 
future performance feedback. Further, we may have MIPS eligible 
clinicians that will not have historical data available, through the 
September 2016 QRUR, to produce performance feedback. For those 
eligible clinicians we will not be able to produce performance 
feedback, until these eligible clinicians submit data through the 
Quality Payment Program. Additionally, to note for MIPS eligible 
clinicians and groups, the Quality Payment Program will produce 
performance feedback as long as quality data is submitted or at least 
one patient and is attributed to a MIPS eligible clinician or group for 
cost or quality measurement.
    Lastly, we note that these QRURs are produced at the TIN level, 
which is the level for applying adjustments under the VM program. We 
recognize that assessments under MIPS may be conducted at either the 
individual or group level, and that payment adjustments will be made at 
the TIN/NPI level; therefore, QRURs may not provide sufficient detail 
for those clinicians who are currently assessed at the TIN level under 
the VM, but who may choose to be assessed at the individual level under 
the Quality Payment Program. To address this issue, we intend, prior to 
the 2018 performance period, to provide as much feedback as technically 
possible to clinicians at the individual level. Since at this time CMS 
will not have performance data for the 2017 performance period (as that 
data is not yet available), we will not be able to provide feedback on 
that data. We intend to look into providing feedback to clinicians on 
the data it does have available, for instance, on claims based cost 
data or claims based outcome measures.
    The September 26, 2016 QRURs show how physician groups and 
physician solo practitioners performed in 2015 on quality and cost 
measures relative to national benchmarks and indicate whether 
physicians will receive an upward, neutral or downward adjustment under 
the VM in 2017. The QRURs also contain important information about care 
delivered to Medicare beneficiaries that can be used to better 
understand and improve quality and cost performance under the VM 
including information about hospitalizations and other providers that 
can be used to improve quality and better coordinate care.
    By utilizing an already existing report, that provides quality and 
resource use (for example, cost) feedback, we intend to focus resources 
on continued user testing with front-line clinicians and other 
stakeholders and development of new and improved methods and mechanisms 
for performance feedback, including but not limited to those suggested 
in these comments. We are utilizing an existing report because it does 
not make sense for us to create a duplicative report containing the 
same information and provide it to clinicians beginning July 1, 2017, 
which would only confuse clinicians by continuing to use the same data 
as provided in the September 26, 2016 QRUR. Additionally, no clinicians 
would have submitted data for the Quality Payment Program to us before 
July 1, 2017. Therefore, we intend to invest our resources in creating 
an easy to understand and meaningful performance feedback for the 
Quality Payment Program beginning July 1, 2018.
    We note, however, that we expect to provide the 2016 annual QRUR in 
early fall 2017 that will show how groups and solo practitioners 
performed in 2016 on the quality and cost measures used to calculate 
the 2018 VM, as well as their 2018 VM payment adjustment. The 2016 
annual QRUR will be the last annual QRUR provided to groups and solo 
practitioners, as the VM program is sunsetting. We believe the 2016 
annual QRUR is important to provide ongoing feedback to clinicians and 
groups to support their successful transition to the Quality Payment 
Program.
    Further we note that in the next performance feedback, we intend to 
provide performance feedback for MIPS data collected in 2017. This data 
could potentially include all applicable data reflecting CY 2017 
performance, including data on the quality and cost performance 
categories; as well as, data regarding the final score and payment 
adjustment. This reflects our commitment to providing as timely 
information as possible to eligible clinicians in order to help them 
predict their performance in MIPS. CMS intends for this performance 
feedback to be available in the new format for the 2017 performance 
period by summer 2018, after the 2017 reporting closes.

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For updates and more information, please see 
QualityPaymentProgram.cms.gov.
    In addition, we solicited 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. We also solicited comments on including the final score in 
performance feedback as the program evolves. The following is a summary 
of the comments we received.
    Comment: Some commenters encouraged CMS to provide information on 
its performance feedback on first year MIPS measures, so that eligible 
clinicians can determine their performance on these measures before 
they are scored on them. The commenter stated that whether or not 
feedback on first year QCDR measures should be reported may have to 
take into consideration such factors as the number of clinicians 
reporting on a measure and other concerns, and should be resolved in 
conjunction with the QCDR sponsor. Another commenter noted that while 
CMS may be unsure how to analyze first year measures, it is important 
for CMS to provide as much data as possible in the performance 
feedback, as long as such data are not shared publically or used to 
evaluate performance.
    Response: We understand the rationale that by providing first year 
measures in performance feedback, MIPS eligible clinicians may get a 
better sense of how they are performing on those measures. We need to 
review the data from the first year measures before these data are 
incorporated into performance feedback, as we want to ensure the data 
we are providing in the performance feedback is useful and actionable 
for our stakeholders. After reviewing data submitted for the first MIPS 
performance period and working with stakeholders on user experience 
testing, we will consider including first year measures in the 
performance feedback.
    For detailed information regarding first year measures and public 
reporting on Physician Compare, we refer commenters to section II.E.10. 
of this final rule with comment period.
    Comment: One commenter believes that CMS should provide feedback 
every 45 days instead of every 6 months in regard to negative, zero, or 
positive MIPS payment adjustment status.
    Response: As noted in the proposed rule (81 FR 28277), regarding 
the MIPS final score, 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 final score and each of the four performance categories in 
future performance feedback once MIPS data becomes available. We note 
that we have not committed to providing feedback every 6 months, though 
we are working to increase the frequency of feedback we can provide.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
(b) MIPS APM Entities
    In the proposed rule, we proposed that MIPS eligible clinicians who 
participate in MIPS APM Entities would receive performance feedback, as 
technically feasible (81 FR 28247). A summary of comments on those 
proposals can be found in section II.E.5.h.(16) of this final rule with 
comment period.
(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. For any 
other performance category (that is, cost, improvement activities, 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 clinicians of the 
availability of their PQRS feedback reports and QRURs, respectively, 
through the CMS portal. However, many health care clinicians are still 
unaware of these reports and/or have difficulty accessing their reports 
in the portal. Further, we are aware that some health care clinicians 
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 proposed to initially make 
performance feedback available using a CMS designated system, such as a 
web-based portal; and if technically feasible perhaps an interactive 
dashboard. As further discussed in the proposed rule (81 FR 28280), we 
also proposed 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 cost, advancing care information and 
improvement activities performance categories. We solicited 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 proposed 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 
solicited comment on additional means that could be used to notify or 
contact MIPS eligible clinicians and groups

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when their performance feedback is available.
    The following is a summary of the comments we received regarding 
our proposal to provide performance feedback through a CMS designated 
system (such as a web-based portal or interactive dashboard), and 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.
    Comment: Commenters stated the feedback should be easy/clear to 
understand and easy to access, with helpful education and outreach. 
Some commenters suggested the process to access feedback should be 
streamlined and less complicated.
    Many commenters recommended an interactive web-based dashboard for 
feedback delivery that provides data in real-time to eligible 
clinicians, at least on a quarterly basis. Some commenters recommended 
the display of such a dashboard show performance feedback through 
graphics. A few commenters recommended to not implement performance 
feedback for the quality and cost performance categories until CMS has 
had a chance to bring online a web portal where MIPS eligible 
clinicians can log in and see their final score. The commenters 
explained that without understanding how they are scoring versus their 
peers under MIPS, many may fall inadvertently to the bottom of the 
quality or cost performance categories.
    One commenter recommended that CMS work with health IT vendors to 
develop a real-time feedback dashboard that can be incorporated into 
health IT products, such as EHRs, as eligible clinicians will not know 
where they are relative to the performance threshold on an annual basis 
until after the close of the performance period. While another 
commenter recommended that, to the extent it is feasible, CMS consider 
partnering with registry vendors to integrate reports in registry 
interfaces, enabling those eligible clinicians reporting via an EHR or 
QCDR to view performance feedback in a dashboard setting that is 
familiar to them.
    Some commenters suggested that CMS create an electronic interactive 
tool for eligible clinicians to quickly gauge their progress by 
calculating scores, which can help eligible clinicians identify 
measures that are applicable to their practice. Another commenter noted 
that an important aspect for clinicians and groups in small, rural and 
underserved areas are intuitive tools to easily calculate their MIPS 
score, whether this tool is embedded within the health IT vendor, 
registry, or available on the CMS Web site. The commenter also stated 
that this must be a robust tool which would allow clinicians and groups 
the ability to securely visualize external data such as aggregate 
claims data used to calculate episode measures.
    One commenter recommended performance feedback be available online 
and in a timely fashion, ideally in the way that the same information 
would be available to the public, but well in advance of publication. 
One commenter suggested CMS leverage the My Quality Net Web site to 
provide performance feedback to clinicians, since hospitals and other 
clinicians are already accustomed to using it for federal quality 
reporting programs.
    Another commenter recommended that CMS create a clinician portal 
that will allow eligible clinicians and other clinicians to estimate 
their payment adjustment.
    Some commenters requested that performance feedback provide the 
ability to drill down for use by individual physicians.
    Response: We agree performance feedback should be clear, easy to 
understand, and provided to eligible clinicians in a user-friendly 
format (for example, web-based interactive dashboard). In the future, 
we intend to provide functionality for an interactive experience for 
performance feedback. As we build the web-based application for 
performance feedback, we will continue working with stakeholders (for 
example, as part of usability testing) to ensure the user experience is 
accounted for when building this system. If technically feasible, we 
will work toward incorporating a means to drill down by individual 
clinicians for performance feedback. We will take all of these 
commenters' recommendations into consideration as we develop 
performance feedback mechanisms. While we cannot speak to the plans of 
health IT vendors, registries, or other third party intermediaries; we 
expect to continue working with them, as well as clinicians, specialty 
organizations, and other stakeholders to promote continued growth in 
the availability of timely, easy-to-use performance feedback for 
clinicians through these mechanisms in complement to the feedback that 
will be available from CMS. Further, since we have not required advance 
registration for reporting, we note that participation in MIPS will be 
at the level at which data is submitted to CMS. Thus, if individual 
data is submitted, feedback will be on the individual level; if group 
data is submitted, feedback will be at the group level.
    Comment: Some commenters suggested a process be included for 
physicians to request and implement revisions when performance feedback 
data are incorrect. Another commenter suggested being allowed to 
resubmit claims that were incorrectly submitted, as by the time 
feedback was provided historically in the PQRS and VM programs it was 
too late and the practice was subject to downward adjustments to 
payments.
    Response: We intend to build in a process for updates/revisions 
needed for performance feedback, which would be separate from the 
targeted review process as described in further detail in section 
II.E.8.c. of this final rule with comment period. We note that as 
described in section II.E.5. of this rule we do not have the ability to 
allow for claims to be resubmitted only for the reason of appending a 
quality data code.
    Comment: One commenter recognized that while the goal is to provide 
quarterly performance feedback, the feedback might not be issued until 
the first half of a year because historically in the PQRS program most 
registries do not open or accept data submission until the second 
quarter of the performance period.
    Another commenter agreed with utilizing vendors, such as 
registries, to communicate performance feedback in real-time so that 
performance can be monitored at any time. While another commenter 
recommended that CMS continue to evaluate and work with vendors to 
determine how health IT vendors and QCDRs can be leveraged to provide 
more ongoing performance feedback to clinicians, as the goal being an 
agile method of analyzing performance without manual entry or mistake. 
One commenter requested that CMS leverage advanced electronic reporting 
mechanisms to reduce the long feedback turnaround time in claims-based 
systems and to provide performance data on improvement activities and 
advancing care information in addition to quality and cost.
    One commenter recommended that CMS provide third party 
intermediaries access to clinician performance feedback for the 
clinicians for whom they are submitting information for in order to 
allow third party intermediaries to validate and troubleshoot any 
issues with the data.
    One commenter suggested that CMS allow clinicians to elect to 
receive their performance feedback through a Regional Healthcare 
Innovative Collaborative (RHIC) that are able to provide a multi-payer 
perspective.

[[Page 77349]]

    Response: In future years of the program, we plan to leverage 
additional pathways such as collaborative efforts with health IT 
vendors, registries, and QCDRs to help disseminate data/information 
contained in the performance feedback to eligible clinicians, where 
applicable. We will look to increase feedback to third party 
intermediaries in the Quality Payment Program; and will continue 
working with stakeholders as we move toward implementing this 
functionality. We also direct these commenters to the third party data 
submission section (II.E.9.) of this final rule with comment period.
    Comment: Some commenters suggested individual eligible clinicians 
should be able to access their performance feedback independently, 
instead of having to access through a group. One commenter suggested 
performance feedback also be available to practice administrators (to 
view all NPIs at the TIN level, as opposed to each individual eligible 
clinician) and related staff. Some commenters suggested that the 
performance feedback also be available to practice staff designated by 
the eligible clinician. Some commenters believed that the EIDM process 
to access performance feedback should be re-evaluated, noting practices 
of all sizes (solo and 2+ for eligible clinicians) only should need one 
EIDM account to view performance feedback, as well as, be allowed to 
submit data for the practice. Another commenter requested that CMS make 
the log-in process for accessing performance feedback more user-
friendly; as currently it is overly complicated with cumbersome 
password requirements that reset at short intervals; which limit access 
to the current PQRS feedback reports and QRURs.
    One commenter agreed with offering clinicians the option to receive 
performance feedback through one channel, and requested that CMS make 
this a priority for future performance feedback years. The commenter 
also recommended that as part of this initiative, CMS work with 
stakeholders toward creating a channel for eligible clinicians to view 
their performance on both quality and cost measures across all (or 
multiple) payers. The commenter also noted that it is critical for 
eligible clinicians to have access to a resource that provides them 
with a complete picture of their practice across all payers.
    Other commenters stated that many clinicians are unaware of the 
current QRURs or have had trouble accessing them, noting difficulty 
with the login process which they believed was being unnecessarily 
complicated, not always clear who has access, and those that have 
access are not usually front-line clinicians. The commenter strongly 
encouraged CMS to push performance feedback out to clinicians as 
opposed to waiting for clinicians to access the feedback.
    Response: We agree the process to access performance feedback 
should be easy and streamlined. While we have taken steps to streamline 
the current PQRS feedback reports and QRURs, more could be done. We 
intend for MIPS eligible clinicians to be able to access their 
performance feedback independently through a web-based application. 
Since performance feedback will contain secure data, we recognize the 
need to balance access with maintaining security. We intend to continue 
the efforts made under the VM program, to engage physicians and 
encourage and assist them to access their performance feedback. We will 
take the comments into account and continue working with stakeholders 
as we build the CMS designated system for performance feedback.
    Comment: One commenter requested that performance feedback data be 
provided without charge.
    Response: As is done currently with the PQRS feedback reports and 
QRURs, performance feedback will also be provided through a CMS 
designated system, with no charge to the eligible clinician.
    After consideration of the comments we are finalizing these polices 
as proposed. In future years of the program, performance feedback will 
continue to be available through a CMS designated system, which we 
intend to be a web-based application. The intent is that in the next 
performance feedback, anticipated to be released around July 1, 2018, 
this feedback will be the first in the anticipated new dashboard 
format. It will be provided via the new Quality Payment Program portal 
and we intend 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. As we have stated previously, we will continue to engage in 
user research with front-line clinicians to ensure we are providing the 
performance feedback data in a user-friendly format, and that we are 
including the data most relevant to clinicians. For updates and more 
information, please see QualityPaymentProgram.cms.gov.
    Additionally, we did not receive comments on our proposal 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. Therefore, we are finalizing this 
policy as proposed.
    We also sought comment for future rulemaking on coordinating with 
third party intermediaries such as health IT vendors and QCDRs as MIPS 
evolves to enable additional feedback to be sent on the cost, advancing 
care information and improvement activities performance categories. We 
did not receive comments on additional feedback that could be sent 
through third party intermediaries. We plan to work with third party 
intermediaries as we continue to develop the mechanisms for performance 
feedback, to see where we may be able to develop and implement 
efficiencies for the Quality Payment Program. Any regulatory changes 
would be made through future notice-and-comment rulemaking.
(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 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.
    We did not request comments in this section, but did receive a 
comment which is summarized below.
    Comment: One commenter believes that if CMS is able to make 
``illustrative calculations'' in advance of a performance year, then 
CMS should be able to provide eligible clinicians with performance 
feedback quarterly in advance of the performance year for all four 
performance categories.
    Response: As we noted in the proposed rule (81 FR 28277-28278), we 
believe ``illustrative calculations'' means an interim, snap shot in 
time of performance, or perhaps a ``dry-run'' of

[[Page 77350]]

the data including measure rates, based on historical data available. 
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 us 
until actual data for MIPS is available. Also, as noted previously in 
this section of this final rule with comment period the goal is to 
provide future performance feedback on a quarterly basis, and once 
technically feasible to include all four performance categories in the 
performance feedback.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
(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) 
(FOIA).
    We did not request comments in this section, but we received the 
following comment:
    Comment: One commenter expressed support for the disclosure 
exemption for MIPS performance feedback under the Freedom of 
Information Act.
    Response: As noted in the proposed rule (81 FR 28278), section 
1848(q)(12)(A)(iv) of the Act provides that feedback made available 
under section 1848(q)(12)(A) of the Act shall be exempt from disclosure 
under FOIA.
(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 MIPS eligible clinicians can 
send their feedback (that is, if they are experiencing issues accessing 
their data, technical questions about their data, etc.) to us. We 
appreciate that MIPS eligible clinicians may have questions regarding 
the information contained in their performance feedback. To assist MIPS 
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 solicited comment on the types of information 
eligible clinicians would like to send to us via this mechanism.
    The following is a summary of the comments we received.
    Comment: Some commenters recommended a prompt and transparent 
notification process when errors or inconsistencies are identified on 
the performance feedback so that errors can be remedied or targeted 
review requests may occur in a timely manner. Another commenter 
suggested that a mechanism would be created for eligible clinicians to 
receive comprehensive periodic feedback or updates from CMS as to how 
they are performing before each performance period ends.
    Other commenters requested that CMS guarantee firm turnaround times 
for performance feedback, and offer teleconferences to work with 
eligible clinicians in reviewing the patient data. While some 
commenters urged CMS to devote the necessary resources, including 
staff, to help clinicians and administrators interpret the performance 
feedback (for example, helpdesk).
    One commenter recommended that CMS provide technical assistance to 
eligible clinicians to help understand performance feedback (for 
example, more practical and specific tips in the help documents for 
education and outreach, especially as this is a new program).
    Response: We appreciate that MIPS eligible clinicians may have 
questions regarding the information contained in their performance 
feedback. To assist MIPS eligible clinicians, we intend to establish 
resources, such as the Quality Payment Program Service Center (for 
example, 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 web-based application. We also intend to 
explore the possibilities of adding a mechanism to receive information 
from eligible clinicians, to a web-based application. These suggestion 
will be taken into consideration for the future development of 
performance feedback.
    Comment: Some commenters suggested using the IHS/Tribal/Urban 
Indian list serve to notify MIPS eligible clinicians and groups when 
their performance feedback is available.
    Response: We agree and will implement this suggestion into the 
education and outreach planned for performance feedback.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
(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 solicited 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 these data (that is, eligible clinicians sharing data). 
We also solicited comment as to whether additional information 
regarding beneficiaries attributed to a MIPS eligible clinician under 
the cost 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.
    The following is a summary of the comments we received.
    Comment: Some commenters suggested performance feedback should 
include patient-level data in order to aid eligible clinicians to 
improve quality and cost. One commenter stated it would be easier to 
provide timely performance feedback to eligible clinicians if smaller 
statistically relevant sample sizes were reported instead of all 
Medicare patient data.

[[Page 77351]]

    Response: As stated above, section 1848(q)(12)(B) of the Act does 
require patient information to be made available to MIPS eligible 
clinicians starting July 1, 2018. These suggestions will be taken into 
consideration as we implement this provision through future rulemaking.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
(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 solicited comment on the fields that should be included in the 
performance feedback template for MIPS eligible clinicians. The 
following is a summary of the comments we received.
    Comment: Some commenters supported the idea of a standardized 
performance feedback template, and encouraged CMS to engage with 
stakeholders and non-physician practitioners to obtain feedback about 
the template. One commenter suggested that CMS should consider a number 
of mechanisms to receive input from stakeholders and provide 
opportunities to learn about the performance feedback tools in 
development--for example, the Agency should consider hosting Open Door 
Forums (ODFs), and ensuring that detailed, comprehensive instructional 
materials are easily available online. One commenter suggested CMS 
revisit the MIPS LEAN Design Team materials from the CMS Quality Summit 
in December 2015. Commenters also suggested that CMS should include 
clear disclaimers about the limitations of the data.
    One commenter suggested that other information could be used in 
performance feedback by providing data on alternatives to the items or 
services provided that would have been more cost effective while 
delivering the same quality of care. Some commenters requested that CMS 
provide individual eligible clinician and group performance feedback in 
order to help eligible clinicians determine whether to continue 
reporting with the group or change to individual reporting.
    Another commenter recommended that performance feedback include 
improved transparency, and additional data points for each reported 
measure. One commenter recommended that the performance feedback would 
show both scoring and decile placement for individual eligible 
clinicians across the areas scored. One commenter believes that all 
reported measures should be included in performance feedback, and every 
field that contributed to the score should be included as well. Some 
commenters suggested performance feedback include data fields that 
would assist with identification of patients served, costs, outcomes, 
where and what type of care was provided, quality of care for patients, 
and care coordination activities and needs; and functionality to 
compare (for example, regionally and nationally) directly against other 
eligible clinicians. One commenter suggested more relevant non-patient 
facing specialties be included in performance feedback.
    Some commenters suggested performance feedback include the place of 
service (POS) codes, geography (including state and Medicare locality), 
health system NPI, the subpart NPI where the services were delivered, 
and the NPI of the entity receiving assignment for professional 
services; as well as the ability to include additional identifiers if 
needed in the future to account for specialties. While another 
commenter recommended performance feedback include information for 
suggested areas where the eligible clinician can improve, which 
promotes quality and helps eligible clinicians avoid penalties. Other 
commenters recommended that the cause for a penalty be clearly 
articulated.
    Some commenters suggested performance feedback include as much data 
as possible as long as it is easy to understand, and recommended 
options for the format of performance feedback. Some commenters 
recommended a basic report containing the following information: 
performance threshold to date, where the clinician stands in 
performance, current possible payment adjustments (with exact reasoning 
for negative payment adjustment in order to improve for future 
reporting), and a roadmap to improve performance and avoid a downward 
adjustment. Some commenters recommended CMS use one comprehensive 
document for the MIPS performance feedback. Some commenters suggested a 
second report be included in the performance feedback on a more 
granular level, and contain MIPS specific components. Commenters also 
suggested that CMS put certain data in supplemental materials (for 
example, advancing care information) or appendices so that it does not 
detract from the main report for performance feedback.
    One commenter suggested that CMS issue an advancing care 
information experience report similar to the annual PQRS Experience 
Report with as much information as possible, including reporting 
experiences by specialty. The commenter noted that CMS could include 
information on whether each objective was met/not met for the base 
score; performance data on the objectives being assessed for the 
performance score; and whether an eligible clinician or group earned 
bonus points for each measure reported under the Public Health and 
Clinical Data Registry Reporting objective other than the Immunization 
Registry Reporting measure. Another commenter recommended that feedback 
for the advancing care information category include the objectives in 
which the practice attested for the previous reporting period and the 
points attributed to those objectives for purposes of calculating the 
composite score.
    A commenter recommended that CMS provide aggregate information by 
specialty to medical societies, as specialty societies do not have 
access to QRUR information at the individual clinician level or in 
aggregate, so they cannot provide meaningful analysis of current cost 
measures and assistance to clinician members. Another commenter 
requested that CMS provide additional data to support performance 
improvement efforts, because while the QRUR provides some ability to 
drill down into the data, the reports only provide patient-level 
expenditure data at the aggregate level compared to national 
benchmarks. While another commenter noted that performance feedback 
should include sufficient details on what patients and care have been 
attributed to the clinician and what other clinicians have partnered in 
that care.
    One commenter requested detailed performance feedback highlighting 
options for improvement activities, discussing incorrect reporting, and 
include geographical components to allow eligible clinicians to review 
geographical variations in care processes to acclimate eligible 
clinicians to this new reporting category. Another commenter 
recommended that

[[Page 77352]]

performance feedback for improvement activities categories be provided 
as soon as possible, and that the feedback from CMS should confirm that 
eligible clinicians have met the requirement by using a nationally 
accredited, certified patient-centered medical home or the degree to 
which they have met the improvement activities requirement through 
high- and medium-weighted improvement activities. One commenter 
believed that for improvement activities performance feedback, CMS 
could include information on how many and which activities were 
completed; the method of data submission used to submit improvement 
activities information; and, in the future, information on improvement 
relative to prior years. In addition, the commenter suggested that CMS 
should provide cumulative data about which improvement activities are 
being reported across MIPS as well as within each specialty 
designation. Another commenter recommended that electing to receive the 
performance feedback should also count as an improvement activity.
    Some commenters suggested that CMS should make available 
performance feedback to eligible clinicians on their high-utilization 
patients in as close to real time as possible or provide practices with 
reports similar to the Hospital Readmission Reductions Program. Another 
commenter requested that CMS provide files to clinician practices 
similar to what are provided to hospitals for the Medicare Spend Per 
Beneficiary measure that is part of Hospital Value-Based Purchasing.
    Some commenters suggested that performance feedback be available 
via paper reports. Another commenter suggested that performance 
feedback be provided in an importable form such as a worksheet as 
opposed to a PDF file, which would allow the eligible clinician more 
options when reviewing with other tools already in use by the eligible 
clinician. While other commenters noted performance feedback should be 
provided in a format that allows eligible clinicians to sort, analyze, 
and review.
    Response: We agree with commenters about continually improving the 
usability of performance feedback, and will continue doing stakeholder 
outreach with the goal that the template for performance feedback will 
be available in a usable and user-friendly format, and different 
options are considered before the performance feedback is displayed in 
a web-based application to MIPS eligible clinicians. We will work with 
stakeholders to consider the best means for providing improvement 
activities and advancing care information in future performance 
feedback.
    We intend to do as much as we can of the development of the 
template for performance feedback by working with the stakeholder 
community in a transparent manner. We think this will both encourage 
stakeholder commentary and make sure we end up with the best possible 
format(s) for feedback. CMS intends for this performance feedback to be 
available in the new format on the 2017 performance period by summer 
2018, after the 2017 reporting closes.
    We have considered the comments received and will take them into 
consideration in the future development of performance feedback through 
separate notice-and-comment rulemaking.
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 payment 
adjustment factor (and, as applicable, the additional MIPS payment 
adjustment factor) applicable to the MIPS 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 proposed to include the MIPS payment 
adjustment factor and, as applicable, the additional MIPS payment 
adjustment factor (collectively referred to as the ``MIPS payment 
adjustment factors'') 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 proposed to make it available through another mechanism as 
determined appropriate by the Secretary (such as a portal or a CMS 
designated Web site) and solicited comment on mechanisms that might be 
appropriate. The first announcement will be available no later than 
December 1, 2018 to meet statutory requirements. We requested comment 
on these proposals.
    The following is summary of the comments we received regarding our 
proposal to include the MIPS payment adjustment factors in the 
performance feedback, if technically feasible.
    Comment: One commenter suggested that performance feedback should 
include a potential MIPS payment adjustment factor based on current 
performance or alternatively a tool to run ``what if'' scenarios 
regarding the clinician's adjustment.
    Response: If technically feasible, we proposed (81 FR 28164) to 
include the MIPS payment adjustment factors in the performance feedback 
for eligible clinicians. We appreciate these suggestions, and we will 
take this into consideration in the development of performance 
feedback.
    Comment: A few commenters expressed concern that 30 days would not 
be enough time to respond to the announcement of the result of 
adjustments. One commenter requested a minimum of 90 days instead, 
while other comments suggested a 120 day notice to allow clinicians the 
ability to plan financially.
    Response: We agree with the commenters and would like to publish 
this information as early as possible to allow clinicians more time to 
review and understand the adjustments that will be applied to their 
payments. We will take this into consideration as we plan for the first 
announcement, which will be available no later than December 1, 2018 to 
meet statutory requirements.
    Comment: One commenter recommended that CMS notify clinicians as 
soon as feasible regarding payment adjustments to allow practices to 
prepare for downward adjustments to payments. Commenter recommended 
that CMS consider providing the adjustment results via letter and 
through the performance feedback if possible, especially in the 
beginning years of the program.
    Response: As noted in the proposed rule (81 FR 28278), the first 
announcement will be available no later than December 1, 2018 to meet 
statutory requirements. We will take these suggestions into 
consideration as we prepare for the first announcement for the 
adjustment factors.
    After consideration of the comments we are finalizing the policy as 
proposed that if technically feasible we will include the MIPS payment 
adjustment factors in the performance feedback. If it is not 
technically feasible to include the MIPS payment adjustment factors in 
the performance feedback, we will notify MIPS eligible clinicians 
through guidance documents or other program communication channels as 
to when and how this information will be announced prior to the 
statutory deadline of December 1, 2018. As discussed above, in future 
years of the program, performance feedback will be available via a CMS 
designated system, which we intend to be a web-based application. We 
also anticipate the announcement of the adjustment factors will be 
available via a web-based

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application as well. Additionally, please see section II.E.8.c. for 
final polices for requesting a targeted review.
c. Targeted Review
    Section 1848(q)(13)(A) of the Act requires the establishment of a 
process under which a MIPS eligible clinician or group may seek an 
informal review of the calculation of the MIPS payment adjustment 
factor (or factors) applicable to such MIPS eligible clinician or group 
for a year.
    We recognize that a principled approach to requesting and 
conducting a targeted review is required under the MACRA to minimize 
burdens on MIPS eligible clinicians or groups and ensure transparency 
under MIPS. We also believe it is important to retain the flexibility 
to modify MIPS eligible clinicians' or groups' final score or MIPS 
payment adjustment based on the results of targeted review. This will 
lend confidence to the determination of the final score and MIPS 
payment adjustments, as well as, providing finality for the MIPS 
eligible clinician or group after the targeted review is completed. It 
will also minimize the need for claims reprocessing. We proposed 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 proposed 
at Sec.  414.1385 to adopt a targeted review process under MIPS wherein 
a MIPS eligible clinician or group may request we review the 
calculation of the MIPS payment adjustment factor under section 
1848(q)(6)(A) of the Act and, as applicable, the calculation of the 
additional MIPS payment adjustment factor under section 1848(q)(6)(C) 
of the Act applicable to such MIPS eligible clinician or group for a 
year. Because this review will be limited to the calculation of the 
MIPS payment adjustment factor and, as applicable, the additional MIPS 
payment adjustment factor, we anticipate we may find it necessary to 
review data related to the measures and activities and the calculation 
of the final score according to the defined methodology. The following 
are examples of circumstances under which a MIPS eligible clinician or 
group may wish to request a targeted review. This is not a 
comprehensive list of circumstances:
     The MIPS eligible clinician or group believes that 
measures or activities submitted to us during the submission period and 
used in the calculations of the final score 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 or group believes that there 
are certain errors made by us, such as performance category scores were 
wrongly assigned to the MIPS eligible clinician or group (for example, 
the MIPS eligible clinician or group 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 or groups 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 Quality 
Payment Program Service Center (referred to as the ``help desk'' in the 
proposed rule) support mechanism as is provided for MIPS as a whole.
    We further proposed at Sec.  414.1385 to adopt the following 
general process for targeted reviews under section 1848(q)(13)(A):
     A MIPS eligible clinician or group 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 or group) 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 or group 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 or group, the supporting information must be 
received from the MIPS eligible clinician or group 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 final score (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 requested comments on these proposals.
    The following is summary of the comments we received regarding our 
proposals for a targeted review process.
    Comment: Several commenters supported the inclusion of a targeted 
review process for MIPS eligible clinicians and groups who believe that 
CMS has assigned them an incorrect final score or MIPS payment 
adjustment. Another commenter believed that it is critical that MIPS 
eligible clinicians have a means to request a review of their MIPS 
payment adjustment factor. The commenter suggested that CMS put into 
place a process that is physician friendly and does not automatically 
assume that the physician is incorrect.
    Response: We agree with the commenters that the process should be 
``physician friendly.'' To accomplish this, we have worked to make our 
process for submitting a targeted review simple and not overly 
burdensome on the MIPS eligible clinician and groups or their 
practices. The request for a targeted review will be based on the MIPS 
eligible clinician's or group's MIPS payment adjustment factor(s) for a 
year. We recommend that MIPS eligible clinicians and groups review this 
information prior to submitting a request for targeted review. For CMS 
to perform a full review, supporting documentation from the MIPS 
eligible clinician or group demonstrating why they believe their MIPS 
payment adjustment factor(s) is inaccurate is critical.
    Comment: A few commenters requested that CMS provide a mechanism 
where a MIPS eligible

[[Page 77354]]

clinician or group can contest a negative MIPS payment adjustment if 
the MIPS eligible clinician believes he or she was inappropriately 
scored under any given MIPS performance category.
    Response: We agree with the commenter and note that for instances 
where a MIPS eligible clinician believes the underlying data used to 
calculate a performance category score is inaccurate due to data 
quality or calculation errors, a targeted review may be requested. MIPS 
eligible clinicians and groups may submit a request for targeted review 
if they believe their negative MIPS payment adjustment factor for a 
year is inaccurate.
    Comment: A few commenters requested that CMS establish a meaningful 
review and appeals processes. One commenter noted that the proposed 
targeted review process does not include a hearing or an opportunity 
for reconsideration.
    Response: We agree and believe the targeted review process we 
proposed and are finalizing would allow for meaningful review. We note 
however that section 1848(q)(13)(A) of the Act describes the review 
process as ``targeted'' and ``informal,'' and on that basis, we do not 
believe a hearing or a second level of review/appeals process is 
warranted; therefore all decisions under the targeted review process 
will be final.
    Comment: A few commenters proposed that CMS should establish an 
appeals process through which MIPS eligible clinicians or groups can 
challenge measures' applicability if the MIPS eligible clinician or 
group does not agree that the measures identified by CMS as being 
applicable to their practice are appropriate.
    Response: We intend to provide detailed performance feedback to the 
MIPS eligible clinicians or groups that will identify which measures 
were calculated as part of their final score, as well as which measures 
were calculated for informational purposes only. We do not anticipate 
that MIPS eligible clinicians or groups would have their final score 
derived based on measures that were not applicable to them, however in 
circumstances where, after reviewing the feedback provided, if the MIPS 
eligible clinician or group believes there is an error made by CMS they 
may file a targeted review request. We refer the commenter to the 
performance feedback section at section II.E.8.a. of this final rule 
with comment period, and the MIPS final score methodology in section 
II.E.6. of this final rule with comment period for more information 
related to our final policies.
    Comment: One commenter requested an improved targeted review 
process under MIPS as compared to the current informal review processes 
under PQRS. The commenter also noted that the communication from CMS 
notifying clinicians and practices of their payment adjustments under 
PQRS has been vague and needs to be customized to each MIPS eligible 
clinician and group. The commenter recommended that notifications 
informing MIPS eligible clinicians and groups of a MIPS payment 
adjustment or low final score should also contain information on the 
reason for the determination. Another commenter requested that CMS work 
with stakeholders to identify ways to improve the timeliness of the 
review process by automating processes, providing additional guidance, 
and seeking additional resources if necessary.
    One commenter stated that clinician experiences with the informal 
review processes in PQRS and the physician value-based payment modifier 
have been frustrating. Further, it has been difficult to understand why 
requests for review were denied. The commenter suggested that CMS 
create a transparent, effective review process.
    Response: We agree with the commenters that to the fullest extent 
possible the communications to MIPS eligible clinicians or groups 
should be customized to each MIPS eligible clinician or group wherever 
possible. We also agree that the targeted review process should be as 
streamlined and automated as possible. We do note however that all 
targeted review determinations will be made on a case by case basis, 
which significantly limits the potential automation of the process. We 
appreciate the recommendation for improvements to the targeted review 
process and will take the recommendations into consideration as we 
further develop the targeted review processes.
    Additionally, we regret the frustrations stakeholders have had 
under the PQRS and VM informal review processes. Under those processes, 
we provided reasons for our decisions about the requests for informal 
review we received. Under the MIPS targeted review process, we intend 
to continue to provide MIPS eligible clinicians or groups with our 
reasons for granting or denying a request for review, and we will make 
an effort to provide additional clarifications of our reasons, if 
needed.
    Comment: One commenter noted that improvements in Quality Payment 
Program Service Center support must be made for high quality support. 
The commenter stated that under PQRS the Help Desk was responsive; 
however, often times they could not provide comprehensive information 
as they had limited data available. Commenters also requested that CMS 
adequately staff the Quality Payment Program Service Center during the 
review period to respond to questions and direct MIPS eligible 
clinicians and groups through the process. Another commenter requested 
providing a mechanism other than calling the Quality Payment Program 
Service Center to obtain answers to potential targeted review questions 
in order to reduce the number of targeted reviews that will be filed.
    Response: We appreciate requests for improvements to the Quality 
Payment Program Service Center. We would also like to note that we will 
continuously review and implement improvements in the future, such as 
the commenters' recommendations for increases in staffing levels during 
surge periods such as the targeted review timeframe. In addition to 
contacting the Quality Payment Program Service Center, we anticipate 
that the Quality Payment Program Web site 
(QualityPaymentProgram.cms.gov) will allow MIPS eligible clinicians or 
groups to received additional information concerning their targeted 
reviews such as the ability to receive status updates. Lastly, in 
regard to other mechanisms available to obtain additional information, 
we would encourage the commenter to review all applicable information 
available on the Quality Payment Program Web site 
QualityPaymentProgram.cms.gov (for example, contact information for the 
Quality Payment Program Service Center, FAQs for targeted review, 
etc.), as well as join relevant education and outreach meetings, such 
as the National Provider Calls.
    Comment: Several commenters suggested that CMS increase the time 
period for MIPS eligible clinicians or groups to respond to CMS's or 
its contractors' requests for additional information. The commenters 
noted the current 10 calendar day proposal does not account for the 
time it takes to process such a request, understand the required 
actions, and gather requested supporting evidence. Further the 
commenters noted that it does not provide room for error and would 
result in a closed targeted review request. Several commenters 
suggested that CMS give MIPS eligible clinicians or groups at least 60 
days to respond to requests if CMS or its contractors request 
additional information from the MIPS eligible clinician. A few 
commenters recommended that CMS allow at least

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20 business days for submission of additional information. While 
another commenter requested CMS allow 30 business days to respond to 
requests for additional information. One commenter requested that 
exceptions be allowed where this timeline may not be feasible. The 
commenter acknowledged CMS may not be able to broaden these timelines 
for the first performance period if CMS implements a later start date, 
but requested that CMS consider if other program modifications--such as 
lowering the data submission thresholds, removing certain problematic 
measures, assessing the number of appeals, and streamlining program 
requirements--will help reduce the number of delays in processing 
requests for targeted review.
    Response: We note that when we refer to ``days,'' we generally mean 
``calendar days'' unless otherwise indicated. We appreciate the 
commenters' concerns and based on public comments received we will 
modify this timeframe from 10 days to 30 days. This response timeframe 
is designed to create open communication between us and the MIPS 
eligible clinician or group during the targeted review period, while 
ensuring that we receive all appropriate supporting documentation 
available to ensure a timely decision can be rendered. We would like to 
note that this 30 day timeframe for responding to requests for 
additional information from CMS is not intended for clarifying 
questions between CMS and the requestor, rather this response timeframe 
is for requests for additional supporting documentation such as copies 
of claims, supporting extracts from the MIPS eligible clinicians' EHR, 
etc. We also may grant extensions for responding to requests for 
additional information on a case by case basis if we believe there are 
extenuating circumstances.
    Comment: A few commenters asked for more information to be made 
available for the targeted review process. The commenters requested a 
timeframe in which CMS would complete these reviews. One commenter 
requested clarity on whether these reviews would be completed on a 
rolling basis, as requests were received, or whether all reviews would 
take place after the July 31 deadline. The commenters recommended the 
process for MIPS eligible clinicians or groups to dispute the MIPS 
final score attributed to them should be straightforward including a 
point of contact, rubric for reviewing performance, supporting 
documentation to facilitate reviews, estimated timeframes, and 
identification of the responsibilities of each party. Further, the 
commenters stated the burden on MIPS eligible clinicians or groups to 
collect and present the information needed to dispute a final score 
should be mitigated. Another commenter also suggested CMS explore 
multiple strategies for disseminating this information, including FAQs, 
flowcharts and dedicated Quality Payment Program Service Center 
personnel.
    Response: We appreciate the request for more information. Requests 
for targeted reviews will be processed on a first come first served 
basis as requests are received. We agree with the commenters that the 
process for filing a request for targeted review should be a 
straightforward process. We intend to publish additional materials such 
as timelines and toolkits to ease the burden on the targeted review 
process. Additional information on the targeted review process will be 
available at QualityPaymentProgram.cms.gov.
    Comment: One commenter recommended that MIPS eligible clinicians or 
groups have a formalized mechanism by which they can dispute erroneous 
information in areas such as reported data for measures, performance 
scores for MIPS categories, and the final score.
    Response: The targeted review process is the mechanism whereby MIPS 
eligible clinicians can request a review of their MIPS payment 
adjustment factor, and as applicable their additional MIPS payment 
adjustment factor. The MIPS payment adjustment factor is determined 
based on the final score, which includes the scores for each of the 
MIPS performance categories. Perceived errors related to the MIPS 
payment adjustment factor calculations can be addressed in the request 
for targeted review.
    Comment: A few commenters suggested that CMS provide a fair and 
transparent process for MIPS eligible clinicians or groups to appeal 
findings in performance feedback. One commenter noted that in general, 
the power is far greater for CMS to audit and potentially recover money 
than it is for a MIPS eligible clinician or group to seek an informal 
review. The commenter believed there should be a more equal power 
balance between CMS and MIPS eligible clinicians with regard to 
targeted review.
    Response: We refer readers to section II.E.8.a. of this final rule 
with comment period for information on policies we are finalizing in 
regard to performance feedback. We believe the relative performance 
that we provide through performance feedback will provide MIPS eligible 
clinicians the fair and transparent process and information they need 
to track performance and to learn about their quality and resource 
utilization performance. Our goal is to provide stakeholders with a 
fair and transparent process for requesting a targeted review. The 
Quality Payment Program Web site, QualityPaymentProgram.cms.gov, will 
allow MIPS eligible clinicians or groups to get additional information 
concerning their targeted reviews.
    Furthermore, we would like to note that for the MIPS, targeted 
review, data validation, and audits are separate and distinct 
processes. Request for targeted reviews are an optional process 
available to MIPS eligible clinicians and groups, and a request for 
targeted review has no bearing on the initiation of a data validation 
and audit request. Lastly, data validation and audit requests do not 
initiate targeted reviews.
    Comment: Commenters recommended CMS and its contractors coordinate 
with third party intermediaries when contacting MIPS eligible 
clinicians or groups for information under a targeted review. 
Commenters recommended that CMS continue to allow MIPS eligible 
clinicians and groups to submit information for informal review without 
the fear of an additional penalty by CMS or its contractors.
    Response: We agree with the commenters that if a MIPS eligible 
clinician or group uses a third party intermediary for data submission, 
the third party intermediary should be able to provide any necessary 
supporting documentation with the consent of the MIPS eligible 
clinician or group. We also would like to note that MIPS eligible 
clinicians or groups will not be penalized for filing a request for 
targeted review. Depending on the findings of the targeted review, it 
is possible that MIPS eligible clinicians' or groups' final score may 
be adjusted, which could potentially lead to a modification to their 
MIPS payment adjustment.
    Comment: One commenter requested that CMS clarify that a 
representative of a group may request a targeted review for the entire 
group and that reviews do not need to be evaluated at the MIPS eligible 
clinician or group level since MIPS eligible clinicians reporting under 
the MIPS group reporting option will have the same final score and 
adjustment factors.
    Response: We agree with the commenter. Authorized representatives 
of groups may file targeted reviews on behalf of their group members.
    Comment: One commenter requested that CMS, through the notice and 
comment rulemaking process, work with MIPS eligible clinicians or 
groups

[[Page 77356]]

to define what other circumstances would merit a targeted review.
    Response: In the proposed rule (81 FR 28279), we have provided 
examples of instances where a MIPS eligible clinician or groups may 
want to request a targeted review, but as we noted, it was not a 
comprehensive list of circumstances. We would encourage all MIPS 
eligible clinicians or groups who believe a targeted review of their 
MIPS payment adjustment factor or additional MIPS payment adjustment 
factor is warranted to submit a request for review.
    Comment: A few commenters requested that for the first few years of 
MIPS the scope of what would be considered an appropriate issue for 
targeted review should be broadened, and recommended that requests for 
targeted reviews should be approved for all MIPS eligible clinicians or 
groups who request them. Another commenter suggested that CMS should 
not have the ability to deny requests for targeted review.
    Response: Section 1848(q)(13)(A) of the Act constrains the scope of 
the targeted review process to the calculation of the MIPS payment 
adjustment factor and the additional MIPS payment adjustment factor. We 
will not broaden the scope of review beyond what is described in the 
statute. Additionally, we cannot automatically approve targeted review 
requests, we must review each request to make a decision based on the 
information received. We may also deny requests for targeted review if 
the request is duplicative of another request or if the request for 
targeted review is outside the statutory parameters or limitations 
mentioned in this rule.
    Comment: One commenter recommended that CMS provide MIPS eligible 
clinicians or groups who request a targeted review and are denied a 
justification for the denial. The commenter further recommended that 
there should be a second level of review for requests that are denied, 
and information regarding the number of reviews requested and the 
number of reviews that are granted each year should be made public.
    Response: If a request for review is denied, we intend to provide a 
reason for the denial in our communication to the MIPS eligible 
clinician or group who submitted the request. An example of why a 
request may be denied is if it is filed after the close of the targeted 
review period. Section 1848(q)(13)(A) of the Act describes the review 
process as ``targeted'' and ``informal,'' and on that basis, we do not 
believe a second level of review or an appeals process is warranted. 
Additionally, since this is a targeted 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.
    Additionally, we will continue to review the consideration to 
publically post information regarding the number of reviews requested 
and number of reviews that are granted each year.
    Comment: One commenter noted that while MIPS eligible clinicians or 
groups are able to request a targeted review of their MIPS reporting, 
it is entirely up to CMS's discretion as to whether such a request is 
granted. The commenter stated that this discretion should not be 
permitted, especially since, according to the proposed rule, if a MIPS 
eligible clinician or group is found to have submitted inaccurate data, 
CMS would reopen, revise, and recoup any resulting overpayment.
    Response: Section 1848(q)(13)(A) of the Act constrains the scope of 
targeted review to the calculation of the MIPS payment adjustment 
factor and the additional MIPS payment adjustment factor. We will not 
grant requests for review outside of the scope specified by the 
statute. As previously mentioned in this section of the final rule with 
comment, for the MIPS, targeted review, data validation, and audits are 
separate and distinct processes. We refer readers to sections II.E.8.e. 
and II.E.9.f. of this final rule with comment period for more 
information regarding data validation and audits and auditing of third 
party intermediaries submitting MIPS data, respectively.
    Comment: One commenter recommended that CMS adjust its appeals 
process for organizations that serve underserved populations.
    Response: We assume that the commenter is referring to the targeted 
review process and appreciate the recommendation to adjust the targeted 
review process for organizations that serve underserved populations. We 
also recognize that many of the MIPS eligible clinicians or groups who 
service these populations may have limited resources.
    Comment: Numerous commenters believe a formal appeals process is 
needed because an informal review process may not be protective enough 
to ensure MIPS eligible clinicians and groups have the opportunity to 
correct misinformation that may adversely impact their Medicare 
payments. One commenter noted that an appeals process is needed in 
situations where MIPS eligible clinicians or groups are unfavorably 
scored at no fault of their own. Another commenter requested that CMS 
institute a formal appeals process through which MIPS eligible 
clinicians can submit information to a contractor during a 30-day 
window. Commenters also recommended an appeals process with two levels 
of appeal, an expedited informal review and a final reconsideration. 
Commenters urged CMS to develop automated and streamlined appeals 
process.
    Response: We believe the targeted review process affords MIPS 
eligible clinicians a sufficient opportunity to identify errors related 
to the calculation of their MIPS payment adjustment factor. Section 
1848(q)(13)(A) of the Act describes the review process as ``targeted'' 
and ``informal,'' and on that basis, we do not believe a second level 
of review or an appeals process is warranted. Additionally, as noted 
previously we agree with the commenters that the MIPS targeted review 
process should be as streamlined and automated as possible. We do note 
however that all targeted review determinations will be made on a case 
by case basis, which significantly limits the potential automation of 
the process. Lastly, in regards to the commenters' request for two 
levels of review, while we can appreciate the advantages that a two-
level review process provides, we believe that the two-level review 
process would significantly delay the timing of decisions rendered to 
MIPS eligible clinicians.
    Comment: Several commenters requested clarification on the time 
period for informal review and receipt of scores. The commenters stated 
that 60 days is too short to review, understand, and test/audit the 
data. Some commenters noted that within 60 days after the close of the 
data submission period, most MIPS eligible clinicians will not know if 
they should request a review until they receive information about what 
their MIPS payment adjustment will be. Instead, the commenters 
recommended a minimum of 90 days after the close of the data submission 
period.
    Several commenters proposed that the timeframe to request a 
targeted review should be based on when the MIPS eligible clinician or 
group receives performance feedback and MIPS payment adjustment factors 
from CMS, not 60 days from the close of the data submission period. 
Another commenter suggested that most MIPS eligible clinicians or 
groups would prefer to request targeted reviews after performance 
feedback is released or at the beginning of a MIPS payment adjustment 
year. The commenter further suggested that CMS develop a timeline for 
targeted review that anticipates the

[[Page 77357]]

needs of MIPS eligible clinicians or groups.
    A few commenters noted that the 60-day deadline to submit a 
targeted review request may be inadequate, because MIPS eligible 
clinicians or groups may not have the data necessary to determine 
whether a targeted review is needed until performance feedback is 
received and analyzed. One commenter requested that MIPS eligible 
clinicians or groups get as much time as needed to submit to the 
targeted review process.
    Several commenters had concerns about the targeted review process 
timeline and urged CMS to allow for review requests on rolling basis 
from data submission deadline until a minimum 90 days after performance 
feedback and MIPS payment adjustment information is provided. Another 
commenter believed that CMS should allow MIPS eligible clinicians or 
groups at least 45 days to review its reports before requesting a 
targeted review. In addition, the commenter stated that CMS should 
allow test submissions in order for MIPS eligible clinicians or groups 
and third party intermediaries to identify any issues prior to final 
submission.
    Response: Based on numerous commenters' feedback we are modifying 
our proposed July 31st deadline for submission of a targeted review 
request. We are finalizing a 60-day period to submit a request for 
targeted review, which begins on the day CMS makes available the MIPS 
payment adjustment factor, and if applicable the additional MIPS 
payment adjustment factor, for the MIPS payment year and ends on 
September 30 of the year prior to the MIPS payment year or a later date 
specified by CMS. We agree with the commenters that prior to submitting 
a request for targeted review, MIPS eligible clinicians should have the 
opportunity to review their MIPS payment adjustment factor(s), their 
performance feedback, and make an informed decision about whether they 
want to request a targeted review. As noted prior, we intend to publish 
additional information such as timelines and toolkits on the targeted 
review process at QualityPaymentProgram.cms.gov.
    In regards to the request to allow for ``test submissions,'' as 
noted in section II.E.9. of this final rule with comment period, we 
intend to provide testing tools prior to the beginning of the 
submission process to reduce any data errors associated with data 
submissions.
    Comment: A few commenters stated that CMS should provide MIPS 
eligible clinicians or groups with two separate deadlines for informal 
review requests: an initial deadline whereby MIPS eligible clinicians 
can submit the request in time to have the error corrected before it 
affects payments, as well as a February 28th final deadline, which 
would both provide MIPS eligible clinicians or groups with an incentive 
to resolve a majority of payment issues in advance of claims 
processing, while still allowing MIPS eligible clinicians or groups 
adequate time to correct any inaccurate adjustments noticed in the 
first few payment periods of a new calendar year. Another commenter 
recommended that CMS give MIPS eligible clinicians or groups as much 
time as possible to submit targeted review requests since the 
adjustments will take time to understand and MIPS eligible clinicians 
or groups will simultaneously be working to report data for the 
subsequent performance period. Further, CMS should amend the informal 
review request forms to include fields that allow MIPS eligible 
clinicians to provide unique situational details, as well as upload 
supporting documentation. No requests for review should be rejected 
``automatically.'' Rather, CMS should consider all review requests on a 
case-by-case basis, taking into account the unique circumstances of 
each request. Finally, the agency should make the targeted review 
decisions in a much more transparent manner.
    Response: We appreciate the detailed suggestions for modifications 
to any request forms and will incorporate as feasible and appropriate. 
We do note however, that it is not feasible to allow for two targeted 
review periods, nor is it feasible to allow for the period to occur 
through February 28 of the MIPS payment year. We are required to begin 
adjusting MIPS eligible clinicians or groups' claims for items and 
services furnished beginning January 1 of the MIPS payment year and 
cannot hold claims processing, nor is it desirable to re-process a 
large volume of claims. If we were to have multiple reviews, it would 
mean significant amounts of claims re-processing for MIPS eligible 
clinicians and ultimately disrupts their practice and creates confusion 
to their patients. Rather, as discussed above, we believe that a 60-day 
period to request targeted review is sufficient. We also appreciate the 
recommendations to provide as much time as possible for MIPS eligible 
clinicians or groups submitting targeted review requests. We believe 
that the targeted review period of 60 days after the MIPS payment 
factors are available provides sufficient opportunities for MIPS 
eligible clinicians or groups to request a targeted review.
    Comment: Several commenters noted that MIPS eligible clinicians or 
groups should not be penalized due to data errors outside their 
control. Further, commenters stated that circumstances when third party 
intermediaries fail to successfully submit data completely or 
accurately need to be considered, and MIPS eligible clinicians should 
not be penalized. Commenters also stated, based on previous informal 
review processes, MIPS eligible clinicians or groups were unfairly 
penalized due to third party intermediary errors. Commenters urged 
consideration for a two-fold approach to allow groups and MIPS eligible 
clinicians, who in good faith tried to submit data but were 
unsuccessful due to third party intermediary issue, to participate in 
MIPS. The two-fold approach includes: (1) The ability to resubmit 
correct data within a reasonable timeframe with evidence of good faith 
attempt; and (2) if resubmission is not feasible, a hold harmless 
policy from any penalty. Another commenter suggested that MIPS eligible 
clinicians or groups should not be unfairly penalized due to inactions 
or errors of external parties, including third party intermediaries and 
CMS itself, and should have the right to file an informal review 
request for reasons beyond their control at any point throughout the 
payment year and be retroactively reimbursed for all improper 
adjustments.
    Response: We understand the concerns regarding third party 
intermediaries. As a general matter, the contractual agreement or other 
arrangement between a MIPS eligible clinician or groups and a third 
party intermediary is not within our control. We suggest that MIPS 
eligible clinicians or groups work with their third party 
intermediaries to ensure data is submitted timely and accurately. MIPS 
eligible clinicians or groups may be able to seek recourse against 
their third party intermediaries if significant issues or problems 
arise. We would like to note that at this time, we do not allow for 
resubmission of data. Rather, we use the original submitted data to 
evaluate a request for targeted review. We continue to express that 
MIPS eligible clinicians or groups are ultimately responsible for the 
data that are submitted by their third party intermediaries and expect 
that MIPS eligible clinicians or groups are ultimately holding their 
third party intermediaries accountable for accurate reporting. We will 
continue to explore the operational feasibility of allowing data 
resubmissions for subsequent years

[[Page 77358]]

of the MIPS through future notice and comment rulemaking.
    After consideration of the comments, we are finalizing policies as 
proposed, except for changes specifically discussed to reflect the 
modified policy for the submission deadline to request a targeted 
review from July 31 to September 30 of the year prior to the MIPS 
payment year or a later date specified by CMS, as well as the change 
for the timeframe whereby MIPS eligible clinician or group may submit 
additional information to assist in their targeted review at the time 
of request from 10 days to 30 days.
    Specifically, we are finalizing at Sec.  414.1385(a) that MIPS 
eligible clinicians or groups may request a targeted review of the 
calculation of the MIPS payment adjustment factor under section 
1848(q)(6)(A) of the Act and, as applicable, the calculation of the 
additional MIPS payment adjustment factor under section 1848(q)(6)(C) 
of the Act applicable to such MIPS eligible clinician or group for a 
year. The process for targeted reviews is:
    (1) MIPS eligible clinicians and groups have a 60-day period to 
submit a request for targeted review, which begins on the day CMS makes 
available the MIPS payment adjustment factor, and if applicable the 
additional MIPS payment adjustment factor, for the MIPS payment year 
and ends on September 30 of the year prior to the MIPS payment year or 
a later date specified by CMS.
    (2) CMS will respond to each request for targeted review timely 
submitted and determine whether a targeted review is warranted.
    (3) The MIPS eligible clinician or group may include additional 
information in support of their request for targeted review at the time 
the request is submitted. If CMS requests additional information from 
the MIPS eligible clinician or group, it must be provided and received 
by CMS within 30 days of the request. Non-responsiveness to the request 
for additional information may result in the closure of the targeted 
review request, although the MIPS eligible clinician or group may 
submit another request for targeted review before the deadline.
    (4) Decisions based on the targeted review are final, and there is 
no further review or appeal.
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 
payment adjustment factor and the amount of the additional MIPS payment 
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 the Physician Compare Internet Web site of the CMS; 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 proposed 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 requested but did not 
receive any comments on this proposal.
    Therefore, we are finalizing Sec.  414.1385 as proposed.
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 CEHRT, 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 proposed certain requirements for MIPS eligible 
clinicians and groups submitting data for the 2017 performance period 
(see section II.E.4. of the proposed rule) under MIPS. Further, we 
proposed 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 
us or our designated entity within 10 business days or an alternate 
timeframe that is agreed to by us 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 us.
     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 non-Medicare beneficiaries where applicable.
    We proposed 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 proposed that we would reopen, 
revise, and recoup any resulting overpayments in accordance with the 
rules set forth at Sec. Sec.  405.980 (re-opening rules), 450.982 and 
450.984 (revising rules); and 405.370 and 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 proposed 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 proposed all MIPS eligible clinicians and groups that submit 
data to us electronically must attest to the accuracy and completeness 
to the best of their knowledge of any data submitted to us. This 
attestation would occur prior to any electronic data submissions, via a 
Web site maintained by us.

[[Page 77359]]

    We requested comments on these proposals, and the following is a 
summary of the comments we received.
    Comment: CMS received several comments regarding the details for 
audit. Commenters believed the proposed rule provided insufficient 
detail regarding payer responsibility and recommended that CMS provide 
greater detail and clarity around the auditing of contracts and any 
obligations or responsibilities payers will have as part of the 
auditing process. Other commenters requested that CMS, through the 
rulemaking process, address additional details about audits such as how 
audit contractors are compensated, how samples are chosen, and 
frequency of audits.
    Response: We appreciate the requests to address details of the 
audit process; however, the process will be addressed through 
subregulatory guidance and, as noted in the proposed rule, we will 
selectively audit on an annual basis.
    Comment: Commenters supported CMS' adding an independent audit with 
an appeals process to ensure due process is upheld.
    Response: We appreciate commenters' support. However, we do want to 
note that there will not be a separate appeals for MIPS eligible 
clinicians outside of the targeted review process described in the 
preceding section of this final rule with comment period.
    Comment: One commenter believed that it is important to institute 
rigorous independent (third party) validation and verification 
procedures to ensure accuracy and completeness of self-reported data. 
The commenter requested that validation requirements be similar to the 
requirements placed on Medicare Advantage plans and other government 
healthcare programs.
    Response: Validation requirements will be provided to a MIPS 
eligible clinician or group in advance of an audit.
    Comment: One commenter expressed concern that data validation 
processes will not address key systematic flaws in medical data 
collection reporting and evaluation such as honest data entry errors or 
intentional misrepresentation of a MIPS eligible clinician's 
performance. The commenter further recognized that the volume of data 
in MIPS may make it difficult to achieve accuracy in the data 
collection and reporting processes as well.
    Response: We are concerned about data entry errors and its 
contribution to MIPS eligible clinicians' performance. We intend to 
thoroughly review all errors that are identified during data validation 
with careful consideration given to inadvertent and episodic data entry 
errors.
    Comment: Commenters supported CMS's proposal to use only one set of 
auditing requirements for the MIPS program, as commenters believed this 
would reduce administrative burden and provide a unified approach to 
MIPS. Commenters also stated support for streamlining the auditing 
process.
    Response: We thank the commenters and appreciate the support for a 
singular set of audit requirements and streamlining the auditing 
process.
    Comment: Commenters believed that direct onsite auditing would be 
too burdensome for single MIPS eligible clinicians, small, and many 
midsize primary care organizations. Commenters proposed that no onsite 
auditing be performed for the first 2 performance periods until CEHRT 
developers and CMS can publish the details of how such audits will be 
conducted. Commenter suggested that: (1) Within these first 2 years, 
MIPS eligible clinicians or groups could volunteer to participate in 
'beta' site testing of the proposed audit methodology and be given 
'bonus' MIPS points added to their final score; or (2) Single solo 
practitioner organizations could be exempt from the onsite auditing 
requirement indefinitely, providing they show they have current support 
contracts in effect with both the CEHRT developer and/or third party 
quality organizations that assist the MIPS eligible clinician or group 
in maintaining compliance within the MIPS program requirements.
    Response: Consistent with upholding the public trust in stewarding 
the Medicare Trust Fund, all MIPS eligible clinicians and groups that 
are scored under MIPS are required to respond to all audit requests and 
audit requirements will be provided in advance to selected MIPS 
eligible clinicians and groups. Since exemptions and other testing or 
audit methodologies suggested by the commenters are not consistent with 
equitable scoring, CMS has identified distinct audit requirements for 
third party entities and auditing of eligible clinicians and groups. 
The audits of third party entities or intermediaries, if employed by an 
eligible clinician or group, are defined separately at Sec.  
414.1400(j). MIPS eligible clinicians or groups will be audited on the 
provisions of care that contributed to their ability to report on an 
activity or measure. CMS will further make every effort to reduce 
reporting burdens for MIPS eligible clinicians and groups during 
audits.
    Comment: A few commenters suggested that CMS clarify whether it or 
another entity will be the primary lead on data validation and auditing 
and the specific documents and data that must be available to pass an 
audit. Further, commenters requested CMS provide additional details 
regarding their methods for conducting audits, including what 
instructions or requirements other entities conducting the audits will 
be provided.
    Response: Data validation and auditing remain under our control and 
authority, although as we have done for other programs, we may engage a 
contractor for certain aspects of the data validation and audit 
processes. Additional information identifying CMS contracted auditing 
entities and instructions regarding data validation and auditing will 
be provided through subregulatory guidance.
    Comment: One commenter strongly recommended that CMS provide 
significant education to physicians about how the program operates, 
including the review and auditing procedures.
    Response: We appreciate the recommendation and will provide 
education to MIPS eligible clinicians or groups about the data 
validation and audit processes. We will provide audit notices, audit 
instructions, and examples of data and charts needed for the validation 
of the provision of care attributable to the measures, objectives, and 
activities on which the MIPS eligible clinicians or group submitted 
data.
    Comment: One commenter stated that they share provider concerns 
related to validation of data from other payers.
    Response: We appreciate the concern about data from other payers. 
Please note that validating data will be reviewed on a case by case 
basis and additional information will be provided through subregulatory 
guidance. During the transition year, data from other payers will be 
used for informational purposes to improve future validation efforts. 
Data from other payers will not be the only source of data used to make 
final determinations on whether an eligible clinician or group passes 
or fails an audit in the transition year. As noted previously, data 
sources for validation and audits include any primary source documents 
such as medical charts and other documents that are attributable to any 
measure or activity reported by an eligible clinician or group.
    Comment: One commenter agreed that reporting patient data across 
all payers is important and believes that more time should be given to 
clinicians to synchronize data for non-Medicare patients.

[[Page 77360]]

    Response: We appreciate comments identifying time needed to 
synchronize data and the potential reporting burden it may have on MIPS 
eligible clinicians or groups. We will review time requirements and 
extensions on a case by case basis for MIPS eligible clinicians or 
groups that require additional time during audits covering non-Medicare 
patients.
    Comment: One commenter encouraged CMS to be consistently 
transparent in communicating with groups and in verification of their 
status. The commenter recommended that groups be able to address any 
inaccuracies or other issues in a transparent, timely fashion.
    Response: Any MIPS eligible clinicians or groups that are subject 
to data validation and audits will have the ability to have any 
questions regarding their status addressed. We will make every effort 
to communicate the status of any audits conducted with the affected 
MIPS eligible clinician or group in a transparent, and timely fashion.
    Comment: One commenter supported attestation of data submission 
accuracy and completeness and suggested that attestation be 
incorporated into the submission process, rather than through a 
separate portal.
    Response: We proposed all MIPS eligible clinicians and groups that 
submit data to us electronically must, to the best of their knowledge, 
attest to the accuracy and completeness of any data submitted to us (81 
FR 28280). We also proposed that this attestation would occur prior to 
any electronic data submissions, via a Web site maintained by us (81 FR 
28280). However, after review of the comments, we are not finalizing 
this policy as proposed. We agree with the commenter and intend to 
build any attestation requirements related to data accuracy into the 
submission process, as technically feasible. We believe building any 
attestation requirements into the submission process will ease the 
burden for the MIPS eligible clinicians and groups to submit this type 
of data to us.
    Comment: One commenter agreed with the strategy to combine the data 
validation process used in PQRS and the auditing process used in the 
Medicare EHR Incentive Program. The commenter agreed that MIPS eligible 
clinicians and groups must attest to the accuracy and completeness of 
any data submitted to CMS prior to any electronic data submissions to 
CMS.
    Response: Thank you for your support to combine the data validation 
process used in PQRS and the auditing process used in the Medicare EHR 
Incentive Program. We intend to establish a unified data validation 
process across the performance categories for MIPS to conserve time and 
efforts for eligible clinicians and groups.
    Comment: Several commenters requested that CMS release an audit 
guide to create more specific guidance prior to the beginning of the 
performance period so that MIPS eligible clinicians or groups know what 
documents and what formats would be required for auditing purposes. 
Further, commenters requested that CMS provide detailed information 
about how to be prepared for an audit, with descriptions of evidence. 
Commenters also recommended that CMS have sufficient resources to staff 
a Quality Payment Program Service Center and develop support materials 
to guide MIPS eligible clinicians and practice administrators through 
the review and audit process.
    One commenter expressed concern that audit documentation 
requirements are not specified in the proposed rule because commenter 
believed such requirements in the past were not published until after 
the beginning of the performance year.
    Response: Audit specifications will be provided through 
subregulatory guidance and MIPS eligible clinicians or groups selected 
for data validation and audits will be provided instructions and 
examples of documents required. Please note that documents that should 
be retained for data validation and audit would be primary source data 
and files, such as medical records and charts, demonstrating the 
provision of care consistent with what is reported during the 
performance period that is being validated or audited. Written 
communication documents that identify CMS contracted auditing entities, 
and audit response instructions will be provided through subregulatory 
guidance to assist eligible MIPS eligible clinicians and groups through 
the review and audit process. Please note, the Quality Payment Program 
Service Center is not the appropriate resource for MIPS eligible 
clinicians, groups or any staff, such as practice administrators, 
undergoing data validation and audits. CMS intends to utilize 
contracted auditing entities with sufficient staff to support and 
assist any eligible clinician, group, or staff, responding to an audit.
    Comment: Commenters suggested a clear delineation of the expected 
audit and oversight of the program for both MIPS eligible clinicians or 
groups and third party intermediaries to ensure that everyone is 
prepared with the proper documentation for audits. Commenters were not 
able to identify how specifications on reporting are to be conducted.
    Response: Specifications for reporting requirements during the 
audit will be provided to MIPS eligible clinicians and groups in 
advance of an audit. Please note that audits of third party 
intermediaries, if employed by an eligible clinician or group, are 
defined separately at Sec.  414.1400(j). MIPS eligible clinicians or 
groups will be audited on the provisions of care that contributed to 
their ability to report on an activity or measure.
    Comment: A few commenters requested that CMS clearly define audit 
documentation for each of the MIPS measures and provide specific 
guidance regarding what data will be required and acceptable for 
attestation and audit purposes. The commenters suggested that specific 
audit guidelines and audit preparation instructions be a part of this 
implementation.
    Response: Since the MIPS measures and activities have numerous and 
well defined requirements, we do not believe specific audit 
documentation requirements for each measure and activity would be 
useful. Audit documentation will be addressed with MIPS eligible 
clinicians and groups that are selected for audit. Instructions for 
completing the audit and examples of documents required, such as 
medical charts and files and other primary source documents, will be 
provided to the MIPS eligible clinicians and groups during the initial 
notice. MIPS eligible clinicians and groups should retain copies of 
medical records, charts, reports and any electronic data utilized to 
determine which measures and activities were applicable and appropriate 
for their scope of practice and patient population for reporting under 
MIPS for up 10 years after the conclusion of the performance period to 
prepare for verification in the event they are selected for an audit. 
This record retention timeframe aligns with the record retention 
timeframes already in place for APMs either established in regulation 
or included in participation agreements. CMS may request any records or 
data retained for the purposes of MIPS for up to 6 years and 3 months.
    Comment: Commenters requested that CMS specify in the final rule 
with comment period what type of audit requests a MIPS eligible 
clinician will have to respond to and specifically requested 
clarification on what would be needed to show they have implemented 
improvement activities.
    Response: We assume that the commenters' request for clarification 
on ``type of audit requests'' is seeking clarification on what mode of

[[Page 77361]]

communication we will use for audit requests. We will use varying 
mechanisms, which may include mail, email or phone calls. MIPS eligible 
clinicians or groups will have to respond to all data validation and 
audit requests. Please note data validation and audits of the quality 
performance category for the transition year will examine a set of 
medical charts to verify that the encounters were reported accurately 
and meet quality measurement requirements. Data validation and audits 
of the other performance categories will be conducted in future years 
and additional information on data validation and audits of such 
categories will be provided through subregulatory guidance.
    Comment: Commenters requested that prior to performing any audit 
for data validation, CMS provide MIPS eligible clinicians, facilities, 
and Medicare Administrative Contractors with guidance on how MIPS 
eligible clinicians or groups and facilities should document MIPS 
eligible clinicians' performance in source documents.
    Response: Guidance on how primary source documents will be used in 
data validation and audits will be provided to selected MIPS eligible 
clinicians or groups in advance of an audit.
    Comment: Several commenters supported auditing, but suggested that 
CMS set clear deadline expectations on both sides, and suggested that a 
10-business day deadline for MIPS eligible clinicians or groups may not 
be feasible in all circumstances. The commenters suggested limiting 
burden on MIPS eligible clinicians or groups by allowing 30 days after 
a request is made and identifying the methodology to select MIPS 
eligible clinicians or groups for audit. Another commenter requested 45 
days to respond to audit requests. While another commenter recommended 
20 business days for a MIPS eligible clinician and 30 business days for 
a group. One commenter noted that this would prevent practices from 
being inadvertently penalized and remove the possibility that 
additional data requests would be inappropriately used by contractors 
as a tool to ``manage'' their workload. Another commenter recommended 
that absent any suspicion of wrongdoing, the timeframe for audits 
should be extended to 30 days, and CMS should consider reimbursement 
for time and effort required to meet the data submission requirements.
    Response: We appreciate the commenters' concerns and 
recommendations and note that we are revising the proposed 10 business 
day timeframe for compliance with data sharing requests to a 45-day 
timeframe. We note that when we refer to ``days,'' we generally mean 
``calendar days,'' unless otherwise specified. We believe this 
timeframe is sufficient as this aligns with the post-payment audit 
timeframe employed by the Center for Program Integrity at CMS. We note 
that the timeframe applies equally to MIPS eligible clinicians and 
groups to maintain program consistency and the 45 day timeframe extends 
beyond any recommended dates from public responses provided. We believe 
that a more generous timeframe will enable both MIPS eligible 
clinicians or groups to satisfactorily comply with data sharing 
requests and to fully complete an audit in a manner that is consistent 
with the practices already established in the Medicare program. Please 
note that those subject to data validation and audits for the 
transition year will be based on a random selection from both MIPS 
eligible clinicians and groups, without consideration for suspicions of 
wrongdoing. We will take the commenter's suggestion to provide 
reimbursement for time and effort required to meet data submission 
requirements into consideration. Details regarding any reimbursement 
will be communicate through subregulatory guidance.
    Comment: Commenters urged CMS to initially take an educational as 
opposed to a punitive approach to audits and reviews, allowing CMS to 
collect and analyze ``common errors'' and publish ``lessons learned'' 
about the MIPS program so MIPS eligible clinicians, medical societies, 
and others can improve the chances of success under MIPS. Another 
commenter suggested that CMS approach auditing of this new program as 
an education tool to correct past mistakes.
    Response: We appreciate the recommendation for a gradual audit 
process and enhanced education for MIPS eligible clinicians or groups. 
We also appreciate the recommendation to publish common errors and 
lessons learned from data validation and audits. We will provide 
examples of correct and incorrect documentation needed to educate and 
instruct MIPS eligible clinicians or groups identified and selected for 
audits and data validation and we will consider publishing additional 
documents in future years as the program matures. We also appreciate 
the feedback to use data validation and audits as an educational tool. 
Please note that during the transition year, the data validation and 
audit process will include education and support for MIPS eligible 
clinicians and groups selected for an audit.
    Comment: Commenters had concerns with the proposal to ``reopen, 
revise, and recoup any resulting overpayments'' if a MIPS eligible 
clinician or group is found to have submitted inaccurate data for MIPS. 
Further, several commenters stated that audits and reviews should 
encourage education and the ability to learn from past mistakes rather 
than penalizing and recouping payments.
    Response: We acknowledge the request to not make audits punitive. 
However, the proposal to pursue reopening and recoupment of payments is 
supported by our current authority to reopen and revise payment 
determinations, and to recoup any Medicare overpayments resulting from 
the submission of inaccurate data that is submitted. We note that any 
recoupments of funds are not penalties; they are payment corrections. 
We routinely pursue recoupments based on identified overpayments that 
have been made.
    Comment: One commenter recommended that CMS create an audit report 
that would detail areas in which MIPS eligible clinicians and groups 
did well and those where improvement was needed. The commenter further 
suggested that the report be organized by medical specialty and 
practice size.
    Response: We cannot determine if the commenter is requesting a 
public audit report or a private audit report created for those MIPS 
eligible clinicians or groups that are selected for the audit. In the 
latter scenario, we intend to provide a report of specific feedback to 
those MIPS eligible clinicians or groups that are selected for an audit 
based on the result of the audit and our findings. In the former 
scenario, we appreciate the benefit of a public audit report and will 
therefore take this recommendation into consideration. We will further 
consider organizing the report, if provided, in a manner that most 
appropriately informs MIPS eligible clinicians and groups and will 
consider organizing the information by specialty and practice size.
    Comment: One commenter suggested that CMS allow any group which, 
upon audit, has submitted inaccurate data to correct and resubmit the 
data before any revisions or recoupments would occur.
    Response: We appreciate the request for groups selected for audit 
to have the ability to resubmit. However, please note that resubmission 
of data for recalculation during an audit is not technically feasible 
at this time. Furthermore, requests for recalculation for data errors 
would require a targeted review request, which will operationally

[[Page 77362]]

occur before any audit and data validation processes begin. Since data 
validation and audits occur separately and after the completion of the 
performance period, the reporting period, and the targeted review 
period, we expect any MIPS eligible clinician or group to provide the 
most accurate and complete data as possible to CMS.
    Comment: Commenters supported a process whereby the MIPS scoring 
and penalties levied accurately reflect the true practice environment, 
but still had questions about the audit process.
    Response: Thank you for your support of the scoring process and 
penalties under MIPS. We recognize commenters have questions about the 
audit process. Please note that audit notification, materials, examples 
and instructions will be provided to any MIPS eligible clinician or 
group selected by CMS for data validation and audit.
    After consideration of the comments, we are finalizing the data 
validation policies as revised in this final rule with comment period. 
Specifically, we are finalizing Sec.  414.1390 as proposed to 
selectively audit MIPS eligible clinicians and groups on a yearly 
basis, and that if a MIPS eligible clinician or group is selected for 
audit, the MIPS eligible clinician or group will be required to do the 
following in accordance with applicable law and timelines CMS 
establishes:
     Comply with data sharing requests, providing all data as 
requested by CMS or our designated entity. All data must be shared with 
CMS or our designated entity within 45 days of the data sharing 
request, or an alternate timeframe that is agreed to by CMS and the 
MIPS eligible clinician or group. Data will 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 non-Medicare beneficiaries where applicable.
    We are also finalizing that we will perform ongoing monitoring of 
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 are 
finalizing that we would reopen and revise the determination in 
accordance with the rules set forth at Sec. Sec.  405.980 (re-opening 
rules), 450.982 and 450.984 (revising rules); and we would collect any 
overpayment in accordance with Sec. Sec.  405.370 and 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 are finalizing our approach 
to recoup improper 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 limit 
each data validation and audit request to the minimum data necessary to 
conduct validation. Based on comments received, we intend to use data 
validation and audits as an educational opportunity for MIPS eligible 
clinicians and groups; therefore, during the transition year, the data 
validation and audit process will include education and support for 
MIPS eligible clinicians and groups selected for an audit.
    Lastly, we are finalizing that all MIPS eligible clinicians and 
groups that submit data to us electronically must attest to the best of 
their knowledge that the data submitted to us is accurate and complete.
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. In this section, we are specifying the criteria 
that must be met to be approved by CMS as a third party intermediary. 
For purposes of this section, the use of the term ``third party'' 
refers to a qualified registry, a QCDR, a health IT vendor that obtains 
data from a MIPS eligible clinician's CEHRT, or a CMS-approved survey 
vendor.
    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 CEHRT; or (4) a CMS-approved survey vendor. We proposed 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 proposed at Sec.  
414.1400(a)(3) that third party intermediaries must meet all the 
criteria designated by us 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 us.
    The following is a summary of the comments we received regarding 
our proposed definition of third party data intermediaries.
    Comment: Some commenters suggested that registries are foundational 
to population health management, as registries foster care improvement, 
inform participants on needed focus areas, highlight performance areas 
for improvement, and identify which patients require interventions. The 
commenters also stated that registries are already in use by ACOs, and 
that under the proposal, MIPS eligible clinicians may satisfy the 
proposal's quality data reporting criteria by using data that is 
already being submitted to a clinical registry or to an ACO. Thus, the 
commenters expressed support for QCDR use under the proposal, as this 
reporting mechanism enhances the importance of existing registries that 
already seek to deliver high quality and high value care, and 
additionally streamlines reporting criteria for MIPS eligible 
clinicians.
    Response: We appreciate the commenters' support for inclusion of 
qualified registries.
    Comment: Some commenters requested that CMS recognize that changes 
to QCDRs, registries, and EHRs require significant financial resources 
and time to plan, incorporate, and test. The commenters added there 
must be ample notice in the rulemaking process for QCDRs, registries, 
and developers to plan and adequately meet these changes. The 
commenters encouraged CMS to establish a program update calendar to 
identify annual data management updates or reprogramming that is 
recurring and make an effort to adjust regulatory implementation dates 
to spread out the data collection, modifications, or updates so that 
they do not all occur during the last quarter of the calendar year.

[[Page 77363]]

    Response: We aim to minimize changes to criteria whenever possible 
because we understand that implementing these changes can in certain 
instances be a lengthy process. However, at this time, we cannot 
provide a specific update calendar. We will adopt changes to the 
criteria through future rulemaking as necessary. We anticipate that as 
we gain experience under the MIPS, we will be able to establish a 
schedule or cycle of updates through future rulemaking.
    Comment: Another commenter recommended that small practices be 
allowed to use PPRNET (Primary Care Practice Research Network--a 
practice based research network and QCDR) to help them submit measures 
for MIPS, and possibly other metrics.
    Response: MIPS eligible clinicians may choose from several data 
submission mechanisms. If PPRNET satisfies the QCDR criteria and is 
approved by CMS as a third party intermediary, then it will be a data 
submission option available for those MIPS eligible clinicians who 
choose to use it.
    After consideration of the comments, we are finalizing our policies 
as proposed. Specifically, we are finalizing 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. 
Additionally, we are finalizing at Sec.  414.1400(a)(3) that third 
party intermediaries must meet all the criteria designated by CMS as a 
condition of their qualification or approval to participate in MIPS as 
a third party intermediary. Lastly, we are finalizing at Sec.  
414.1400(a)(3)(ii), all submitted data must be submitted in the form 
and manner specified by CMS.
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 final score methodology, to encourage MIPS 
eligible clinicians to report on applicable measures for 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 
improvement activities 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 
proposed 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 criteria, and the criteria 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 us.
    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 for 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 improvement activities 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 cost performance category since these measures are 
administrative claims-based. Therefore, we proposed 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:
     Quality;
     Improvement activities; or
     Advancing care information, if the MIPS eligible clinician 
or group is using CEHRT.
    We believe this approach would permit a single QCDR to report on 
the quality, advancing care information, and improvement activities 
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 proposed 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 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.
    The following is a summary of the comments we received regarding 
our proposals on the definition of a QCDR and the performance 
categories for which a QCDR is allowed to submit data on behalf of MIPS 
eligible clinicians.
    Comment: Several commenters agreed with the proposal to allow third 
party entities, such as QCDRs, to submit data for the categories of 
quality, advancing care information, and improvement activities. The 
commenters believed allowing MIPS eligible clinicians to use a single, 
third party data submission method reduces the administrative burden on 
MIPS eligible clinicians, facilitates consolidation, and 
standardization of data from disparate EHRs and other systems, and 
enables the third parties to provide timely, actionable feedback to 
MIPS eligible clinicians on opportunities for improvement in quality 
and value. Some commenters requested that CMS quickly release 
additional guidance to QCDRs regarding the capabilities that would be 
necessary to report the range of performance categories for the 
transition year of MIPS. One commenter believed this would allow for 
streamlined data submission and more complete feedback to MIPS eligible 
clinicians through QCDRs.

[[Page 77364]]

    Response: We intend to finalize our proposal that QCDRs will have 
the flexibility to submit data on behalf of any of the following 
performance categories: Quality, improvement activities, and advancing 
care information. In addition, we intend to release additional guidance 
to third party intermediaries regarding the submission standards that 
QCDRs would need to comply with for data submissions across the 
performance categories. We will publish this information at 
QualityPaymentProgram.cms.gov prior to the beginning on the performance 
period.
    Comment: Another commenter was pleased that CMS understood the 
potential and value of QCDRs and included QCDRs as a reporting option 
across several of the MIPS components and improvement activities. For 
those performance categories where QCDR reporting is an option, such as 
improvement activities and advancing care information performance 
categories, the commenter requested that CMS outline specifics as soon 
as possible to ensure registry technology vendors can meet the needs of 
MIPS eligible clinicians selecting the MIPS pathway.
    Response: We thank the commenter for their support of our 
proposals. In addition, we intend to release additional guidance to 
third party intermediaries regarding the submission standards that 
QCDRs would need to comply with for data submissions across the 
performance categories. We will publish this information at 
QualityPaymentProgram.cms.gov prior to the beginning of the performance 
period.
    Comment: A few commenters did not support the criterion that QCDRs 
must have the capability to submit for all performance categories. The 
commenters believed that while this could reduce burden for MIPS 
eligible clinicians, choosing to support one or more performance 
categories is a business decision and should not be regulated and would 
limit the MIPS eligible clinician's choice of QCDRs in the early years 
of MIPS, as not all third party entities would necessarily be able to 
meet the criteria for submittal for all three performance categories.
    Response: We would like to explain that we did not propose to 
require that QCDRs must have the capability to submit data for all 
performance categories, rather we proposed that they would have the 
option to do so. We agree with the commenters that requiring all QCDRs 
to be able to submit data for all performance categories is premature 
until stakeholders such as third party entities gain experience under 
the MIPS.
    Comment: Another commenter agreed with and requested that CMS 
reinforce its definition of a QCDR as one that collects medical or 
clinical data for the purpose of patient and disease tracking to foster 
improvement in the quality care provided to patients. The commenter 
requested that CMS notify QCDRs are soon as possible if a non-MIPS QCDR 
measure will not be renewed in future years for other reason.
    Response: We appreciate the commenters' support for our proposed 
definition of a QCDR. We would like to explain that QCDRs that have 
been previously approved under the PQRS program will need to self-
nominate and confirm their ability to meet the requirements of a QCDR 
under the MIPS. We are not able to ``grandfather'' any existing QCDRs 
over from the PQRS program to the MIPS program. We do anticipate 
however that the overwhelming majority of QCDRs that were able to meet 
the requirements under PQRS will be able to meet the requirements under 
MIPS. Furthermore, we anticipate that the non-PQRS measures that QCDRs 
had approved under PQRS, would in most instances be approved as non-
MIPS measures, if the QCDR chooses to submit these measures for 
approval to CMS.
    After consideration of the comments received, we are finalizing the 
QCDR policies as proposed. Specifically, we are finalizing 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:
     Quality;
     Improvement activities; or
     Advancing care information, if the MIPS eligible clinician 
or group is using CEHRT.
    Additionally, we are finalizing 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 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 proposed 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.
    The following is a summary of the comments we received regarding 
the establishment of an entity seeking to qualify as a QCDR.
    Comment: Some commenters proposed that in lieu of having an 
establishment requirement that aligns with the start of the performance 
period that CMS should consider options for making other aspects of the 
eligibility criteria more flexible.
    Response: We believe that a QCDR should be established and 
collecting quality data at the time of self-nomination. Having a 
process to accept data and report it by the time the entity self-
nominates reduces the chance that the entity will not be able to 
successfully submit their MIPS eligible clinician's data during the 
data submission period.
    Comment: One commenter supported the proposal for the establishment 
of a QCDR entity, particularly that participants do not need to be 
using the QCDR to report MIPS data to CMS, but need to be submitting 
data to the QCDR for quality improvement. The commenter believed this 
would allow registries hosted by non-physician clinician groups to 
obtain QCDR certification despite lack of inclusion of such clinicians 
in the definition of a MIPS eligible clinician in the initial years of 
MIPS.
    Response: We agree and thank the commenter for their support. We 
note that registries hosted by non-physician clinician groups may 
satisfy the QCDR criteria and be approved by CMS as a third party 
intermediary.
    Comment: Some commenters requested clarification regarding what 
defines a participant (for example, reporting entity (group or 
clinician) or individual clinicians) in the requirement that a QCDR 
needs to have 25 participants by January 1 of the performance period.
    Response: We would like to note that a ``participant'' is a MIPS 
eligible clinician. Therefore, we require the QCDR to have 25 MIPS 
eligible

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clinicians by January 1 of the performance period to become qualified 
for a given performance period as a QCDR.
    Comment: Other commenters stated that the expectations for QCDR 
self-nomination may be unrealistic for new endeavors. Specifically, 
requiring a QCDR to have at least 25 participants by January 1 of the 
performance period assumes the existence of the registry prior to self-
nominating as a QCDR. Consequently, a registry would have to be in 
existence, based on its own structural requirements and specifications, 
before it could self-nominate. The commenter appreciated the decision 
to require self-nomination on an annual basis and supports the 
information criteria that CMS proposes for self-nomination. The 
commenter believed the data submission criteria outside the self-
nomination process are too restrictive and should be revised and that 
the final rule with comment period should include appeals, grievance, 
and corrective action processes.
    Response: We require at least 25 participants in an effort to 
ensure that potential QCDRs have experience in data collection and 
calculation capabilities. For appeals, MIPS has a targeted review 
process please refer to section II.E.8.c. of this final rule with 
comment period for more information
    Comment: One commenter requested that CMS consider potential 
approval of the Scientific Registry of Transplant Recipients (SRTR) as 
a QCDR. The commenter also requested CMS work with the transplant 
community and assist in overcoming current barriers related to QCDR 
technical requirements. Other commenters requested that when CMS 
compiles the list of entities qualified to submit data as a QCDR, that 
CMS accept the Indian Health Service (IHS) Resource and Patient 
Management System (RPMS) as a qualified entity. The commenter requested 
CMS work with IHS to ensure that the RPMS is capable of meeting MIPS 
reporting criteria.
    Response: We would like to explain that while we will consider all 
entities that seek to qualify as a QCDR, we cannot conclude that a 
particular entity is capable of meeting our criteria in advance of the 
qualification process. It is important to note that an entity must meet 
the criteria in Sec.  414.1400(c) and be approved by CMS to qualify as 
a QCDR. We will develop further subregulatory guidance, including 
through tribal consultation to address issues raised by entities that 
want to be QCDRs.
    After consideration of the comments received on the establishment 
of an entity seeking to qualify as a QCDR we are finalizing the 
policies as proposed. Specifically, we are finalizing 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.
(2) Self-Nomination Period
    For the 2017 performance period we proposed 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 proposed 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 us 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, we believe 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 proposed 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 or 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.
    The following is a summary of the comments we received regarding 
the self-nomination period.
    Comment: A few commenters agreed with the self-nomination period 
for the 2017 performance period.
    Response: We appreciate the support from the commenters.
    Comment: Some commenters opposed the proposed deadlines for QCDR 
self-nomination of January 15, 2017 for the 2017 performance period and 
November 1 for the 2018 performance period and beyond. Specifically, 
the commenters stated that if CMS finalizes a performance period for 
the 2019 MIPS payment adjustment of January 1, 2017 through December 
31, 2017, the commenters requested that CMS extend the QCDR self-
nomination deadline to March 31, 2017. Other commenters opposed the 
data proposed for QCDR self-nomination given the timing that 
regulations will be finalized and recommended extending the deadline to 
3 months following the start of the performance period for the 2019 
MIPS payment adjustment. Another commenter requested that CMS extend 
the self-nomination deadline to February 28, 2017. The commenter stated 
that QCDRs need additional time to determine that their systems will 
work with or can be updated to accommodate new MIPS requirements.
    Response: We acknowledge the short timeline, but our intention was 
to complete the QCDR approval process as early as possible to allow 
MIPS eligible clinicians the most time in choosing the QCDR they intend 
to use. We note, that while QCDRs that have previously been approved 
under the PQRS program do need to self-nominate for consideration under 
the MIPS, we anticipate that the overwhelming majority of the existing 
QCDRs will be able to meet the requirements finalized here. The 
requirements to qualify as a QCDR have been fairly consistent since we 
started using QCDRs under the PQRS program.
    After consideration of the comments received on the self-nomination 
period we are finalizing the policies as proposed. Specifically, for 
the 2017 performance period we are finalizing 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, the self-nomination period must occur 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

[[Page 77366]]

provide all information requested by us at the time of self-nomination.
    We are finalizing our proposal to require other information 
(described below) of QCDRs at the time of self-nomination. All self-
nomination information must be submitted to 
[email protected]. If technically feasible we will 
accept self-nomination information via a web-based tool we will provide 
any further information on the web-based tool at 
QualityPaymentProgram.cms.gov. 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 or 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 proposed 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, or improvement activities).
     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, CEHRT, 
other (please explain). If a combination of methods (Claims, web-based 
tool, Practice Management System, CEHRT, 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 improvement activities 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, improvement activities, and advancing care 
information, as applicable). Periodic examinations may be completed to 
compare patient record data with submitted data or ensure MIPS quality 
measures or other performance category (improvement activities, 
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 us 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 us when submitting a 
risk-adjusted measure on behalf of the QCDR's MIPS eligible clinicians 
for the performance period.
    The following is a summary of the comments we received regarding 
information required at the time of self-nomination for QCDRs.
    Comment: A few commenters stated that the self-nomination process 
for QCDRs does not allow flexibility to update or change information in 
response to a CMS review or a previous years' experience. The 
commenters believed that CMS should review measures and the validation 
strategy after the prior year's measure submission or CMS should have a 
process for allowing submission of modifications.
    Response: We agree that timely feedback regarding the possible 
elimination of non-MIPS measures is important and are committed to 
providing this information to QCDRs as early as possible. We cannot 
wait for the data to be sent in for the prior year's submissions before 
finalizing QCDR information for the next performance period as doing so 
would mean that we could not publish the list of qualified QCDRs before 
the performance period. For example, this would mean that for the 2018 
year, we would not be able to publish the list of QCDRs until summer 
2018, which we believe is too late within the performance period for 
MIPS eligible clinicians to make their selection. That is, half of the 
performance period would have transpired before the list of qualified 
entities was publically posted.
    Comment: One commenter requested that CMS remove the requirement 
for annual self-nomination when significant changes have not been made 
to the QCDR.
    Response: We will take this under consideration as we develop the 
criteria for QCDRs in future years.
    Comment: One commenter sought clarification from CMS regarding any 
changes to the QCDR self-nomination criteria for 2017 and beyond.
    Response: Any changes to the self-nomination criteria for QCDRs 
would be addressed in future rulemaking.
    Comment: Several commenters believed it was important to note that 
QCDR criteria for data validation plans are sufficient to ensure 
accuracy of data.
    Response: We agree with the commenters' input.
    Comment: Another commenter supported the criterion to have QCDRs 
submit risk-adjusted measure results.
    Response: We appreciate the commenters' support.

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    Comment: One commenter stated that MIPS eligible clinicians should 
not be held responsible for errors or delays by third party 
intermediaries. The commenters stated CMS should require testing and 
provide data validation on data submitted to EHR vendors and QCDRs that 
is submitted to CMS. The commenters stated CMS should then inform MIPS 
eligible clinicians about any errors found through the data validation 
process.
    Response: We are in the process of refining the testing process to 
facilitate accurate reporting. However, we note that MIPS eligible 
clinicians are ultimately responsible for the data that are submitted 
by their third party intermediary and we expect that they are holding 
their third party intermediary accountable for accurate reporting. 
Additionally, we plan to have a probation and disqualification process 
for QCDRs with high error rates, as discussed below, in this final rule 
with comment period, in the section entitled ``Probation and 
Disqualification of a Third Party Intermediary.'' While we do not want 
to remove any QCDRs from participation, it is imperative that we (and 
MIPS eligible clinicians) receive accurate and actionable data.
    Comment: Another commenter stated May 31 is too soon to provide the 
results of the executed data validation plan of the year following the 
performance period. A June 30 timeframe would be better.
    Response: We appreciate the commenter's concerns. However, we 
believe it is important to allow MIPS eligible clinicians time to 
select a QCDR before the performance period. Part of continued 
participation in the program for QCDRs is for CMS to review the data 
validation execution reports. As such, this date is needed for earlier 
publication of the following program year's QCDRs.
    Comment: Another commenter stated it is critical that CMS work with 
QCDRs to ensure that CMS can accept formats that allow each registry to 
demonstrate the unique features of its data, especially embedded risk 
adjustment.
    Response: We encourage all non-MIPS measures be risk-adjusted 
(where appropriate) but it is up to the QCDR and measure developer or 
owner to define the risk-adjustment elements and methodology for the 
measure.
    Comment: One commenter requested that CMS: (1) Disclose publicly 
that the criteria for non-MIPS measures must meet to be approved; (2) 
articulate the circumstances under which a QCDR may be approved, but 
not its specialty-specific measures; and (3) delineate the practical 
implications for a QCDR that is approved through the self-nomination 
process when its non-MIPS measures are not.
    Response: Approval of non-MIPS measures is part of the QCDR 
approval process. In cases where NO non-MIPS measures are approved but 
the QCDR is approved, the QCDR can elect to participate in the program 
reporting any MIPS measures the QCDR so chooses. We have included, in 
this final rule with comment period, in the section below entitled 
``Identifying Non-MIPS Quality Measures'' the elements that will factor 
into CMS' non-MIPS measure approval process.
    Comment: Some commenters recommended that CMS allow a 3-year period 
of automatic measure approval through the QCDR self-nomination process.
    Response: We do not believe that measures should be automatically 
approved for use by a QCDR for 3 years. As the science changes or the 
evidence evolves, measures may need to be updated or changed 
altogether. Additionally, we do not guarantee that a QCDR will be a 
qualified entity for 3 years. The QCDR's tenure in the program is 
dependent on the QCDR's desire to continue participating in the program 
and meeting the criteria for the program (including submitting accurate 
data and measure results).
    After consideration of the comments received on the information 
required at the time of self-nomination for QCDRs we are finalizing the 
policies as proposed. Specifically, a QCDR must provide the information 
described above to us at the time of self-nomination to ensure that the 
QCDR data is valid.
(4) QCDR Criteria for Data Submission
    In addition, we proposed 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 CEHRT, 
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 CEHRT.
     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 us 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. We believe risk-adjustment for certain outcomes measures is 
important to account for the differences in the complexities of care 
provided to 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 improvement 
activities 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 improvement 
activities, advancing care information, or quality performance 
category, all results as of the performance feedback 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 performance feedback 
is generated.
     Possess benchmarking capability (for non-MIPS quality 
measures) that

[[Page 77368]]

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. We will 
review the quality measures and determine if they are appropriate for 
QCDR reporting.
     Enter into and maintain with its participating MIPS 
eligible 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 or patient specific data on Medicare and non-Medicare 
beneficiaries on behalf of MIPS eligible clinicians and groups.
     Obtain and keep on file signed documentation that each 
holder of an NPI whose data are submitted to the QCDR, has authorized 
the QCDR to submit quality measure results, improvement activities 
measure and activity results, advancing care information objective 
results and numerator and denominator data or patient-specific data on 
Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS 
participation. This documentation should be obtained at the time the 
MIPS eligible clinician or group signs up with the QCDR to submit MIPS 
data to the QCDR and must meet the requirements of any applicable laws, 
regulations, and contractual business associate agreements. Groups 
participating in MIPS via a QCDR may have their group's duly authorized 
representative grant permission to the QCDR to submit their data to us. 
If submitting as a group, each individual MIPS eligible clinician does 
not need to grant their individual permission to the QCDR to submit 
their data to us.
     Not be owned and managed by an individual locally owned 
single specialty group (for example, single specialty practices with 
only one practice location or solo practitioner practices are 
prohibited from self-nominating to become a qualified QCDR).
     Be able to separate out and report on all payers including 
Medicare Part B FFS patients and non-Medicare patients.
     Provide the measure numbers for the MIPS quality measures 
on which the QCDR is reporting.
     Provide the measure title for the MIPS quality measures 
and improvement activities (if applicable) on which the QCDR is 
reporting.
     Report the number of eligible instances (reporting 
denominator).
     Report the number of instances a quality service is 
performed (performance numerator).
     Report the number of performance exclusions, meaning the 
quality action was not performed for a valid reason as defined by the 
measure specification.
     Comply with a CMS-specified secure method for data 
submission, such as submitting the QCDR's data in an XML file.
     Sign a document verifying the QCDR's name, contact 
information, cost for MIPS eligible clinicians or groups to use the 
QCDR, services provided, and the measures and specialty-specific 
measure sets the QCDR intends to report. Once posted, on the QCDR's or 
CMS Web site, the QCDR will need to support the measures or measure 
sets confirmed by the QCDR. Failure to do so will preclude the QCDR 
from participation in MIPS in the subsequent year.
     Must provide attestation statements during the data 
submission period that all of the data (quality measures, improvement 
activities, and advancing care information measures and objectives, if 
applicable) and results are accurate and complete.
     For purposes of distributing performance feedback to MIPS 
eligible clinicians, collect a MIPS eligible clinician's email 
addresses and have documentation from the MIPS eligible clinician 
authorizing the release of his or her email address.
     Be able to calculate and submit measure-level reporting 
rates or, upon request, the data elements needed to calculate the 
reporting and performance rates by TIN/NPI and/or TIN.
     Be able to calculate and submit, by TIN/NPI and/or TIN, a 
performance rate (that is the percentage of a defined population who 
receive a particular process of care or achieves a particular outcome 
based on a calculation of the measures' numerator and denominator 
specifications) for each measure on which the TIN/NPI or TIN reports 
or, upon request the Medicare beneficiary data elements needed to 
calculate the performance rates.
     Provide the performance period start date the QCDR will 
cover.

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     Provide the performance period end date the QCDR will 
cover.
     Report the number of reported instances, performance not 
met, meaning the quality actions was not performed for no valid reason 
as defined by the measure specification.
     For data validation purposes, provide information on the 
entity's sampling methodology. For example, it is encouraged that 3 
percent of the MIPS eligible clinicians be sampled with a minimum 
sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS 
eligible clinicians. For each MIPS eligible clinicians sampled, it is 
encouraged that 25 percent of the MIPS eligible clinicians' 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.
     Submit all of the measures (MIPS measures and non-MIPS 
measures) including specifications for the non-MIPS measures to us on a 
designated Web page. The measures must address a gap in care. Outcome 
or other high priority types of measures are preferred. Simple 
documentation or ``check box'' measures are discouraged.
    The following is a summary of the comments we received regarding 
QCDR criteria for data submission.
    Comment: A few commenters stated that some QCDRs were not designed 
to collect cross-cutting measures. Another commenter requested that CMS 
remove the requirement that MIPS eligible clinicians reporting the 
quality performance category via a QCDR must report on one cross-
cutting measure and an outcome measure. The commenter believed CMS 
should provide flexibly in light of the QCDR's specialty focus. Another 
commenter was concerned that extending the cross-cutting measure 
requirement to QCDRs would lessen the utility of QCDRs for specialties 
that do not have directly applicable measures on the cross-cutting 
measure list, and noted that only one proposed (and problematic) cross-
cutting measure was applicable to emergency medicine. Further, the 
commenter was concerned that the cross-cutting measure requirement 
threatened to undermine QCDR's original goal of providing specialties 
flexibility to report on truly meaningful measures that were not 
tethered to a traditional measure set.
    Response: As discussed in section II.E.5.b.(3) of this final rule 
with comment period, we have modified our proposal for the quality 
performance category for the transition year of MIPS. We are removing 
the requirement to report a cross-cutting measure and finalizing that 
for the applicable performance period, the MIPS eligible clinician or 
group would report at least six measures including at least one outcome 
measure. Due to this modification of criteria in the quality 
performance category, we are not finalizing the requirement that QCDRs 
must be able to report on a cross-cutting measure. We do strongly 
encourage, however, that where appropriate to their clients' scope of 
practice, these measures be incorporated. It is our expectation that 
QCDRs would be able to report program measures and their own non-
program measures.
    Comment: Several commenters disagreed with the following QCDR 
criteria for data submission due to privacy concerns: (1) Submit to CMS 
data on measures, activities, and objectives for all patients, not just 
Medicare patients; and (2) be able to separate out and report on all 
payers including Medicare Part B FFS patients and non-Medicare 
patients. Another commenter sought clarification on why CMS wanted the 
submission of measures and activities on all patients from QCDRs, not 
just CMS beneficiaries. The commenters had concerns regarding HIPAA 
requirements.
    Response: We desire all-payer data for all submission mechanisms, 
to create a more comprehensive picture of the practice performance. 
Section 1848(q)(5)(H) of the Act authorizes the Secretary to include, 
for purposes of quality measurement and performance analysis, data 
submitted by MIPS eligible clinicians with respect to items and 
services furnished to individuals who are not Medicare beneficiaries. 
As discussed in section II.E.5.b. of this final rule with comment 
period, we are finalizing our proposal to require MIPS eligible 
clinicians to report all-payer data on quality measures where possible. 
We would like to explain that QCDRs should be able to supply sufficient 
information such that CMS, as well as the QCDR, can determine whether a 
given non-MIPS measure is ``topped out,'' as discussed in section 
II.E.5.c. of this final rule with comment period. Additionally, the 
information received by us is in the aggregate. That is, no personally 
identifiable health data is provided to CMS by registries or QCDRs.
    Comment: One commenter supported CMS' proposal to use all-payer 
data for the QCDRs, qualified registry, and EHR submission mechanisms. 
The commenter recommended that CMS work with RHICs to incorporate 
multi-payer claims and clinical data into reporting mechanisms, and 
support regional data aggregators engaged in measurement and public or 
private reporting. In addition, the commenter recommended that CMS do 
more to incorporate all-payer data, including enabling data sharing 
through regional intermediaries.
    Response: We appreciate the commenters' support and will consider 
the suggestions in future rulemaking.
    Comment: Some commenters stated they are concerned about 
administrative burden of data collection and measure reporting, 
especially the infrastructure changes that are necessary to be 
identified as a QCDR.
    Response: We recognize that for those organizations that choose to 
become a QCDR there are certain requirements that must be met, which 
may be construed as burdensome. We would like to explain, however, that 
there is no requirement for any individual or organization to become or 
report via a QCDR. We will continue to work with stakeholders to ensure 
that any of our requirements do not become overly burdensome, but 
instead provide flexibilities both to the entities seeking to become a 
QCDR as well as to MIPS eligible clinicians.
    Comment: Several commenters supported CMS' proposal to allow QCDRs 
to submit data for the quality, advancing care information, and 
improvement activities performance categories but noted that many QCDRs 
may only be able to submit data on the quality performance category. 
One commenter encouraged CMS to retain reporting in the three 
categories optional for QCDRs in the future. This commenter opposed the 
proposal to allow health IT vendors and qualified registries to submit 
data for all the MIPS categories, expressing concerns that this would 
be an unintended disincentive for these entities to become 
interoperable and that health IT vendors would have access to enormous 
amounts of data. Another commenter recommended that CMS provide 
significant flexibility with timelines to allow translating data into 
non-MIPS measures for inclusion in QCDRs. The commenter believed 
requiring QCDRs to submit data for all non-claims based MIPS 
performance categories will add to the value that they provide, 
although additional specifics related to submissions for the three 
categories are needed.
    Response: We appreciate the commenters' support to allow QCDRs to 
submit data for the quality, improvement activities, and advancing care 
information performance categories. To explain, we did not propose to 
require that QCDRs must have the capability to submit data for all 
performance categories, rather we

[[Page 77370]]

proposed that they would have the option to do so. We intend to provide 
flexibility to allow translating data into non-MIPS measures for 
inclusion in QCDRs.
    Comment: Some commenters were concerned about expanding QCDRs' 
capabilities by allowing them to submit data on measures, activities, 
or objectives from quality, improvement activities, and advancing care 
information performance categories. The commenters were concerned that 
QCDRs would provide quality measure specifications including data 
elements for non-MIPS quality measures intended for reporting from 
CEHRT, thus allowing CMS to collect any data CMS wants by collecting it 
as a non-MIPS measure.
    Response: We do not specify what measures QCDRs should develop, nor 
do we require that a specific QCDR be used by MIPS eligible clinicians 
or even a specific measure within the QCDR be submitted by a particular 
MIPS eligible clinician. Please reference the criteria for approval of 
non-MIPS measures discussed in section II.E.9.a.(6) entitled 
``Identifying Non-MIPS Quality Measures'' of this final rule with 
comment period.
    Comment: Other commenters requested that CMS continue to recognize 
QCDR-related activities on this list and to allow QCDRs to define 
specific improvement activities for MIPS eligible clinicians through 
the already-established QCDR approval process for measures and 
activities.
    Response: We agree with this comment and will consider this in 
future program years as we gain more experience with the improvement 
activities performance category.
    Comment: Several commenters did not endorse mandatory participation 
in the support calls, nor do they endorse mandatory in-person 
attendance at the QCDR kick-off meeting in Baltimore, MD, or the 
proposal that more than one unexcused absence could result in the QCDR 
or registry being precluded from participation in the program. The 
commenters believed the proposed data submission, validation, and 
ongoing auditing criteria are sufficient motivators to encourage QCDRs 
and qualified registries to utilize the support resources provided.
    Response: We respectfully disagree. We believe mandatory 
participation in support calls and attendance at the QCDR kick-off 
meeting are important to help improve the reliability of the data CMS 
receives for scoring in MIPS. As the number of QCDRs increases and the 
complexity of the program grows, it may be necessary to have an in-
person meeting at CMS central office in Baltimore, MD to convey the 
necessary information to QCDRs. As such, CMS wants assurance from 
potential QCDRs that they will attend an in-person meeting yearly if 
needed.
    Comment: Another commenter requested clarification in the final 
rule with comment period on whether or not a MIPS eligible clinician's 
email address and release documentation is a requirement when metrics 
are being reported at the group level instead of the individual level.
    Response: When reporting at the group level, we require that the 
QCDR or qualified registry obtain permission to submit data to CMS from 
the person authorized by the group to make decisions regarding 
participation in the Quality Payment Program. The QCDR or registry 
should maintain this documentation for 6 years and 3 months but does 
not need to send it to CMS unless requested. Similarly, the email of 
the group's representative should also be collected by the QCDR or 
qualified registry.
    Comment: A few commenters agreed with the proposal that once the 
QCDR elects to submit specific measures, they must support those 
services or measures. The commenters requested that CMS provide 
clarification that throughout the performance period, QCDRs should be 
able to add MIPS measures to their lists of available services or 
measures as they have time to build those throughout the year. The 
commenters noted that they do not want to be limited to only supporting 
MIPS measures signed up for in November prior to the performance 
period, as final lists of available MIPS measures will not be available 
to the QCDR until that same November prior to the performance period. 
The commenters further noted that QCDRs will need time to include 
additional measures released by CMS in the final list of MIPS measures 
available for the performance period.
    Response: We agree with the commenters and will allow for this 
flexibility to the fullest extent feasible. QCDRs are still required to 
submit their MIPS and non-MIPS measures to us by the deadlines of 
January 15th for the first performance period and by November 1 prior 
to the performance period for future years for review and approval by 
us. We will however on a case-by-case basis allow QCDRs and qualified 
registries to request review and approval for additional MIPS measures 
throughout the performance period. Any new measures that are approved 
by us will be added to the information related to the QCDR or qualified 
registry on the CMS Web site, as technically feasible. We anticipate 
only being able to update this information on the Web site on a 
quarterly basis, as technically feasible. We would like to explain that 
this flexibility would only apply for MIPS measures; QCDRs will not be 
able to request additions of any new non-MIPS measures throughout the 
performance period. Lastly, we note that QCDRs will not be able to 
retire any measures they are approved for during the performance 
period. Any measures QCDRs wish to retire would need to be retained 
until the next annual self-nomination process and applicable 
performance period.
    Comment: Some commenters recommended that CMS further incentivize 
the creation of specialty-wide registries that ensure data collection 
efforts are not limited to data from individual EHRs; QCDRs must 
support whole specialties or disease categories.
    Response: There are no provisions in the statue that expressly 
allow for this specialty-specific incentive. Furthermore, we believe 
that specialists should determine if there is a need for a specialty 
specific QCDR.
    Comment: Other commenters requested that when a QCDR measure 
steward licenses a measure to another QCDR, the licensed measure does 
not count toward the 30 non-MIPS QCDR measure limit of the license. The 
commenters requested CMS provide adequate protections to safeguard any 
intellectual property associated with a measure steward's risk 
adjustment methodology, especially in regard to posting non-MIPS QCDR 
measure specifications.
    Response: It is to the responsibility of the measure owner to 
address intellectual property safeguard concerns for non-MIPS measure 
specifications. Licensed non-MIPS measures will still be considered in 
the total non-MIPS measures allowed for each QCDR that utilizes the 
measure. The work to incorporate the non-MIPS measure into the CMS 
system does not change if the measure is reported by one QCDR or more 
QCDRs.
    Comment: A few commenters stated that CMS should allow QCDRs to 
give other QCDRs permission to use its measures. The commenters 
believed sharing measures across QCDRs allows similar types of MIPS 
eligible clinicians (for instance, those in a particular subspecialty) 
to report the same measure regardless of their TIN structure. In 
addition, the commenters stated CMS should request that when sharing 
these measures, QCDRs collaborate to establish benchmarks.

[[Page 77371]]

    Response: We agree with this comment and currently allow and 
encourage the sharing of non-MIPS measures including benchmarking data, 
if desired, between QCDRs.
    Comment: Another commenter stated CMS can improve the QCDR 
submission process by providing more guidance during the validation 
process, giving feedback on submission accuracy (and making the vendor 
responsible for submitting corrected data), and providing validation on 
calculated reporting and performance rates as data submitted (including 
flagging errors).
    Response: We provide aggregate data issues information to each 
QCDR, that is, number and types of errors for individual QCDRs each 
year. We agree with the commenter that providing these additional data 
elements is beneficial. We are currently exploring ways to determine 
the operational feasibility of this under the MIPS.
    Comment: A few commenters did not support the proposal to require 
performance feedback at least six times a year. Rather, the commenter 
encouraged four performance feedback instead, to allow a greater sample 
size in each report and additional time to risk-adjust measures. 
Another commenter stated four performance feedback would allow a 
greater sample size in each report and additional time to risk-adjust 
measures.
    Response: While we believe ``real-time'' feedback should be the 
goal for QCDRs, we acknowledge the extra burden six performance 
feedback will place on some entities and, as such, will modify the 
requirement to four performance feedback per year for the transition 
year of MIPS. However, please note we intend to increase the number of 
required performance feedback to six by MIPS payment year 2020 and will 
propose to require ``real time'' feedback as soon as it is technically 
feasible.
    Comment: Some commenters stated that if a QCDR or other entity does 
not submit accurate data, then the MIPS eligible clinicians using that 
reporting mechanism should not be penalized and instead should be 
assessed as ``average'' for the impacted performance category(ies).
    Response: We do not guarantee that QCDRs will be successful in 
submitting data to us. MIPS eligible clinicians should carefully 
consider the reputation of the entity when making their vendor 
selection. We note that practices are ultimately responsible for the 
data that are submitted by their third party intermediaries and expect 
that they are ultimately holding their third party intermediaries 
accountable for accurate reporting. We are planning to note entities 
with high data errors on the published list of QCDRs in the future. 
Please refer to section II.E.6. of this final rule with comment period 
for further information on scoring.
    Comment: Other commenters stated it would be helpful for CMS to 
inform stakeholders of calculation errors and anything that does not 
comply with specifications, such as zero rates, as early as possible. 
The commenters stated that if testing requires any type of practice 
audit or request for information from practices for data validation 
purposes, CMS should inform vendors of any communication to practices 
so that vendors can work with CMS to ensure that practices understand 
the purpose of the validation request. In addition, the commenters 
stated that in advance of, or concurrent with, updates to quality 
measures, CMS should clearly identify a timeline when testing tools 
will be available and at what point the version will be ``static.'' 
Finally, the commenters stated that suggested milestones should be made 
available so that health IT vendors can incorporate measure testing 
into their product's timeline.
    Response: We currently report many types of errors to the 
submitting entity at the time of submission. Additionally, timelines 
are reviewed on each support call (monthly leading up to and during the 
submission window) as well as notification of specifications and the 
availability of the testing tool.
    Comment: A few commenters stated while CMS provides proposals for 
third party intermediaries to be disqualified due to data errors, the 
commenters believed it was important to establish a standardized 
testing process in the beginning, prior to the data submission period, 
so the data was as accurate as possible as they are analyzed for the 
purpose of scoring MIPS eligible clinicians and groups. The commenters 
stated CMS should offer a voluntary testing window each quarter. The 
commenters added that vendors that opt to take advantage of this 
testing window should receive feedback on whether files are transmitted 
appropriately.
    Response: We currently offer pre-submission testing for QCDRs under 
PQRS and intend to continue to offer a similar function under MIPS. We 
cannot currently provide a timeline for availability of this testing 
function but we do note that it will be made available to QCDRs prior 
to the submission period. We envision that this testing function will 
mimic the submission process as closely as technically feasible. We 
will provide additional details on this testing process through QCDR 
support calls and at the QualityPaymentProgram.cms.gov.
    Comment: Another commenter requested additional clarity regarding 
the requirement to provide information on the entity's process for data 
validation for both individual MIPS eligible clinicians and groups 
within a data validation plan. While the commenter believed it was 
reasonable to expect vendors who are also registries to perform quality 
assurance testing to confirm that calculations are correct and based on 
the data in the fields being sampled, the proposal suggests a more 
detailed review of individual patients' charts, which the commenter 
believed would be impossible for vendors who are receiving only an 
extract of the fields necessary to calculate measures and not 
extracting the entire record.
    Response: We do not mandate the specifics of the data validation 
strategy; rather, we suggest examples of previously accepted plans. It 
is the responsibility of the entity to ensure the data given to them by 
the MIPS eligible clinician is both accurate and complete. The 
attestation statement required at the time of submission requires the 
entities to stand behind the data they submit. Entities may need to 
work with their MIPS eligible clinicians to have the needed chart 
access for data verification.
    Comment: Some commenters supported CMS' efforts to ensure the 
integrity of data and appreciated the proposal to provide an initial 
probationary period where the entity is given the opportunity to 
correct identified issues. However, immediate disqualification could 
adversely affect entities, such as a QCDR, that, because of lack of 
experience or an unintentional error, failed to meet data integrity 
standards. The commenter noted it would also adversely impact the MIPS 
eligible clinicians who rely on these entities to satisfy federal 
quality reporting mandates.
    Response: We appreciate the comment and do not want QCDRs to be 
eliminated from the program, however, we must balance our goal of QCDR 
inclusion with the need to receive accurate and usable data. Neither 
the MIPS eligible clinicians nor the MIPS program will benefit from 
inaccurate data as known inaccurate data cannot be used in the program 
for payment or calculation of benchmarks. We refer readers to section 
II.E.9.e. entitled ``Probation and Disqualification of a Third Party 
Intermediary'' of this final rule with comment period for more 
information on probation and disqualification of third party 
intermediaries.

[[Page 77372]]

    Comment: Other commenters requested more transparency concerning 
the review of non-MIPS measures in QCDRs. The commenters noted that in 
the past the review of these measures has been conducted with limited 
input from the measure owners, and with less than 24 hours to formulate 
a response. The commenters believed with clearer guidance, this process 
could be more effective at identifying gaps in care.
    Response: We have provided additional clarification, in this final 
rule with comment period in section II.E.9.a.(6) entitled ``Identifying 
Non-MIPS Quality Measures,'' for the criteria we will use in 
considering measures and their suitability for the MIPS program. As the 
measures are expected to be fully developed prior to self-nomination, 
the additional requested information should be readily available to the 
QCDR. Additionally, QCDRs will not be given less than 24 hours to 
respond to CMS when initially being asked for measure clarification.
    Comment: A few commenters supported the proposal allowing QCDRs to 
submit either XML or QRDA formats. The commenters believed that these 
format determinations were best made by each individual QCDR. The 
commenters appreciated that CMS is not proposing to require QCDRs to 
use only QRDA for capturing and transmitting data. The commenters 
stated that CMS should work with registries and other stakeholders to 
identify emerging standards that support a more scalable and flexible 
data reporting format.
    Response: We appreciate the commenters' support. We will continue 
to work with QCDRs and other stakeholders to identify and improve our 
data transmission formats and methods.
    Comment: Other commenters supported CMS' proposals to allow QCDRs 
to define specific improvement activities for specialty and non-patient 
facing MIPS eligible clinicians through the existing QCDR approval 
process for measures and activities.
    Response: We appreciate the support.
    Comment: Some commenters opposed the proposal that the QCDR must be 
able to indicate the data source if the data was derived from CEHRT 
because it would be difficult to require QCDRs to parse out which data 
fields are populated from EHRs.
    Response: This information is necessary to give MIPS eligible 
clinicians additional credit for using CEHRT for the quality 
performance category. These bonus points are described in more detail 
in section II.E.6.a.(2)(f) of this final rule with comment period.
    Comment: Other commenters did not believe QCDRs should be held 
responsible for TIN/NPI mismatches, as QCDRs rely on the MIPS eligible 
clinicians to provide accurate TIN/NPI information. Rather, the 
commenters requested that CMS allow QCDRs to run tests similar to SEVT 
testing, ideally in the middle of the performance period, to allow 
QCDRs to determine whether TIN/NPI inaccuracies exist.
    Response: We are exploring the technical feasibility of allowing 
this type of testing under the MIPS.
    Comment: Some commenters supported the requirement for vendors to 
complete CMS-sponsored submission testing and requests that CMS include 
in its testing tools and Submission Engine Validation Tool (SEVT) 
process, validation of data content as well as format.
    Response: We support the commenter's sentiment. As noted 
previously, we intend to offer a pre-submission testing process that 
will mimic as closely as possible the MIPS submission process QCDRs 
would experience.
    Comment: A few commenters stated they supported: (1) Allowing 
flexible reporting options, such as contracting with third party 
submitters to report on behalf of QCDR owners and agreed with CMS that 
third party intermediaries should meet all criteria designated by CMS 
as a condition of their qualification or approval to participate in 
MIPS; (2) agreed that requiring the use of the QRDA could continue to 
be a reporting impediment for XML-based third party submitters; (3) 
concurred that CMS should be cautious in too quickly moving entities to 
a probationary phase because of difficulties encountered while making 
good faith efforts to comply with CMS' complex processes; and (4) 
believed that aligning CMS processes with ONC certification 
requirements would be highly preferable to adding an additional CMS 
process to assure CMS form and manner requirements are met. Other 
commenters generally agreed with the proposal to require data 
submission vendors to submit data in the form and manner approved by 
CMS. In addition, they agreed with the proposal to allow the vendor to 
submit data for three performance categories through the third party 
intermediary.
    Response: We agree and appreciate the support. We will monitor 
readiness, explore areas to streamline, and align electronic clinical 
quality measure (eCQM) development, testing, certification of products 
to the eCQM specifications and use of these measures in CEHRT and in 
reporting. Some QCDRs may choose to certify and may be working toward 
eCQM development, and CMS and ONC are committed to supporting this 
effort; however, we recognize that readiness among QCDRs even for MIPS 
eCQM certification is varied. We recognize that QCDRs may use data 
other than or in addition to that available from CERHT for their 
measures. In addition, some QCDRs are already successfully collecting 
and reporting measures for CMS programs without use of standards-based 
formats. Therefore, we are not requiring QCDRs be, use, or connect to 
CEHRT in order to report data under any MIPS performance category.
    Comment: A few commenters supported the proposal regarding QCDRs 
and other intermediaries providing feedback to participants on quality 
measures.
    Response: We appreciate the commenters support.
    Comment: Another commenter strongly supported CMS maintaining its 
current policy for reporting criteria in which QCDRs have a choice 
regarding public reporting strategies.
    Response: We appreciate the commenters' support. We refer readers 
to section II.E.10. of this final rule with comment period for final 
policies regarding public reporting on Physician Compare.
    Comment: Other commenters suggested providing flexibility for 
QCDRs. The commenters appreciated the proposals to foster the growing 
acceptance of QCDRs in clinical care, but stated it can only be 
achieved if CMS recognizes that QCDRs need the flexibility to 
incorporate measures into the registry as each specialty or clinician 
field sees fit for its patient population.
    Response: We appreciate the comment, however there are basic 
criteria for quality measures to be included in our program. These are 
outlined in section II.E.5.c. of this final rule with comment period.
    Comment: Some commenters requested clarification as to why CMS is 
proposing to measure requirements that may not be relevant to the data 
the registry collects, especially when QCDR measures will be held to 
such a high threshold of review.
    Response: QCDR measures are expected to at least meet the regular 
MIPS measures requirements. Measures included in MIPS also undergo 
scrutiny including having to go through the MUC/MAP process. If the 
commenter is questioning why we require certain data elements such as 
the source of the data (that is, EHR, web portal, claims, etc.), this 
is needed to provide bonus points,

[[Page 77373]]

when applicable, to MIPS eligible clinicians who are using certified 
EHR technology to collect and manage quality measures data.
    Comment: Some commenters recommended extending the deadline for 
QCDR submission of measures to April 30th following the performance 
year because American College of Surgeons (ACS) registries used as 
QCDRs generally have a lock date of 90 days past the date of surgery to 
allow ample time to track outcomes in which no data is received. 
Following the 90-day lock data, time is needed for data analysis and 
risk adjustment. The commenters indicated that the current submission 
deadline would not permit the submission of data for October, November 
or December, which is a high-volume period for surgery.
    Response: We acknowledge the commenter's concern, but we cannot 
extend the data submission timeframe and still have adequate time to 
process the information and make the appropriate calculations for 
accurate scoring for the MIPS.
    Comment: Other commenters requested that CMS provide clearer 
guidance on what specific criteria must be met for a measure to fall 
into each specific high priority measures well in advance of the QCDR 
self-nomination process.
    Response: The measures that are considered high priority are 
outcomes, appropriate use, patient safety, efficiency, patient 
experience, and care coordination.
    Comment: One commenter encouraged CMS work with QCDR applicants to 
provide them feedback on measures that are submitted in the application 
process.
    Response: We have held calls with potential QCDRs in the past to 
discuss measure issues and potential measures. In addition, we have 
worked and will continue to work with potential QCDRs and provide 
feedback on self-nominated measures.
    Comment: Other commenters were very disappointed with CMS's 
decision not to adopt new policies or procedures to implement section 
105(b) of MACRA (Pub. L. 114-10) which requires CMS to provide QCDRs 
with access to Medicare data for purposes of linking such data with 
clinical outcomes data and performing scientifically valid analysis or 
research to support quality improvement or patient safety. The 
commenters believed that CMS also ignored the fact that section 105(b) 
of MACRA is intended to provide QCDRs with access to Medicare data for 
quality improvement purposes, not just research, and that the broad and 
continuous access needed for quality improvement purposes is 
fundamentally different than the access to Medicare data for research 
purposes provided by Research Data Assistance Center (ResDAC). The 
commenters stated that CMS's decision not to issue a rule implementing 
section 105(b) of MACRA violates the black letter principles of 
statutory construction. The commenters believed CMS should match 
Medicare claims data with Social Security Death Master File (SSDMF) 
death data before providing it to QCDRs to greatly enhance the accuracy 
and robustness the Medicare claims data. Some commenters stated that 
the Secretary should match Medicare claims data with SSDMF data before 
providing it to QCDRs. Because the commenters believed that the 
ultimate purpose for accessing death data was to enhance the accuracy 
of patient outcomes information, including verification of patient life 
status and date of death, and not the acquisition of the actual death 
data set itself, QCDRs would greatly benefit from the Secretary 
matching Medicare claims data with SSDMF death data to verify patient 
death status, and sharing the matched data set with QCDRs.
    Response: We recently finalized regulations at 42 CFR 401.722 to 
implement section 105(b) of MACRA. As discussed in the Medicare 
Program; Expanding Uses of Medicare Data by Qualified Entities final 
rule published in the July 7, 2016 Federal Register (81 FR 44471), we 
recognize that the research request pathway may not be consistent with 
the types of analyses QCDRs envision conducting using the CMS data. As 
a result, we finalized regulations to allow QCDRs to serve as quasi-
qualified entities. The qualified entity program, which was created by 
section 10332 of the Affordable Care Act and modified by section 105 of 
MACRA, authorizes us to provide standardized extracts of Medicare Parts 
A and B claims data and Part D event data to approved qualified 
entities. Qualified entities must combine the Medicare data with claims 
data from other sources and use the combined data to produce public 
performance reports on providers and suppliers. Qualified entities may 
use the combined data to conduct non-public analyses and provide or 
sell these analyses to certain authorized users. They may also provide 
or sell the combined data or provide the Medicare claims data alone at 
no cost to providers, suppliers, hospital associations, and medical 
societies.
    Under the regulations at Sec.  401.722, QCDRs are allowed to serve 
as quasi qualified entities, provided the QCDR agrees to meet all the 
requirements of the program with the exception of the requirement at 
Sec.  401.707(d) that the organization submit information about the 
claims data it possesses from other sources. In addition, for the 
purposes of QCDRs serving as quasi qualified entities, we defined 
combined data as, at a minimum, CMS claims data combined with clinical 
data or a subset of clinical data. We believe that the requirements of 
the qualified entity program create an appropriate framework for QCDRs 
to conduct analyses to support quality improvement and patient safety 
and to work directly with providers and suppliers on issues related to 
quality improvement and patient safety.
    With regard to the SSDMF, we recognize that death information is a 
key aspect of analyses of patient outcomes, but we do not have the 
authority to disclose the SSDMF to QCDRs. However, we have the date of 
death information for Medicare patients and we include this date of 
death information on the data files that are shared with qualified 
entities and those that are shared with QCDRs who are approved as quasi 
qualified entities.
    Comment: One commenter requested that CMS clarify whether QCDR 
quality data can be submitted through the QRDA standard and whether 
QCDRs may report eCQMs.
    Response: QCDRs may elect to report any MIPS measures, including 
eCQMs. Additionally, if the data required for a non-MIPS measures is 
captured electronically in the proper manner as defined in CEHRT, the 
data can be sent to the QCDR electronically and used as a non-MIPS 
eCQM. QCDRs will be able to use the data submission standard when 
submitting their MIPS eCQMs. Additional details will be provided on the 
Quality Payment Program data submission standard via QCDR support calls 
and at QualityPaymentProgram.cms.gov.
    Comment: Some commenters recommended that CMS provide MIPS eligible 
clinicians with cost estimates for electronic data submissions through 
registries and EHRs, as well as time estimates for submission of 
attestations through the CMS Web Interface to assist MIPS eligible 
clinicians in determining which submission method would be the least 
burdensome and most cost-effective.
    Response: We have information related to the burden of 
participation in section III.B.12. of this final rule with comment 
period. Additionally, we will post cost data for registries and QCDRs 
on the qualified posting list.

[[Page 77374]]

    Comment: A few commenters stated that the proposal should emphasize 
the role of QCDRs to ensure reporting and data submission are flexible, 
meaningful, and useful. The proposed QCDR data completeness requirement 
increasing from 50 to 90 percent would require reassuring MIPS eligible 
clinicians of the value of QCDR participation and reporting. One 
commenter requested Medicare claims data access to QCDRs be considered 
in future rulemaking.
    Response: Based on the overwhelming feedback received, we do not 
intend to finalize the data completeness thresholds as proposed. The 
numerous details the commenters cited on the increased burden the data 
completeness thresholds will impose on MIPS eligible clinicians is not 
intended. We want to ensure that an appropriate, yet achievable, level 
of data completeness is applied to all MIPS eligible clinicians. Based 
on stakeholder feedback for the transition year of MIPS, as discussed 
in section II.E.5.b.(3)(b) of this final rule with comment period, we 
will finalize a 50 percent data completeness threshold for claims, 
registry, QCDR, and EHR submission mechanisms. Additionally, we will 
take the commenter's request for access to Medicare claims data into 
consideration for future rulemaking.
    Comment: Some commenters stated that March 31 is a welcome 
extension from the Feb 28 submission deadline. They also stated that 
bi-annual and quarterly reporting would be advantageous only if CMS 
intends to provide timely quarterly feedback to MIPS eligible 
clinicians. The commenter stated that because of the added burden of 
submission throughout the reporting year, this reporting option would 
only be useful when CMS can provide feedback that quickly. 
Additionally, if quarterly reporting would be required going forward, 
EHR vendors would need to have additional notice regarding measure 
additions and updates in order to prepare for a sooner submission 
period than had been required under annual reporting. Finally, the 
commenters stated that a January 1 submission deadline seems 
unnecessary since most practices are closed for the New Year holiday. 
Further MIPS eligible clinicians need several days to compile their 
data after the last day of the performance period. The commenters 
suggested that CMS consider delaying the data submission period to 
January 15-April 15 so that reports could be compiled and tested for 
submission prior to the open of submission. Additionally, the 
submission portal should have fewer down times during the 1st quarter 
to compensate for MIPS eligible clinicians submitting their files. The 
commenters suggested limiting the maintenance in the first quarter to 
only have two scheduled downtimes, one in January and one in February, 
leaving all of March, when heavy data submission is occurring.
    Response: We cannot extend the submission period to April 15 and 
still process the data, calculate the final score and perform the other 
necessary tasks in time to make MIPS payment adjustments for the 
upcoming payment year. With respect to the downtime of our system, the 
system is shared by multiple components and programs at CMS and thus 
maintenance weekends must occur regularly throughout the year. We do 
note that we publish the scheduled maintenance weekends in advance so 
QCDRs have the ability to build these downtimes into their schedules 
for data submission.
    Comment: One commenter noted that they could not measure MIPS 
eligible clinicians by individual patient outcomes, but could measure 
and accredit team-based performance. The commenter's outcomes registry 
cannot be a qualified reporting registry for MACRA as currently 
proposed, because its outcomes are not and could never be physician--
specific. The commenter suggested that CMS take advantage of 
commenter's Center for International Bone Marrow Transplant Research 
registry, not only for evaluating team-based quality outcomes for 
hematopoietic SCT (HCT) patients but for assistance in helping other 
specialties with team-based care enhance their outcomes reporting.
    Response: CMS allows group reporting by qualified registries and 
QCDRs. If the ``team'' referred to in the comment practices under one 
tax identification number (TIN), the measures (if reported by a QCDR 
and approved by CMS) could be reported for all of the MIPS eligible 
clinicians under the particular TIN.
    After consideration of the comments received on the QCDR criteria 
for data submission we are finalizing our policies as proposed, with 
the following exceptions: Specifically, we have decided to alter the 
requirement to provide timely feedback to MIPS eligible clinicians six 
times a year. Rather based on feedback from stakeholders we will 
finalize the requirement as follows: Provide timely feedback, at least 
four 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 improvement activities, advancing care information, or quality 
performance category, all results as of the performance feedback 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 
performance feedback is generated.
    Additionally, based on our policies finalized in section 
II.E.5.b.(3) of this final rule with comment period, we are not 
requiring MIPS eligible clinicians to submit data on cross-cutting 
measures. Therefore, we are finalizing the requirement at Sec.  
414.1335(a)(1)(i) for QCDRs as follows: Be able to submit results for 
at least six quality measures including 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.
(5) QCDR Measure Specifications Criteria
    A QCDR must provide specifications for each measure, activity, or 
objective the QCDR intends to submit to CMS. We proposed at Sec.  
414.1400(f) the QCDR must provide the following information:
     Provide descriptions and narrative specifications for each 
measure activity, or objective for which it will submit to us by no 
later than January 15 of the applicable performance period for which 
the QCDR wishes to submit quality measures or other performance 
category (improvement activities and advancing care information) data. 
In future years, starting with the 2018 performance period, those 
specifications must be provided to us by no later than November 1 prior 
to the applicable performance period for which the QCDR wishes to 
submit quality measures or other performance category (improvement 
activities and advancing care information) data.
     For non-MIPS quality measures, the quality measure 
specifications must include: name or title of measures, NQF number (if 
NQF-endorsed), descriptions of the denominator, numerator, and when 
applicable, denominator exceptions, denominator exclusions, risk 
adjustment variables, and risk adjustment algorithms. The narrative

[[Page 77375]]

specifications provided must be similar to the narrative specifications 
we provide in our measures list. CMS will consider all non-MIPS 
measures submitted by the QCDR but the measures must address a gap in 
care and outcome or other high priority measures are preferred. 
Documentation or ``check box'' measures are discouraged. Measures that 
have very high performance rates already or address extremely rare gaps 
in care (thereby allowing for little or no quality distinction between 
MIPS eligible clinicians) are also unlikely to be approved for 
inclusion.
     For MIPS measures, the QCDR only needs to submit the MIPS 
measure numbers and the specialty-specific measure sets (if 
applicable).
     The QCDR must publicly post the measure specifications (no 
later than 15 days following our approval of these measure 
specifications) for each non-MIPS quality measure it intends to submit 
for MIPS. The QCDR may use any public format it prefers. Immediately 
following posting of the measures specification information, the QCDR 
must provide us with the link to where this information is posted. We 
would then post this information when it provides its list of QCDRs for 
the year.
    The following is a summary of the comments we received regarding 
QCDR measure specifications criteria.
    Comment: A few commenters opposed CMS' proposal to have measures 
specifications submitted by January 15, as they do not believe this 
gives enough time for QCDRs to determine which measures would be 
appropriate for the MIPS following the issuance of the final rule with 
comment period, which is expected to be released in November 2016. 
Another commenter suggested QCDRs should be given until March 31 of the 
applicable performance period (that is March 31, 2017 for the 2019 MIPS 
payment adjustment) to submit this information.
    Response: We thank the commenters for their feedback. We appreciate 
the concerns raised regarding the timelines for measure submission. We 
believe, however, that it is important that MIPS eligible clinicians 
can make their selection of measures prior to or at the onset of the 
performance period to ensure they can build these measures into their 
quality workflow.
    After consideration of the comments regarding the proposal on the 
QCDR measure specifications criteria we are finalizing the policies as 
proposed at Sec.  414.1400(f).
(6) Identifying Non-MIPS Quality Measures
    To explain the definition of a non-MIPS quality measures for 
purposes of QCDRs submitting data for the MIPS quality performance 
category, we proposed at Sec.  414.1400(e) to consider the following 
types of quality measures to be non-MIPS quality measures:
     A measure that is not contained in the annual list of MIPS 
quality measures for the applicable performance period.
     A measure that may be in the annual list of MIPS quality 
measures but has substantive differences in the manner it is submitted 
by the QCDR. For example, if a MIPS quality measure is only reportable 
via the CMS Web Interface and a QCDR wishes to report this quality 
measure on behalf of its MIPS eligible clinicians, the quality measure 
would be considered a non-MIPS quality measure. This is because we 
would have only extracted the data collected from this quality measure 
using the CMS Web Interface, in which we utilize a claims-based 
assignment and sampling methodology to inform the groups on which 
patients they are to report, and the reporting of this quality measure 
would require changes to the way that the quality measure is calculated 
and reported to us via a QCDR instead of through the CMS Web Interface. 
Therefore, due to the substantive changes needed to report this quality 
measure via a QCDR, this CMS Web Interface quality measure would be 
considered a non-MIPS quality measure. CMS would not be able to 
directly compare MIPS eligible clinicians submitting the quality 
measure using the CMS Web Interface to those submitting the quality 
measure using the QCDR. Thus, this would be considered a non-MIPS 
quality measure.
     In addition, the CAHPS for MIPS survey currently could be 
submitted only using a CMS-approved survey vendor. Although the CAHPS 
for MIPS survey is proposed for inclusion in the MIPS measure set, we 
consider the changes that will need to be made available for reporting 
by individual MIPS eligible clinicians (and not as a part of a group) 
significant enough as to treat the CAHPS for MIPS survey as a non-MIPS 
quality measure for purposes of reporting the CAHPS for MIPS survey via 
a QCDR. To the extent that further clarification on the distinction 
between a MIPS and a non-MIPS measure is necessary, we will provide 
additional guidance on our Web site.
    The following is a summary of the comments we received regarding 
identifying non-MIPS quality measures.
    Comment: A few commenters requested that CMS increase the number of 
allowed non-MIPS measures to be well above 30, potentially 
incrementally on an annual basis. One commenter believed doing so would 
limit the flexibility that QCDRs need to support MIPS eligible 
clinician reporting, particularly for MIPS eligible clinicians that 
have few MIPS measures available to report. Another commenter strongly 
recommended that CMS increase the cap of 30 measures within any given 
QCDR because increasing the cap will allow multi-specialty groups 
comprised of diagnostic radiologists and interventional radiologists to 
report via the same QCDR.
    Response: We appreciate the suggestion and will evaluate the 
feasibility of this request for future program years.
    Comment: One commenter supported the proposal for non-MIPS quality 
measure specifications for QCDRs.
    Response: We appreciate the support.
    Comment: Some commenters stated they strongly recommend that QCDRs 
maintain the authority to make an initial determination about how best 
to classify each of their measures, including whether it falls into a 
high priority category.
    Response: We will accept the QCDR's recommendation if the measure 
has been endorsed by NQF in a particular category. We reserve the right 
to not accept non-MIPS QCDR measures or the suggested category 
designated for the measure.
    Comment: One commenter requested more transparency to the non-MIPS 
quality measure approval process. The commenter requested rather than 
going through a rigorous approval process, CMS should require each QCDR 
to have a transparent, clearly-defined process for developing and 
updating the data elements and quality measures utilized in their 
measures. The commenter believed these processes should include an 
opportunity for public input, timelines for review and approval of new 
measures or changes to existing measures, a peer-review process, and 
adequate patient protections and consent procedures. The commenter 
believed QCDRs should identify data collection methods, including 
opportunities to collect patient-reported outcomes, and risk-adjustment 
strategies. The commenter stated that CMS should not dictate how each 
QCDR registry implements the standards, as flexibility is needed to 
respond to the evolving standard of care and the rigors and challenges 
of collecting data. In addition, the commenter encouraged CMS to work 
to incorporate these

[[Page 77376]]

recommendations through future rulemaking.
    Response: We will take these suggestions into consideration in 
future rulemaking.
    Comment: One commenter requested clarification on whether QCDRs can 
report non-MIPS measures using the XML format with, data extracted from 
an EHR electronically using applicable interoperability standards, and 
if these measures would meet CMS' proposed end-to-end electronic 
reporting requirement, to qualify for the electronic reporting bonus 
point.
    Response: We would like to explain that QCDRs will be able to 
report non-MIPS measures using the CMS-specified data submission 
standard. More specific details, including the full technical 
specifications for submitting non-MIPS measures to CMS for the 2017 
performance period, will be issued via subregulatory guidance at 
QualityPaymentProgram.cms.gov. We refer readers to the quality 
performance category scoring discussion in section II.E.6.a.(2) of this 
final rule with comment period for more details.
    Comment: A few commenters noted that there are quality measures 
that do not require certification and sought clarity from CMS on their 
specific certification requirements. The commenters specifically 
questioned if a registry would need to be certified to Sec.  
170.315(c)(1) through (3) to submit quality measures electronically or 
if the use of QRDA data structure requires certification. Some 
commenters recommended that the reporting mechanism requirements 
include discussion about third party intermediaries with incomplete 
measure certification and recommended that clinicians only be required 
to exhaust measures that are MIPS certified.
    Response: While a registry, QCDR, or other third party intermediary 
is not required to certify to submit MIPS eCQMs or non-MIPS measures to 
meet the requirements to qualify for the electronic reporting bonus, a 
registry may obtain certification to the CQM related certification 
criteria at Sec.  170.315(c)(1) through (3) to support the accuracy and 
standardization of clinician reporting. Registries are encouraged to 
seek certification to Sec.  170.315(c)(4) (clinical quality measures--
filter) if their services include reporting measures results to CMS or 
providing performance feedback to their participants at various levels 
of aggregation, such as individual clinician, patient, group, or 
population. We note that certification for the Sec.  170.315(c) 
criteria is measure-specific and includes only those CQM for which eCQM 
specifications have been published by CMS; however, these measures may 
use value sets and specifications that overlap with MIPS eCQMs. A 
registry may submit a submit a MIPS eCQM using either health IT 
certified to import and calculate (Sec.  170.315(c)(2)) and report 
(Sec.  170.315(c)(3)) those MIPS measures, or using an automated, 
verifiable software to process data, calculate and electronically 
report to the Quality Payment Program-accepted non-MIPS or registry 
measures consistent with CMS-vetted protocols. In either case, the 
registry's participating eligible clinicians would in turn need to 
record the clinical data for those CMS-published measures in their 
CEHRT and export to the registry in the required standard HQMF or QRDA 
using health IT certified to record and export (Sec.  170.315(c)(1)).
    The MIPS measures for which eCQM specifications are available can 
be readily identified by presence of a CMS e-Measure ID and by 
inclusion of ``EHR'' in the ``Data Submission Method'' column for that 
measure in the Appendix Table A: Individual Quality Measure Available 
for MIPS Reporting in 2017 of this final rule with comment period. 
Specifications and additional information relevant to submitting eCQMs 
to CMS are available at QualityPaymentProgram.cms.gov.
    A QCDR that is submitting non-MIPS measures is not required to use 
HQMF or QRDA, and may choose to use an API or other relevant standards 
supported by its participants' health IT to achieve standards-based 
access to quality measurement data. Because the HQMF and QRDA standards 
are familiar to many health IT vendors and EHR vendors, a registry 
might choose to use one or both of these standards to implement non-
MIPS measures. In this case, we would encourage the registry to use the 
development and testing tools available via the CMS-ONC eCQI Resource 
Center Web site (https://ecqi.healthit.gov/), to the extent applicable 
to their measure development and implementation approaches.
    Comment: Other commenters recommended that QCDR measures, 
particularly those focused on the improvement activities performance 
category, should be used to satisfy some requirements for improvement 
activities since there are no MIPS measures which are relevant to many 
subspecialists. The commenters stated that QCDR measures are not among 
the 200 measures that CMS has identified as being able to contribute to 
the quality performance category reporting score. The commenters stated 
that it appears that if MIPS eligible clinicians use QCDR measures as 
one of the six required measures, the method of scoring will penalize 
MIPS eligible clinicians for using non-standard measures.
    Response: The MACRA legislation requires four performance 
categories of the MIPS program. We cannot count the reporting of QCDR 
measures which would count in the quality performance category of the 
program to also count for the improvement activities performance 
category. If a MIPS eligible clinician uses a QCDR outcome measure as 
one of their six measures for the quality performance category, this 
would still count toward satisfying the reporting requirement. However, 
there are specific instances in which one improvement activity may be 
applicable to two performance categories. For example, the CAHPS for 
MIPS survey is included under the quality performance category, as well 
as the improvement activities performance category as a high weighted 
activity in the Beneficiary Engagement subcategory noted in Table H of 
the Appendix in this final rule with comment period. In addition, 
certain improvement activities may count for bonus points in the 
advancing care information performance category if the MIPS eligible 
clinician uses CEHRT. Reporting extra outcome or other high priority 
measures would still earn the MIPS eligible clinician bonus points, as 
discussed in section II.E.6.a.(2)(e) of this final rule with comment 
period. Regarding adding improvement activities to the improvement 
activities inventory for future years we refer readers to section 
II.E.5.f.(8)(b) of this final rule with comment period for the 
discussion on the annual call for activities.
    Comment: One commenter recommended that as part of the call for 
quality measures, contributions be entered into a single pool of eCQM 
definitions that get reviewed to ensure the measure is able to be 
derived from CEHRT data and reported on using CEHRT. They noted that 
the past practice of allowing various organizations to have different 
definitions, measure, and reporting formats has created unnecessary 
difficulty for clinicians and their CEHRT to effectively collect and 
report on the measure. The commenter further recommended that we arrive 
on a single definition for a measure for anybody to use with an 
interest in that measure and a single report format to make it easier 
to report to various organizations (CMS, registries, etc.) based on the 
same underlying data from the CEHRT. The commenter specifically 
recommended

[[Page 77377]]

that eCQMs be that single definition for a measure and that the QRDA be 
the single report format.
    Response: We thank the commenter for their suggestion. We refer the 
commenter to section II.E.5.c.(2) of this final rule with comment 
period for more detail on our requirements for the MIPS call for 
quality measures. We agree that there is value in trying to streamline 
the measure specification standards and data submission standards. We 
do not believe however that the eCQM measure specification standard, 
specifically the Health Quality Measure Format (HQMF) or that the QRDA 
data submission format can be that unified format for the transition 
year of MIPS. We will continue to evaluate this issue and address any 
changes in future notice and comment rulemaking.
    After consideration of the comments regarding the proposal 
regarding identifying non-MIPS quality measures we are finalizing the 
policies as proposed at Sec.  414.1400(e).
(7) Collaboration of Entities To Become a QCDR
    In the CY 2016 PFS final rule (80 FR 71136 through 71138) we 
finalized our proposal to allow collaboration of entities to become a 
QCDR based on our experience with the qualifying entities wishing to 
become QCDRs for performance periods. We received feedback from 
organizations who expressed concern that the entity wishing to become a 
QCDR may not meet the criteria of a QCDR solely on its own. We believe 
this policy supporting entity collaboration should be continued under 
MIPS. Therefore, we proposed at Sec.  414.1400 that an entity that may 
not meet the criteria of a QCDR solely on its own but could do so in 
conjunction with another entity, would be eligible for qualification 
through collaboration with another entity.
    We proposed to allow that an entity that uses an external 
organization for purposes of data collection, calculation, or 
transmission may meet the definition of a QCDR provided the entity has 
a signed, written agreement that specifically details the relationship 
and responsibilities of the entity with the external organization 
effective as of September 1 the year prior to the year for which the 
entity seeks to become a QCDR (for example, September 1, 2016, to be 
eligible to participate for purposes of the 2017 performance period). 
Entities that have a mere verbal, non-written agreement to work 
together to become a QCDR by September 1 the year prior to the year for 
which the entity seeks to become a QCDR would not fulfill this proposed 
requirement. We requested comments on these proposals.
    The following is a summary of the comments we received regarding 
collaboration of entities to become a QCDR.
    Comment: Some commenters recommended the deadline for a written 
agreement between entities collaborating to become a QCDR be November 1 
rather than September 1 to align with the November 1 deadline to self-
nominate.
    Response: We require this element to be completed at the beginning 
of the self-nomination period to enable and encourage QCDRs to self-
nominate as early as possible.
    Comment: Some commenters were not in favor of allowing entities 
that do not meet the QCDR criteria to collaborate with external 
organizations to qualify as QCDRs. The commenters were concerned that 
the language of this provision is so broad that it would allow health 
IT vendors and other commercial entities to become QCDRs without any 
participation of MIPS eligible clinician-led professional organizations 
that are focused on quality improvement relating to specific medical 
procedures, conditions, or diseases. The commenters believed language 
should be clarified to state that QCDRs that involve multiple 
organizations must be led and controlled by MIPS eligible clinician-led 
professional organizations or similar entities that are focused on 
quality improvement relating to particular types of medical procedures, 
conditions, or diseases.
    Response: Many specialty societies including subspecialty groups 
may not have the resources to develop the software platform needed to 
be a QCDR and thus partner with outside entities to support their QCDR. 
We believe that prohibiting specialty groups from partnering with 
outside entities would only serve to harm smaller societies and 
possibly prevent their participation in MIPS or at least limit their 
ability to measure and report data meaningful to their practice.
    After consideration of the comments received on the collaboration 
of entities to become a QCDR we are finalizing the policies as 
proposed. Specifically, we are finalizing at Sec.  414.1400 that an 
entity that may not meet the criteria of a QCDR solely on its own but 
could do so in conjunction with another entity, would be eligible for 
qualification through collaboration with another entity.
b. Health IT Vendors and Other Third Parties That Obtain Data From MIPS 
Eligible Clinician's CEHRT
    Currently, clinicians seeking to meet CMS quality program 
technology requirements must use EHR technology that is certified and 
meets the CEHRT definition established under the EHR Incentive Programs 
at 42 CFR 495.4. The Office of the National Coordinator for Health 
Information Technology (ONC) health IT certification program has 
established standards and other criteria for structured data that EHRs 
must use in order to be successfully tested and certified. We proposed 
to maintain this standard and require EHR-based data submission 
(whether transmitted directly from the EHR or from a data intermediary) 
to be CEHRT to submit quality measures, advancing care information, and 
improvement activities data for MIPS. In addition, we proposed at Sec.  
414.1400(a)(4) that health IT vendors that obtain data from a MIPS 
eligible clinician's CEHRT, like other third party intermediaries, 
would have to meet all criteria designated by us as a condition of 
their qualification or approval to participate in MIPS as a third party 
intermediary. This includes submitting data in the form and manner 
specified by us as proposed at Sec.  414.1400(a)(4)(ii). We anticipate 
that for the initial years of MIPS the form and manner requirements 
would be similar to what was used in the PQRS program. However, at a 
minimum these will be modified to address the four performance 
categories under MIPS and MIPS data calculation needs. As we gain 
experience under MIPS we anticipate that these form and manner 
requirements may change in future years to ease reporting burden. 
Historical form and manner requirements under the PQRS program are 
available at https://www.qualitynet.org/imageserver/pqrs/registry2015/index.htm or https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/QRDA_2016_CMS_IG.pdf. In addition, 
health IT vendors must comply with our QRDA Implementation Guides if 
submitting data from a CEHRT, which we anticipate will be similar to 
the one noted above. We anticipate providing further subregulatory 
guidance that would identify the CEHRT data formats that clinicians 
must submit. In addition, we proposed at Sec.  414.1325(b)(2) and 
(c)(2) to allow individual MIPS eligible clinicians and groups to 
submit data using CEHRT for the quality, improvement activities, or 
advancing

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care information performance categories.
    Although section 1848(q)(5)(B)(ii)(I) of the Act specifically 
requires the Secretary to encourage MIPS eligible clinicians to report 
on applicable measures using EHR technology with respect to the quality 
performance category, the statute does not specifically address 
allowing a third party intermediary--such as a health IT vendor--to 
submit on a MIPS eligible clinician's behalf for the other performance 
categories. Although we could limit the usage of health IT vendors 
assessing the quality performance category under MIPS, we believe it 
would be less burdensome for MIPS eligible clinicians if we expand the 
health IT vendors' capabilities. By allowing health IT vendors to 
report on the quality, advancing care information, and improvement 
activities 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. Our 
intention is to encourage health IT vendors to design systems that are 
able to support new types of EHR reporting (for example, improvement 
activities and advancing care information) from MIPS eligible 
clinicians and groups--this would be in addition to the quality measure 
data that we already can accept. Therefore, we proposed at Sec.  
414.1400(a)(2) to expand health IT vendors' capabilities by allowing 
health IT vendors to submit data on measures, activities, or objectives 
for any of the following MIPS performance categories:
     Quality;
     Improvement activities; or
     Advancing care information.
    As proposed at Sec.  414.1400(a)(1), health IT vendors submitting 
data on behalf of a MIPS eligible clinician or group would be required 
to obtain data from the MIPS eligible clinician's CEHRT. We believe 
this approach would permit a single health IT vendor to report on 
quality, advancing care information, and improvement activities 
performance category requirements for MIPS on behalf of multiple 
eligible clinicians or groups and should mitigate the risks, costs, and 
burden of MIPS eligible clinicians having to report multiple times to 
meet the requirements of MIPS.
Health IT Vendors Data Criteria
    We further proposed that health IT vendors must be able to do the 
following:
     For measures, activities, and objectives under the 
quality, advancing care information, and improvement activities 
performance categories, and as proposed at Sec.  414.1400(a)(4)(i); if 
the data is derived from CEHRT, the health IT vendor must be able to 
indicate this data source.
     Either transmit data from the certified EHR technology or 
through a data intermediary in the CMS-specified form and manner, or 
have the ability for the individual MIPS eligible clinician and group 
to be able to submit data directly from their CEHRT, in the CMS-
specified form and manner.
    For MIPS eligible clinicians who choose to electronically submit 
quality, advancing care information, and improvement activities data 
extracted from their CEHRT to an intermediary, the intermediary would 
then submit the measure and activity data to us in a CMS-specified form 
and manner on the MIPS eligible clinician's behalf for the respective 
performance period. In addition to meeting the appropriate data 
submission criteria for the quality, advancing care information, and 
improvement activities performance categories for the MIPS EHR 
submission mechanism, MIPS eligible clinicians who choose the EHR 
submission mechanism would be required to have CEHRT meeting the 
proposed definition at Sec.  414.1305. We requested comments on these 
proposals.
    The following is a summary of the comments we received regarding 
health IT vendors and other third parties that obtain data from an 
eligible clinician's CEHRT, referred to throughout this section as 
``health IT vendors.''
    Comment: Some commenters disagreed with the following health IT 
vendors' data criterion: Either transmit data from the CEHRT or through 
a data intermediary in the CMS-specified form and manner, or have the 
ability for the individual MIPS eligible clinician and group to be able 
to submit data directly from their CEHRT, in the CMS-specified form and 
manner. The commenters stated that they believed this requirement would 
be an intrusion the privacy of their patients.
    Response: The standards for submission for MIPS do not vary 
significantly from the existing standards and privacy protections in 
place for programs such as PQRS, and the EHR Incentive Programs. We 
intend to maintain these important privacy protections for patients in 
any new system designed for MIPS reporting. However, we would like to 
explain that the policy outlined here is only a requirement for health 
IT vendors or other authorized third parties submitting data on behalf 
of an MIPS eligible clinician or group for participation in MIPS. In 
order to do such a submission, the health IT vendor or third party must 
meet the form and manner requirements which include privacy and 
security standards. Additional details will be provided on the Quality 
Payment Program data submission standard at 
QualityPaymentProgram.cms.gov.
    Comment: A few commenters recommended making a requirement for 
health IT vendors to build and maintain products that meet federal 
specifications rather than forcing MIPS eligible clinicians to purchase 
and constantly upgrade expensive often-bulky systems. Another commenter 
encouraged standards developers to introduce accelerated cycle times 
for updating standards, especially new and modified standards required 
to support automation of quality reporting along with incorporating a 
degree of flexibility to accommodate the needs of a rapidly changing 
health IT landscape.
    Response: We thank the commenters for their feedback and note that 
our intent is to align the adoption of the key health IT standards 
across CMS quality reporting programs. That is to say, the standards we 
adopted for the use of certified health IT are industry standards which 
are first reviewed, analyzed, and adopted by the Secretary and are a 
part of ONC's Health IT Certification Program. These standards include 
key language for capturing structured data and document formats which 
are used by CMS programs and within the wider health care arena. In 
order to accommodate new standards and modifications as they arise, ONC 
periodically releases a new Edition of certification criteria which 
includes important updates as well as new functions to support 
clinicians leveraging health IT for patient care. CMS maintains a 
definition of CEHRT which requires clinicians to transition to new 
Editions over time in a consistent manner across our programs 
referencing certified health IT. These updates are essential to 
ensuring clinicians are using standards with high efficacy, accuracy, 
and the appropriate patient safety and security protocols.
    We established the definition of CEHRT to set the federal 
specifications for clinicians using certified health IT within our 
programs. For a certified health IT product or products to meet the 
CEHRT definition they must include Health IT Modules which are 
certified to certification criteria under the ONC Health IT 
Certification Program and are related to certain CMS program reporting. 
These include the ability to calculate the advancing care information 
measures, as well as the ability to accurately capture and export

[[Page 77379]]

CMS eCQMs. Further, the CEHRT definition includes functions which 
reference a wide range of file transport standards including the CCDA 
and QRDA formats as well as the API functionality. CMS and ONC then 
work together to further develop and publish specifications for health 
IT vendors which meet the form and manner requirements for reporting to 
our programs. For the Quality Payment Program, CMS and ONC will work to 
ensure that similar processes and testing of specifications is 
completed to support accurate and efficient CEHRT-based reporting for 
program participants. Additional details will be provided on the 
Quality Payment Program data submission standard at 
QualityPaymentProgram.cms.gov. For further information on the CEHRT 
definition adopted for the Quality Payment Program at Sec.  414.1305, 
we direct readers to section II.E.5.g. of this final rule with comment 
period.
    Comment: A few commenters believed that based on the proposal, it 
is difficult to determine if health IT vendors and third party data 
submission vendors are held to the same standards. The commenters 
requested that health IT vendors be held to the same criteria as QCDRs 
under MIPS. This includes providing regular feedback to participants 
and explaining methodologies. The commenters were concerned that the 
proposal was too broad and that health IT vendors and other entities 
could become QCDRs without MIPS eligible clinician-led professional 
organization participation. Several commenters requested that CMS 
reduce or eliminate the criteria related for third party 
intermediaries.
    Response: Health IT vendors and QCDRs are distinct submission 
mechanisms that have differing requirements and capabilities under 
MIPS. Generally, QCDRs which are engaged in quality measurement 
activities are held to standards related to these services. Health IT 
vendors provide services related to the development, implementation, 
and support of health IT systems. Some health IT vendors offer data 
submission services to CMS programs as a part of their support of 
health IT services. Other health IT vendors maintain a range of data 
transmission, aggregation, and calculation services or functions 
separate from the EHR immediately installed in the practice location, 
for example those operating a cloud-based system. Still other health IT 
vendors offer certified health IT products which allow a health care 
provider to autonomously manage their EHR system and electronically 
extract or export and report data to CMS programs directly from their 
CEHRT using functions which meet CMS form and manner requirements. 
Still other scenarios and potential options related to other authorized 
third parties not involved in the direct provision of EHR systems may 
be available to support MIPS participation. For example, some HIE 
organizations are exploring the option of supporting provider data 
submission by establishing partnerships with health IT vendors to 
submit data on behalf of their customers. The policies noted in this 
section which apply to health IT vendors apply to other authorized 
third parties and across each of these circumstances and other 
potential related scenarios. In this section of the final rule with 
comment period, we are explaining only that health IT vendors are 
accountable to ensure that their products and services meet the form 
and manner required regardless of which scenario or submission method 
is applicable when submitting on behalf of a MIPS eligible clinician or 
group.
    We note that form and manner requirements for the submission are 
related to the requirements defined for the measures and activities in 
each performance category within this final rule with comment period. 
Therefore, we note that while there is no specific standard or 
certification requirement for a health IT vendor or other authorized 
third party submitting data on behalf of an eligible clinician or group 
beyond the form and manner specifications for the submission mechanism, 
the eligible clinician or group must still meet the category or measure 
specific requirements. For example, within the quality performance 
category there are different requirements for CQMs which must be met 
depending on the measures an MIPS eligible clinician or group chooses 
to report, and the form and manner must be used for the submission 
mechanism appropriate for reporting those selected measures. This is 
consistent with prior CMS policy for PQRS and the EHR Incentive 
Programs, and is reflected in the CEHRT definition for the quality 
payment programs at Sec.  414.1305 for MIPS eligible clinicians or 
groups supported by these services. For example, the CQM submission 
requirement within that CEHRT definition states at paragraph 
(1)(ii)(B)(3) that a CQM submission meets certain certification 
criteria and can be electronically accepted by CMS if the data is 
submitted electronically. We reiterate that there are no certification 
criteria associated with measurement for the improvement activities 
performance category. For further information on how the CEHRT 
definition applies for MIPS eligible clinicians and groups under the 
quality performance category, we direct readers to the end-to-end 
electronic reporting bonus in section II.E.6. of this final rule with 
comment period. For further information on how the use of CEHRT is 
applicable for MIPS eligible clinicians and groups for the advancing 
care information performance category, we direct readers to section 
II.E.5.g. of this final rule with comment period. Finally, for 
information on how the use of CEHRT is applicable for APM Entities, we 
direct readers to section II.F.4.b. of this final rule with comment 
period.
    We appreciate the commenter's concern however on health IT vendors 
becoming a QCDR without the sponsorship or governance of a professional 
organization and would like to refer the commenter above to section 
II.E.9.a.(7) of this final rule with comment period, where we discuss 
the requirements of allowable partnerships between IT vendors and 
specialty organizations. We further disagree with setting no 
requirements for any third party intermediary as these policies ensure 
both that the MIPS eligible clinician is provided appropriate supports 
and protections and that CMS is able to accept and use the data 
submitted on their behalf.
    Comment: A few commenters stated the qualification requirements for 
companies in the general health IT vendor category (in contrast to 
requirements for PQRS submitters) are unclear. Many commenters 
requested CMS clarify what constituted a submission method that would 
need to be certified and requested clarification and additional details 
regarding what third party submission must do regarding submitting data 
for all performance categories. While some believed that EHR vendors 
can add improvement activities criteria into their systems fairly 
easily. Other commenters stated there is no current certification for 
improvement activities data and it is unclear how a MIPS eligible 
clinician could use CEHRT to submit improvement activities data without 
criteria for how to record or transmit such data. Some commenters 
requested an interim rule defining the specific requirements to become 
certified for MIPS data submission.
    Some commenters agreed with the health IT vendor criteria at Sec.  
414.1400(a)(2). However, the commenters were concerned about the 
ability of health IT vendors to incorporate mechanisms for reporting 
the new advancing care information and improvement activities 
performance

[[Page 77380]]

categories into QRDAs under the current reporting deadlines and without 
new implementation guides. Second, commenters noted that the most 
recent draft of the HL7 Quality Reporting Document Architecture (QRDA) 
had not incorporated these new performance categories as of the 
publication of the MIPS proposed rule and noted that this would be 
essential for facilitating vendor efforts to make software 
modifications. Third, once the QRDA is updated to accommodate the MIPS, 
it will be important for CMS to test and validate the reporting 
standards related to the inclusion of these new performance categories.
    Response: In our proposal, we stated our intent to encourage health 
IT vendors to design systems that are able to accept new types of EHR 
data (for example, improvement activities and advancing care 
information performance categories) from MIPS eligible clinicians and 
groups--would be in addition to the quality measure data that we 
already can accept directly through electronic reporting from CEHRT. 
Therefore, we proposed at Sec.  414.1400(a)(2) to expand health IT 
vendors' capabilities by allowing health IT vendors to submit data on 
measures, activities, or objectives for the quality, improvement 
activities, or advancing care information performance categories. We 
also proposed to require that EHR-based data submission (whether 
transmitted directly from the EHR or from a data intermediary) meet the 
CEHRT definition before it can submit quality measures, advancing care 
information, and improvement activities performance category data for 
MIPS. However, as noted in public comments, no certification criteria 
currently exists which is specific to the improvement activities 
performance category of MIPS and while there are criteria required for 
the calculation of measures within the advancing care information 
performance category, there is not a submission format certification 
requirement. We do not intend to add new burden on developers who are 
already working toward certification to the 2015 Edition certification 
criteria, nor do we intend to require MIPS eligible clinicians to 
obtain new certified Health IT Modules beyond the current CEHRT 
definition. For these reasons, we are finalizing a modified version of 
our proposal to require use of CEHRT for EHR-based data submission 
purposes for the 2017 performance period. We will continue to require 
the use of CEHRT for those items that the MIPS eligible clinician or 
group is reporting where that criterion is part of the current CEHRT 
definition for the 2014 Edition and 2015 Edition certification criteria 
for CY 2017 and the 2015 Edition only for CY 2018 and subsequent years, 
as defined for the Quality Payment Program at Sec.  414.1305. For 
instance, CEHRT may be required when submitting CMS eCQMs for which 
certification criteria exist for use depending on the selected 
submission mechanism (see section II.E.6. of this final rule with 
comment period for further details on end-to-end electronic reporting). 
The CEHRT definition also includes certification criteria for 
calculating advancing care information performance category objectives 
and measures included in the certification criteria (see section 
II.E.5.g. of this final rule with comment period for further details on 
the advancing care information performance category objectives and 
measures). We direct readers to section II.E.5.g. of this final rule 
with comment period for further discussion of the CEHRT definition 
adopted for the Quality Payment Program at Sec.  414.1305.
    However, we do agree with the commenters who note that the 
inclusion of improvement activities performance category reporting 
should be allowed for health IT vendors and we intend to allow MIPS 
eligible clinicians and groups the option to submit improvement 
activities performance category data in a manner similar to current 
reporting. In this way, we maintain our intent to encourage health IT 
vendors to design systems to be able to accept and support new types of 
data reporting within EHR systems. We further note that for MIPS, we 
are maintaining the requirement that submissions be reported in the 
form and manner specified by CMS. That form and manner will be 
specified by CMS for each available submission method through 
subregulatory guidance consistent with prior CMS quality reporting 
programs.
    We appreciate the commenter's feedback regarding the use of the 
QRDA and note than in prior years the CMS Implementation Guide (IG) 
included updated specifications for the QRDA that are similar to the 
types of updates that could potentially be included for reporting on 
advancing care information and improvement activities performance 
categories in MIPS. We do, however, understand and acknowledge the 
commenters concern on the timing of development to the IG as well as 
the need for adequate time for development, testing, and verification 
of any future updates to the QRDA Implementation Guide. We note that we 
will provide additional details related to the Quality Payment Program 
data submission standard at QualityPaymentProgram.cms.gov. We will 
continue to engage the vendor community as we implement MIPS in order 
to ensure that developers are aware of applicable criteria pertaining 
to the advancing care information, quality, and improvement activities 
performance categories and to obtain feedback and input on potential 
timing and development requirements to support reporting. We refer 
reader to section II.E.5.g. of this final rule with comment period for 
further discussion on CEHRT in the MIPS program.
    Comment: Some commenters recommended CMS collaborate more with 
health IT vendors. The commenters acknowledged that groups have a very 
difficult time finding a vendor that knows the requirements and can 
assist the groups. Other commenters stated they are concerned that 
allowing the health IT vendors use intermediaries to submit data to CMS 
would result in cost, waste, and risk of security breaches.
    Response: We thank the commenters for their suggestions and note 
that we will continue to engage the vendor and health IT vendor 
community as we implement MIPS. We appreciate the commenters expressing 
the concern and recognize that health IT vendors provide varying types 
of functions. We encourage MIPS eligible clinicians and groups to 
review the types of functions and services health IT vendors would be 
able to provide before selecting a health IT vendor in order to ensure 
that needs of the MIPS eligible clinician or group would be able to be 
met. For MIPS eligible clinicians, groups, or the supporting health IT 
vendors that do not have the functionality to submit data to CMS, the 
use of intermediaries may be necessary and beneficial. However, we note 
that any entity providing submission services on behalf of an MIPS 
eligible clinician or group must be authorized by the MIPS eligible 
clinician or group as a surrogate or proxy to submit data to CMS on 
their behalf. In addition, when an MIPS eligible clinician (a HIPAA 
covered entity) or health IT vendor (a HIPAA business associate) shares 
ePHI with an intermediary (another business associate) to perform a 
function for the covered entity all these entities must comply and 
abide by the HIPAA Privacy, Security, and Breach Notification Rules and 
all CMS policies pertaining to privacy and security.
    Comment: Some commenters were concerned that they believed CMS was 
moving away from the use of ONC-certified health IT products for 
calculating measures and requested that

[[Page 77381]]

CMS work with ONC to clarify in the final rule with comment period what 
the expectations/requirements are for third party calculation and 
submission. The commenters noted that it was unclear if a third party 
submitting on behalf of an MIPS eligible clinician or group will be 
receiving raw data from CEHRT and would be required to calculate 
numerators and denominators, or if they would be receiving already 
calculated data from CEHRT where the third party intermediary could 
pass the already calculated data electronically to CMS.
    Response: First, our goal is to encourage flexibility for the MIPS 
eligible clinician and the health IT vendors that support the MIPS 
eligible clinician. We, therefore, note that either scenario described 
where the third party performs calculations or where that third party 
submits already calculated data, would be acceptable for MIPS eligible 
clinicians and groups reporting to MIPS. We note that in either case, 
the third party would not be required to also be separately certified; 
however, the third party may test the calculations or certify to the 
calculations if there is an applicable certification criterion defined 
in the CEHRT definition for the Quality Payment Program at Sec.  
414.1305. While testing and certification is optional, we do strongly 
encourage this action to support accurate measurement where 
certification is available for the measure. In either case, the data 
must be appropriately electronically exported or extracted from the 
MIPS eligible clinicians' CEHRT. This means that if the MIPS eligible 
clinician is performing an export of raw data, the appropriate CEHRT 
function must be used if applicable for that data transmission, and if 
the MIPS eligible clinician is calculating and then exporting the data, 
the appropriate CEHRT function must be used if applicable for that 
calculation and data transmission. We refer readers to section 
II.E.5.g. of this final rule with comment period for further 
information specific to the capture, calculation, and submission of 
CQMs related to the end-to-end electronic reporting bonus within the 
quality performance category.
    We note that it is not our intent to move away from the use of 
certified health IT for calculating measures, but rather our intent is 
to recognize and accommodate the variability among MIPS eligible 
clinicians in technology use and adoption. Through these policies, we 
are seeking to reduce the burden and remove entry barriers to 
participation where possible for those MIPS eligible clinicians who may 
be engaging with CEHRT, meaningful use, quality measurement, and 
improvement activities for the first time as an individual MIPS 
eligible clinician or group. By allowing for greater flexibility in the 
first few years of the program, we are establishing a guide path to 
move toward expanded adoption, implementation, use, and innovation of 
certified health IT. In this way, we are allowing for adequate time for 
MIPS eligible clinicians, health IT vendors, and other third party 
entities like QCDRs to develop, test, implement, and monitor health IT 
systems designed to support participation in MIPS. However, where 
relevant standards have been established as part of the certification 
program, we believe that applying these standards will support more 
reliable, accurate quality measurement, and we will work with Quality 
Payment Program participants and the health IT vendor community to 
continue to expand the availability and applicability of these tools. 
Finally, we are maintaining our focus on electronic reporting that is 
standards-based. We also believe this approach encourages increased 
adoption and use within the health care industry of advanced health IT 
amongst MIPS eligible clinicians and APM entities. We intend to publish 
specific standards that third party intermediaries will need to follow 
for data submission through subregulatory guidance and will work with 
health IT vendors to develop, test, and verify that guidance for MIPS 
data submission.
    Comment: A few commenters sought clarification on the statement 
that EHR-based systems are required to be certified for multiple 
programs. Other commenters stated that beyond what is already required 
for CEHRT certification, they did not believe that CMS should force 
third party intermediaries to implement reporting capabilities that may 
be outside of their organizational and client priorities.
    Response: First, the CEHRT definition is what MIPS eligible 
clinicians and groups must use to meet certain requirements of MIPS 
related to the use of certified health IT. The CEHRT definition is not 
applicable to a QCDR, registry, or other third party providing health 
IT support services to an MIPS eligible clinician or group, although 
these groups may choose to develop or adopt certain elements of 
certified health IT in order to support reliable standards based 
measurement where relevant certification criteria exist.
    Second, there are not separate CEHRT requirements for separate CMS 
programs which reference CEHRT. The ONC-established certification 
criteria which are included in the CEHRT definition for the Quality 
Payment Program at Sec.  414.1305 and required for MIPS are not 
specific to a single component of CMS programs. Instead, ONC certifies 
individual Health IT Modules to perform specific functions using 
specific standards and implementation specifications that are part of 
the ONC Editions of certification criteria which are required only for 
those health IT vendors which are seeking to have their health IT 
certified. CMS then defines a package or collection of those certified 
Health IT Modules which an MIPS eligible clinician or group must 
possess to meet the CMS definition of CEHRT. The definition of CEHRT is 
currently substantively the same for MIPS, the EHR Incentive Programs, 
and Advanced Alternate Payment Models. This means that if an MIPS 
eligible clinician has an EHR system that meets the CEHRT definition, 
that system can support participation in each program (MIPS, EHR 
Incentive Program of AAPM) for which that clinician is eligible. The 
MIPS eligible clinician, or a health IT vendor submitting on their 
behalf, can report using data from that CEHRT for any such program 
without any additional certification as long as the submission meets 
the form and manner requirements established by CMS.
    Finally, there are multiple data submission methods available to 
MIPS eligible clinicians and groups. These multiple paths for reporting 
are designed to allow for flexibility to select the method most 
relevant for their practice, processes, and available features. For 
each of these submission methods, any submission on behalf of an MIPS 
eligible clinician or group must meet the form and manner requirements 
for data submission to us for that method. We understand a third party 
may offer a wide range of services to an MIPS eligible clinician or 
group beyond data submission to us. However, if that third party is 
offering data submission services for MIPS eligible clinicians, they 
must meet the form and manner specifications related to the chosen 
submission method. It is essential to maintain form and manner 
requirements specific to each of those methods in order to ensure the 
data can be accurately received, validated, and used to establish the 
appropriate payment adjustment for the performance period. We believe 
the flexibility of multiple paths will help to minimize burden on MIPS 
eligible clinicians, groups, and authorized third party intermediaries 
submitting on their behalf.
    Comment: Some commenters believed that since the final list of 
quality measures will not be published until the end of the year, it 
will be impossible to make any EHR configuration changes

[[Page 77382]]

that may be necessary for the reporting of the measures. In addition, a 
few commenters noted that EHR vendors will not have sufficient time to 
develop dashboards for tracking quality and advancing care information 
performance in MIPS before January 1, 2017. The commenters believed 
that EHR vendors will have to develop measurement logic for tracking 
and reporting group reporting of advancing care information before 
March 1, 2018 and several improvement activities rely on the use of 
EHRs may also create a need for system changes.
    Response: We recognize and can appreciate the concerns raised by 
the commenters. We have instituted numerous flexibilities in the 
transition year of MIPS to account for additional time needed for 
development and implementation. In addition, CMS and ONC will work 
together with health IT vendors on development, testing, and 
verification pathways for measure calculation and group reporting to 
support MIPS data reporting.
    Comment: Some commenters were concerned about the complexity of how 
CEHRT interacts with other products and registries and what 
capabilities should be certified. Other commenters recommended that new 
ONC EHR certifying criteria require meaningful data flow into 
registries and QCDRs, and that formats be amenable for the CMS Web 
Interface to reduce data burden. One commenter requested ongoing 
adoption of data interoperability standards for clinical data registry 
so they become interoperable with structured EHR clinical data.
    Response: At present, the definition of CEHRT established by CMS 
for MIPS at Sec.  414.1305 aligns with ONC certification criteria and 
includes requirements for a range of document formats which could be 
leveraged to engage with third parties such as registries, HIE 
organizations, and even with other health care providers who may not 
yet have access to certified health IT. In this way, technology that 
meets the definition of CEHRT supports the interoperable electronic 
exchange of data among varied settings across multiple platforms. CMS 
and ONC are working together to continue to advance the health IT 
infrastructure and support interoperability. We recognize that in the 
present environment, not all data received and used by qualified 
registries is derived from EHRs and readiness for certified health IT 
adoption among QCDRs varies greatly within the industry. While we agree 
that electronic transmission of the data elements needed to calculate 
quality measures would reduce burden on MIPS eligible clinicians and be 
potentially beneficial, we do not think it is appropriate for qualified 
registries to be required at this time to adopt a potentially costly 
change to their data collection model without adequate time to plan, 
test, implement, and ensure the efficacy of any such transition. We 
will continue to review and analyze readiness and engage with 
stakeholders to consider future development and needs.
    After consideration of the comments regarding health IT vendors 
that obtain data from MIPS eligible clinician's CEHRT, we are 
finalizing that the MIPS eligible clinicians who choose the EHR 
submission mechanism would be required to have certified EHR technology 
meeting the CEHRT definition for the quality payment program at Sec.  
414.1305 as proposed. In addition, we are finalizing the proposed 
policies for submission with modifications as follows.
    We are not finalizing a requirement for any certification criteria 
related to the submission of data beyond those which are currently 
defined within the CEHRT definition for the quality payment programs at 
Sec.  414.1305.
    In addition, we are further noting that the requirements within the 
CEHRT definition apply to the MIPS eligible clinician or group, not to 
the health IT vendor or other third party intermediary supporting that 
MIPS eligible clinician with data submission. We are finalizing at 
Sec.  414.1325(b)(2) and (c)(2) to allow MIPS eligible clinicians and 
groups to submit data for the improvement activities performance 
category, and data exported or extracted from CEHRT for the quality and 
advancing care information performance categories, either directly to 
CMS or with the support of a third party intermediary such as a health 
IT vendor or other authorized third party.
    Additionally, we are finalizing modifications to our proposal at 
Sec.  414.1400(a)(1) and (a)(2) that a health IT vendor or other 
authorized third party intermediary may submit data for the improvement 
activities performance category, and data exported or extracted from 
CEHRT for the quality and advancing care information performance 
categories, on behalf of an MIPS eligible clinician or group.
    We are finalizing at Sec.  414.1400(a)(4) that health IT vendors 
and other authorized third party intermediaries that obtain data 
exported or extracted from a MIPS eligible clinician's CEHRT would have 
to meet all criteria designated by us as a condition of their 
qualification or approval to participate in MIPS as a third party 
intermediary. As noted, this would include authorization by the MIPS 
eligible clinician or group to submit on their behalf and also includes 
submitting data in the form and manner specified at Sec.  
414.1400(a)(4)(ii).
    Finally, we are finalizing a modification to the proposed policy 
regarding the requirements for health IT vendors to state that health 
IT vendors or other authorized third party intermediary that are 
submitting on behalf of an MIPS eligible clinician or group must be 
able to do the following to submit MIPS data to us:
     For measures, activities, and objectives under the 
quality, advancing care information, and improvement activities 
performance categories, and as proposed at Sec.  414.1400(a)(4)(i); if 
the data is exported or extracted from certified EHR technology, the 
health IT vendor or third party must be able to indicate this data 
source; and
     Transmit the data electronically exported or extracted 
from the CEHRT to us directly or through a data intermediary in the 
CMS-specified form and manner.
c. Qualified Registries
    We proposed to define a qualified registry at Sec.  414.1305 as a 
medical registry, a maintenance of certification program operated by a 
specialty body of the American Board of Medical Specialties or other 
data intermediary that, with respect to a particular performance 
period, has self-nominated and successfully completed a vetting process 
(as specified by CMS) to demonstrate its compliance with the MIPS 
qualification criteria specified by CMS for that performance period. 
The registry must have the requisite legal authority to submit MIPS 
data (as specified by CMS) on behalf of a MIPS eligible clinician or 
group to CMS. In addition, we proposed at Sec.  414.1400(a)(2) to 
expand a qualified registry's capabilities by allowing qualified 
registries to submit data on measures, activities, or objectives for 
any of the following MIPS performance categories:
     Quality;
     Improvement Activities; or
     Advancing care information, if the MIPS eligible clinician 
or group is using certified EHR technology.
    The following is a summary of the comments we received regarding 
the proposed qualified registry definition and expanded capabilities 
proposal.
    Comment: Some commenters agreed with the proposed definition of a 
qualified registry.
    Response: We appreciate the commenters support.

[[Page 77383]]

    Comment: Several commenters agreed with the proposal to allow third 
party intermediaries, such as qualified registries, to submit data for 
the performance categories of quality, advancing care information, and 
improvement activities. The commenters believed allowing MIPS eligible 
clinicians to use a single, third party submission method reduces the 
administrative burden on MIPS eligible clinicians, facilitates 
consolidation, and standardization of data from disparate EHRs and 
other systems, and enables the third parties to provide timely, 
actionable feedback to MIPS eligible clinicians on opportunities for 
improvement in quality and value.
    Response: We thank the commenters for their support.
    Comment: A few commenters did not support the criteria that 
qualified registries must have the capability to submit for all 
performance categories. The commenters believed that while this could 
reduce burden for MIPS eligible clinicians, choosing to support one or 
more performance categories is a business decision and should not be 
regulated. In addition, the commenters stated this would limit the MIPS 
eligible clinician's choice in the early years of MIPS, as not all 
third party entities would necessarily be able to meet the criteria for 
submittal for all three performance categories.
    Response: While we do encourage qualified registries to be able to 
support for all performance categories we do not require that all MIPS 
performance categories be reported by a qualified registry. Rather we 
require that a qualified registry be able to report the quality 
performance category and note that it is the registry's choice to be 
qualified to the advancing care information and improvement activities 
performance categories.
    After consideration of the comments on the qualified registry 
policies above we are finalizing the policies at Sec. Sec.  414.1305 
and 414.1400(a)(2) as proposed.
(1) Establishment of an Entity Seeking To Qualify as a Registry
    We proposed at Sec.  414.1400(h) that in order for an entity to 
become qualified for a given performance period as a qualified 
registry, the entity must be in existence as of January 1 of the 
performance period for which the entity seeks to become a qualified 
registry (for example, January 1, 2017, to be eligible to participate 
for purposes of performance periods beginning in 2017). The qualified 
registry must have at least 25 participants by January 1 of the 
performance period. These participants do not necessarily need to be 
using the qualified registry to report MIPS data to us; rather, they 
need to be submitting data to the qualified registry for quality 
improvement. We also proposed a qualified registry must provide 
attestation statements from the qualified registry/MIPS eligible 
clinicians during the data submission period that all of the data 
(quality measures, improvement activities, and advancing care 
information measures and objectives, if applicable) and results are 
accurate and complete.
    The following is a summary of the comments we received regarding 
our proposal for the establishment of an entity seeking to qualify as a 
registry.
    Comment: A few commenters expressed concern for the proposed 25-
participant minimum for qualified registries for an entity to become 
qualified for a given performance period as the commenters believed the 
criteria were arbitrary. Further, the commenters stated that 
participants should be required to be in place on January 1 as they did 
not believe registries would have the potential to pull historical data 
from the performance period.
    Response: As the MIPS program relies on the ability of CMS to 
receive accurate data for MIPS eligible clinicians, we believe it is 
important to approve established entities who have demonstrated their 
ability to collect and calculate data. We require a 25 participant 
minimum for entities to self-nominate as a qualified registry because 
we have found in past programs that 25 participants is an adequate 
number of participants that will prevent small clinical practices from 
attempting to be their own registry. We are concerned that potentially 
smaller practices may not have the IT expertise to report their data 
and there is no intermediary to validate the submitted data. 
Additionally, having existing registry members will help to ensure that 
the entity has at least some experience collecting and calculating 
quality measure data.
    After consideration of the comments received regarding our proposal 
for the establishment of an entity seeking to qualify as a registry, we 
are finalizing the policies at Sec.  414.1400(h) as proposed.
(2) Self-Nomination Period
    For the 2017 performance period, we proposed at Sec.  414.1400(g) 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 proposed to establish the self-nomination period from 
September 1 of the prior year until November 1 of the year in which the 
qualified registry seeks to be qualified. Entities that desire to 
qualify as a qualified registry for purposes of MIPS for a given 
performance period would need to provide all requested information to 
us at the time of self-nomination and would need to self-nominate for 
that performance period. Having qualified as a qualified registry does 
not automatically qualify the entity to participate in subsequent MIPS 
performance periods. For example, a qualified registry may choose not 
to continue participation in the program in future years, OR the 
qualified registry may be precluded from participation in a future 
year, due to multiple data or submission errors as noted below. As 
such, we believe 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 proposed to require further information of qualified registries 
at the time of self-nomination. All self-nomination information must be 
submitted to [email protected]. If technically feasible 
we will accept self-nomination information via a web-based tool; we 
will provide any further information on the web-based tool at 
QualityPaymentProgram.cms.gov. If an entity becomes qualified as a 
qualified registry, they would need to sign a statement confirming this 
information is correct prior to us listing their qualifications on 
their Web site. Once we post the qualified registry on our Web site, 
including the services offered by the qualified registry, we would 
require the qualified registry to support these services/measures for 
its clients as a condition of the entity's qualification as a qualified 
registry for purposes of MIPS. Failure to do so will preclude the 
qualified registry from participation in MIPS in the subsequent 
performance year.
    We did not receive any comments regarding our proposals for the 
qualified registry self-nomination period. Therefore, we are finalizing 
the policies at Sec.  414.1400(g) as proposed.
(3) Information Required at the Time of Self-Nomination
    We proposed that a qualified registry must provide the following 
information to us at the time of self-nomination:
     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).

[[Page 77384]]

     MIPS performance categories (that is, categories for which 
the entity is self-nominating to report. For example, quality measures, 
advancing care information, or improvement activities).
     Performance Period.
     Vendor Type (for example, qualified 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; CEHRT; 
other (please explain). If a combination of methods (Claims, web-based 
tool, Practice Management System, CEHRT, or other) is utilized, please 
state which method(s) the entity utilizes to collect data (performance 
numerator and denominator).
     Indicate the method the entity will use to verify the 
accuracy of each TIN/NPI and/or TIN it is intending to submit (for 
example; National Plan and Provider Enumeration System (NPPES), CMS 
claims, tax documentation).
     Describe the method 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 improvement activities and advancing 
care information performance categories 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 qualified registry 
is submitting data on; that is, quality, improvement activities, and 
advancing care information, as applicable). Periodic examinations may 
be completed to compare patient record data with submitted data or 
ensure MIPS quality measures or other performance category (improvement 
activities and advancing care information) activities, measures, or 
objectives were accurately reported and performance calculated based on 
the appropriate measure specifications (that is, accuracy of numerator, 
denominator, and exclusion criteria) or performance category criteria.
     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 MIPS eligible clinicians submitted to 
CMS by the qualified registry be sampled with a minimum sample of 10 
TIN/NPIs or a maximum sample of 50 MIPS eligible clinicians. For each 
MIPS eligible clinician sampled, it is encouraged that 25 percent of 
the MIPS eligible clinicians' 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 31st of the year following the performance period. If the 
results indicate the qualified registry's validation reveals inaccuracy 
or low compliance provide to us an improvement plan. Failure to 
implement improvements may result in the qualified registry being 
placed in a probationary status or disqualification from future 
participation.
    We did not receive any comments on the proposal regarding 
information required at the time of self-nomination for a qualified 
registry. Therefore, we are finalizing the above policies as proposed.
(4) Qualified Registry Criteria for Data Submission
    Further, we proposed that a qualified registry must perform the 
following functions:
     For measures, activities, and objectives under the 
quality, advancing care information, and improvement activities 
performance categories and as proposed at Sec.  414.1400(a)(4)(i); if 
the data is derived from CEHRT, the qualified registry must be able to 
indicate this data source.
     A qualified registry 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 to us, quality measures and activities data on all 
patients, not just Medicare patients.
     Submit quality measures, advancing care information, or 
improvement activities performance categories data and results to us in 
the applicable MIPS performance categories for which the qualified 
registry is providing data.
     Provide timely feedback, at least four times a year, on 
all of the MIPS performance categories that the qualified registry will 
report to us. That is, if the qualified registry will be reporting on 
data for the improvement activities, advancing care information, or 
quality performance category, all results as of the performance 
feedback date should be included in the information sent 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 qualified registry reports. The qualified registry is only required 
to provide feedback based on the MIPS eligible clinician's data that is 
available at the time the performance feedback is generated.
     A qualified registry must comply with any request by us to 
review the data submitted by the qualified registry 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 qualified registry kick-off meeting (if held) at our 
headquarters in Baltimore, MD. More than one unexcused absence could 
result in the qualified registry being precluded from participation in 
the program for that year. If a qualified registry is precluded from 
participation in MIPS, the individual MIPS eligible clinician or group 
would need to find another entity 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 qualified registry 
may result in notations on our qualified registry posting of low data 
quality and would place the qualified registry on probation (if they 
decide to self-nominate for the next program year). If the qualified 
registry 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 qualified 
registry may lead to the disqualification of the qualified registry 
from participation in the following year's program. As we gain 
additional experience with qualified registries, we

[[Page 77385]]

intend to revisit and enhance these thresholds in future years.
     Be able to report at least six quality measures including 
one cross-cutting measure and one outcome measure. If an outcome 
measure is not available, be able to report another high priority 
measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures).
     Enter into and maintain with its participating MIPS 
eligible clinicians an appropriate Business Associate agreement that 
provides for the qualified registry's receipt of patient-specific data 
from an individual MIPS eligible clinician or group, as well as the 
qualified registry'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 or 
group.
     Obtain and keep on file signed documentation that each 
holder of an NPI whose data are submitted to the qualified registry, 
has authorized the qualified registry to submit quality measure 
results, improvement activities measure and activity results, advancing 
care information objective results and numerator and denominator data 
or patient-specific data on Medicare and non-Medicare beneficiaries to 
us for the purpose of MIPS participation. This documentation should be 
obtained at the time the MIPS eligible clinician or group signs up with 
the qualified registry to submit MIPS data to the qualified registry 
and must meet any applicable laws, regulations, and contractual 
business associate agreements. Groups participating in MIPS via a 
qualified registry may have their group's duly authorized 
representative grant permission to the qualified registry to submit 
their data to us. If submitting as a group each individual MIPS 
eligible clinician does not need to grant their individual permission 
to the qualified registry to submit their data to us.
     Not be owned and managed by an individual locally-owned 
single specialty group (for example, single specialty practices with 
only one practice location or solo practitioner practices are 
prohibited from self-nominating to become a MIPS qualified registry).
     Be able to separate out and report on all payers, 
including Medicare Part B FFS patients and non-Medicare patients.
     Provide the measure numbers for the MIPS quality measures 
on which the qualified registry is reporting.
     Provide the measure title (and specialty-specific measure 
set title, if applicable) for the MIPS quality measures and improvement 
activities (if applicable) on which the qualified registry is 
reporting.
     Indicate if the qualified registry will be reporting the 
advancing care information component measures and objectives.
     Report the number of eligible instances (reporting 
denominator).
     Report the number of instances a quality service is 
performed (performance numerator).
     Report the number of performance exclusions, meaning the 
quality action was not performed for a valid reason as defined by the 
measure specification.
     Comply with a CMS-specified secure method for data 
submission, such as submitting the qualified registry's data in an XML 
file.
     Sign a document verifying the qualified registry's name, 
contact information, cost for MIPS eligible clinicians or groups to use 
the qualified registry, services provided, and the specialty-specific 
measure sets the qualified registry intends to report. Once posted on 
the qualified registry's CMS Web site, the qualified registry will need 
to support the measures or measure sets confirmed by the qualified 
registry. Failure to do so will may preclude the qualified registry 
from participation in MIPS in the subsequent year.
     Must provide attestation statements during the data 
submission period that all of the data (quality measures, improvement 
activities, and advancing care information measures and objectives, if 
applicable) and results are accurate and complete.
     For purposes of distributing performance feedback to MIPS 
eligible clinicians, collect a MIPS eligible clinician's email 
address(es) and have documentation from the MIPS eligible clinician 
authorizing the release of his or her email address.
     Be able to calculate and submit measure-level reporting 
rates or, upon request, the data elements needed to calculate the 
reporting and performance rates by TIN/NPI and/or TIN.
     Be able to calculate and submit, by TIN/NPI or TIN, a 
performance rate (that is the percentage of a defined population who 
receive a particular process of care or achieves a particular outcome 
based on a calculation of the measures' numerator and denominator 
specifications) for each measure on which the TIN/NPI and/or TIN 
reports or, upon request the Medicare and non-Medicare level data 
elements needed to calculate the performance rates.
     Provide the performance period start date the qualified 
registry will cover.
     Provide the performance period end date the qualified 
registry will cover.
     Report the number of instances in which the applicable 
submission criteria were not met, for example, the quality measure was 
not reported and a performance exclusion did not apply.
     For data validation purposes, provide information on the 
entity's sampling methodology. For example, if is encouraged that 3 
percent of the MIPS eligible clinicians be sampled with a minimum 
sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS 
eligible clinicians. For each MIPS eligible clinician sampled, it is 
encouraged that 25 percent of the MIPS eligible clinicians' 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.
    The following is a summary of the comments we received regarding 
our proposal for the qualified registry criteria for data submission.
    Comment: One commenter requested assurance that Immunization 
Registries and Immunization Information Systems (IIS) did not fall into 
the category of a qualified registry.
    Response: We would like to explain that any organization that would 
like to become a qualified registry for the MIPS must self-nominate and 
meet the requirements of qualified registries described within this 
final rule with comment period.
    Comment: One commenter recommended the Quality Markers program 
(qualified vendor and a qualified registry under PQRS) as a reporting 
tool.
    Response: We would like to explain that any organization that would 
like to become a qualified registry for the MIPS must self-nominate and 
meet the requirements of qualified registries described within this 
rule. MIPS eligible clinicians and groups have the option to choose 
whatever data submission method best suits their practice.
    Comment: A few commenters agreed that a qualified registry must 
provide attestation statements from the qualified registry or MIPS 
eligible clinicians during the data submission period that all the data 
and results are accurate and complete.
    Response: We appreciate the support and are working to streamline 
this process for registries by allowing the attestation at the time of 
actual data submission.
    Comment: One commenter was concerned about the cost of the 
qualified registries and questioned if CMS could provide a qualified 
registry or EHR at low cost.

[[Page 77386]]

    Response: We will take the commenters suggestion under 
consideration of creating a CMS registry or EHR for future rulemaking.
    After consideration of the comments regarding qualified registry 
criteria for data submission we are finalizing the above policies as 
proposed with one modification. Based on our policies finalized in 
section II.E.5.b.(3) of this final rule with comment period, we are not 
requiring MIPS eligible clinicians to submit data on cross-cutting 
measures. Therefore, we are finalizing at Sec.  414.1335(a)(1)(i) the 
requirement for registries as follows: Be able to submit results for at 
least six quality measures including 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 registry must provide a 
justification for not including an outcome measure.
d. CMS-Approved Survey Vendors
    As discussed in the proposed rule (81 FR 28188), we proposed to 
allow groups to report CAHPS for MIPS survey measures. We proposed the 
data collected on the CAHPS for MIPS survey measures would be 
transmitted to us via a CMS-approved survey vendor.
    For purposes of MIPS, we proposed to define a CMS-approved survey 
vendor at Sec.  414.1305 as a survey vendor that is approved by us for 
a particular performance period to administer the CAHPS for MIPS survey 
and transmit survey measures data to us. We proposed at Sec.  
414.1400(i) that vendors are required to undergo the CMS approval 
process for each year in which the survey vendor seeks to transmit 
survey measures data to us. We anticipate retaining the same policies 
and procedures we currently follow for a CMS-approved survey vendor for 
PQRS and apply them to a MIPS CMS-approved survey vendor. We proposed 
the following criteria for a CMS-approved survey vendor for the CAHPS 
for MIPS survey. A CMS-approved survey vendor for CAHPS for MIPS must:
    (1) Comply with and complete the Vendor Participation Form--We 
anticipate retaining the same application process and Vendor 
Participation Form that was required for the CAHPS for PQRS survey. 
Please refer to http://www.pqrscahps.org/en/participation-form/ for 
further details. Therefore, we proposed at Sec.  414.1400(i) that all 
CMS-approved survey vendor applications and materials will be due April 
30 of the performance period. However, we sought comments on whether 
the deadline for CMS-approved survey vendor applications and materials 
should be earlier, such as prior to the beginning of the performance 
period. In addition, we proposed the following items will be required 
for your organization to be a CMS-approved survey vendor of the CAHPS 
for MIPS survey:
     Meet all of the Minimum Survey Vendor Business 
Requirements at the time of the submission of the Vendor Participation 
Form; and
     Complete the Vendor Participation Form.
    (2) Comply with the Minimum Survey Vendor Business Requirements--We 
anticipate retaining the same minimum survey business requirements that 
were required for the CAHPS for PQRS survey. Please refer to http://www.pqrscahps.org/en/business-requirements/ for further details. We 
proposed Applicant Organizations (survey vendor and subcontractors) 
must possess all required facilities and systems to implement the CAHPS 
for MIPS survey. Subcontractors will be subject to the same 
requirements as the applicant vendor. Organizations that are approved 
to administer the CAHPS for MIPS s-Survey must conduct all their CAHPS 
for MIPS business operations within the United States. This requirement 
applies to all staff and subcontractors. In addition, we proposed to 
request information regarding:
     Relevant organization and survey experience.
     Survey capability and capacity.
     Adherence to quality assurance guidelines and 
participation in quality assurance activities.
     Documentation requirements.
     Adhere to all protocols and specifications, and agree to 
participate in training sessions
    Specifically, to obtain our approval, we proposed that survey 
vendors would be required to undergo training, meet our standards on 
how to administer the survey, and submit a quality assurance plan. We 
would provide the identified survey vendor with an appropriate sample 
frame of beneficiaries from each group that has contracted with the 
survey vendor and elected to participate in the CAHPS for MIPS survey. 
The survey vendor would also be required to administer the survey 
according to established protocols to ensure valid and reliable 
results. More information on quality assurance and protocols can be 
reviewed at http://www.pqrscahps.org/en/quality-assurance-guidelines/. 
CMS-approved survey vendors would be supplied with mail and telephone 
versions of the survey in electronic form, and text for beneficiary 
pre-notification and cover letters. CAHPS for MIPS surveys can be 
administered in English, Spanish, Cantonese, Mandarin, Korean, Russian 
and/or Vietnamese. Survey vendors would be required to use appropriate 
quality control and security (to include encryption and backup) 
procedures to maintain survey response data. The data would then be 
securely sent back to us for scoring and/or validation in accordance 
with applicable law. To ensure that a survey vendor possesses the 
ability to transmit survey measures data for a particular performance 
period, we propose to require survey vendors to undergo this approval 
process for each year in which the survey vendor seeks to transmit 
survey measures data to us. We requested comments on this proposal.
    The following is a summary of the comments we received regarding 
the CMS-approved survey vendors.
    Comment: One commenter recommended that CMS[hyphen]approved survey 
vendors should have 2 years of prior experience selecting random 
samples based on specific eligibility criteria, work with their 
contracted client medical group(s) or MIPS eligible clinician(s) to 
obtain patient data for sampling via HIPAA compliant electronic data 
transfer processes, and adequately document the sampling process.
    Response: We will take these comments into consideration in future 
rulemaking.
    After consideration of the comments regarding CMS-approved survey 
vendors we are finalizing Sec. Sec.  414.1305 and 414.1400(i) and the 
above policies as proposed.
e. Probation and Disqualification of a Third Party Intermediary
    We proposed at Sec.  414.1400(k) a process for placing third party 
intermediaries on probation and for disqualifying such entities for 
failure to meet certain standards established by CMS. Specifically, we 
proposed that if at any time we determine that a third party 
intermediary (that is, a QCDR, health IT vendor, qualified registry, or 
CMS-approved survey vendor) has not met all of the applicable criteria 
for qualification, we may place the third party intermediary on 
probation for the current performance period and/or the following 
performance period, as applicable.
    In addition, we proposed that we require a corrective action plan 
from the

[[Page 77387]]

third party intermediary to address any deficiencies or issues and 
prevent them from recurring. We proposed the corrective action plan 
must be received and accepted by us within 14 days of the CMS 
notification to the third party intermediary of the deficiencies or 
probation. Failure to comply with this would lead to disqualification 
from MIPS for the subsequent performance period.
    We proposed probation to mean that, for the applicable performance 
period, the third party intermediary would not be allowed to miss any 
meetings or deadlines and would need to submit a corrective action plan 
for remediation or correction of deficiencies identified that resulted 
in the probation.
    In addition, we proposed that if the third party intermediary has 
data inaccuracies including (but not limited to) TIN/NPI mismatches, 
formatting issues, calculation errors, data audit discrepancies 
affecting in excess of 3 percent (but less than 5 percent) of the total 
number of MIPS eligible clinicians or groups submitted by the third 
party intermediary, we would annotate on the CMS qualified posting that 
the third party intermediary furnished data of poor quality and would 
place the entity on probation for the subsequent MIPS performance 
period with the opportunity to go on probation for a year to correct 
their deficiencies.
    Further, we proposed if the third party intermediary does not 
reduce their data error rate below 3 percent for the subsequent 
performance period, the third party intermediary would continue to be 
on probation and have their listing on the CMS Web site continue to 
note the poor quality of the data they are submitting for MIPS for one 
additional performance year. After 2 years on probation, the third 
party intermediary would be disqualified for the subsequent performance 
year. Data errors affecting in excess of 5 percent of the MIPS eligible 
clinicians or groups submitted by the third party intermediary may lead 
to the disqualification of the third party intermediary from 
participation for the following performance period. In placing the 
third party intermediary on probation; we would notify the third party 
intermediary of the identified issues, at the time of discovery of such 
issues.
    Finally, we proposed if the third party intermediary does not 
submit an acceptable corrective action plan within 14 days of 
notification of the deficiencies and correct the deficiencies within 30 
days or before the submission deadline--whichever is sooner, we may 
disqualify the third party intermediary from participating in MIPS for 
the current performance period and/or the following performance period, 
as applicable. We requested comments on these proposals.
    The following is a summary of the comments we received regarding 
probation and disqualification of a third party intermediary.
    Comment: A few commenters agreed that CMS should implement a 
process for placing third party intermediaries on probation for 
disqualifying such entities for failure to meet certain standards.
    Response: We appreciate the commenters' support.
    Comment: Some commenters expressed concern about the potential for 
qualified QCDRs and registries to subsequently fail to fulfill their 
reporting criteria and advised CMS to finalize language holding MIPS 
eligible clinicians harmless in the event of a vendor data failure.
    Response: CMS cannot ensure that third party intermediaries will 
meet the applicable submission criteria in all instances. We can, 
however, monitor the success of these entities and preclude their 
participation in the program in future years. Further, we note that 
MIPS eligible clinicians are ultimately responsible for the data that 
is submitted by their third party intermediaries and expect that MIPS 
eligible clinicians are ultimately holding their third party 
intermediaries accountable for accurate reporting. We refer readers to 
section II.E.8.c. of this final rule with comment period for more 
information on the targeted review process.
    Comment: A few commenters supported CMS' proposal to provide an 
initial probationary period where a third party intermediary can 
correct identified issues, and recommends that if a QCDR is found not 
able to submit accurate data, then CMS should assess MIPS eligible 
clinicians who used that QCDR as ``average'' for the MIPS quality 
performance category. The commenters recommended that CMS change the 
corrective action plan deadline to 21 days or any timeline as agreed 
upon by both CMS and the submitter, as depending on the issue and the 
entity, 14 days may not be reasonable. Another commenter believed that 
14 days is too short to properly diagnose a problem and 30 days is too 
short to solve it. The commenter requested 30 days for diagnosis and 45 
for the implementation of the solution, to prevent hasty coding that 
may cause future errors.
    Some commenters proposed that at least 30 days be allowed for the 
corrective action plan and an additional 45 days to deploy the 
solution; the imminence of a reporting deadline should not limit the 
time available to deploy a solution; such haste could create additional 
problems for clinicians and CMS. The commenters also recommended that 
CMS have provisions in place to use updated data submitted after the 
reporting deadline. The commenters stated that 14 days could be much 
too little time to properly diagnose a problem and propose and test a 
solution. Similarly, 30 days could be much too little time to deploy a 
solution that could require patching software and changes in clinician 
workflows.
    Other commenters stated that timeframes in this section are 
unreasonably short and recommended they be extended. They believed that 
it is unreasonable for CMS to expect that a health IT vendor would be 
able to verify that a problem exists, identify and troubleshoot the 
source of the problem, and present a precise solution for correcting 
the problem, within 14 days. The commenters requested that CMS extend 
this to 30 days, at a minimum. The commenters believed for the 
correcting deficiencies, 30 days may be unreasonably short and 
depending on the nature of the problem, believed it can take anywhere 
from a week to several months to program a software patch, and even 
longer to correct the problem through a software upgrade. The 
commenters requested that CMS extend this to 90 days, at a minimum.
    Response: We acknowledge the challenges of a 14 day time period for 
correction of errors by qualified registries and QCDRs, however we 
believe that the data should be submitted early in the submission 
window which would allow for a longer correction timeframe. 
Additionally, we encourage the qualified entity to run their results 
through a quality assurance check before submission. The requested time 
extension would affect CMS' ability to calculate and report final score 
to MIPS eligible clinicians and their ability to question the results 
before any MIPS payment adjustments are made the following year.
    Comment: A few commenters did not believe QCDRs should be placed on 
probation if they submit data with inaccuracies. The commenters 
believed this should be consistent across document and measurement 
criteria.
    Response: We want the MIPS eligible clinicians using QCDRs and 
qualified registries to be able to have confidence that their data is 
collected, analyzed, and reported accurately. We provide QCDRs and 
qualified registries a report of the data issues discovered from each 
previous participation year so that the

[[Page 77388]]

entities have an opportunity to correct any identified problems. 
Accordingly, we believe the best way to ensure we receive accurate data 
from QCDRs and qualified registries and to protect participating MIPS 
eligible clinicians is to place entities with high data issue rates on 
probation or disqualify them from participating in future program 
years. At the same time, we note that TINs are ultimately responsible 
for the data that are submitted by their third party intermediaries and 
expect that TINs are ultimately holding their third party 
intermediaries accountable for accurate reporting.
    Comment: A few commenters expressed concern with the 
disqualification process and the resulting financial impact to MIPS 
eligible clinicians and groups. The commenters stated that the third 
party intermediaries have limited financial risk and burden if they are 
disqualified, and that financial burden rests on the MIPS eligible 
clinicians and groups.
    Response: We note that MIPS eligible clinicians and groups are 
ultimately responsible for the data that are submitted by their third 
party intermediaries and expect that MIPS eligible clinicians and 
groups should ultimately hold their third party intermediaries 
accountable for accurate reporting. We believe that operational and 
policy protections that we are putting in place through this final rule 
with comment period will significantly limit the number of third party 
intermediaries from being disqualified during the performance period.
    Comment: Some commenters stated that they support CMS' proposal for 
probation and disqualification of third party intermediaries.
    Response: We appreciate the commenters' support.
    Comment: Other commenters stated that if a QCDR, qualified 
registry, or EHR vendor is not submitting correct and valid data (after 
testing, validation and the opportunity to correct), then the QCDR 
should be placed on a corrective action plan. The commenters added that 
if after the probationary period the QCDR is still not adequately 
submitting data, the QCDR should be excluded from future performance 
periods until such time that it could show through testing that it is 
able to submit valid data.
    Response: We appreciate the comment. If the QCDR or qualified 
registry has a large percent of their participants whose final data is 
inaccurate and not usable, then the entity may be excluded from future 
program years.
    Comment: Some commenters suggested that to help resolve potential 
and on-going issues, CMS should develop a root-cause analysis toolkit 
that vendors could use to help self-identify issues.
    Response: We agree with this suggestion and will look at the 
feasibility of doing this for future program years.
    Comment: A few commenters stated that if a vendor is incapable of 
submitting accurate data, then the MIPS eligible clinicians who used 
that vendor should be held harmless from any penalties. Another 
commenter noted the absence of ``hold harmless'' provisions to ensure 
MIPS eligible clinicians would not be subject to penalties under MIPS 
if a third party intermediary were to have any error rate, and 
particularly if the intermediary were disqualified, or if they pull out 
of the market at any point during the reporting period. Similar 
provisions are included as part of CMS' EHR Incentive Program in the 
form of hardship exceptions. Specifically, CMS grants hardship 
exceptions when clinicians faced extreme and uncontrollable 
circumstances in the form of issues with the certification of the EHR 
product or products such as delays or decertification. The commenters 
stated CMS must include such provisions in the final rule with comment 
period.
    Response: We note that MIPS eligible clinicians are ultimately 
responsible for the data that are submitted by their third party 
intermediaries and expect that MIPS eligible clinicians and groups 
should ultimately hold their third party intermediaries accountable for 
accurate reporting. We will consider cases of vendors leaving the 
marketplace during the performance period on a case by case basis. We 
would, however, need proof that the MIPS eligible clinician had an 
agreement in place with the vendor at the time of their withdrawal from 
the marketplace.
    Comment: One commenter requested that CMS revisit thresholds in 
regards to data errors as they believed the strict thresholds for 
corrective action may be counterproductive.
    Response: We believe it is necessary to give QCDRs and qualified 
registries fair notice of the expectation for their performance (as a 
QCDRs and qualified registries). Data errors affecting in excess of 5 
percent of the MIPS eligible clinicians or groups submitted by the 
third party intermediary may lead to the disqualification of the third 
party intermediary from participation for the following performance 
period. We chose a 5 percent data error rate because from past 
experience under the PQRS program we have found that a 5 percent error 
rate increases the confidence interval for third party intermediary 
scoring under MIPS. If the third party intermediaries data is 
incomplete or inaccurate, this can adversely affect the program as a 
whole and all MIPS eligible clinicians may suffer from inaccurate or 
missing data. The QCDR or qualified registry is responsible for 
ensuring accurate data calculation and submission.
    Comment: Some commenters expressed appreciation of the critical 
importance of accuracy of submitted data. The commenters believed, 
however, that the proposed error thresholds are too stringent (for 
example, data audit discrepancies affecting in excess of 3 percent but 
less than 5 percent of the MIPS eligible clinicians or groups 
submitted); and that these thresholds as proposed do not take into 
account the materiality of the errors, or whether they are concentrated 
in specific clinicians, which could occur due to interactions between 
workflows and measure logic. The commenters stated there would also 
need to be exclusions for data calculation errors that could be 
attributed to poorly or inadequately specified measures. In addition, 
the commenters stated that until we have mature, well-vetted and error-
free measures, this potential will continue to exist and should not 
result in probation or suspension.
    Another commenter believed it would be virtually impossible for 
most QCDRs to meet the 3 percent error rate criteria to avoid the low 
data quality notation and threatened probation. The commenter 
recommended that CMS review the proposal for a 3 percent error rate and 
adopt an error rate that is more feasible for QCDRs to achieve at this 
early stage in their development. A few commenters stated it will be 
important not to penalize submitters with errors in calculations in 
excess of the three to five percent in the proposed rule if the 
calculation error is due to a different interpretation of an 
imprecisely-specified measure.
    Response: We established the thresholds of data errors affecting in 
excess of 5 percent of the MIPS eligible clinicians or groups submitted 
by the third party intermediary may lead to the disqualification of the 
third party intermediary from participation for the following 
performance period. We chose a 5 percent data error rate based on past 
experience under the PQRS program we have found that a 5 percent error 
rate increases the confidence interval for third party intermediary 
scoring under MIPS. In addition, third party

[[Page 77389]]

intermediaries are considered have experience with handling and 
calculating data and are experts in quality reporting. The data they 
submit not only affects the MIPS eligible clinicians and groups for 
whom they report but can affect other MIPS clinicians as the overall 
program (MIPS payment incentives vs. MIPS payment adjustments) is 
budget neutral. Accurate data is therefore imperative for the program 
as a whole.
    Comment: One commenter recommended that CMS establish a process for 
notifying MIPS eligible clinicians ahead of terminating or placing an 
entity on probation. This would provide the MIPS eligible clinician 
time to research an alternative submission mechanisms or vendor.
    Response: We agree with the commenter. We intend to notify MIPS 
eligible clinicians when a third party intermediary is terminated or 
placed on probation via the qualified posting.
    Comment: Another commenter requested a 2-year grace period for 
implementing of CMS' proposal for probation and disqualification of 
third party intermediaries, as QCDRs will need to gain experience with 
these new performance categories.
    Response: We would like to note that registry reporting has 
occurred since 2008, and QCDRs have been in use since 2014. We believe 
this is an adequate time for qualified registries and QCDRs to be able 
to report data with few or no errors.
    After consideration of the comments regarding auditing of third 
party intermediaries submitting MIPS data, we are finalizing the 
proposal at Sec.  414.1400(k) to include that if at any time we 
determine that a third party intermediary (that is, a QCDR, health IT 
vendor, qualified registry, or CMS-approved survey vendor) has not met 
all of the applicable criteria for qualification, we may place the 
third party intermediary on probation for the current performance 
period and/or the following performance period, as applicable. In 
addition, we are finalizing that we require a corrective action plan 
from the third party intermediary to address any deficiencies or issues 
and prevent them from recurring. We are finalizing the corrective 
action plan must be received and accepted by us within 14 days of the 
CMS notification to the third party intermediary of the deficiencies or 
probation. Failure to comply with this would lead to disqualification 
from MIPS for the subsequent performance period. In addition, we are 
finalizing that probation means for the applicable performance period, 
the third party intermediary would not be allowed to miss any meetings 
or deadlines and would need to submit a corrective action plan for 
remediation or correction of deficiencies identified that resulted in 
the probation. Further, we are finalizing that if the third party 
intermediary has data inaccuracies including (but not limited to) TIN/
NPI mismatches, formatting issues, calculation errors, data audit 
discrepancies affecting in excess of 3 percent (but less than 5 
percent) of the total number of MIPS eligible clinicians or groups 
submitted by the third party intermediary, we would annotate on the CMS 
qualified posting that the third party intermediary furnished data of 
poor quality and would place the entity on probation for the subsequent 
MIPS performance period with the opportunity to go on probation for a 
year to correct their deficiencies. In addition, we are finalizing that 
if the third party intermediary does not reduce their data error rate 
below 3 percent for the subsequent performance period, the third party 
intermediary would continue to be on probation and have their listing 
on the CMS Web site continue to note the poor quality of the data they 
are submitting for MIPS for one additional performance year. After 2 
years on probation, the third party intermediary would be disqualified 
for the subsequent performance year. Data errors affecting in excess of 
5 percent of the MIPS eligible clinicians or groups submitted by the 
third party intermediary may lead to the disqualification of the third 
party intermediary from participation for the following performance 
period. In placing the third party intermediary on probation; we would 
notify the third party intermediary of the identified issues, at the 
time of discovery of such issues. Further, we are finalizing that if 
the third party intermediary does not submit an acceptable corrective 
action plan within 14 days of notification of the deficiencies and 
correct the deficiencies within 30 days or before the submission 
deadline--whichever is sooner, we may disqualify the third party 
intermediary from participating in MIPS for the current performance 
period and/or the following performance period, as applicable.
(f) Auditing of Third Party Intermediaries Submitting MIPS Data
    We proposed at Sec.  414.1400(j) that any third party intermediary 
(that is, a QCDR, health IT vendor, qualified registry, or CMS-approved 
survey vendor) must comply with certain auditing criteria as a 
condition of their qualification or approval to participate in MIPS as 
a third party intermediary. Specifically, we proposed the entity must 
make available to us the contact information of each MIPS eligible 
clinician or group on behalf of whom it submits data. The contact 
information would include, at a minimum, the MIPS eligible clinician or 
group's practice phone number, address, and, if available, email. 
Further, we proposed the entity must retain all data submitted to us 
for MIPS for a minimum of 10 years. We requested comments on this 
proposal.
    The following is a summary of the comments we received regarding 
auditing of third party intermediaries submitting MIPS data.
    Comment: A few commenters noted that CMS proposed that an entity 
must retain all data submitted to CMS for MIPS for a minimum of 10 
years. The commenters stated that they believe this amount of time is 
excessive and is an invasion of privacy. Another commenter recommended 
using a lesser time period similar to other health record criteria. 
Other commenters requested that CMS maintain the current criteria to 
obtain and keep on file signed documentation for 7 years as is 
currently required under PQRS.
    Another commenter stated that CMS should only require a QCDR to 
obtain and keep on file signed documentation that each holder of an NPI 
whose data is submitted to the QCDR and who has authorized the QCDR to 
submit quality measure results, improvement activities (if applicable), 
advancing care information objective results and numerator and 
denominator data (if applicable) and/or patient-specific data on 
Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS 
participation for 3 years beyond each reporting year for which a user 
participates via the QCDR.
    Response: We believe that a 10-year record retention, as proposed, 
for third party intermediaries is appropriate. We are creating a policy 
that is intended to align across the various components of the Quality 
Payment Program and is consistent with the record retention requirement 
for APMs. This consistency will provide a streamline transition between 
the MIPS program and the APM program. We are requiring third party 
intermediaries to retain copies of the contact information and 
permission to submit data on behalf of a MIPS eligible clinician or 
group and the aggregated data submitted by the third party intermediary 
for up to 10 years after the performance year to prepare for 
verification in the event they are selected for an audit. For the 
purposes of auditing we reserve the right to

[[Page 77390]]

lookback 6 years and 3 months. Refer to section II.E.8.e. of this final 
rule with comment period for information on record retention 
requirements for MIPS eligible clinicians and groups.
    Comment: Some commenters requested that CMS provide important 
clarification that the audits called for in this section are focused on 
the accuracy of the health IT vendor and their products and not on the 
MIPS eligible clinician or group. The commenters further requested that 
any findings related to the audit of the third party intermediary would 
be focused on the third party intermediary only and would not lead to 
actions affecting the MIPS eligible clinician.
    Response: We would like to explain that as a condition of their 
qualification or approval to participate in MIPS, third party 
intermediaries are required to comply with certain auditing criteria, 
which include a request for an audit, from us or the federal 
government. Specifically, an applicant or current third party 
intermediary must consent to and agree to comply with an audit by us or 
the federal government of all related documentation and data they 
stored or submitted on behalf of any MIPS eligible clinicians or 
groups. Those who fail to comply with audit requests will be considered 
for non-qualified status. This clarification is consistent with the 
same approach in the auditing provision for addressing MIPS eligible 
clinicians found in section II.E.8.e. of this final rule with comment 
period. Data inaccuracies on the part of the third party vendor will be 
considered when the third party intermediary requests to continue 
participation in the Quality Payment Program in subsequent years (self-
nomination). Data inaccuracies discovered during an audit of a third 
party intermediary and occurring due to inaccurate data submitted by 
the MIPS eligible clinician or group, could result in the MIPS eligible 
clinician or group's data being reviewed as well.
    Comment: Other commenters stated that the third party intermediary 
should not be held responsible for the accuracy of data provided or 
stored by MIPS eligible clinicians or groups when the third party 
intermediary would not be in a position to assess the validity of the 
data.
    Response: We appreciate the concern regarding third party 
intermediaries' responsibility for data accuracy and validity. We would 
like to explain that the primary purpose of auditing third party 
intermediaries is to ensure that accurate data is submitted and to 
maintain the integrity of MIPS payment adjustments made in accordance 
with program determinations and scoring that are based on data 
submitted by third party intermediaries. Thus, as part of the 
qualification and approval requirement to comply with auditing criteria 
third party intermediaries must ensure that the data they submit to us 
on behalf of MIPS eligible clinicians and groups is accurate. To meet 
this requirement, third party intermediaries must have a data 
validation plan in place, they must execute this plan after they submit 
data to us, and they must send us the results of their data validation 
execution report. Please note we also expect third party intermediaries 
to notify us if their data validation results include a finding that 
data submitted by a MIPS eligible clinician or group is invalid. Those 
third party intermediaries who fail to comply with these data 
validation requirements, as part of their auditing compliance, will be 
considered non-qualified or non-approved for future MIPS program years.
    Comment: Some commenters stated that any negative findings from an 
audit under this section should not impact the MIPS eligible clinician 
or group and that they should be ``held harmless'' from any negative 
MIPS adjustments or other civil monetary penalties (CMPs) under the 
False Claims Act.
    Response: We understand the concerns regarding the impact audits 
under this section have on MIPS eligible clinicians and groups. As a 
general matter, the contractual agreement or other arrangement between 
a MIPS eligible clinician or groups and a third party intermediary is 
not within our authority to control and we are not a party to such 
agreements or arrangements. However, we note that MIPS eligible 
clinicians and groups may be able to seek recourse against their third 
party intermediary if significant issues or problems arise. 
Notwithstanding, MIPS eligible clinicians and groups are ultimately 
responsible for the data submitted by their third party intermediary on 
their behalf and we expect MIPS eligible clinicians and groups to hold 
their third party intermediary accountable for accurate data 
submissions. Moreover, we suggest that MIPS eligible clinicians and 
groups work with their third party intermediary to ensure data is 
submitted timely and accurately.
    Comment: A few commenters requested that CMS provide data 
validation of calculated reporting and performance rates while data is 
submitted by third party intermediaries including flagging any errors 
on both format and values.
    Response: We are working on increasing the data checks beyond 
formatting issues in the submission engine validation tool which can be 
used for testing prior to data submission. Additionally, we are looking 
at incorporating additional data checks in the portal to be used at the 
time a file is submitted. This is an on-going process.
    After consideration of the comments regarding auditing of third 
party intermediaries submitting MIPS data, we are modifying the 
proposal at Sec.  414.1400(j) to include the proposed policies that any 
third party intermediary (that is, a QCDR, health IT vendor, qualified 
registry, or CMS-approved survey vendor) must comply with the following 
procedures as a condition of their qualification and approval to 
participate in MIPS as a third party intermediary: (1) The entity must 
make available to CMS the contact information of each MIPS eligible 
clinician or group on behalf of whom it submits data. The contact 
information will include, at a minimum, the MIPS eligible clinician or 
group's practice phone number, address, and, if available, email; and 
(2) the entity must retain all data submitted to CMS for MIPS for a 
minimum of 10 years. In addition, we are adding that for the purposes 
of auditing, CMS may request any records or data retained for the 
purposes of MIPS for up to 6 years and 3 months.
10. Public Reporting on Physician Compare
    This section contains the approach for public reporting on 
Physician Compare for the MIPS, APM, and other information as required 
by the MACRA.
    Physician Compare draws its operating authority from section 
10331(a)(1) of the Affordable Care Act. As required, by January 1, 
2011, we developed a Physician Compare Internet Web site with 
information on physicians enrolled in the Medicare program under 
section 1866(j) of the Act, as well as information on other EPs who 
participate in the PQRS under section 1848 of the Act. More information 
about Physician Compare can be accessed on the Physician Compare 
Initiative Web site at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
    The first phase of Physician Compare was launched on December 30, 
2010 (http://www.medicare.gov/physiciancompare). Since the initial 
launch, Physician Compare has been continually improved and more

[[Page 77391]]

information has been added. Currently, Web site users can view 
information about approved Medicare professionals, such as name, 
Medicare primary and secondary specialties, practice locations, group 
affiliations, hospital affiliations that link to the hospital's profile 
on Hospital Compare as available, Medicare Assignment status, 
education, residency, and American Board of Medical Specialties (ABMS), 
American Osteopathic Association (AOA), and American Board of Optometry 
(ABO) board certification information. For group practices, users can 
view group practice names, specialties, practice locations, Medicare 
assignment status, and affiliated professionals. In addition, Medicare 
professionals and group practices that satisfactorily or successfully 
participated in a CMS quality program have a green check mark on their 
profile page to indicate their commitment to quality.
    Consistent with section 10331(a)(2) of the Affordable Care Act, 
Physician Compare also phased in public reporting of information on 
physician performance that provides comparable information on quality 
and patient experience measures for reporting periods beginning January 
1, 2012. To the extent that scientifically sound measures are developed 
and are available, Physician Compare is required to include, to the 
extent practicable, the following types of measures for public 
reporting, for example: Measures collected under PQRS and an assessment 
of efficiency, patient health outcomes, and patient experience, as 
specified. The first set of quality measures were publicly reported on 
Physician Compare in February 2014. Currently, Physician Compare 
publicly reports 14 group practice level measures collected through the 
Web Interface for groups of 25 or more EPs participating in 2014 under 
the PQRS and for ACOs participating in the Shared Savings Program or 
Pioneer ACO program, and six individual level measures collected 
through claims for individual EPs participating in 2014 under the PQRS. 
A complete history of public reporting on Physician Compare is detailed 
in the CY 2016 PFS final rule (80 FR 71117 through 71122).
    As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 
67547 and 80 FR 70885) Physician Compare will expand public reporting 
over the next several years. This expansion includes publicly reporting 
both individual EP (now referred to as clinician) and group practice 
level QCDR measures starting with 2015 individual clinician measures on 
Physician Compare in late 2016, and expanding public reporting of group 
practice QCDR measures in late 2017 (80 FR 71125).
    Section 1848(q)(9)(A) and (D) of the Act facilitates the 
continuation of the phased approach to public reporting by requiring 
the Secretary to make available on the Physician Compare Web site, in 
an easily understandable format, individual MIPS eligible clinician and 
groups performance information, including:
     The MIPS eligible clinician's final score;
     The MIPS eligible clinician's performance under each MIPS 
performance category (quality, cost, improvement activities, and 
advancing care information);
     Names of eligible clinician's in Advanced APMs and, to the 
extent feasible, the names of such Advanced APMs and the performance of 
such models; and
     Aggregate information on the MIPS, posted periodically, 
including the range of final scores for all MIPS eligible clinician's 
and the range of the performance of all MIPS eligible clinician's for 
each performance category.
    The proposals related to each of these requirements are addressed 
below.
    Section 1848(q)(9)(B) of the Act also requires that this 
information indicate, where appropriate, that publicized information 
may not be representative of the eligible clinician's entire patient 
population, the variety of services furnished by the eligible 
clinician, or the health conditions of individuals treated. The 
information mandated for Physician Compare under section 1848(q)(9) of 
the Act will generally be publicly reported consistent with section 
10331(a)(2) and 10331(b) of the Affordable Care Act, and like all 
measure data included on Physician Compare, will be comparable. In 
addition, section 10331(b) of the Affordable Care Act requires that we 
include, to the extent practicable, processes to ensure that data made 
public are statistically valid, reliable, and accurate, including risk 
adjustment mechanisms used by the Secretary. In addition to the public 
reporting standards identified in the Affordable Care Act--
statistically valid and reliable data that are accurate and 
comparable--we have established a policy that, as determined through 
consumer testing, the data we disclose generally should resonate with 
and be accurately interpreted by consumers to be included on Physician 
Compare profile pages. Together, we refer to these conditions as the 
Physician Compare public reporting standards (80 FR 71118 through 
71120). Section 10331(d) of the Affordable Care Act also requires us to 
consider input from multi-stakeholder groups, consistent with sections 
1890(b)(7) and 1890A of the Act. We also continue to receive general 
input from stakeholders on Physician Compare through a variety of 
means, including rulemaking and different forms of stakeholder outreach 
(for example, Town Hall meetings, Open Door Forums, webinars, education 
and outreach, Technical Expert Panels, etc.).
    In addition, section 1848(q)(9)(C) of the Act requires the 
Secretary to provide an opportunity for MIPS eligible clinicians to 
review the information that will be publicly reported prior to such 
information being made public. This is generally consistent with 
section 10331(a)(2) of the Affordable Care Act, under which we have 
established a 30-day preview period for all measurement performance 
data that allows physicians and other eligible clinicians to view their 
data as it will appear on the Web site in advance of publication on 
Physician Compare (80 FR 71120). Section 1848(q)(9)(C) of the Act also 
requires that MIPS eligible clinicians be able to submit corrections 
for the information to be made public. We proposed that this extension 
of the current Physician Compare 30-day preview period will be 
implemented starting with data from the 2017 MIPS performance period. 
We proposed a 30-day preview period in advance of the publication of 
data on Physician Compare (81 FR 28290). We proposed to coordinate 
efforts between Physician Compare and the four performance categories 
of MIPS in terms of data review and any relevant data resubmission or 
correction. All data available for public reporting--measure rates, 
scores, and attestations--would be available for review and correction 
during the targeted review process (81 FR 28278). The process would 
begin at least 30 days in advance of the publication of new data. Data 
under review will not be publicly reported until the review is 
complete. All corrected measure rates, scores, and attestations 
submitted would be available for public reporting. The technical 
details of the process would be communicated directly to affected MIPS 
eligible clinicians and groups and detailed outside of rulemaking.
    As with the current process, the details would be made public on 
the Physician Compare Initiative page on cms.gov and communicated 
through Physician Compare and other CMS listservs.
    The following is a summary of the comments we received regarding 
our proposal to implement a 30-day preview

[[Page 77392]]

period in advance of the publication of data on Physician Compare.
    Comment: Some commenters requested that CMS extend the preview 
period from 30 days to 45, 60, or 90 days. Some commenters noted 30 
days was too short, and others more specifically indicated more time 
was needed to fully review their data.
    Response: Finalizing a 30-day preview period for MIPS eligible 
clinicians is consistent with the preview period we have adopted for 
Physician Compare for other types of data (80 FR 71120), and has proven 
sufficient to fully review the data currently publicly reported. We 
will explore the preview period duration to assess it is providing 
adequate time for review and data resubmission, when necessary, once 
the Quality Payment Program begins to receive a higher volume of data 
on a more frequent basis, which will be done through separate notice-
and-comment rulemaking.
    Comment: Commenters requested that data being contested is not 
published on Physician Compare.
    Response: We will coordinate efforts between Physician Compare and 
the four performance categories of MIPS in terms of targeted review and 
any relevant data resubmission or correction. All data available for 
public reporting--measure rates, scores, and attestations--will be 
available for review and correction during the targeted review process 
(see II.E.8.c. of this final rule with comment period). The process 
will begin at least 30 days in advance of the publication of new data. 
Data under a review will not be publicly reported until the review is 
complete. As proposed, all corrected measure rates, scores, and 
attestations submitted will be available for public reporting. The 
technical details of the process will be communicated directly to 
affected MIPS eligible clinicians and groups and detailed outside of 
rulemaking.
    After consideration of the comments, we are finalizing our policy 
as proposed. As consistent with current practice (80 FR 71120), we are 
adopting a 30-day preview period in advance of the publication of data 
on Physician Compare.
    In addition, section 1848(q)(9)(D) of the Act requires that 
aggregate information on the MIPS be periodically posted on the 
Physician Compare Web site; including the range of final scores for all 
MIPS eligible clinicians and the range of performance for all MIPS 
eligible clinicians for each performance category.
    Lastly, section 104(e) of the MACRA requires the Secretary to make 
publicly available, on an annual basis (beginning with 2015), in an 
easily understandable format, information for physicians and other 
eligible clinician's on items and services furnished to Medicare 
beneficiaries, and to include, at a minimum:
     Information on the number of services furnished under Part 
B, which may include information on the most frequent services 
furnished or groupings of services;
     Information on submitted charges and payments for Part B 
services; and
     A unique identifier for the physician or other eligible 
clinician that is available to the public, such as an NPI.
    The information would further be required to be made searchable by 
at least specialty or type of physician or other eligible clinician; 
characteristics of the services furnished (such as, volume or groupings 
of services); and the location of the physician or other eligible 
clinician.
    Therefore, at Sec.  414.1395(a) we proposed public reporting of an 
eligible clinician's MIPS data; in that for each program year, we would 
post on a public Web site, in an easily understandable format, 
information regarding the performance of MIPS eligible clinicians or 
groups under the MIPS. This proposal and related public comments are 
addressed in detail below.
    Furthermore, in accordance with section 104(e) of the MACRA, we 
finalized a policy in the CY 2016 PFS final rule (80 FR 71130) to add 
utilization data to the Physician Compare downloadable database. 
Utilization data is currently available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier.html. This 
information will be integrated on the Physician Compare Web site via 
the downloadable database using the most current data starting with the 
2016 data, targeted for initial release in late 2017 (80 FR 71130). Not 
all available data will be included. The specific HCPCS codes included 
will be determined based on analysis of the available data, focusing on 
the most used codes. Additional details about the specific HCPCS codes 
that will be included in the downloadable database will be provided to 
stakeholders in advance of data publication. And, all data available 
for public reporting--on the consumer-facing Web site pages or in the 
downloadable database--will be available for review during the 30-day 
preview period.
    We believe section 10331 of the Affordable Care Act supports our 
overarching goals of the MACRA by providing consumers with quality 
information that will help them make informed decisions about their 
health care, while encouraging clinicians to improve the quality of 
care they provide to their patients. In accordance with section 10331 
of the Affordable Care Act, section 1848(q)(9) of the Act, and section 
104(e) of the MACRA, we plan to continue to publicly report performance 
information on Physician Compare. As a result, we proposed inclusion of 
the following information on Physician Compare (81 FR 28291 through 
28293).
a. Final Score, Performance Categories, and Aggregate Information
    As noted, section 1848(q)(9)(A) and (D) of the Act requires that we 
publicly report on Physician Compare the final score for each MIPS 
eligible clinician, performance of each MIPS eligible clinician for 
each performance category, and periodically post aggregate information 
on the MIPS, including the range of final scores for all MIPS eligible 
clinicians and the range of performance of all the MIPS eligible 
clinicians for each performance category. We proposed that these data 
would be added to Physician Compare for each MIPS eligible clinician or 
group, either on the profile pages or in the downloadable database, as 
technically feasible. Statistical testing and consumer testing, as well 
as consultation of the Physician Compare Technical Expert Panel (TEP), 
would determine how and where these data are reported on Physician 
Compare. We requested comments on these proposals.
    The following is a summary of the comments we received regarding 
our proposal to publicly report on Physician Compare the final score 
for each MIPS eligible clinician, performance of each MIPS eligible 
clinician for each performance category, and periodically post 
aggregate information on the MIPS, including the range of final scores 
for all MIPS eligible clinicians and the range of performance of all 
the MIPS eligible clinicians for each performance category.
    Comment: Commenters suggested that CMS limit initial public 
reporting on MIPS clinicians to their final score and performance 
category participation and not publicly report any of the specific 
measures within any of the performance categories at this time. Some 
commenters, however, expressed concern with public posting of the final 
score for clinicians because they believe it does not fully represent 
quality and

[[Page 77393]]

may be misleading regarding the quality of care provided. There was 
also concern it may lead to comparisons across different specialties. 
Some of these and other commenters encouraged CMS to report the 
specific measures within performance categories instead of the final 
score. Another commenter opposed publishing the final score for groups 
with fewer than ten eligible clinicians. Other commenters recommended 
that CMS delay publishing final scores and performance by category 
until it has been further tested to ensure it is fully understood by 
consumers and truly represents quality care, and to ensure clinicians 
have time to learn from and improve on their early performance.
    Some commenters believe all category scores should be visible on 
Physician Compare rather than just the final score noting the final 
score oversimplifies performance without taking into consideration 
things like higher costs. Another commenter recommended that in the 
first few years of MIPS data be shared only with clinicians and after 
this period consider all MIPS data for public reporting.
    Other commenters suggested that CMS implement precautions before 
releasing certain information (for example, quality, cost, and 
utilization data) on Physician Compare as individualized data without 
explanation could be misleading, and instead encouraged CMS to release 
this information only to professional societies. Another commenter 
encouraged CMS to include contextual information to clarify which 
eligible clinicians could and could not submit data in the first 2 
years of MIPS so lack of reporting is not misinterpreted by consumers.
    Additional commenters encouraged CMS to obtain ample feedback from 
patients and clinicians prior to posting information to Physician 
Compare to ensure that public reporting standards are upheld, including 
the requirement that all data resonate with and be accurately 
interpreted by consumers. Another commenter stated it is important for 
CMS to determine the accuracy of the data posted on Physician Compare.
    Response: Data for the final score and performance categories will 
be added to Physician Compare for each MIPS eligible clinician or 
group, either on the profile pages or in the downloadable database. 
Statistical testing and consumer testing, as well as consultation of 
the Physician Compare TEP, will determine how, where, and when these 
data are best reported on Physician Compare. Publicly reporting MIPS 
data continues the ongoing phased approach to public reporting we have 
been engaging in since the release of the 2012 PQRS data, allowing us 
to continue this public reporting process and therefore continue to 
provide helpful information valued by consumers in their health care 
decision-making process.
    The statistical and consumer testing done ensures the data are 
accurate, they represent quality of care, and they are well understood 
and correctly interpreted by consumers. The nature of how clinicians 
and groups are searched on Physician Compare facilitates comparison 
within specialty, not across. And, language is currently available on 
the site to explain that lack of data does not mean lack of quality 
care, and this concept has been well understood in previous consumer 
testing. Previous testing has also shown that consumers not only 
accurately interpret but need aggregate scoring, such as composite 
scores and star ratings, to best understand what are often complex 
data. These aggregations are not oversimplifications, but beneficial 
tools for the average consumer to use to best interpret the data. And, 
although we appreciate the request to have more time to learn from and 
improve on the data collected, as a continuation of the existing public 
reporting plan, we believe clinicians have had the opportunity to 
benefit from previous years of data submission as public reporting was 
slowly phased in under the PQRS and the data under MIPS are well timed 
for public reporting.
    Comment: Commenters believe CMS should include MIPS information in 
the downloadable database as they supported making public all 
statistically valid and reliable data, but appreciated the importance 
of not overwhelming consumers with too much information on profile 
pages. Some commenters stated that they would like all information 
added to the profile pages, including basic demographic and descriptive 
information, to be proposed for public comment along with results of 
statistical and consumer testing for measure data.
    Response: Again, as noted, typically data considered for public 
reporting on public profile pages must meet all public reporting 
criteria. Summary reports of TEP meetings are shared publicly on the 
Physician Compare Initiative Web site on CMS.gov. This documentation 
provides an overview of the statistical and consumer testing conducted 
as part of the measure review process for Physician Compare. To fulfill 
the purpose of the Web site and ensure consumers have the information 
they need to make informed health care decisions it is important to 
continue to include quality information on the profile pages in 
addition to making data available in the downloadable database, as 
appropriate.
    Comment: One commenter objected to the public reporting of zeroes 
on the Physician Compare Web site; indicating this could misrepresent 
physicians who choose not to share data.
    Response: We will take this into consideration as we analyze data 
for public reporting on Physician Compare. However, it is important to 
note that if a measure is not submitted, there is no performance rate 
publicly reported. If a measure is reported and the performance rate is 
zero, this is available for public reporting.
    Comment: One commenter expressed concern about public reporting, 
generally, noting that without virtual groups by specialty, the 
consequences for many specialties will be inaccurate scoring. They will 
be unable to report correct measures.
    Response: Only those groups and eligible clinicians with measure 
data will be scored and have measure data included on Physician 
Compare. The data reported will be at the clinician and group level 
respectively. The absence of Virtual Groups will not impact the data 
consumers see for clinicians and groups. As Virtual Groups are 
implemented we will take this feedback into consideration for public 
reporting on Physician Compare.
    Comment: One commenter recommended that CMS thoroughly explain 
Physician Compare data to the consumers. The commenter agreed that some 
of the performance categories were difficult to understand for both 
consumers and clinicians.
    Response: As noted, all data included on the Physician Compare 
profile pages is tested with consumers to ensure that the information 
is accurately interpreted and meaningful to consumers. In addition to 
consumer testing, we are also engaging in increasing consumer outreach 
around Physician Compare and MACRA data, specifically, to ensure this 
information is clear and useful to consumers. This process will be 
ongoing.
    After consideration of the comments and for the reasons we 
explained previously, we are finalizing our proposal to report on 
Physician Compare the final score for each MIPS eligible clinician, 
performance of each MIPS eligible clinician for each performance 
category, and to periodically post aggregate information of such data. 
Accordingly, we are finalizing Sec.  414.1395(a), which provides

[[Page 77394]]

that for public reporting of an eligible clinician's MIPS data in that 
for each program year, we will post on a public Web site, in an easily 
understandable format, information regarding the performance of MIPS 
eligible clinicians or groups under the MIPS. As we discussed in this 
final rule with comment period, such data will be posted on Physician 
Compare, as required by MACRA; however, we will use statistical and 
consumer testing for purposes of determining how and where such data 
will be reported on Physician Compare. A detailed discussion of 
comments for each performance category of MIPS data is included below.
    In addition, we solicited comment on the advisability and technical 
feasibility of including data voluntarily reported by eligible 
clinicians and groups that are not subject to MIPS payment adjustments, 
such as those practicing through RHCs, FQHCs, etc., on Physician 
Compare, which would be addressed through separate notice-and-comment 
rulemaking.
    The following is a summary of the comments we received regarding 
our solicitation of comments for including data voluntarily reported by 
eligible clinicians and groups that are not subject to MIPS payment 
adjustments.
    Comment: One commenter supported giving FQHCs who voluntarily 
submit data under MIPS, appropriately adjusted for patients' social 
determinants of health, the option to have the data published on 
Physician Compare. Another commenter also generally supported allowing 
any eligible clinician or group that voluntarily reported data to have 
the data publicly reported on Physician Compare. One commenter did 
caution against publicly reporting RHC data noting concern around the 
assumptions that could be drawn from the data.
    Response: We may consider these suggestions in future notice-and-
comment rulemaking.
b. Quality
    As detailed in the proposed rule, consistent with the current 
policy that makes all current PQRS measures available for public 
reporting, we proposed to make all measures under the MIPS quality 
performance category (81 FR 28184) available for public reporting on 
Physician Compare (81 FR 28291). This would include all available 
measures reported via all available submission methods, and applies to 
both MIPS eligible clinicians and groups. Also consistent with current 
policy, although all measures will be available for public reporting 
not all measures will be made available on the consumer-facing Web site 
profile pages. As explained in the proposed rule (81 FR 28291), 
providing too much information can overwhelm consumers and lead to poor 
decision making. Therefore, consistent with section 
1848(q)(9)(A)(i)(II) of the Act, we proposed that all measures in the 
quality performance category that meet the statistical public reporting 
standards would be included in the downloadable database, as 
technically feasible. We also proposed that a subset of these measures 
would be publicly reported on the Web site's profile pages, as 
technically feasible, based on consumer testing. Statistical testing 
and consumer testing would determine how and where measures are 
reported on Physician Compare. In addition, we proposed to apply our 
existing policy of not publicly reporting first year measures, meaning 
new measures that have been in use for less than 1 year, regardless of 
submission methods. After a measure's first year in use, we would 
evaluate the measure to see if and when the measure is suitable for 
pubic reporting (81 FR 28291).
    Currently, there is a minimum sample size requirement of 20 
patients for performance data to be included on the Web site. As part 
of the MIPS and APMs RFI we asked for comment on moving away from this 
requirement and moving to a reliability threshold for public reporting. 
In general, commenters supported a minimum reliability threshold. As a 
result, we proposed to institute a minimum reliability threshold for 
public reporting this data on Physician Compare (81 FR 28291).
    The reliability of a measure refers to the extent to which the 
variation in measure is due to variation in quality of care as opposed 
to random variation due to sampling. Statistically, reliability depends 
on performance variation for a measure across entities, the random 
variation in performance for a measure within an entity's panel of 
attributed beneficiaries, and the number of beneficiaries attributed to 
the entity. High reliability for a measure suggests that comparisons of 
relative performance across entities, in this case groups or eligible 
clinicians, are likely to be stable and consistent, and that the 
performance of one entity on the quality measure can confidently be 
distinguished from another. Conducting analysis to determine 
reliability of the data collected will allow us to calculate the 
minimum reliability threshold for those data. Once an appropriate 
minimum reliability threshold is determined, the reporting of 
reporters' performance rates for a given measure can be restricted to 
only those meeting the minimum reliability threshold.
    We proposed to also include the total number of patients reported 
on per measure in the downloadable database to facilitate transparency 
and more accurate understanding and use of the data. We requested 
comments on these proposals (81 FR 28291).
    We also solicited comment on the types of data that should be 
reported on Physician Compare as the MIPS program evolves, specifically 
in regard to the quality performance category. Any regulatory changes 
would be made in separate notice-and-comment rulemaking.
    The following is a summary of the comments we received regarding 
our proposal related to public reporting data from the MIPS quality 
performance category (81 FR 28291).
    Comment: Several commenters agreed with the proposal that all 
measures in the quality performance category that meet the public 
reporting standards should be included in the downloadable database, as 
technically feasible. Some noted it was beneficial because then QCDRs 
and qualified registries can use this data to report back to eligible 
clinicians and groups on how they compare to others. Other commenters 
noted that the quality performance category measures should only be 
reported if there were clear measure descriptions that allowed 
consumers to understand the measures in context and individual measures 
were reported along with benchmark and score ranges. Some commenters 
cautioned against publicly reporting measures for specific specialties 
that may be more difficult for consumers to understand.
    Response: In this final rule, we are finalizing our proposal that 
all measures in the quality performance category that meet the 
statistical public reporting standards will be included in the 
downloadable database, as technically feasible. Per suggestions that 
commenters made regarding consumer understanding of the quality 
performance category measure data, only those measures that also test 
well with consumers will be included on the public facing profile 
pages. This includes testing plain language measure descriptions that 
provide the information in an easy-to-understand format and in context, 
to ensure measures are fully explained and accurately understood. We 
also plan to include, as feasible, the individual measures in addition 
to the aggregate information as consumers and clinicians find value in 
both.
    Comment: Some commenters recommended not publicly reporting on

[[Page 77395]]

new measures for as many as 3 years so that clinicians and groups had 
more time to learn from the measures and their performance in early 
years of reporting.
    Response: We are finalizing our proposal to continue to not 
publicly report first year measures, meaning new measures that have 
been in use for less than 1 year, regardless of submission methods. 
After a measure's first year in use, we will evaluate the measure to 
see if and when the measure is suitable for public reporting and will 
take into consideration concerns expressed around publishing newer data 
during that review process. However, experience with public reporting 
to date has shown that 1 year is generally sufficient and provides 
adequate time to assess the measure and to provide clinicians and 
groups an opportunity to gain experience collecting the measure as well 
as provide feedback to help them improve on the measure before the data 
are made public.
    Comment: Commenters supported the use of a minimum reliability 
threshold for measures, and agreed with the use of Physician Compare 
public reporting standards, because together these will ensure accurate 
data that are statistically comparable. One commenter also noted it was 
important to ensure adequate sample sizes in addition to the 
reliability threshold.
    Response: We appreciate this support and agree and will move 
forward with the reliability threshold in conjunction with our existing 
public reporting standards and minimum sample size of 20 to ensure 
confidentiality and sufficient data.
    Comment: One commenter stated that data needed to be properly 
vetted for accuracy and multiple commenters noted data should be risk-
adjusted prior to being posted on Physician Compare.
    Response: We agree data should be vetted prior to being publicly 
reported on Physician Compare. As stated previously, data from the 
quality performance category must meet our statistical public reporting 
standards to be publicly reported on Physician Compare. As explained in 
section II.E.5.b. of this final rule with comment period, under the 
IMPACT Act, ASPE has been conducting studies on the issue of risk 
adjustment for sociodemographic factors on quality measures and cost, 
as well as other strategies for including SDS evaluation in CMS 
programs. We will closely examine the ASPE studies when they are 
available and incorporate findings as feasible and appropriate through 
future rulemaking.
    After consideration of the comments and for the reasons we 
discussed in this final rule with comment period, we are finalizing our 
policies as proposed.
c. Cost
    As detailed in the proposed rule, we proposed, consistent with 
section 1848(q)(9)(A)(i)(II) of the Act, to make all measures under the 
MIPS cost performance category (see 81 FR 28196) available for public 
reporting on Physician Compare. This includes all available measures 
reported via all available submission methods, and applies to both MIPS 
eligible clinicians and groups.
    We have found that cost data do not resonate with consumers and can 
instead lead to significant misinterpretation and misunderstanding. 
Therefore, we proposed to include a sub-set of cost measures, that meet 
the aforementioned public reporting standards, on Physician Compare, 
either on profile pages or in the downloadable database, if technically 
feasible (81 FR 28291 through 28292). Statistical testing and consumer 
testing would determine how and where measures are reported on 
Physician Compare. In addition, we proposed not to publicly report 
first year measures, meaning new measures that have been in use for 
less than 1 year, regardless of submission methods. After a measure's 
first year in use, we would evaluate the measure to see if and when the 
measure is suitable for pubic reporting (81 FR 28292). We requested 
comments on these proposals.
    We also solicited comment on the types of data that should be 
reported on Physician Compare as the MIPS program evolves, specifically 
in regard to the cost performance category. Any regulatory changes 
would be made in separate notice-and-comment rulemaking.
    The following is a summary of the comments we received regarding 
our proposal related to public reporting of data from the MIPS cost 
performance category.
    Comment: Some commenters recommended that CMS not publicly report 
cost measures. One commenter mentioned that cost data requires other 
information such as specifics about the patient population served and 
needs to be reported in the context of other quality measures. 
Similarly, another commenter recommended the cost measures not be 
publicly reported without being risk adjusted and without more 
information about what portion of a clinician's total patient 
population is included in the data. Another commenter recommended that 
cost information not be displayed until CMS develops better, more 
applicable measures for cost. Other commenters opposed publication 
because the data do not resonate with consumers and can be 
misinterpreted and therefore recommended consumer testing on this 
category to ensure the necessary context is provided so consumers fully 
understand the information.
    Another commenter appreciated the proposal to limit public 
reporting on the Physician Compare Web site to a subset of cost 
measures that meet the public reporting standards, and to include the 
total number of patients reported on per measure in the downloadable 
database so that quality data is accurately interpreted per practice 
size.
    Response: We appreciate the commenters' concerns. As explained in 
this final rule with comment period, we are awaiting ASPE's report on 
risk adjustment and will evaluate that report with the concerns raised 
here about patient population variation in mind. The cost measures will 
be reported in conjunction with performance information for all MIPS 
performance categories, as technically feasible, which will provide 
additional context for this information. And, as with all data publicly 
reported, the measures will only be included on public facing pages if 
consumer testing shows the measures are accurately interpreted and in 
fact resonate with consumers. Therefore, as technically feasible, and 
based on our statistical public reporting standards and consumer 
testing we will publicly report cost measures on Physician Compare. We 
note that we intend to make cost data publicly available in the 
downloadable database, regardless of consumer testing performance, for 
use in research if it meets our other public reporting standards.
    Comment: Some commenters recommended not publicly reporting on new 
measures for 3 years, noting the data should first be shared only with 
eligible clinicians and groups before being considered for public 
reporting so that they could learn from the data in the early years of 
reporting.
    Response: As explained in our discussion about the quality 
performance category in this final rule with comment period, our 
experience with public reporting to date has shown that 1 year is 
generally sufficient and provides adequate time to assess the measure 
and to provide clinicians and groups an opportunity to gain experience 
collecting the measure as well as provide feedback to help them improve 
on the measure before the data are made public. So we do not believe 3 
years is needed. Accordingly, we are

[[Page 77396]]

finalizing a policy not to publicly report first year measures, meaning 
new measures that have been in use for less than 1 year, regardless of 
submission methods and performance category as we have generally found 
1 year to be sufficient to evaluate new measures. After a measure's 
first year in use, we will evaluate the measure to see if and when the 
measure is suitable for pubic reporting appreciating the concerns 
raised.
    After consideration of the comments and for the reasons we 
discussed in this final rule with comment period, we are finalizing our 
policies as proposed. Based on the policies being finalized in 
II.E.5.e. of this final rule with comment period we may not have data 
for public reporting in year 1, the transition year, of MIPS for the 
cost performance category.
d. Improvement Activities
    As detailed in the proposed rule, we proposed, consistent with 
section 1848(q)(9)(A)(i)(II) of the Act, to make all activities under 
the MIPS improvement activities performance category (81 FR 28209) 
available for public reporting on Physician Compare (81 FR 28292). This 
includes all available improvement activities reported via all 
available submission methods, and applies to both MIPS eligible 
clinicians and groups.
    We proposed to include a subset of improvement activities data that 
meet the aforementioned public reporting standards, on Physician 
Compare, either on the profile pages or in the downloadable database, 
if technically feasible (81 FR 28292). For those eligible clinicians 
that successfully meet the improvement activities performance category 
requirements this may be posted on Physician Compare as an indicator. 
The improvement activities performance category is a new field of data 
for Physician Compare so concept and consumer testing will be needed to 
ensure these data are understood by consumers. Therefore, we proposed 
that statistical testing and consumer testing would determine how and 
where improvement activities are reported on Physician Compare. In 
addition, since we do not publicly report first year measures, we 
proposed to also apply this policy to improvement activities, meaning 
new improvement activities that have been in use for less than 1 year, 
regardless of submission methods. After an improvement activity's first 
year in use, we would evaluate the activity to see if and when the 
activity is suitable for pubic reporting (80 FR 71118). We requested 
comments on these proposals.
    We also solicited comment on the types of data that should be 
reported on Physician Compare as the MIPS program evolves, specifically 
in regard to the improvement activities performance category. Any 
regulatory changes would be made in separate notice-and-comment 
rulemaking.
    The following is a summary of the comments we received regarding 
our proposal related to public reporting of data from the MIPS 
improvement activities performance category.
    Comment: One commenter recommended that CMS gain experience with 
the improvement activities category before adding that information to 
Physician Compare. Other commenters recommended that improvement 
activities not be reported on Physician Compare until we performed 
consumer and statistical testing to validate the category as accurate 
and ensured the data were being publicly reported with enough context 
so that consumers accurately interpreted the data. One commenter 
recommended only including a subset of the improvement activities data 
on Physician Compare.
    Response: We do acknowledge that the improvement activities 
performance category is a new field of data for Physician Compare so, 
as noted, concept and consumer testing will be needed to ensure these 
data are understood by consumers and presented in a way that is easy to 
understand and with appropriate context. Prior to any data being 
released on Physician Compare, statistical testing and consumer testing 
will determine how and where improvement activities are publicly 
reported and if it is most appropriate to publicly report all available 
data or only a subset as suggested.
    Comment: Some commenters recommended not publicly reporting on new 
improvement activities for as many as 3 years so there was an 
opportunity to learn from the measures in the early years of reporting, 
while other commenters recommended improvement activities data only be 
shared with eligible clinicians and groups and not be considered for 
public reporting for at least the first few years if at all.
    Response: We are finalizing a policy not to publicly report first 
year activities, meaning new improvement activities that have been in 
use for less than 1 year, regardless of submission methods, will not be 
considered for public reporting. After an improvement activity's first 
year in use, we will evaluate the activity to see if and when the 
activity is suitable for pubic reporting. As 1 year has proven 
sufficient to understand if quality measures are appropriate and 
accurate and has provided sufficient time for clinicians and groups to 
learn from these data, we believe the same will be true for performance 
activities. However, again, after the first year, we will further 
review to ensure more time is not needed.
    After consideration of the comments and for the reasons we 
articulated previously, we are finalizing our policies as proposed.
e. Advancing Care Information
    Since the beginning of the EHR Incentive Programs in 2011, 
participant performance data has been publicly available in the form of 
public use files on the CMS Web site. In the 2015 EHR Incentive 
Programs final rule, we addressed comments requesting that we not only 
continue this practice but also include a wider range of information on 
participation and performance. In that rule, we stated our intent to 
publish the performance and participation data on Stage 3 objectives 
and measures of meaningful use in alignment with quality programs which 
utilize publicly available performance data such as Physician Compare 
(80 FR 62901). At this time there is only a green check mark on 
Physician Compare profile pages to indicate that an eligible clinician 
successfully participated in the current Medicare EHR Incentive Program 
for eligible clinicians.
    As MIPS will now include advancing care information as one of the 
four MIPS performance categories, we proposed, consistent with section 
1848(q)(9)(i)(II) of the Act, to include more information on an 
eligible clinician's performance on the objectives and measures of 
meaningful use on Physician Compare (81 FR 28292). An important 
consideration is that to meet the aforementioned public reporting 
standards, the data added to Physician Compare must resonate with the 
average Medicare consumer and their caregivers. Consumer testing to 
date has shown that people with Medicare value the use of certified EHR 
technology and see EHR use as something that if used well can improve 
the quality of their care. In addition, we believe the inclusion of 
indicators for clinicians who achieve high performance in key care 
coordination and patient engagement activities provide significant 
value for consumers.
    We therefore proposed to include an indicator for any eligible 
clinician or group who successfully meets the advancing care 
information performance category, as detailed in the proposed

[[Page 77397]]

rule (81 FR 28215), as technically feasible on Physician Compare (81 FR 
28292). Also, as technically feasible, we proposed to include 
additional indicators (81 FR 28292), including but not limited to the 
indicators specified in section II.E.5.g. of this final rule with 
comment period such as, identifying if the eligible clinician or group 
scores high performance in patient access, care coordination and 
patient engagement, or health information exchange; as further 
specified in the proposed rule (81 FR 28215). We also proposed that any 
advancing care information objectives or measures would need to meet 
the public reporting standards applicable to data posted on Physician 
Compare, either on the profile pages or in the downloadable database. 
This would include all available objectives or measures reported via 
all available submission methods, and would apply to both MIPS eligible 
clinicians and groups. Statistical testing and consumer testing would 
determine how and where objectives and measures are reported on 
Physician Compare. In addition, we proposed to apply our policy of not 
publicly reporting first year measures (80 FR 71118), meaning new 
measures that have been in use for reporting for less than 1 year, 
regardless of submission methods. After a measure's first year in use, 
we would evaluate the measure to see if and when the measure is 
suitable for pubic reporting (81 FR 28292). We requested comment on 
these proposals.
    We also solicited comment on potentially including an indicator to 
show low performance in the advancing care information performance 
category, as well as, the types of data that should be reported on 
Physician Compare as the MIPS program evolves, specifically in regard 
to the advancing care information performance category. Additionally, 
we would need to perform consumer testing and evaluate the feasibility 
of potentially including an indicator to show low performance in the 
advancing care information performance category to ensure this is 
understood by consumers. Any regulatory changes would be made in 
separate notice-and-comment rulemaking.
    The following is a summary of the comments we received regarding 
our proposal related to public reporting of data from the MIPS 
advancing care information performance category.
    Comment: A commenter recommended that CMS designate physician 
performance in the advancing care information category with a green 
check mark as it has done for the EHR Incentive Program, while some 
commenters recommended against publicly reporting an indicator for this 
performance category. One commenter suggested limiting information 
publicly reported on this category to an indicator showing use of 
certified EHR technology, generally.
    Response: As technically feasible, and based on consumer testing, 
we will include indicators for the advancing care information 
performance category on Physician Compare as this is an extension of 
our existing public reporting related to EHR Incentive Program 
participation and this information is deemed valuable by consumers and 
their caregivers. We will use the statistical and consumer testing 
methods we have adopted for Physician Compare to determine the final 
presentation and timing of data reported on the Web site.
    Comment: Some commenters recommended not showing low performance in 
the advancing care information category, which one commenter stated 
would be confusing to consumers without adequate context. Other 
commenters recommended not adding an indicator of high performance 
until the performance score is more refined. Some commenters disagreed 
with CMS' proposal to include additional indicators, including but not 
limited to, identifying if the eligible clinician or group scores high 
performance in patient access, care coordination and patient 
engagement, or health information exchange. Other commenters noted that 
continued indication of performance category success is acceptable, but 
publicly reporting individual metrics within the advancing care 
information performance category is not. Additional commenters raised 
concerns about publicly reporting the advancing care information 
because performance in this category is not solely under the control of 
the eligible clinician, especially for hospital-based clinicians.
    Response: Viewing this as a continuation of our current public 
reporting, and based on consumer testing, we will include indicators 
for the advancing care information performance category, as technically 
feasible. Part of testing is ensuring that the appropriate context is 
provided for consumers to understand not only all the data points or 
indicators included, but also the factors that impact performance. This 
means we will ensure that consumers fully understand individual metrics 
versus a simple mention of participation success prior to including 
individual metrics. And, we will evaluate understanding of attribution 
to ensure certain types of clinicians, specifically hospital-based 
clinicians, are not unfairly measured. All of these considerations, and 
the additional concerns raised, will be taken into account and 
statistical and consumer testing will be done to determine the final 
presentation and timing of data reported on the Web site.
    Comment: Some commenters recommended not publicly reporting on new 
measures for as many as 3 years, and first only sharing this 
information with the eligible clinicians and groups until they gain 
experience with the measures and learn from the measures in the early 
years of public reporting.
    Response: As previously noted, under existing programs 1 year has 
proven sufficient for evaluating the measure for public reporting, so 
we do not believe using a longer time frame of 3 years is necessary. 
Accordingly, we are finalizing a decision not to publicly report first 
year measures or indicators, meaning new measures or indicators that 
have been in use for reporting for less than 1 year, regardless of 
submission methods. After a measure or indicator's first year in use, 
we will evaluate the measure or indicator to see if and when the 
measure or indicator is suitable for pubic reporting.
    Comment: One commenter requested that CMS indicate a disclaimer on 
the clinician's profile if they were exempt from participating in the 
advancing care information performance category.
    Response: We will evaluate the need for including disclaimers based 
on the final data available for public reporting and consumer testing.
    After consideration of the comments and for the reasons we 
discussed in this final rule with comment period, we are finalizing our 
policies as proposed.
f. Utilization Data
    We previously finalized a policy to include utilization data in the 
Physician Compare downloadable database in late 2017 using the most 
currently available data (80 FR 71130) to meet section 104(e) of the 
MACRA. As there are thousands of Healthcare Common Procedure Coding 
System (HCPCS) codes in use, not all available data will be included. 
The specific HCPCS codes included will be determined based on analysis 
of the available data, focusing on the most used codes. The goal will 
be to include counts that can facilitate a greater understanding and 
more in-depth analysis of the other measure and performance data being 
made available. We proposed to continue to include utilization data in 
the Physician Compare downloadable database (81 FR 28292). We requested 
comment on this proposal.

[[Page 77398]]

    The following is a summary of the comments we received regarding 
our proposal to continue to include utilization data in the Physician 
Compare downloadable database.
    Comment: Some commenters supported including utilization data in 
the downloadable database, though one commenter suggested CMS make the 
specific HCPCS codes included available for public comment. One 
commenter recommended that CMS implement precautions such as including 
only aggregated data in the downloadable database or making this 
information available only to professional societies, citing concern 
that without explanation this data could be misleading. Other 
commenters recommended CMS only publicly report data suitable for an 
eligible clinicians profile page noting that if it can be 
misinterpreted by consumers, it may be misused by other stakeholders. 
Another commenter recommends that CMS provide a disclaimer regarding 
the limits of utilization data.
    Response: To satisfy section 104(e) of the MACRA, we implemented a 
policy to begin to include utilization data in the Physician Compare 
downloadable database in late 2017 using the most currently available 
data, and previously finalized the specific codes to be included would 
be determined via data analysis, and reported at the eligible clinician 
level (80 FR 71130). We proposed to continue this policy of reporting 
utilization data. Given that section 104 of the MACRA requires the 
utilization data to be searchable by specialty, characteristics of 
services, and location of eligible clinician, we believe it is 
necessary to report the data un-aggregated. Aggregated data are 
available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier2014.html. Given the audience of the downloadable 
database is predominantly the professional community and third-party 
data users, we believe the data are appropriate for inclusion in the 
downloadable database. The audience for the public facing profile pages 
and the use of the information on those pages is significantly 
different. We will take recommendations to add additional context and 
disclaimers around the use and limits of the utilization to the 
downloadable database data dictionary under consideration.
    After consideration of the comments and for the reasons we 
articulated, we are finalizing the policy as proposed.
g. APM Data
    As discussed above, section 1848(q)(9)(A)(ii) of the Act requires 
us to publicly report names of eligible clinicians in Advanced APMs 
and, to the extent feasible, the names and performance of Advanced 
APMs. We see this as an opportunity to continue and build on reporting 
we are now doing of ACO data on Physician Compare. At this time, if a 
clinician or group submitted quality data as part of an ACO, there is 
an indicator on the clinician's or group's profile page indicating 
this. In this way, it is known which clinicians and groups took part in 
an ACO. Also, currently, all ACOs have a dedicated page on the Web site 
to showcase their data. If technically feasible, we proposed to use 
this model as a guide as we add APM data to Physician Compare. We 
proposed to indicate on eligible clinician and group profile pages when 
the eligible clinician or group is participating in an APM (81 FR 
28293). We also proposed to link eligible clinicians and groups to 
their APM's data, as relevant and possible, through Physician Compare. 
Data posting would be considered for both Advanced APMs and APMs that 
are not considered Advanced APMs.
    At the outset, APMs will be very new concepts for consumers. 
Testing shows that at this time, ACOs are not a familiar concept to the 
average Medicare consumer. It is very easy for consumers to 
misunderstand an ACO as just a type of group. We expect at least the 
same lack of familiarity when introducing the broader concept of APM, 
of which ACOs comprise only one type. In these early years, indicating 
who participated in APMs and testing language to accurately explain 
that to consumers provides useful and valuable information as we 
continue to evolve Physician Compare. As we come to understand how to 
best explain this concept to consumers, we can continue to assess how 
to most fully integrate these data on the Web site. We requested 
comment on these proposals.
    The following is a summary of the comments we received regarding 
our proposal to publicly report names of eligible clinicians in 
Advanced APMs and, to the extent feasible, the names and performance of 
Advanced APMs.
    Comment: Commenters supported CMS' proposal to use the current 
approach for reporting ACO involvement as a model for reporting APM 
involvement, and one commenter supported publicly reporting APM data at 
the individual eligible clinician level. Another commenter noted the 
importance of gradually integrating the APM data onto Physician Compare 
agreeing this is a new concept for consumers that will need to be fully 
explained. Some commenters did express concern that APM information may 
be difficult for consumers to understand, and one commenter suggested 
CMS provide additional contextual information including how the APM is 
structured and how APM structure influences comparability.
    Response: We agree using the ACO reporting model is a beneficial 
approach, and we support the gradual integration of the APM data onto 
Physician Compare as informed by consumer testing. This will ensure the 
information is presented in a way that is accurately interpreted and 
most beneficial to consumers. We will take recommendations to add 
additional contextual information into consideration as we work to 
include this information on the Web site.
    Comment: One commenter asked for clarification as to how CMS will 
prevent the display of APM data on Physician Compare from giving APM 
participants an advantage over MIPS participants.
    Response: We do not believe that one type of data provides an 
advantage over the other based on consumer understanding of the 
information currently available. Testing shows that consumers do prefer 
data at the individual eligible clinician level over data aggregated to 
the group or ACO level, but they find value in all data presented. We 
will keep this concern in mind as we continue to test APMs with 
consumers, however.
    After consideration of the comments and for the reasons we set 
forth, we are finalizing this policy as proposed.
h. Miscellaneous Comments
    Some of the comments received did not specifically relate to the 
public reporting proposals in the proposed rule. The following is a 
summary of these miscellaneous comments.
    Comment: A commenter supported including the number of patients 
reported per measure in the downloadable database. Another commenter 
stated that if QCDRs are going to take on a more important role in the 
Quality Payment Program, CMS should set better standards with regard to 
the public reporting of QCDR data and the issue of non-MIPS quality 
measures. One commenter recommended that Physician Compare have quality 
measures that reflect the physicians' specific contributions to patient 
care and outcomes, which emphasize the team-based approach that certain 
specialties take, such as palliative care. One commenter

[[Page 77399]]

recommended publicly reporting performance information only if eligible 
clinicians can have an assurance that their reported data is normalized 
and comparable. This commenter opposed publicly reporting performance 
information otherwise. One commenter recommended providing educational 
tools for patients viewing Physician Compare. This commenter believed 
that this will enable patients who view eligible clinicians on 
Physician Compare to note when a physician could not participate in a 
specific performance category listed.
    One commenter supported the inclusion of ABMS board certification 
and participation in Maintenance of Certification (MOC) Programs on 
Physician Compare. Another commenter recommended MOC participation as a 
measure in future rulemaking as part of quality performance data 
publicly reported on Physician Compare.
    One commenter believed that payers, providers, large group 
purchasers, and consumers should be fully empowered to access, use, 
share, contribute, and benefit from data that improve their health care 
decision making. Another commenter recommended including Medicare 
Advantage plan quality information that is comparable to FFS 
information on Physician Compare. One commenter recommended that 
Physician Compare provide comparative quality information and 
comparative pricing data across services; estimated costs for in 
network and out of network costs; allow consumer to customize the 
provider information to highlight the most relevant information; expand 
provider information to include the most relevant topics for consumers, 
such as patient-reported outcome measures; online decision-support 
tools, as well as assistive and cognitive technology tools.
    One commenter recommended CMS provide a method for comparing IHS, 
Tribal, and urban Indian providers. The commenter also recommended that 
CMS remain aware of these providers as distinct when collecting and 
reporting data.
    One commenter recommended providing a disclaimer that publicly 
reported final scores are not admissible judicially. Another commenter 
recommended a disclaimer on Physician Compare that performance 
information should not be used to determine whether an act of medical 
negligence has occurred.
    One commenter recommended that CMS provide a disclaimer where 
insufficient performance data exists on Physician Compare which 
explains why certain eligible clinicians do not have data publicly 
reported. Another commenter recommended that CMS indicate whether an 
eligible clinician has been excluded from reporting data so consumers 
do not potentially misinterpret limited performance data on the 
eligible clinicians profile page.
    Response: We appreciate the points, concerns, and suggestions 
raised by commenters and, if feasible and appropriate under the 
statute, we may possibly consider these issues in future rulemaking.
    Comment: One commenter supported allowing QCDRs to publicly report 
their performance data on their Web site. One commenter asked whether 
CMS will post all QCDR performance data on Physician Compare or allow 
QCDRs to post their performance data on their Web site. Another 
commenter recommended that QCDRs be able to provide a link to an 
external site that publicly reports information on clinicians 
associated with that QCDR.
    Response: To note current policies that will be carried forward 
under MIPS, QCDRs can choose to report their unique measures on their 
own Web site and provide a link for Physician Compare to include or on 
Physician Compare profile pages. All data that meet public reporting 
standards are included in the downloadable database, however.
    Comment: One commenter asked CMS to clarify the process for how 
partial data submission during a performance period is publicly 
reported on Physician Compare. Another commenter recommended publicly 
reporting eligible clinicians who report fewer than the required number 
of quality measures along with their reasoning for doing so. This 
commenter believes this will increase transparency.
    Response: To note current policies that will be carried forward 
under MIPS if feasible and appropriate, each measure submitted is 
evaluated on a measure-by-measure basis. If the specific measure meets 
all public reporting standards, it will be publicly reported even if 
the eligible clinician, for example, is not a satisfactory reporter 
under PQRS (for example, the clinician did not satisfactorily report 9 
measures across 3 domains). As a result, clinicians that report partial 
data do have data included on Physician Compare.
    Comment: One commenter recommended CMS provide a method for 
comparing IHS, Tribal, and urban Indian clinicians. The commenter also 
recommended that CMS remain aware of these clinicians as distinct when 
collecting and reporting data.
    Response: We appreciate the points, concerns, and suggestions 
raised by the commenter and, if feasible and appropriate under the 
statute, we may possibly consider these issues in future rulemaking and 
will conduct tribal consultation with tribes and tribal officials, as 
feasible and appropriate.
    Comment: Many commenters supported information that is publicly 
reported be statistically valid, reliable, scientifically based, and/or 
meaningful to consumers and eligible clinicians and request CMS focus 
on ensuring the data on Physician Compare are as accurate, reliable, 
and representative as possible. They also requested adequate 
disclaimers when there are limitations to the available data or 
questions about their completeness. Commenters also encouraged CMS to 
ensure the data included on Physician Compare are clear and useful to 
consumers. One commenter was concerned with inaccurate data being 
reported on Physician Compare, and recommended publishing MIPS data 
with an adequate description of the program including eligibility 
rules. Another commenter expressed some concern with the accuracy of 
the information and its usefulness for consumers.
    One commenter recommended a principal focus be on providing 
reliable and useful data rather than expediency.
    Response: We appreciate your comments and remain dedicated to 
publicly reporting data that generally meet public reporting standards.
    Comment: One commenter recommended that updates in PECOS be updated 
on Physician Compare within a short time frame, such as 30 days.
    Response: Data are refreshed on Physician Compare bi-weekly. Edits 
to PECOS do take longer to be reflected on the site as a result of the 
time it takes for MACs to review and verify information as needed. We 
are continually working to improve this timeline.

F. Overview of Incentives for Participation in Advanced Alternative 
Payment Models

    Section 1833(z) of the Act, as added by section 101(e)(2) of the 
MACRA, requires that an incentive payment be made to Qualifying APM 
Participants (QPs) for participation in eligible alternative payment 
models (referred to as Advanced APMs). Key statutory elements of the 
incentives for participation in Advanced APMs under the Quality Payment 
Program addressed in the proposed rule include:
     Beginning in 2019, if an eligible clinician participates 
in a certain type of APM (an Advanced APM), that eligible

[[Page 77400]]

clinician may become a QP. Eligible clinicians who become QPs are 
excluded from MIPS.
     For years from 2019 through 2024, QPs receive a lump sum 
incentive payment equal to 5 percent of their prior year's payments for 
Part B covered professional services, and beginning in 2026, QPs 
receive a higher update under the PFS than non-QPs.
     For 2019 and 2020, eligible clinicians may become QPs only 
through participation in Advanced APMs.
     For 2021 and later, eligible clinicians may become QPs 
through a combination of participation in Advanced APMs and Other Payer 
Advanced APMs.
    This section of the rule discusses public comments and finalizes 
the definitions, requirements, procedures, and thresholds of 
participation that will govern this program.
1. Policy Principles
    Several core policy principles are derived from both the MACRA law 
and the Department's broad vision for better care, smarter spending, 
and healthier people. These principles drive many of our decisions in 
developing the overall framework for making APM Incentive Payments to 
QPs and for approaching interactions between MIPS and APMs discussed in 
the proposed rule. In addition to increasing the quality and efficiency 
of care delivered in the Medicare program and across the health system, 
these principles include the following seven goals:
     To the greatest extent possible, continue to build a 
portfolio of APMs that collectively allows participation for a broad 
range of physicians and other practitioners. We believe finding better 
ways to deliver care across settings and specialties can lead to 
improved health outcomes and more efficient health care spending. Doing 
this requires active CMS engagement with stakeholders, as well as input 
from those stakeholders to refine ideas in ways that meet statutory and 
delivery system reform goals.
     Design the program such that the APM Incentive Payment is 
attainable by increasing numbers of Advanced APM participants over 
time, yet remains reserved for those eligible clinicians participating 
in organizations that are truly engaged in care transformation. We 
believe the structure of the law is clear in that the APM Incentive 
Payments are earned through participation in APMs that are designed to 
be challenging and involve rigorous care improvement activities. In 
general, we believe eligible clinicians that receive incentives should 
be those who: take on financial risk for potential losses under an APM; 
are accountable for performance based on meaningful quality metrics; 
and use certified EHR technology.
     Maximize participation in both Advanced APMs and other 
APMs. Although we want to maintain high standards for eligible 
clinicians to earn the APM Incentive Payment, we also want to enable 
and encourage high levels of participation in a broad range of APMs, 
including those that are not Advanced APMs. We believe participation in 
any APM offers eligible clinicians and beneficiaries significant 
benefits.
     Create policies that allow for flexibility in future 
innovative Advanced APMs. We do not want to constrain the robust 
development of new Advanced APMs by framing standards only in terms of 
today's APMs but rather in ways that allow many avenues for meeting the 
Advanced APM criteria.
     Support multi-payer models and participation in innovative 
models in Medicaid and commercial markets in order to promote high 
quality and efficient care across the health care market.
     Minimize burden on organizations and professionals. 
Between APM participation and MIPS reporting, we hope to coordinate 
administrative processes, minimize overall reporting burden, and make 
transitioning between being a QP and being subject to MIPS as seamless 
as possible.
     We do not intend to create additional performance 
assessments or audits beyond those specified under an APM. Rather, we 
believe the process for determining whether an eligible clinician 
receives the APM Incentive Payment should focus on the relative degree 
of participation by eligible clinicians in Advanced APMs, not on their 
performance within the APM. The Quality Payment Program does not alter 
how each particular APM measures and rewards success within its design. 
Rather, it rewards a substantial degree of participation in certain 
APMs.
2. Overview of Proposed APM Policies
    The incentives for Advanced APM participation established by the 
statute include several sets of related requirements that must be met. 
Three distinct roles play important parts in the program structure: (1) 
The Advanced Alternative Payment Model (Advanced APM), which is a 
health care payment and/or delivery model that includes payment 
arrangements and other design elements as part of a particular approach 
to care improvement and that by its design satisfies the criteria set 
forth in section 1833(z) of the Act; (2) the Advanced APM Entity, which 
is the entity participating in the Advanced APM; and (3) the eligible 
clinician, who is the individual physician or practitioner, or group of 
physicians or practitioners, who is a participant of the Advanced APM 
Entity and may be determined to be a QP.
    In this final rule with comment period, we describe a series of 
steps that result in the determination of certain eligible clinicians 
as QPs for a particular year (the payment year). QPs will receive the 
APM Incentive Payment as specified in section 1833(z) of the Act for 
each of the years they qualify from 2019 through 2024, and the 
differential update incentive in section 1848(d)(20) of the Act for 
each of the years they qualify beginning in 2026. Per section 
1833(z)(1)(A) of the Act, the APM Incentive Payment that an eligible 
clinician receives as a QP for a year between 2019 and 2024 is a lump 
sum payment equal to 5 percent of the QP's estimated aggregate payments 
for Medicare Part B covered professional services (services paid under 
or based on the Medicare PFS) for the prior year. Eligible clinicians 
who are QPs for a year are also excluded from MIPS for that year. In 
addition, beginning in 2026, QPs receive a higher Medicare PFS update 
(the ``qualifying APM conversion factor'') than non-QPs. This QP 
determination is made for one calendar year at a time.
    The steps that will result in a QP determination can be summarized 
as follows: (1) We determine whether the design of an APM meets three 
specified criteria for it to be deemed an Advanced APM; (2) an entity 
(the Advanced APM Entity) with a group of individual eligible 
clinicians participates in the Advanced APM; (3) we determine whether, 
during a performance period (the QP Performance Period), the eligible 
clinicians in the Advanced APM Entity collectively have at least a 
specified percentage of their aggregate Medicare Part B payments for 
covered professional services, or patients who received covered 
professional services, through the Advanced APM; (4) all of the 
eligible clinicians in the Advanced APM Entity are designated QPs for 
the payment year associated with that QP Performance Period. Those QPs 
would receive the 5 percent lump-sum APM Incentive Payments mentioned 
above for the payment year. This QP determination process would occur 
each year following the QP Performance Period, with the first payment 
year being 2019. Figure B illustrates the

[[Page 77401]]

stages of determinations that result in QP determinations.
[GRAPHIC] [TIFF OMITTED] TR04NO16.008

    The following is a summary of the comments we received generally 
regarding the incentives for participation in Advanced APMs.
    Comment: Some commenters expressed support for the policy 
principles and goals for Advanced APMs. Many commenters expressed a 
desire for more opportunities to participate in Advanced APMs. Many 
commenters specifically called for new Advanced APMs that focus on 
small or rural practices or specialty practices such as surgery, 
emergency medicine, dentistry, or long-term care. Some commenters 
suggested focusing on specific beneficiary populations. Other 
commenters expressed support for transitional pathways to Advanced APM 
participation, and changes to existing APMs both in order to change 
them into Advanced APMs and make them more accessible to new 
participants.
    Some commenters appreciated that the inception of this part of the 
Quality Payment Program will serve as a catalyst for more Advanced APMs 
and an acceleration of the movement from volume- to value-based 
payment. One commenter expressed concern that the process used to 
create and approve new Advanced APMs is too slow. One commenter 
expressed concern that because QPs in an Advanced APM Entity can earn 
the 5 percent APM Incentive Payment without demonstrating improved 
quality, controlled cost, or both, there will be no change to health 
care delivery, and that clinicians would not have a strong incentive to 
change their practice patterns. One commenter recommended CMS evaluate 
its overall approach and perhaps abandon Advanced APMs.
    Response: We agree with commenters that it is paramount for us to 
develop and offer more Advanced APM opportunities in the future. In 
order to increase participation in both APMs and Advanced APMs, we 
recognize that we must strive to create offerings for clinicians across 
the entire care continuum and across geographic regions.
    We plan to achieve these goals in the immediate and long-term 
future by expanding opportunities for clinicians to participate in 
existing Advanced APMs, changing certain existing APMs to meet the 
Advanced APM criteria, and developing new Advanced APMs, especially 
based on recommendations from the PTAC. The PTAC is discussed in 
section II.F.10. of this final rule with comment period. We note that 
not all models that are derived from PTAC recommendations must be 
Advanced APMs.
    The incentives for Advanced APM participation, as specified under 
section 1833(z) of the Act, do not provide for consideration of 
eligible clinicians' performance in terms of quality, cost, or other 
factors in making determinations as to whether eligible clinicians are 
QPs for a year. However, we believe the performance requirements that 
are applicable to eligible clinicians under each Advanced APM will 
incentivize participants to make improvements in care delivery so as to 
improve quality of care and reduce expenditures. Additionally, the 
Transforming Clinical Practice Initiative (TCPI) is a $685 million CMS 
Innovation Center initiative designed to support 140,000 clinicians in 
sharing, adopting, and further developing comprehensive quality improve 
strategies, which are expected to lead to greater improvements in 
patient health and reduction in health care costs.
    In regard to the request for transitional pathways to Advanced APM 
participation, section 1848(q)(11) of the Act provides $100 million in 
funding over 5 years for CMS to provide technical assistance to help 
clinicians develop the capabilities to be successful

[[Page 77402]]

in the Quality Payment Program. These technical assistance efforts will 
target eligible clinicians in individual or small group practices of 15 
or fewer, focusing on those practicing in rural areas, health 
professional shortage areas (HPSAs), and medically underserved areas 
(MUAs), as well as practices with low composite scores under the MIPS.
    The planned technical assistance will support small practices by 
helping them think through what they need to be successful under the 
Quality Payment Program, such as what quality measures and/or EHR may 
be appropriate for their practices' needs. The planned technical 
assistance would also educate clinicians about clinical practice 
improvement activities and how these activities could fit into their 
practices' workflow, or help practices evaluate their options for 
joining an APM. We believe this technical assistance, combined with our 
continued outreach and education efforts, will provide substantial 
support to eligible clinicians in their transition into APMs and 
Advanced APMs.
3. Terms and Definitions
    The APM track of the Quality Payment Program uses a set of 
interrelated defined terms. The basis for some core terms are set forth 
at sections 1833(z)(3) and 1848(q)(1)(C)(iii) of the Act, and others we 
will define in this final rule with comment period.
    We use the statutory text as a foundation to develop definitions 
for other key terms used in this final rule with comment period. The 
terms cover three primary topics: (1) The different types of APMs and 
their participating entities and clinicians; (2) the timing, process 
and thresholds for determining QPs and Partial Qualifying APM 
Participants (Partial QPs); and (3) the payment of the 5 percent lump 
sum incentive (APM Incentive Payment) to QPs.
    We are finalizing definitions for the following terms specific to 
incentives for participation in Advanced APMs, which are located at 
Sec.  414.1302 of new subpart O:
     Affiliated Practitioner.
     APM Entity.
     APM Incentive Payment.
     Attributed beneficiary.
     Attribution-eligible beneficiary.
     Alternative Payment Model (APM).
     Advanced Alternative Payment Model (Advanced APM).
     Advanced APM Entity.
     Eligible clinician.
     Episode payment model.
     Incentive Payment Base Period.
     Medicaid APM.
     Medicaid Medical Home Model.
     Medical Home Model.
     Other Payer Advanced APM.
     Other payer arrangement.
     Partial Qualifying APM Participant (Partial QP).
     Partial QP Patient Count Threshold.
     Partial QP Payment Amount Threshold.
     Qualifying APM Participant (QP).
     QP Patient Count Threshold.
     QP Payment Amount Threshold.
     QP Performance Period.
     Threshold Score.
a. Definitions of APM Entity and Advanced APM Entity
    The MACRA uses the term ``Eligible APM'' in the heading for section 
1833(z) of the Act, in section 1848(q)(9)(A)(ii) of the Act, and 
indirectly defines it at section 1833(z)(3)(D) of the Act as the APM in 
which ``eligible alternative payment entities'' participate. We have 
decided to use the term ``Advanced'' in lieu of ``Eligible,'' for those 
APMs defined by section 1833(z)(3)(C) of the Act that meet the criteria 
under section 1833(z)(3)(D) of the Act. Rather than referring 
indirectly, as is done in section 1833(z)(3)(D)(i) of the Act, to the 
APM in which an eligible alternative payment entity participates, we 
believe it is essential to the understanding of this final rule with 
comment period to be able to identify and finalize requirements 
directly for an Advanced APM.
    Similarly, we proposed to use the term ``Advanced APM Entity'' 
instead of ``alternative payment entity'' because it highlights the 
connected but different roles of the Advanced APM (for example, a CMS 
Innovation Center ACO model meeting specified criteria) and the 
Advanced APM Entity (for example, a specific ACO participating in that 
ACO model). We also believed that it was important to the clarity of 
the proposed rule to define ``APM Entity'' in addition to ``Advanced 
APM Entity'' so that we can easily distinguish between the two under 
both MIPS and the APM incentives. We proposed that an APM Entity is an 
entity that participates in an APM or Other Payer APM through a direct 
agreement with CMS or a non-Medicare other payer, respectively. These 
APM Entities will be primarily responsible for the cost and quality of 
care provided to beneficiaries through the APM. The term ``eligible 
alternative payment entity'' (which we refer to as an ``Advanced APM 
Entity'') is defined under section 1833(z)(3)(D) of the Act. We 
proposed that an Advanced APM Entity is an APM Entity that participates 
in an Advanced APM that, through terms of a direct agreement with CMS 
or through federal law or regulation, meets the criteria finalized in 
this rule.
    The following is a summary of the comments we received regarding 
our proposed definitions of the terms APM Entity and Advanced APM 
Entity.
    Comment: Commenters noted that a direct CMS agreement is not 
necessarily the operative legal instrument for entities to participate 
in APMs. They were concerned that the proposed definition would 
inadvertently prevent APM Entities from being considered Advanced APM 
Entities. One commenter stated concern that hospitalists would not be 
included under this definition of APM Entity and supported a more 
inclusive definition. One commenter disliked the set of terms related 
to APMs, such as Advanced APMs, APM Entities, and Other Payer Advanced 
APMs, and believed they were unclear. Another commenter stated that the 
definition of APM Entity was too restrictive, and requested that CMS 
expand it to include any entity that executed a Participation 
Agreement. One commenter criticized the use of the term Advanced APM 
and suggested that we use either Qualifying APM or Eligible APM.
    Response: We appreciate the attention to the definitions and agree 
that the definitions of APM Entity and Advanced APM Entity should not 
be a barrier to eligible clinicians becoming QPs, but rather 
descriptors of the entities that are participating in APMs and Advanced 
APMs, respectively. We believe that the proposed terms clearly 
distinguish each while showing the relationship between the terms, such 
as how an APM Entity participates in an APM. We understand that 
``qualifying'' or ``eligible'' could also have been used in the 
definitions because these are used in the statute. However, we chose 
``Advanced APM'' because we believe it reflects the element of 
additional rigor relative to APMs, allowing the term to serve as a 
meaningful descriptor of a certain type of APM.
    We are modifying our proposed definition of APM Entity to no longer 
require a direct agreement with CMS in all cases. Instead, we are 
defining APM Entity to mean an entity that participates in an APM or 
payment arrangement with CMS or another payer, respectively, through a 
direct agreement with CMS or the other payer, or through federal or 
state law or regulation. We are also finalizing the definition of 
Advanced APM Entity to mean an APM Entity that participates in an 
Advanced APM or Other Payer Advanced APM with CMS or a non-Medicare 
other payer, respectively, through a direct agreement with CMS or

[[Page 77403]]

the payer or through federal or state law or regulation. We note that 
we determine whether an APM is an Advanced APM or a payment arrangement 
is an Other Payer Advanced APM consistent with the criteria finalized 
in this final rule with comment period.
    These changes are important because some APMs define participation 
through a voluntarily signed agreement whereas other APMs may define 
participation through rulemaking or based on federal or state statutory 
requirements. For example, the CJR model defines participant hospitals 
(the APM Entities) in regulation based on their geographic location in 
specified Metropolitan Statistical Areas (MSAs). These definitions 
ensure that entities participating in APMs and Advanced APMs by various 
binding legal means are included in the definitions of APM Entity and 
Advanced APM Entity, respectively.
b. Definitions of Medical Home Model and Medicaid Medical Home Model
    We also proposed to define the terms ``Medical Home Model'' and 
``Medicaid Medical Home Model'' as subsets of APMs and Other Payer 
APMs, respectively. The MACRA does not define ``medical homes'' but 
sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 
1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act 
make medical homes an instrumental piece of the law.
    We note that medical homes would be the APM Entities in an APM, not 
the APM itself. The requirements in the MACRA and in this final rule 
with comment period actually relate to the disposition of the APM, not 
the participating APM Entities. For instance, as described in section 
II.F.4.b.(6) of this final rule with comment period, section 1115A(c) 
of the Act relates to the expansion of models (APMs), not the 
participants (APM Entities) of such models. APM participants are not 
expanded under section 1115A(c) of the Act. Therefore, we discuss 
medical homes in terms of the Medical Home Model, which is the concept 
to which the MACRA and this final rule with comment period actually 
refer. Although the definitions are identical but for their payer 
context, we distinguish Medicaid Medical Home Models because there are 
specific requirements for them under the determination of Other Payer 
Advanced APMs as described in section II.F.7.b.(3) of this final rule 
with comment period.
    We proposed that a Medical Home Model must have the following 
elements:
     Model participants include primary care practices or 
multispecialty practices that include primary care physicians and 
practitioners and offer primary care services.
     Empanelment of each patient to a primary clinician.
    In addition to these elements, we proposed that a Medical Home 
Model must have at least four of the following elements:
     Planned coordination of chronic and preventive care.
     Patient access and continuity of care.
     Risk-stratified care management.
     Coordination of care across the medical neighborhood.
     Patient and caregiver engagement.
     Shared decision-making.
     Payment arrangements in addition to, or substituting for, 
FFS payments (for example, shared savings or population-based 
payments).
    The two required elements are consistent with the fundamental 
characteristics of medical homes in the various incarnations and 
accreditation standards across the health care market. Therefore, we 
believe that an APM cannot be a Medical Home Model unless it has a 
primary care focus with an explicit relationship between patients and 
their practitioners. To determine that an APM has a primary care focus, 
we proposed that the Medical Home Model will have to involve specific 
design elements related to eligible clinicians practicing under one or 
more of the following Physician Specialty Codes: 01 General Practice; 
08 Family Medicine; 11 Internal Medicine; 37 Pediatric Medicine; 38 
Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse 
Specialist; and 97 Physician Assistant. We solicited comment on whether 
this proposal for determining that an APM has a primary care focus is 
sufficiently specified.
    We believe the optional elements should be present in Medical Home 
Models, but individually, each is less definitive of a characteristic 
than the two required elements. We also want to adhere to our principle 
of supporting future flexibility of APM design. Extensive rigid Medical 
Home Model criteria would not serve the purpose of promoting the 
development of new and potentially better ways of managing patient care 
through primary care.
    We solicited comment on these elements and which of the elements 
should be required as opposed to optional. Our proposed definition of 
Medicaid Medical Home Model is identical to Medical Home Model, except 
that it specifically describes a payment arrangement operated by a 
State under title XIX. It is important to separate the terms because 
Medicaid Medical Home Models have distinct implications in the Other 
Payer Advanced APM determination and the QP determination under the 
All-Payer Combination Option.
    The following is a summary of the comments we received regarding 
our proposed definitions of the terms Medical Home Model and Medicaid 
Medical Home Model.
    Comment: Several commenters addressed the terms used to describe 
Medical Home Models, and supported the proposed definitions. One 
commenter supported CMS' classification of a medical home as an 
``entity'' rather than as a ``model.'' One commenter recommended that 
CMS alter the term ``medical home'' to ``medical home entity'' to 
clarify that it is a TIN or collection of TINs that is an accountable 
unit within the Medical Home Model. This same commenter also suggested 
creating two new terms: ``Advanced Medicaid Medical Home Model'' and 
``Other Payer Advanced Medical Home Model.'' One commenter suggested it 
makes more sense to name Medical Home Models ``Primary-Care Focused 
Models'' and incorporate the term in the proposed required elements.
    Response: We thank commenters for their attention to this 
definition. We believe that the term ``Medical Home Model'' best 
reflects the intent of the statute's use of the term medical homes 
expanded under section 1115A(c) of the Act as specified in section 
1833(z) of the Act. We believe it makes the most sense, in context, to 
read the statutory references to ``medical home'' to identify a 
specific type of APM that potentially could be expanded, rather than to 
refer to an entity made up of eligible clinicians and other health care 
providers that would participate in an APM. That is why we proposed to 
define ``Medical Home Model'' as the APM and ``APM Entity'' as the 
participants in APMs. We use the term APM Entity as a general term to 
describe all entities that are participants in APMs and, except when it 
is expedient to implement statutory requirements, we do not believe we 
should create additional terms to describe subcategories of APM 
Entities as multiple terms could create confusion. Similarly, we 
believe that the terms Medical Home Model and Medicaid Medical Home 
Model provide sufficient clarity for purposes of implementing the 
statute, and that creating additional definitions may create confusion.

[[Page 77404]]

    Comment: Several commenters addressed how we define primary care as 
part of a Medical Home Model and a Medicaid Medical Home Model. One 
commenter agreed with our proposal to require a primary care focus as 
an essential requirement for Medical Home Models and encouraged CMS to 
additionally require that Medical Home Model participants be primary 
care medical home practices or multi-specialty practices that offer 
primary care, and empanelment of each patient to a primary care 
physician. The same commenter encouraged CMS to include in the optional 
elements for a Medical Home Model: Whole person orientation, quality 
and safety.
    In addition, the commenter expressed concern with our proposal to 
include certain eligible clinicians within Medical Home Models, as they 
are not always primary care practitioners, that is, 50 Nurse 
Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant. 
One commenter wanted more information on the licensing description for 
each category of eligible clinician and more information on the list of 
physician specialty codes. Another commenter sought clarification on 
whether or not the code for Nurse Practitioners includes all Nurse 
Practitioner codes or if the APM should specify codes for certain 
primary care certifications, and another commenter recommended that 
codes for family nurse practitioners, geriatric nurse practitioners, 
adult nurse practitioners, and others be included. A few other 
commenters recommended that CMS add code ``16 Obstetrics and 
Gynecology'' to the list of specialties that we would use to determine 
a primary care focus in a Medical Home Model. One commenter requested 
that occupational therapists to be considered a required component of 
any Medical Home Model. Another commenter suggested that behavioral 
health organizations be included in the definition of Medical Home 
Model. Some commenters requested clarification regarding the definition 
of ``parent organization'' and ``empanelment'' as it relates to Medical 
Home Models.
    A few commenters recommended CMS to broaden its definition of a 
Medical Home Model to include APMs that focus on specialty care. 
Another commenter suggested CMS to include specialist-focused Medical 
Home Models as a viable option for qualifying as an Advanced APM 
regardless of risk, much like it proposed for primary care-focused 
Medical Home Models. One commenter appreciated that CMS provided for 
elements such as continuity of care, coordination of chronic and 
preventive care, and coordination across the medical neighborhood, 
which will assist multispecialty practices when seeking to participate 
in an Advanced APM, but believed the definition we proposed for a 
Medical Home Model would largely exclude specialty-focused models. An 
additional commenter requested CMS to consider adding additional 
specialties to the approved list of Physician Specialty Codes to whom 
the patient may be assigned within the Medical Home Model. Another 
commenter expressed concern that Medicaid Medical Home Models might be 
prohibited from empaneling patients to any specialists, and one other 
commenter suggested that we add to the definition of Medical Home 
Models as a requirement the attribution of patients to specialists. One 
commenter suggested we address the special needs of children as a 
requirement in our definition. Another commenter requested information 
clarifying the relationship between the Medical Home Model definition 
and certified patient-centered medical home, and asked whether patient-
centered medical home certification is a requirement to be considered a 
Medical Home Model.
    Response: We appreciate commenters' input and will consider the 
suggestions for future rulemaking applicable to performance periods 
after 2017. We believe that the proposed definition is sufficient to 
identify Medical Home Models that might be in place for the 2017 QP 
Performance Period. However, we are modifying the proposed definition 
to emphasize the primary care focus. We note that because a Medical 
Home Model is a type of APM, having a primary care focus means that 
there are specific design elements that target eligible clinicians with 
the specified specialty codes. We are also adding code ``16 Obstetrics 
and Gynecology'' to the list of specialty codes that we will use to 
determine primary care focus because we agree with the commenter that 
these physicians often coordinate primary care services for women.
    We clarify that the definition of Medical Home Model does not 
include a requirement for patient-centered medical home certification. 
A certified patient-centered medical home is a practice-level 
designation, whereas a Medical Home Model is a type of APM (a payment 
model) defined in this final rule with comment period.
    We believe that empanelment is a commonly understood term used in 
existing APMs and primary care practices that does not need to be 
defined in this rulemaking. We believe that empanelment methodologies 
are specific to each Medical Home Model, and we do not want to unduly 
restrict APM design flexibility by prescribing how and to whom 
empanelment may be done. Although we note that Medical Home Models must 
have a primary care focus, we do not specify that empanelment in a 
Medical Home Model must be only to primary care practitioners. Finally, 
we discuss the meaning of ``parent organization'' in section 
II.F.4.b.(4) of this final rule with comment period in the context of 
the Advanced APM financial risk criterion.
    Comment: One commenter encouraged CMS to move towards measuring 
whether meaningful shared decision-making has occurred, specifically 
through patient-reported measures. This commenter also requested that 
CMS establish clear standards for practices to ensure that clinicians 
have the skills and training to furnish shared decision-making services 
at a high level of quality and to effectively use shared decision 
making tools. In addition, commenters recommended that shared decision-
making be re-framed as an integral part of ``shared care planning'' 
which occurs across a patient's lifespan rather than in a single 
episode of care and consisted of two key elements: (1) Patients faced 
with a treatment decision must be informed about all the reasonable 
options, including doing nothing, and told what is known about the 
potential risks, benefits and alternatives to those options; and (2) 
patients must be meaningfully involved in the decision making process. 
A few commenters suggested CMS require that all seven criteria must be 
met for an APM to be a Medical Home Model or a Medicaid Medical Home 
Model, and one of these commenters suggested CMS should define 
activities that demonstrate how those criteria can be satisfied. The 
same commenter also recommended adding an eighth element related to 
coordinating delivery of care with other services that address social 
determinants of health.
    Response: We thank the commenters for their suggestions. We believe 
that the suggestions may prove to be too prescriptive when setting 
standards that apply across many APMs, and we are concerned that 
imposing additional requirements would contradict our principle of 
supporting APM flexibility. For instance, we could develop an APM that 
addresses social determinants of health, but requiring social 
determinants of health to be an element of an APM in order for it to be 
considered a Medical Home Model

[[Page 77405]]

would be so strict as to exclude as Medical Home Models APMs that are 
widely available or focused on discrete care improvement goals. 
Therefore, we continue to believe that defining Medical Home Model to 
require a small set of core characteristics of medical home homes, 
along with a flexible set of additional characteristics, is the 
appropriate approach to maintain our principle to support APM 
flexibility. Defining Medical Home Model this way will allow for the 
inclusion of additional elements when actually creating a Medical Home 
Model to customize the APM for testing particular ways to improve the 
cost and quality of care.
    We are finalizing the definitions of Medical Home Model and 
Medicaid Medical Home Model with modifications to emphasize the 
requirement that the APM have a primary care focus, clarify the 
required versus additional elements, and add Obstetrics and Gynecology 
(specialty code 16) as a primary care specialty. We are finalizing the 
definitions as follows:
    A Medical Home Model or Medicaid Medical Home Model is an APM or 
payment arrangement under title XIX, respectively that we determine to 
have the following required elements:
     Primary care focus with participants that include primary 
care practices or multispecialty practices that include primary care 
physicians and practitioners and offer primary care services. For the 
purposes of this provision, primary care focus means involving specific 
design elements related to eligible clinicians practicing under one or 
more of the following Physician Specialty Codes: 01 General Practice; 
08 Family Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 
37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant.
     Empanelment of each patient to a primary clinician.
    In addition to these required elements, a Medical Home Model or 
Medicaid Medical Home Model must have at least four of the following 
additional elements:
     Planned coordination of chronic and preventive care.
     Patient access and continuity of care.
     Risk-stratified care management.
     Coordination of care across the medical neighborhood.
     Patient and caregiver engagement.
     Shared decision-making.
     Payment arrangements in addition to, or substituting for, 
FFS payments (for example, shared savings, population-based payments).
c. Other Definitions
    We believe that the proposed terms and definitions are sufficient 
to clearly implement the Quality Payment Program. These terms cover all 
steps of the APM Incentive Payment process, from participation in 
Advanced APMs to QP determinations and payment of incentives. We are 
aware that this is a complex program and that we propose to define a 
significant number of terms. We believe that, in general, it is 
preferable to use more, distinctive terms than to use fewer broader 
terms that could overlap and convey different meanings in different 
contexts. For instance, Partial QP Patient Count Threshold is a highly 
specific term, but we believe that it is necessary in context because 
there are differences between QPs and Partial QPs, and there are 
differences between the payment amount and patient count thresholds 
used to determine whether an eligible clinician becomes a QP or a 
Partial QP.
    We sought comment on these terms, including our proposed 
definitions, the relationship between terms, any additional terms that 
we should formally define to clarify the explanation and implementation 
of this program, and potential conflicts with other terms used by CMS 
in similar contexts. We also sought comment on the naming of the terms 
and whether there are ways to name or describe their relationships to 
one another that make the definitions more distinct and easier to 
understand. For instance, we wanted to know if commenters believe there 
are more intuitive or efficient terms than those proposed that would 
still adhere to the statutory language and the intended purposes of the 
terms. In particular, we indicated that we would consider options for a 
framework of definitions that might more intuitively distinguish 
between APMs and Other Payer APMs and between APMs and Advanced APMs.
    We also sought comment on alternative terms or definitions that 
could be useful in the calculations described in the proposed 
regulations in Sec. Sec.  414.1430, 414.1435, 414.1440, and 414.1445 of 
this final rule with comment period and easily understood by 
stakeholders.
    Comment: Some commenters expressed concern that non-physician 
practitioners are not included in the Advanced APM considerations and 
should be more explicitly represented in APM design. Some commenters 
requested that the Advanced APM CEHRT criterion should be waived for 
APMs that include non-physician practitioners because such clinicians 
were not eligible for incentive payments or subject to reduced Medicare 
payments related to the meaningful use of CEHRT under the Medicare EHR 
Incentive Program. Other commenters simply inquired about whether PTs, 
OTs, and SLPs are eligible to become QPs. One commenter found it 
confusing to use the term ``professional'' instead of the term 
``clinician.''
    Response: We appreciate that commenters expressed concern about the 
inclusion of non-physician practitioners in Advanced APMs. We believe 
it is important to clarify that physicians are not the only eligible 
clinicians who can become QPs. The list of eligible clinicians is 
defined in section 1833(z)(3)(B) of the Act (by cross-reference to the 
definition of ``eligible professional'' in section 1848(k)(3)(B)), and 
includes: physicians, physician assistants, nurse practitioners, 
clinical nurse specialists, certified registered nurse anesthetists, 
certified nurse-midwives, clinical social workers, clinical 
psychologists, registered dietitians or nutrition professionals, 
physical or occupational therapists, qualified speech-language 
pathologists, and qualified audiologists; and a group that includes 
these professionals.
    Therefore, any of those eligible clinicians who participate in 
Advanced APMs can become QPs for a year and receive the associated APM 
Incentive Payment. Each APM has its own focus, and many offer 
opportunities for non-physician practitioners to be participants. 
Although altering the design of existing or future APMs is beyond the 
scope of this final rule with comment, we welcome ideas on how to 
further engage underrepresented clinicians as we work hard to develop 
more APM opportunities. Finally, we do not believe it would be 
appropriate to waive the Advanced APM CEHRT requirement for APM 
Entities that may comprise non-physician practitioners. We believe it 
is also important to note that, as described in full in section 
II.F.4.b.(1) of this final rule with comment period, the Advanced APM 
criteria describe requirements that apply within APMs, but not 
necessarily to all APM Entities or eligible clinicians in the APM. 
Under the finalized policy in section II.F.4.b.(1), an APM does not 
necessarily have to specify that all non-physician practitioners use 
CEHRT in order to be an Advanced APM.
    We are finalizing the definition of ``eligible clinician'' as 
proposed. Eligible clinician has the meaning of the term ``eligible 
professional'' as defined in section 1848(k)(3) of the Act, is

[[Page 77406]]

identified by a unique NPI and includes any of the following: A 
physician; a practitioner described in section 1842(b)(18)(C) of the 
Act; a physical or occupational therapist or a qualified speech-
language pathologist.; a qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act) or a group that includes these 
professionals.
    We received no comments in response to our other proposed terms and 
definitions.
    We are finalizing all other definitions listed in this section as 
proposed.
4. Advanced APMs
    This section defines and outlines the proposed criteria for 
Advanced APMs, APMs through which eligible clinicians would have the 
opportunity to become QPs as specified in section 1833(z)(3)(C) and (D) 
of the Act. Other Payer Advanced APMs, types of alternative payment 
arrangements related to the All-Payer Combination Option, are addressed 
in section II.F.7. of this final rule with comment period.
    An Advanced APM must, by statute, meet certain requirements, and we 
are finalizing policies for these requirements within this section. 
First, the broad category of APMs is defined at section 1833(z)(3)(C) 
of the Act, which states that an APM is any of the following: (i) A 
model under section 1115A (other than a health care innovation award); 
(ii) the Shared Savings Program under section 1899; (iii) a 
demonstration under section 1866C; or (iv) a demonstration required by 
federal law.
    We believed it was necessary to propose additional clarification 
around the requirements as defined in section 1833(z)(3)(C)(iv) of the 
Act given the broad scope of programs and demonstrations required by 
federal legislation that are administered by the Department. We 
proposed that in order to be an APM as a ``demonstration required by 
Federal law,'' the demonstration must meet the following 3 criteria: 
(1) The demonstration must be compulsory under the statute, not just a 
provision of statute that gives the agency authority, but one that 
requires the agency to undertake a demonstration; (2) there must be 
some ``demonstration'' thesis that is being evaluated; and (3) the 
demonstration must require that there are entities participating in the 
demonstration under an agreement with CMS or under a statute or 
regulation. We solicited comments on our proposal for these criteria 
defining a demonstration required under federal law.
    We received no comments regarding our proposal that these three 
criteria must be satisfied in order for a demonstration to be 
considered an APM as a ``demonstration required by Federal law.''
    We are finalizing our proposal that an APM that is considered a 
demonstration required by Federal law is one that meets the following 3 
criteria: (1) The demonstration must be compulsory under the statute, 
not just a provision of statute that gives the agency authority, but 
one that requires the agency to undertake a demonstration; (2) there 
must be some ``demonstration'' thesis that is being evaluated; and (3) 
the demonstration must require that there are entities participating in 
the demonstration under an agreement with CMS or under a statute or 
regulation.
    Second, to be considered an Advanced APM, an APM must meet all 
three of the following criteria, as required under section 
1833(z)(3)(D) of the Act. The criteria are:
     The APM must require participants to use CEHRT;
     The APM must provide for payment for covered professional 
services based on quality measures comparable to those in the quality 
performance category under MIPS;
     The APM must either require that participating APM 
Entities bear risk for monetary losses of a more than nominal amount 
under the APM, or be a Medical Home Model expanded under section 
1115A(c) of the Act. For a discussion of Medical Home Models under this 
criterion, see section II.F.4.b.(6) of this final rule with comment 
period.
    In some cases, APMs offer multiple options or tracks with 
variations in the level of financial risk, or multiple tracks designed 
for different types of organizations, and we proposed to assess the 
eligibility of each such track or option within the APM independently. 
For instance, the Shared Savings Program has three distinct tracks, the 
Comprehensive ESRD Care Initiative (CEC) consists of a two-sided track 
for large dialysis organizations and a one-sided track for non-large 
dialysis organizations with the option for non-large dialysis 
organizations to elect to participate in the two-sided risk track 
beginning in 2017, and the Next Generation ACO Model has two risk 
arrangement options that feature different levels of financial risk.
    Significant distinctions between the design of different tracks or 
options may mean that some tracks or options within an APM would meet 
the Advanced APM criteria while other tracks or options would not. For 
example, APM Entities may have the option to assume two-sided risk 
(meaning that they bear a portion of the losses when spending exceeds 
expectations and share in the savings when spending is below 
expectations) or one-sided risk (meaning that they share in the savings 
when spending is below expectations, but do not bear a portion of the 
losses when spending exceeds expectations) under an APM. If the one-
sided risk track does not meet the standard for financial risk as 
discussed in section II.F.4.b.(3) of this final rule with comment 
period, APM Entities in this track would not be Advanced APM Entities, 
whereas those in the two-sided risk track could be Advanced APM 
Entities. In these instances, we would distinguish that the APM is only 
an Advanced APM for specific options or tracks.
    The following is a summary of the comments we received regarding 
our proposal to make Advanced APM determinations for each individual 
track or option within in APM when applicable.
    Comment: Commenters expressed general agreement that in cases where 
APMs offer multiple options or tracks, we should evaluate each option 
or track against the Advanced APM criteria independently.
    Response: We thank the commenters for their responses and agree 
that this proposal is logical.
    We are finalizing the proposal to consider different tracks or 
options within an APM separately for purposes of making Advanced APM 
determinations. All entities participating in Advanced APMs are 
Advanced APM Entities, and distinguishing between the model and the 
participating entities allows us to directly identify and discuss the 
requirements unique to each. This approach to identifying Advanced APMs 
and Advanced APM Entities is also consistent with our finalized 
proposals for determining QPs, described in section II.F.5. of this 
final rule with comment period, at the Advanced APM Entity level.
a. Advanced APM Determination
    To determine Advanced APMs and to support transparency for the 
Quality Payment Program, we proposed to establish a process by which we 
identify and notify the public of the APMs (including specific APM 
tracks or options) that would be considered Advanced APMs for a QP 
Performance Period. We indicated that we would post an initial 
notification to our Web site prior to the beginning of the first QP 
Performance Period and update the information on a rolling basis as 
explained below. We believed that making this information available in 
a timely and accessible format is

[[Page 77407]]

important for stakeholders to understand how we apply the Advanced APM 
criteria to existing APMs and to be informed as early as possible about 
whether an APM they are considering joining is an Advanced APM.
    We proposed two phases of Advanced APM determinations and notice. 
First, we proposed to release an initial set of Advanced APM 
determinations no later than January 1, 2017, for APMs that will be 
operating during the first QP Performance Period. Second, for new APMs 
announced after January 1, 2017, we would include its Advanced APM 
determination in conjunction with the first public notice of the APM, 
such as the Request for Applications (RFA) or final rule. In 
preliminary discussions of potential APMs, such as proposed rules, we 
will provide a non-binding determination based on the proposed APM 
design. We proposed that determinations of Advanced APMs would be 
posted on our Web site and updated on an ad hoc basis to the extent 
feasible, but no less frequently than annually, as new APMs become 
available and others end or change. Both the initial and ad hoc 
notifications would contain descriptions of whether each track or 
option within an APM would have in different Advanced APM statuses. We 
believe that this proposal incorporates both the interest in immediate 
dissemination of Advanced APM determinations for the existing APM 
portfolio following finalization of this rule and the structure for 
making the Advanced APM status a regular part of the development and 
release of new APMs in the future.
    We solicited comment on the proposals for both the initial and ad 
hoc notices of Advanced APM determinations. In particular, we solicited 
comments on optimal times, locations, formats, and other methods of 
notice of Advanced APM determinations to promote clarity and 
consistency as to which APMs are considered Advanced APMs for a 
particular QP Performance Period.
    The following is a summary of the comments we received regarding 
our proposed process to make and notify the public of Advanced APM 
determinations.
    Comment: Some commenters requested that we develop a transparent 
public process for determining which APMs are Advanced APMs. For 
example, some commenters stated there should be a public comment 
process before each APM is determined to be an Advanced APM. Other 
commenters stated that the public should have public input into how we 
determine which APMs are Advanced APMs. Other commenters simply stated 
that they want timely information necessary to be able to make educated 
decisions about the APM participation.
    Response: We agree with the commenters that transparency is 
important to the future development and determination of Advanced APMs. 
This rulemaking process is part of that public input process and gives 
stakeholders and the public an opportunity to provide input into the 
criteria and process by which we make and announce Advanced APM 
determinations, as well as develop new APMs. Our proposal described how 
we would make Advanced APM determinations publicly available as new 
models are announced. We also publish Requests for Information (RFIs) 
and proposed rules for purposes of developing certain APMs, which are 
further opportunities for public input as we make Advanced APM 
determinations. In addition, the PTAC, as described in section II.F.10. 
of this final rule with comment period, represents a significant new 
pathway for the public to offer new ideas for implementation as APMs.
    However, we do not find it practical or meaningful to hold a public 
comment process regarding each Advanced APM determination. These 
determinations will be factual applications of the Advanced APM 
criteria, as prescribed by statute and established in this final rule, 
to the design of a particular APM. The opportunities for meaningful 
input are in the development of the criteria and the APMs, but not in 
the administrative task of determining whether the APM meets the 
Advanced APM criteria. Soliciting input on Advanced APM determinations 
for individual models could also significantly delay when stakeholders 
would know whether an APM is an Advanced APM.
    Comment: Several commenters urged us to make the first round of 
official Advanced APM determinations either in this final rule or as 
soon as possible after this final rule is published with subsequent 
updates in a timely manner that allows for APM participation decisions 
based on those determinations. The commenters expressed that knowing 
the Advanced APM status of an APM is very important to decisions 
regarding participation. Some commenters expressed frustration that for 
2017 they had to make APM participation decisions prior to the 
publication of this final rule with comment period. Commenters also 
stated that the expiration of the APM Incentive Payment after 6 years 
puts additional pressure on clinicians to join Advanced APMs as soon as 
possible, and expressed a wish for a greater number of immediate 
opportunities to participate in Advanced APM.
    Response: We appreciate the comments and support for our proposed 
policy regarding the timeliness of Advanced APM determinations, and we 
agree that it is essential going forward that we provide determinations 
as soon as practicable in order to support decision making by eligible 
clinicians and entities. Following publication of this final rule with 
comment period, we will release the 2017 list of Advanced APMs as soon 
as possible but no later than January 1, 2017. Then, we will update 
this list with each material APM amendment or new APM release.
    We understand the difficulties of a notice and comment rulemaking 
process when eligible clinicians and entities are trying to make 
business decisions that can be impacted by policy decisions in a final 
rule. The proposed rule offered our early thoughts as to which APMs 
might be considered Advanced APMs in 2017. We encourage stakeholders 
keep in mind that the designs of APMs themselves offer substantial 
rewards, and we believe that those design elements should be the 
primary considerations for eligible clinicians and entities in deciding 
whether or not to participate in a given APM. Also, in sections II.F.1. 
and II.F.10. of this final rule with comment period we discuss how we 
plan to increase the number of Advanced APM opportunities each year.
    Some concerns expressed by commenters about Advanced APM 
determinations are closely linked with our policies on the QP 
Performance Period and the MIPS performance period, and the interaction 
between these policies. We encourage commenters to see the discussion 
of the QP Performance Period in section II.F.5.a. of this final rule 
with comment period, which describes the operational relationships that 
address the need to make QP determinations in time for their exclusion 
from MIPS.
    Comment: Some commenters suggested that we collaboratively develop 
and vet the format and style of Advanced APM notifications with 
stakeholders to make them as helpful as possible to potential 
participants.
    Response: Although the development of education and outreach 
materials regarding the Quality Payment Program is a subregulatory 
activity, we agree with commenters and plan to actively engage relevant 
stakeholders in the development of our messages and materials. 
Materials related to particular APMs are outside the scope of this 
final rule with comment period.

[[Page 77408]]

    We are finalizing the process for determining Advanced APMs and 
notifying the public of those determinations as proposed. We will 
release an initial set of Advanced APM determinations as soon as 
possible but no later than January 1, 2017. For new APMs that are 
announced after the release of our initial set of Advanced APM 
determinations, we will include Advanced APM determinations in 
conjunction with the first public notice of the APM, such as the 
Request for Applications (RFA) or final rule. Likewise, if we make 
changes to an APM that change the determination of whether the APM is 
an Advanced APM, we will include public notice with the announcement. 
All determinations of Advanced APMs will be posted on our Web site and 
updated on an ad hoc basis, but no less frequently than annually, as 
new APMs become available and others end or change. Both the initial 
and ad hoc determinations will include descriptions of whether each 
track or option within an APM is or is not an Advanced APM.
    In section II.F.7. of this final rule with comment period, we 
finalize how we would identify Other Payer Advanced APMs. The Other 
Payer Advanced APM identification process goes into effect starting in 
the third QP Performance Period (applicable for payment year 2021) and 
aligns with the availability of the All-Payer Combination Option for QP 
determinations.
b. Advanced APM Criteria
    Under the statute, for an APM to be an Advanced APM it must meet 
the criteria set forth in sections 1833(z)(3)(C) and (D) of the Act and 
discussed below. An Advanced APM must be an APM that:
     Requires its participants to use certified EHR technology 
(CEHRT), as described in section II.F.4.b.(1) of this final rule with 
comment period;
     Provides for payment for covered professional services 
based on quality measures comparable to measures under the quality 
performance category under MIPS, as described in section II.F.4.b.(2) 
of this final rule with comment period; and
     Either (a) requires its participating Advanced APM 
Entities to bear financial risk for monetary losses that are in excess 
of a nominal amount, as described in section II.F.4.b.(3) of this final 
rule with comment period, or (b) is a Medical Home Model expanded under 
section 1115A(c) of the Act, as described in section II.F.4.b.(4) of 
this final rule with comment period.
    These requirements as set forth in the statute and as proposed must 
be met through the design of the APM. Whether an APM is an Advanced APM 
depends solely upon how the APM is designed, rather than on assessments 
of participant performance within the APM. Some stakeholders have 
suggested that actual performance (for example, on CQMs or on whether 
the Advanced APM Entity generates savings) be considered in the 
determination of QPs. However, the incentives for Advanced APM 
participation, as specified under section 1833(z) of the Act, do not 
provide for consideration of actual performance in making such 
determinations. Performance assessments are already part of APMs, and 
we believe it is important and consistent with the statutory framework 
to continue to foster flexibility in structuring the specific rewards 
and consequences of performance within each APM.
    For example, an APM that ties payments to performance on quality 
measures comparable to those under MIPS may be an Advanced APM 
regardless of an Advanced APM Entity's actual performance on those 
quality measures. If an Advanced APM Entity fails to meet quality 
performance standards under the Advanced APM, it would face 
consequences within the Advanced APM, such as financial penalties, loss 
of access to data or certain waivers, or termination of its 
participation agreement. The termination scenario would have the 
downstream effect of terminating Advanced APM Entity status and the 
eligible clinicians' potential eligibility for the APM Incentive 
Payment because the entity would no longer be participating in the 
Advanced APM. As another example, an Advanced APM Entity that bears 
more than nominal financial risk for monetary losses in accordance with 
the standards set forth in section II.F.4.b.(3) of this final rule with 
comment period would be an Advanced APM Entity regardless of whether it 
actually earns savings or generates losses under the Advanced APM. This 
would work similarly for an Other Payer Advanced APM.
    We do not intend to add additional performance assessments on top 
of existing Advanced APM standards. As stated in the discussion of 
policy principles at the beginning of section II.F.1. of this final 
rule with comment period, the proposed QP determination process 
assesses the relative degree of participation of the Advanced APM 
Entity and eligible clinician in Advanced APMs, not their performance 
as assessed under the APM. The Quality Payment Program would not alter 
how each particular APM measures and rewards success within its design. 
Rather, the APM incentive track of the Quality Payment Program rewards 
a substantial degree of participation in Advanced APMs.
    The following is a summary of the comments we received generally 
regarding our Advanced APM criteria proposals.
    Comment: Many commenters stated their belief that the Advanced APM 
criteria are generally too complex and restrictive and that they should 
be simpler and more flexible in order to: (1) Reflect the current level 
of clinician readiness for quality measurement, EHR use, and risk 
arrangements; (2) allow more APMs to meet the criteria; and (3) 
encourage broad participation in APMs. Some commenters believe that the 
most popular APMs should be Advanced APMs, and that if APMs are not 
Advanced APMs, clinicians will be deterred from participation in a way 
that could reverse recent progress towards greater APM participation. 
Some commenters stated that all Innovation Center models should be 
considered Advanced APMs, regardless of whether or not they meet the 
criteria. Other commenters suggested that we reward clinicians for 
demonstrating movement toward APMs or Advanced APMs or that we consider 
APMs that move toward meeting the Advanced APM criteria in the future 
to be deemed Advanced APMs in the interim. One commenter recommended 
that there should be two paths: One that most clinicians should strive 
for, and a more difficult path restricted to 20 percent of all 
clinicians. One commenter recommended that CMS allow small practices 
that report quality via a QCDR to be considered as participants in the 
Advanced APMs.
    Response: We understand that commenters consider the Advanced APM 
criteria too complex or too demanding. We agree with commenters that, 
all else equal, less complex criteria are preferable, regardless of the 
underlying difficulty for APMs to meet the criteria. Accordingly, in 
finalizing this rule, we have made several policy changes in order to 
simplify the Advanced APM criteria--for the CEHRT criterion by not 
changing over time the percentage of use an APM must require; and for 
the financial risk criterion by eliminating the marginal risk 
components of the nominal amount standard.
    Regarding the stringency of the criteria, we agree with some of the 
concerns raised by commenters. In particular, we agree in that the 
magnitude of the proposed requirements for the financial risk criterion 
was too

[[Page 77409]]

high, and we are modifying our final policies accordingly. On the other 
hand, it has never been our expectation that all or most clinicians 
will participate in Advanced APMs immediately, nor do we believe that 
was the statutory intent. As such, we do not believe the fact that not 
all APMs qualify as Advanced APMs in itself implies that the criteria 
are overly stringent. We worked within the statutory structure to 
define the Advanced APM criteria, which inherently are meant to 
distinguish between APMs with more and less challenging terms. That 
said, we believe that all APMs offer meaningful opportunities and 
benefits to clinicians, particularly as on-ramps to eventual 
participation in Advanced APMs.
    Finally, it is important for commenters and stakeholders to keep in 
mind that no eligible clinicians or APM Entities are directly subject 
to these Advanced APM criteria. These are standards used to determine 
which APMs are Advanced APMs. The APM designs contain the terms under 
which APM Entities participate, and many Advanced APMs will have 
requirements that far exceed the Advanced APM criteria set in this 
final rule. Changing the Advanced APM criteria will not affect the 
requirements for participants in any particular Advanced APM.
    Comment: Some commenters stated that the Advanced APM criteria 
should be wholly different from those proposed. For instance, some 
commenters expressed that we should synchronize the criteria with the 
APM Framework developed by the Health Care Payment Learning and Action 
Network (LAN) APM Framework and Progress Tracking Work Group, which 
classified four categories of APMs.
    Some commenters were supportive of the Advanced APM framework but 
expressed support for additional criteria for determining Advanced 
APMs, such as demonstrating that the payment approach will reinforce 
the delivery of coordinated patient- and family-centered care; 
requiring a clinical care model that reinforces a strong primary care 
foundation; a focus on care coordination; shared care planning; health 
IT infrastructure development; population health management; risk 
management; emphasis on consumer experience; and several more. One 
commenter suggested that we remove the Advanced APM designation from 
Advanced APMs that fail to demonstrate successful outcomes.
    Response: We appreciate the input on how Advanced APMs should be 
determined and designed, and we agree that these concepts are important 
in the design of particular APMs. However, the statute specifies the 
criteria we must use to determine Advanced APMs, and we are 
implementing the statutory criteria in this rulemaking process. 
Although the comments on additional specifications for Advanced APMs 
are beyond the scope of this final rule with comment period, we remind 
the commenters of the PTAC, as described in section II.F.10. of this 
final rule with comment period, and note that commenters can submit 
ideas for APM designs directly to the Innovation Center.
(1) Use of Certified EHR Technology
    The first criterion an APM must meet to be considered an Advanced 
APM is that it requires participants in the APM to use certified EHR 
technology (as defined in section 1848(o)(4) of the Act), as specified 
in section 1833(z)(3)(D)(i)(I) of the Act.
(a) Definition of Certified EHR Technology
    For this Advanced APM criterion, we proposed to adopt the 
definition of CEHRT proposed for MIPS under Sec.  414.1305. In the 2015 
EHR Incentive Programs final rule (80 FR 62872 through 62873), we 
established the definition of CEHRT that must be used by EPs to meet 
the Meaningful Use objectives and measures in specific years. This 
definition is similar to the definition that applies to eligible 
hospitals, CAHs, and EPs in the Medicare EHR Incentive Programs. The 
definition includes the certification criteria for a wide range of 
standards for use in capturing patient health information like vital 
signs, medications and medication allergies, problem list, and lab 
results among other data elements included in the common clinical data 
set (CCDS). It also includes the certification criteria and standards 
for functions related to information exchange, patient engagement, 
quality reporting, and protecting the privacy of electronic protected 
health information. For further information on the certification 
criteria, see the 2015 Edition Certification Criteria final rule (80 FR 
62602 through 62759) and for example Table 8: ``Common Clinical Data 
Set'' (80 FR 62696).
    This approach aligns the APM health IT certification requirements 
for Advanced APMs with those used by MIPS eligible clinicians. We 
understand this proposed CEHRT definition may include some EHR 
functionality used by MIPS eligible clinicians which may be less 
relevant for an APM participant, and likewise APM participants may use 
additional functions that are not required for MIPS participation. 
However, we observe that APM participants often work in the same office 
space, group, entity, or organization with eligible clinicians that are 
not APM participants. At times they might share common resources, such 
as the same EHR system. Using the same CEHRT definition for both MIPS 
and Advanced APMs would allow eligible clinicians to continue to use 
shared EHR systems and give eligible clinicians flexibility of 
participation as a MIPS eligible clinician or an eligible clinician in 
an Advanced APM without needing to change or upgrade EHR systems. 
Although updates to the certified health IT for APM participants, MIPS 
participants, or both may be necessary in future years, we believe that 
aligning the APM and MIPS definition for CEHRT is appropriate at this 
time.
    We solicited comment on the proposed definition of CEHRT for 
Advanced APMs.
    The following is a summary of the comments we received regarding 
our proposal to adopt the same definition of CEHRT for Advanced APMs as 
proposed for MIPS.
    Comment: Many commenters expressed strong support for aligning the 
definition of CEHRT for Advanced APMs with the definition of CEHRT used 
in MIPS. Several commenters suggested this alignment would reduce 
administrative costs and reduce confusion among clinicians. One 
commenter suggested the CEHRT definition be more specific and rigorous. 
Some commenters suggested specific features and functionality (for 
example, empanelment of patients, stratification of the patient 
population, display of eCQM results by clinician and practice site) 
should be included as required components of the CEHRT definition. One 
commenter indicated that all Advanced APMs will have different HIT 
needs; therefore, specific HIT features should not be required for all 
Advanced APMs.
    Response: We appreciate the commenters' suggestions and support for 
the proposed definition of CEHRT for Advanced APMs. Although a few 
commenters suggested the CEHRT definition include additional health IT 
capabilities not included in the CEHRT definition, we believe it is 
more important to maintain consistency across programs at this time. We 
also note that, although Advanced APMs must require eligible clinicians 
in Advanced APM Entities to use systems that at least meet the CEHRT 
definition, APMs have the flexibility to set additional health IT 
requirements as necessary to support specific criteria or goals under 
the APM.

[[Page 77410]]

    Comment: A commenter suggested that the care plan criterion 
finalized in the 2015 Edition Certification Criteria should also be 
included in the CEHRT definition.
    Response: The ONC health IT certification program defines the 
testing and certification criteria for a wide range of potential 
standards and functions for certified health IT beyond those used for 
the meaningful use objectives and measures. In some cases, these 
criteria support other specific CMS program needs; in other cases, they 
may relate to public quality improvement initiatives in the health care 
industry. For example, the filtering criteria for eCQMs may support 
advanced electronic clinical quality measurement by APMs, and the care 
plan certification criterion may support care coordination especially 
in chronic disease management. Both of these new functions are 
available for clinicians within the 2015 Edition, and clinicians may 
use health IT modules certified to these criteria to support quality 
measurement, clinical practice improvement activities and participation 
in an APM or other payer arrangement.
    The CEHRT definition merely sets the baseline requirements that 
eligible clinicians must have to meet the meaningful use objectives and 
measures, which are designed to be applicable for a wide range of 
clinician types in a diverse range of settings. These requirements are 
not intended to limit clinicians electing to use more advanced 
functions or to use health IT in other ways. Rather, the CEHRT 
definition is intended to ensure that a user has the tools needed to 
succeed in meeting the objectives and measures, without creating 
additional burden to obtain health IT unrelated to their practice. As 
stated in the proposed rule at 81 FR 28299, we intend to maintain 
continuity for APM participants with the definition recently finalized 
for the eligible clinicians participating in the MIPS advancing care 
information performance category, described at Sec.  414.1305. This is 
also consistent with the EHR Incentive Program's CEHRT definition at 42 
CFR 495.4. Therefore, we are finalizing the same definition of CEHRT 
under the Advanced APM CEHRT use criterion as we have finalized for 
MIPS at Sec.  414.1305. We will consider whether to include the care 
plan and other potentially new or advanced certified health IT modules 
in future rulemaking.
    Comment: One commenter believes that a strong, broad Health IT 
infrastructure should be a key element used to identify Advanced APMs 
rather than the narrow proposed CEHRT criteria. This commenter defined 
this as the adoption of EHRs, patient registries, or an alternative IT 
architecture that allows for timely exchange of health data with other 
clinicians involved in a patient's care and generation of meaningful 
data analytics. One commenter recommended that CMS engage the health IT 
community before introducing additional APMs that rely heavily upon IT 
products and services, especially if those models have unique or 
specialized technology requirements.
    Response: We agree that Advanced APMs need a strong health IT 
infrastructure as a foundation for communicating and delivering 
comprehensive and coordinated care to their patients. However, we also 
believe that it is important to leave flexibility for individual models 
to tailor their health IT requirements to the needs of their particular 
population and goals. Section 1833(z)(3)(D)(i)(I) of the Act requires 
that Advanced APMs require their APM participants to use CEHRT (as 
defined in section 1848(o)(4) of the Act), and we continue to believe 
the definition we proposed meets this criterion while maintaining 
flexibility for individual APMs to set broader health IT requirements.
    We are finalizing the definition of CEHRT for Advanced APMs as 
proposed. We believe the CEHRT definition for Advanced APMs aligns the 
APM health IT certification requirements for Advanced APMs with those 
used by MIPS eligible clinicians and will permit eligible clinicians 
using shared systems to participate in both programs without requiring 
changes to their health IT systems.
(b) Requiring the Use of CEHRT
    The statute does not specify the number of eligible clinicians who 
must use CEHRT or how CEHRT must be used in an Advanced APM. We believe 
we have discretion to define the ways in which an Advanced APM requires 
the use of CEHRT. In accordance with section 1833(z)(3)(D)(i)(I) of the 
Act, we proposed that an Advanced APM must require at least 50 percent 
of eligible clinicians (or each hospital if hospitals are the APM 
participants) to use the certified health IT functions outlined in the 
proposed definition of CEHRT to document and communicate clinical care 
with patients and other health care professionals. Communicating 
clinical care means that other eligible clinicians and/or the patient 
can view the clinical care information. We also proposed an alternative 
set of criteria that would be applicable to the Shared Savings Program 
to demonstrate the use of CEHRT by eligible clinicians participating in 
ACOs to allow the Shared Savings Program to be an Advanced APM, as 
discussed further below. We proposed the 50 percent CEHRT use threshold 
would be confined to the first QP Performance Period (proposed to be 
2017, as discussed later in this final rule with comment period). That 
is, only in 2017 could APMs use the 50 percent threshold for eligible 
clinicians in each participating entity to meet the use of CEHRT 
requirement. We proposed that the threshold requirement for use of 
CEHRT would increase to 75 percent beginning for the second QP 
Performance Period (proposed to be 2018). The CEHRT requirement for 
Advanced APMs in which hospitals are the participants would remain the 
same over time because it is an all-or-nothing requirement of the 
hospital as a single entity.
    We believe there are a few reasons why having a lower threshold 
requirement for the use of CEHRT by the eligible clinicians 
participating in an APM Entity in the first year is appropriate. First, 
we wanted to ensure that APMs have sufficient time to alter their terms 
and conditions to meet this standard. We also acknowledge that eligible 
clinicians would be expected to upgrade from technology certified to 
the 2014 Edition to technology certified to the 2015 Edition for use in 
2018, and some eligible clinicians who have not yet adopted CEHRT may 
wish to delay acquiring CEHRT products until a 2015 Edition certified 
product is available.
    This CEHRT requirement would be based on the requirements that an 
APM places on its participating APM Entities. In determining whether an 
APM meets this criterion, we did not propose to assess the level of use 
of each APM Entity or individual eligible clinician participating in 
the APM but rather whether the APM requirements meet the standard set 
forth in the proposed rule.
    We invited comment on whether the proposed thresholds for use of 
CEHRT for APM Entities that are not hospitals (50 percent for the first 
QP Performance Period (proposed 2017) and 75 percent for the second QP 
Performance Period (proposed 2018) and later are appropriate, or if we 
should consider additional options such as a higher or lower percentage 
in 2018, or an additional incremental increase for 2019. We also 
invited comment on whether we should consider higher thresholds for 
APMs that target eligible clinician populations with higher-than-
average adoption of certified health IT, such as eligible clinicians in 
patient-centered medical homes. Finally, we

[[Page 77411]]

invited comment on whether we should explore ways to set lower 
thresholds for those APMs targeting eligible clinician populations that 
may have lower average adoption of certified health IT, such as 
specialty-focused APMs.
    The following is a summary of the comments we received regarding 
the proposed thresholds for use of CEHRT for APM Entities that are not 
hospitals.
    Comment: Numerous commenters supported the proposed criterion for 
the 2017 QP Performance Period. However, the majority of those 
commenters stated that CMS should not raise the CEHRT use requirement 
to 75 percent in 2018 and later. A few commenters requested that CMS 
provide more time to meet the 50 percent requirement, that CMS should 
have lower thresholds for certain specialties, or that any increase be 
gradual. Many commenters indicated that raising the threshold in 2018 
to 75 percent would be unattainable for some APM Entities. Some 
commenters also suggested that this criterion not apply if their MIPS 
advancing care information performance category weight is reduced to 
zero (for example, because they are hospital-based, have insufficient 
internet coverage, are non-patient facing, or were not previously 
included as an Eligible Professional in the Meaningful Use program). 
Another commenter supported the threshold but indicated some 
specialties should be excluded.
    Response: We appreciate the support for the proposed CEHRT use 
threshold of 50 percent for Advanced APMs for the 2017 performance 
period. We believe that setting the threshold at 50 percent of eligible 
clinicians allows APMs sufficient room to meet this requirement even if 
the APM includes some participants who do not have internet access, 
lack face-to-face interactions, or are hospital-based. We understand 
the commenters' concerns that raising the threshold to 75 percent in 
2018 may create an overly rigorous standard for Advanced APMs and agree 
that it would be prudent to wait until we have more information on how 
the threshold would impact specific APMs, such as specialty APMs, 
before increasing the threshold, if at all. As a result, we are not 
finalizing our proposal to increase the requirement of APMs to require 
75 percent CEHRT use after the first QP Performance Period.
    Comment: Alternatively, a few commenters supported raising the 
threshold for CEHRT, especially for APMs with above average health IT 
adoption among participants, and another commenter supported increasing 
the threshold for CEHRT use in Advanced APMs over time. Some commenters 
indicated that the requirement to use CEHRT should not be based on any 
threshold but instead be based only on an attestation of CEHRT adoption 
by the Advanced APM eligible clinicians. One commenter requested CEHRT 
use be limited to a 90-day period in 2017.
    Response: We agree with the commenter that certain APMs have APM 
Entities that may be able to meet a higher CEHRT use threshold. We note 
that some current APMs include CEHRT use requirements that exceed a 50 
percent threshold. Since we expect many, widely varied APMs to be 
developed and implemented over the next few years, we believe we should 
use this time to gather more information on which APMs would be able to 
meet a higher Advanced APM CEHRT use requirement. We do not believe a 
90-day period of use is a meaningful standard because the CEHRT is used 
by eligible clinicians principally as a medical record to document and 
communicate the clinical care they provide to their patients. Medical 
record documentation of clinical care is an ongoing activity and 
therefore we see no reason to limit the criterion of this activity to a 
90 day period. We want to clarify for commenters that the requirement 
for CEHRT use in order for an APM to be an Advanced APM is applicable 
to the APM, not necessarily to all of the APM participants. The 
Advanced APM itself could have more stringent requirements and require 
the use of CEHRT in a variety of ways so long as it requires at least 
50 percent of the eligible clinicians in each APM Entity use CEHRT. We 
do not discount the value of the commenters' suggestions but rather 
believe that they could or should be incorporated into APM design 
rather than adopted as the minimum requirement for an APM to be 
considered an Advanced APM. We appreciate the commenter's suggestion 
for a process to ascertain whether the CEHRT criterion is met by having 
the eligible clinicians who are participating in Advanced APMs attest 
that they have adopted CEHRT rather than including the use of the 50 
percent threshold, but we believe the use of a threshold best defines 
how an Advanced APM must require its participants to use CEHRT in 
accordance with the statutory CEHRT use criterion.
    Comment: One commenter recommended that a different threshold 
regarding the adoption of certified HIT should apply to any potential 
pathology-focused APM because laboratory information systems are not 
considered certified HIT or EHR technology.
    Response: Presently, CMS does not have an Advanced APM that 
includes individual pathologists as participants of the APM. We will 
monitor this issue for new APMs and consider the applicability of the 
CEHRT requirement for APMs in which the majority of the eligible 
clinicians do not use CEHRT due to lack of certified systems for a 
particular specialty.
    Comment: A few commenters stated agreement with a uniform CEHRT use 
threshold for all Advanced APMs other than the Shared Savings Program.
    Response: We thank commenters for their support, and agree that the 
same thresholds should be consistent across APMs other than the Shared 
Savings Program for which we are finalizing a different use of CEHRT 
requirement.
    Comment: A few commenters urged CMS to provide flexibility so that 
an APM would meet the EHR criterion to be an Advanced APM if it allowed 
eligible clinicians working in a facility such as a hospital that has 
CEHRT to be deemed to be using CEHRT. A commenter requested that CMS 
consider models such as BPCI and CJR as meeting this criterion if 
participating hospitals are using CEHRT. A commenter also indicated 
that as a medical group participating in BPCI Model 2, it uses CEHRT 
and thus should meet this criterion. Another commenter stated that use 
of any technology within an APM should not imply ownership, control, or 
the ability of any single user to meet overarching, explicit criteria. 
The commenter stated that over 90 percent of the nation's hospitals 
have achieved Meaningful Use, but hospitalists are unlikely to be 
counted in the 50 percent threshold of ``use'' as currently proposed by 
CMS.
    Response: We reiterate that the use of CEHRT criterion applies to 
APMs and the requirements they impose on participating APM Entities, 
not to the individual APM Entities participating in APMs. For instance, 
the use of CEHRT criterion would be applied to the design of an APM to 
assess whether it has a requirement that its participants use CEHRT in 
a prescribed manner that meets this Advanced APM criterion. We assess 
the APM's requirements to determine whether an APM meets the Advanced 
APM CEHRT criterion. A participant cannot meet this criterion simply by 
using CEHRT; the APM must require the use of CEHRT in its terms and 
conditions, or a regulation or other legal vehicle through which APM 
Entities are held accountable. Conversely, an Advanced APM Entity that 
fails to meet the requirement to use CEHRT under the Advanced APM would 
have consequences under the

[[Page 77412]]

terms of the Advanced APM, but such failure to meet the requirement has 
no bearing on whether or not the APM itself is an Advanced APM. 
Therefore, it would not be appropriate or practical to build in 
specific policies around attestation of CEHRT use by eligible 
clinicians or APM Entities, or to carve out policies for specific 
clinician types or settings. We further note that, as proposed, the 50 
percent CEHRT use threshold pertains only to the requirements that the 
APM imposes on eligible clinicians within its participating APM 
Entities. However, if the APM is one in which hospitals are the main 
participants, then we proposed that the APM must require hospitals to 
maintain CEHRT in order for the APM to be an Advanced APM. We do not 
believe that the use of CEHRT requirement implies that the physicians 
or other participants must invest in duplicative technology to 
participate in the APM, but rather that the APM must require a certain 
threshold level of CEHRT use to document and communicate clinical care 
for their patient population. As is noted above, the use of CEHRT 
criterion for an Advanced APM is based on the requirements that an APM 
places on its participating APM Entities. Therefore, in APMs where an 
APM Entity may use CEHRT in its operations and participation in the 
APM, but the APM does not explicitly require the use of CEHRT by the 
APM Entity, the APM would not meet the use of CEHRT criterion for an 
Advanced APM.
    Comment: One commenter recommended that CMS require clinicians 
participating in the CJR and Bundled Payment for Care Improvement 
(BPCI) models report data for the advancing care information MIPS 
performance category and allow that reporting to meet the CEHRT 
requirement.
    Response: We appreciate the suggestion. We believe the proposals 
for CEHRT use can be applied to these APMs as proposed and therefore 
there is no need to establish additional detail for the mechanism of 
requiring CEHRT. As previously stated above it is the APM that must 
require the use of CEHRT in order to meet this Advanced APM 
requirement, and not individual entities or clinicians. Consequently, 
reporting advancing care information to MIPS is not a substitute for 
the APM to meet this Advanced APM requirement. We also considered these 
comments in developing proposed amendments to CJR (see 81 FR 50793).
    Comment: One commenter recommended that the Advanced APM use of 
CEHRT criterion be aligned with advancing care information in MIPS.
    Response: The definition of CEHRT for MIPS and Advanced APMs will 
be the same. However, to require that CEHRT use requirements in 
Advanced APMs be aligned with the MIPS advancing care information 
performance category would go beyond what the statute requires, and as 
we have stated, we generally want APMs to retain the flexibility to 
require activities performed using CEHRT that may vary from those 
prescribed under the advancing care information performance category in 
MIPS.
    Comment: Some commenters sought additional clarity in how APMs 
would identify their respective denominator of eligible clinicians. 
Commenters suggested that CMS represent the method for calculating the 
denominator of eligible clinicians using a mathematical expression, as 
well as how the level of proof required would translate to an entity-
level percentage-based measurement.
    Response: We will assess for each APM whether the requirements for 
CEHRT use meet the threshold for an Advanced APM. We will require that 
each APM have procedures in place to ensure that its requirements for 
the use of CEHRT are met. Additionally, the methods used to ascertain 
whether the 50 percent CEHRT use threshold is met may be unique to each 
APM. We do not intend to prescribe for APMs the mechanism for 
enforcement of their CEHRT use requirement.
    We are finalizing our proposal that an Advanced APM must require at 
least 50 percent of eligible clinicians in each APM Entity to use the 
certified health IT functions outlined in the proposed definition of 
CEHRT to document and communicate clinical care with patients and other 
health care professionals. However, we are not finalizing our proposal 
to increase the requirement of Advanced APMs to require 75 percent 
CEHRT use in the subsequent year. We will maintain the 50 percent CEHRT 
use requirement for the second performance year and beyond and consider 
making any potential changes through future rulemaking. If the APM has 
hospitals as its APM Entities, the APM would need to require the 
hospitals to use CEHRT in order to be an Advanced APM, and the 50 
percent threshold does not apply. We will monitor the level of CEHRT 
use that is required in current APMs and assess the applicability of 
this criterion to new APMs. We will continue to consider additional 
changes to the CEHRT use criterion for Advanced APMs in future 
rulemaking, particularly considering Other Payer Advanced APMs.
(c) Requiring Use of CEHRT in the Shared Savings Program
    We also proposed an alternative criterion for determining whether 
an APM meets the CEHRT use requirement, exclusively for the Shared 
Savings Program. We believe this method is appropriate for the Shared 
Savings Program because although the Shared Savings Program requires 
ACOs to encourage and promote the use of enabling technologies (such as 
EHRs) to coordinate care for assigned beneficiaries, a specific level 
of CEHRT use is not required for participation in the program. Instead, 
the Shared Savings Program includes an assessment of EHR use as part of 
the quality performance standard which directly impacts the amount of 
shared savings/losses generated by the Shared Savings Program ACO. In 
contrast to APMs authorized by section 1115A of the Act, we would have 
to undertake significant rulemaking to adopt an eligibility standard 
for the Shared Savings Program that is consistent with the criterion 
for other APMs. Following such rulemaking, we would have to collect 
additional information from each existing and applying ACO outside the 
routine application process in the weeks prior to the start of the 2017 
performance year. We believed this process could introduce uncertainty 
and burden for CMS, ACOs, and participating eligible clinicians. 
Moreover, we stated that we believed that the proposed alternative 
criterion would build on established Shared Savings Program rules and 
incentives that directly tie the level of CEHRT use to the ACO's 
financial reward which in turn has the effect of directly incentivizing 
ever-increasing levels of CEHRT use among eligible clinicians. We 
believe that the proposed alternative criterion for the Shared Savings 
Program is consistent with the goals of the APM incentive and reduces 
burden and uncertainty for the Shared Savings Program participants. 
Therefore, because most other APMs can accommodate a new CEHRT use 
requirement for eligible clinicians without modification to our 
regulations, we proposed to restrict this method to the Shared Savings 
Program. We proposed that this alternative would allow the Shared 
Savings Program to meet the criterion if it holds APM Entities 
accountable for their eligible clinicians' use of CEHRT by applying a 
financial penalty or reward based on the degree of CEHRT use (such as 
the percentage of eligible clinicians that use

[[Page 77413]]

CEHRT or the engagement in care coordination or other activities using 
CEHRT). One of the quality measures used in the Shared Savings 
Program's quality performance standard assesses the degree to which 
certain eligible clinicians in the ACO successfully meet the 
requirements of the EHR Incentive program, which requires the use of 
CEHRT. Successful reporting of the measure for a performance year gives 
the ACO points toward its overall quality score, which in turn affects 
the amount of shared savings or shared losses an ACO could earn or be 
liable for, respectively. Because of this, ACOs in the Shared Savings 
Program actively promote and seek to improve upon the EHR measure 
annually, leading to greater use of CEHRT among eligible clinicians 
participating in Shared Savings Program ACOs. We explained that we 
believe our proposed criteria for APMs, generally, and our alternative 
for the Shared Savings Program, would satisfy requirements under the 
statute, as both hinge upon the Advanced APM requiring that its 
participants use CEHRT with consequences for failure to meet the APM's 
standards. We solicited comment on our proposed methods for the Shared 
Savings Program to meet the Advanced APM CEHRT use criterion.
    Comment: Commenters supported using the proposed alternative 
criterion to determine whether the Shared Savings Program meets the 
CEHRT use requirement.
    Response: We thank the commenters for their support.
    We are finalizing this alternative criterion exclusively for the 
Shared Savings Program as proposed. This alternative criterion would 
allow the Shared Savings Program to meet the criterion if it holds APM 
Entities accountable for their eligible clinicians' use of CEHRT by 
applying a financial penalty or reward based on the degree of CEHRT 
use.
    The Shared Savings Program meets this criterion by tying 
performance on ACO-11, a quality measure that assesses the meaningful 
use of EHR technology by certain eligible clinicians in the ACO, to the 
amount of shared savings earned or shared losses incurred by an ACO. We 
will use data submitted to us through the MIPS advancing care 
information performance category for purposes of assessing performance 
on ACO-11 under all tracks of the Shared Savings Program.
    Eligible clinicians who become QPs by participating in an Advanced 
APM will be exempt from reporting in the advancing care information 
performance category for purposes of MIPS. However, under Sec.  
425.500(c) of our regulations, Shared Savings Program ACOs must submit 
data on ACO quality performance measures according to the method of 
submission established by CMS. Thus, certain eligible clinicians, as 
designated in the specifications of ACO-11, participating in ACOs under 
all tracks of the Shared Savings Program must report for purposes of 
the advancing care information performance category according to MIPS 
specifications, regardless of whether they are excluded from MIPS for 
the year, in order for the Shared Savings Program to assess the ACO's 
performance on ACO-11, as required by the Advanced APM CEHRT use 
criterion. As discussed above, we will establish our final policies 
with respect to the specifications of ACO-11 in the forthcoming CY 2017 
PFS final rule with comment period.
    We also note that in the CY 2017 PFS Proposed Rule, we propose 
certain modifications to the EHR measure under the Shared Savings 
Program (81 FR 46429 through 46430). We will establish our final 
policies for the specifications of ACO-11 that will be used to assess 
ACO performance on this measure in 2017 and subsequent years as 
finalized in the forthcoming CY 2017 PFS final rule.
    In addition to the previous proposals, we were interested in what 
other health IT functionalities APM participants might need to 
effectively provide care to their patients and how the use of 
interoperable health IT can strengthen and encourage higher quality 
patient care and more effective care coordination across all APMs. 
Recent research and input from experts, practitioners, and the public 
have identified priority health IT capabilities that would be important 
for participants in APMs but are not yet widely available in current 
health IT systems, such as the ability to manage and track status of 
referrals and create and maintain electronic shared care plans for 
team-based care management. More information about this research is 
available at https://www.healthit.gov/facas/sites/faca/files/HITPC_AHMWG_Meeting_Slides_Final_Version_9_2015-11-10.pdf.
    We believe that all patients, families, and healthcare 
professionals should have consistent and timely access to health 
information in a standardized format that can be securely exchanged 
between these parties (See HHS August 2013 Statement, ``Principles and 
Strategies for Accelerating Health Information Exchange''). The secure, 
appropriate exchange of health information can help health care 
professionals improve quality of care through more robust care 
coordination, and improve the efficiency of care through access to 
patient information across settings. Interoperability is a key priority 
for the healthcare industry. HHS recently received pledges from 
companies that provide 90 percent of the EHRs used by hospitals 
nationwide, available at https://www.healthit.gov/commitment, as well 
as the top five largest health care systems in the country, to help 
consumers easily and securely access their electronic health 
information; help clinicians share individuals' health information for 
care with other clinicians and their patients whenever permitted by law 
and not block electronic health information; and implement federally 
recognized, national interoperability standards, policies, guidance, 
and practices for electronic health information.
    A growing number of organizations across the country are now 
focused on facilitating health information exchanges (HIEs) among 
healthcare professionals at the national, state, and community levels. 
There were 267 organizations providing HIE services operating in the 
U.S. in 2014, including community-based organizations, statewide 
efforts, and other healthcare delivery entities supporting exchange, 
according to https://ehi-rails-app.s3.amazonaws.com/uploads/article/file/476/2014_eHI_Data_Exchange_Survey_Results_Webinar_Slides.pdf. 
While representing a wide variety of stakeholders, services and 
structures, these organizations play an important role in facilitating 
care coordination and data sharing for many health care professionals 
across the country. We encourage the growth of these services and 
encourage health care professionals to explore partnering with 
organizations offering HIE services.
    We solicited comment on how requirements for the use of CEHRT 
within APMs could evolve to support expanded participation in 
organizations supporting HIEs. The following are the comments received 
in response to our request for comment related to advancing 
participation in HIE through the use of CEHRT in Advanced APMs.
    Comment: Regarding the future incorporation of HIE participation 
into the health IT requirements for APMs, a commenter supported 
recognition for this participation, but suggested that CMS also 
determine whether a clinician has achieved better care coordination. 
One commenter recommended that participation in HIEs be required as 
part of CEHRT standards. Several commenters suggested that CMS identify 
interoperability measures or standards that easily align with the use

[[Page 77414]]

of health IT and the achievement of interoperability goals, perhaps 
focused on specialty-specific use cases. Another commenter suggested 
that interoperability goals could be achieved through focusing on 
specialty-specific use cases rather than data quantity evaluations, and 
that these use cases should be developed in consultation with 
stakeholders. One commenter supported additional emphasis on usability 
and compatibility of electronic data collected by HIEs, but the 
commenter was concerned that HIE data are not always readable by EHR 
systems. The commenter stated that meaningful health information 
exchange requires sending the information, receiving the information, 
and being able to use the information for patient care. Another 
commenter urged CMS to state its goals before asking how the use of 
interoperable health IT strengthens and encourages higher quality 
patient care and more effective care coordination across all APMs. One 
commenter did not believe new health IT standards and certification 
criteria are needed; rather, the existing standards need to be 
recognized and adopted in a consistent manner that does not vary by 
vendor. Implementation guides promulgated by standards organizations 
may be helpful in this regard. The commenter also urged more research 
on how EHRs affect workflows, both positively and negatively, 
particularly as workflows are changing due to reporting requirements.
    Response: We thank commenters for supporting the idea of 
recognizing participation in an organization facilitating HIE as part 
of future CEHRT requirements for APMs, and agree that care coordination 
through the secure, electronic exchange of health information is an 
important capability for providers participating in an Advanced APM. We 
note that while Advanced APMs are required to base payment on quality 
measures comparable to those in MIPS, in order to encourage flexibility 
and innovation for APMs, CMS is not identifying the specific measures 
which APMs must use. In future rulemaking, we will consider how to 
incorporate participation in an organization facilitating HIE into the 
Advanced APM CEHRT requirement.
    Comment: Commenters provided a variety of recommendations regarding 
the health IT capabilities that APM participants will need to 
effectively provide care to patients. Commenters focused on improved 
capabilities to manage and incorporate data, including improved 
capacity to manage and present interoperable health information in 
usable workflow and more standardization around how data is extracted 
from different systems. Commenters also suggested further work on 
health IT capabilities to improve referral processes, such as the 
ability to look up information about other clinicians, including 
specialty, commitment to care coordination, patient preference, and 
alignment with the patient's health plan network; ability to cross-
reference the organization's preferred providers and preferred 
providers identified by the patient or plan; and better integration of 
preferred provider lists into document templates used in the referral 
process.
    Response: We thank the commenters for their responses and will take 
these recommendations into consideration in the future as we continue 
to examine the CEHRT use requirement for Advanced APMs.
(2) Comparable Quality Measures
    The second criterion for an APM to be an Advanced APM is that it 
provides for payment for covered professional services based on quality 
measures comparable to measures under the performance category 
described in section 1848(q)(2)(B)(i) of the Act, which is the MIPS 
quality performance category. We interpret this criterion to require 
the APM to incorporate quality measure results as a factor when 
determining payment to participants under the terms of the APM.
    Our proposed policy for this criterion was informed by our proposed 
policy for the MIPS quality performance category. Quality measures 
under the MIPS quality performance category are discussed in section 
II.E.3.b. of this final rule with comment period. In that section, we 
discuss our proposal for eligible clinicians to select quality measures 
from the MIPS measures list for the first MIPS performance period. We 
indicated that we would publish a list of quality measures annually, 
through notice and comment rulemaking, from which MIPS eligible 
clinicians may choose measures for assessment under the MIPS quality 
performance category. The measures included in the annual list of MIPS 
measures must adhere to specific criteria that include the following: 
(1) Measures must have an evidence-based focus if the measures are not 
endorsed by a consensus-based entity as described in section 
1848(q)(2)(D)(v) of the Act; and (2) new measures and the method for 
developing and selecting such measures, including clinical and other 
data supporting such measures, must be submitted to a specialty-
appropriate, peer-reviewed journal prior to inclusion of the measure in 
MIPS as described in section 1848(q)(2)(D)(iv) of the Act.
    The statute also established priorities for both the quality 
domains of measures to be developed and the types of measures to be 
prioritized in the measure development plan, which are located, 
respectively, at sections 1848(s)(1)(B) and (D) of the Act. The 
priority measure types include outcome, patient experience, care 
coordination, and measures of appropriate use of services such as 
measures of overuse.
    We wanted to ensure that APMs have the latitude to base payment on 
quality measures that meet the goals of the APM and assess the quality 
of care provided to the population of patients that the APM 
participants are serving. It is important to note that many APMs 
include some common measures that are proposed for inclusion in MIPS. 
For example, many of the quality measures used in the Shared Savings 
Program and the Next Generation ACO Model are also proposed for 
inclusion in MIPS.
    However, APMs that focus on patients with specific clinical 
conditions such as end-stage renal disease (ESRD), or on patients 
undergoing specific surgical procedures, would have valid reasons for 
including different quality measures than those that target more 
general populations. Similarly, some APMs may focus on specialist 
eligible clinicians for whom there may be only a small number of valid 
and relevant quality measures. Lastly, we cannot predict the specific 
care goals and payment designs of future PFPMs and other APMs. 
Consequently, we did not want to impose measure requirements that would 
prevent us from including quality measures that may be better suited to 
the specific aims of new innovative APMs.
    We proposed that the quality measures on which the Advanced APM 
bases payment must include at least one of the following types of 
measures provided that they have an evidence-based focus, and are 
reliable, and are valid:
    (1) Any of the quality measures included on the proposed annual 
list of MIPS quality measures;
    (2) Quality measures that are endorsed by a consensus-based entity;
    (3) Quality measures developed under section 1848(s) of the Act;
    (4) Quality measures submitted in response to the MIPS Call for 
Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
    (5) Any other quality measures that CMS determines to have an 
evidence-based focus and be reliable and valid.
    We believe that quality measures that are endorsed by the National 
Quality

[[Page 77415]]

Forum (NQF) would meet these criteria. Because each APM Entity is 
different, there needs to be the flexibility to determine which 
measures are most appropriate for use in their respective APM for the 
purpose of linking those measures to payment under the APM. Measures 
that could be used in both MIPS and APMs are beneficial to eligible 
clinicians who may switch from one program to the other, but we also do 
not want to restrict APMs from including new innovative measures that 
may not be included in MIPS initially, or until later years of the 
program.
    We also proposed to establish an Innovation Center quality measure 
review process for those measures that are not NQF-endorsed or included 
on the final MIPS measure list to assess whether the quality measures 
have an evidence-based focus, and are reliable and valid. For example, 
the Comprehensive ESRD Care Model includes NQF# 0226 Influenza 
Immunization for the ESRD Population which is not a measure included 
for reporting in MIPS but meets the proposed criteria for MIPS-
comparable quality measures. We stated that we believe, under the 
proposed categories, MIPS-comparable quality measures could include 
measures that are fully developed after being tested in an APM and 
found to be reliable and valid. Similarly, we indicated that we believe 
MIPS-comparable quality measures could include QCDR measures provided 
that the QCDR measures used by the Advanced APM for payment have an 
evidence-based focus and are reliable and valid.
    The statute identifies outcome measures as a priority measure type, 
and we wanted to encourage the use of outcome measures for quality 
performance assessment in APMs. Therefore, we proposed that in addition 
to the general comparable quality measure requirements proposed, an 
Advanced APM must include at least one outcome measure if an 
appropriate measure (that is, the measure addresses the specific 
patient population and is specified for the APM participant setting) is 
available on the MIPS list of measures for that specific QP Performance 
Period, determined at the time when the APM is first established. If 
there is no such measure available on the MIPS list at the time the APM 
is established, then we would not require an outcome measure be 
included after APM implementation.
    We also noted that under the statute and in this proposal, not all 
quality measures under which an APM is assessed are required to be 
``comparable'' and not all payments under the APM must be based on 
comparable measures. However, at least some payments must be tied to 
measures comparable to MIPS, regardless of whether those comparable 
measures are the only ones the APM uses. Under this proposal, APMs 
retain sufficient freedom to innovate in paying for services and 
measuring quality. For instance, an APM may have incentive payments 
related to quality, total cost of care, participation in learning 
activities, and adoption of health IT. The existence of all of the 
payments associated with non-quality aspects does not preclude the APM 
from meeting this Advanced APM criterion. In other words, this 
criterion only sets standards for payments tied to quality measurement, 
not other methods of payment. Conversely, an APM may, as current models 
at the CMS Innovation Center currently do, test new quality measures 
that do not fall into the MIPS-comparable standard. So long as the APM 
meets the requirements set forth in this criterion, there is no 
additional prescription for how the APM tests additional measures that 
may or may not meet the standards under this criterion.
    We indicated that we believe this framework would provide the 
flexibility needed to ensure APM quality performance metrics meet the 
APM's goals. We invited comments on whether measures to be considered 
comparable to MIPS should all be reliable and valid and have an 
evidenced-based focus.
    The following is a summary of the comments we received regarding 
our proposed Advanced APM quality measures criterion.
    Comment: The majority of commenters support CMS' proposal. 
Commenters sought additional insight and specificity on the types of 
quality measures that would be tied to Advanced APM payments and also 
suggested CMS seek stakeholder input regarding what measures are 
included in Advanced APMs. One commenter stated that while they support 
the proposed requirement that MIPS-comparable measures for the Advanced 
APM criteria be evidence-based, reliable and valid, they believe a 
minimum number of 10 measures should be required to be included in the 
Advanced APM.
    Response: Examples of measures that would meet the proposed 
criterion for MIPS-comparable measures include almost any quality 
measure that is NQF endorsed, or measures included in the final list of 
MIPS quality measures, provided that the measure has an evidence-based 
focus, is reliable, and is valid. The Advanced APM criterion to include 
measures comparable to MIPS does not require CMS seek stakeholder input 
on the measure(s) used in Advanced APMs, but we do welcome stakeholder 
input on our selected measures for inclusion in Advanced APMs through 
other vehicles, for example, RFIs or subsequent proposed rules. With 
respect to the number of measures for performance assessment included 
in Advanced APMs, there is no statutory requirement that a specific 
number of measures need to be included in order for the APM to provide 
for payment for covered professional services based on MIPS-comparable 
quality measures, and we believe Advanced APMs generally should retain 
flexibility to require the appropriate number of measures for its 
goals.
    Comment: One commenter supported principles that left selection of 
quality measures to the Advanced APM in our reference to ``any other 
quality measures that CMS determines to have an evidence-based focus 
and be reliable and valid.'' However, the commenter urged CMS to always 
have the goal that any measure that has an evidence-based focus and is 
reliable and valid would also either: (1) Be on the annual list of MIPS 
measures; (2) be endorsed by an consensus-based entity; (3) be a 
quality measure developed under section 1848(s) of the Act; or (4) be a 
quality measure submitted in response to the MIPS Call for Quality 
Measures. The commenter recommended that CMS clarify its intent to have 
no measure qualify as MIPS-comparable for more than 2 years based 
solely on meeting the specifications as ``any other quality measures 
that CMS determines to have an evidence-based focus and be reliable and 
valid.''
    Response: We thank the commenters for their support and suggestion 
regarding the types of measures that we consider MIPS-comparable. We 
proposed that the quality measures on which the Advanced APM bases 
payment must include at least one of the following types of measures 
provided that they have an evidence-based focus, and are reliable and 
valid: (1) Any of the quality measures included on the proposed annual 
list of MIPS quality measures; (2) quality measures that are endorsed 
by a consensus-based entity; (3) quality measures developed under 
section 1848(s) of the Act; (4) quality measures submitted in response 
to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) 
of the Act; or (5) any other quality measures that CMS determines to 
have an evidence-based focus and be reliable and valid. We believe the 
fifth ``principle'' above provides us the flexibility to view a

[[Page 77416]]

measure that is submitted to a consensus-based entity for endorsement 
as comparable to MIPS quality measures, even if the measure has not 
received endorsement at the time it is proposed for inclusion in the 
Advanced APM. We do not believe we need to combine principle number 5 
with one of the other principles as long as the measure is reliable, 
valid and has an evidenced-based focus. We do not believe it is 
necessary to place a time limit on the use of a MIPS-comparable measure 
that does not already meet one of the four other principles. However, 
we would strongly encourage stakeholders to submit measures for 
inclusion on the MIPS measure list once they have been tested in an 
APM.
    Comment: One commenter was opposed to the proposed definition of 
measures that are comparable to MIPS. The commenter did not agree with 
the proposed measure types for the MIPS-comparable set of quality 
measures, stating that CMS should not include quality measures that 
have merely ``an evidence-based focus.'' The commenter is concerned 
that CMS in the past has pressed for a quality measure that 
incentivizes lower quality care, under the guise of evidence and 
suggested it would be better for CMS to add additional considerations 
such as whether the measure has achieved its purpose to affect 
physicians' behavior.
    Response: The proposal to include an evidence-based focus as one of 
the requirements for measures to be comparable to MIPS measures is 
consistent with the statutory requirement for MIPS measures, except for 
those measures originating from a QCDR. While we believe that measures 
that qualify as MIPS-comparable under our proposed criteria can include 
measures that also have a demonstrable track record of influencing 
physician behavior, we do not believe it would be consistent with the 
MIPS statute to include this as a consideration.
    Comment: A commenter recommended that CMS put in place a more 
robust framework to ensure that Advanced APMs utilize quality measures 
that accurately and reliably reflect the care an individual patient 
receives under these models. The commenter believes that, as Advanced 
APM participants bear financial risk for monetary losses that are in 
excess of a nominal amount, the quality measures in place are all the 
more important as a protection for patients against a narrow focus on 
cost-containment. The commenter was also concerned that CMS' proposed 
framework is not sufficient to ensure that Advanced APMs utilize robust 
quality measure sets, and that framework skews too much toward 
providing flexibility to these APMs. Another commenter encouraged CMS 
to continually look at measures that monitor for any perverse 
incentives that may occur as CMS experiments with Advanced APMs. For 
example, stinting on, or forgoing, care to save costs in the short term 
is a risk not usually prevalent in FFS, but could be a risk in certain 
Advanced APMs. In developing all APMs, the commenter stated that CMS 
should always ensure that they contain a quality component that meets 
the proposed criteria and that the measures in the APM reflect 
monitoring for the desired outcomes of the model.
    Response: We assess all APM designs for possible perverse 
incentives and the potential for care stinting activities prior to 
implementation. We agree that we should continually monitor for 
perverse incentives and behaviors such as care stinting, and we 
actively perform these assessments now. We believe that both the 
inclusion of payment based on performance on quality measures in the 
Advanced APMs and the ongoing monitoring and evaluations conducted on 
all APMs are mechanisms for identifying whether appropriate care is 
withheld to save costs. The Advanced APM requirement for inclusion of 
MIPS-comparable measures does not represent a quality measure strategy 
for Advanced APMs. It is a statutory requirement that an APM must meet 
in order to be an Advanced APM. Rather, the Advanced APM quality 
strategy typically includes quality and/or utilization measures that 
correspond with the key payment and practice transformation activities 
being tested in the APM. This is why the majority of APMs include more 
than just one quality measure and many different types of quality 
performance measures (for example, process, clinical outcome, patient 
experience of care or patient reported outcome measures) to assess the 
clinical care provided by eligible clinicians under the APM. Our goal 
in developing APMs is to ensure that all patients realize better care, 
improved clinical outcomes and more efficient cost-effective care. We 
believe our existing quality standards and strategies promote these 
goals and the statutory requirement to include MIPS-comparable measures 
to be an Advanced APM further reinforces these goals.
    Comment: One commenter requested additional transparency regarding 
the quality measures that an individual Advanced APM includes, and 
suggested that CMS should establish a Web page on which Advanced APMs 
will identify the quality measures they include and how these measures 
meet the ``similar to'' standard. This information should include: 
details of how the measure is calculated; its limitations; whether the 
measure is included in the current (or any former) MIPS measure sets; 
how the measure was developed, and by whom; and whether it is endorsed 
by a national standards-setting organization (for example, NQF).
    Response: We appreciate this suggestion. Many, if not all, APMs 
include their quality measures list on either the CMS or Innovation 
Center Web site. Because the Advanced APM MIPS-comparable quality 
measure requirement is a new requirement, we will assess the need to 
develop a public-facing site with the information the commenter 
suggests.
    Comment: Some commenters suggested CMS provide additional 
flexibility to Advanced APMs in the selection of outcome measures and 
measures used for specialty APMs. One commenter requested that CMS not 
require any outcome measures for 2 to 3 years. Yet another commenter 
agreed that all measures should have an evidence-based focus to be 
included in the Advanced APM.
    Response: We believe the proposed criteria for inclusion of 
measures that are comparable to MIPS provides CMS and Advanced APMs the 
flexibility the commenter recommends. The measure(s) included to meet 
this criterion can be a measure on the MIPS measure list or can be 
selected from another program or source such as the list of consensus-
endorsed measures maintained by the NQF. We believe that outcome 
measures should be included in all APMs wherever possible and that 
there is no need to wait 2 to 3 years before including outcome measures 
in Advanced APMs. Presently, many APMs include one or more outcome 
measures in their quality measure set; therefore, we do not anticipate 
that this policy will prevent any APMs from being Advanced APMs in the 
first QP Performance Period.
    Comment: One commenter expressed concern that providing Advanced 
APMs with the proposed degree of flexibility will allow quality 
performance to slip, and stated that current quality measures used by 
Advanced APMs fall short of providing useful information.
    Response: Most APMs are designed to include quality and cost/
utilization measures that are aligned with the goals of the APM, and 
that address the populations and clinical care delivered by the APM 
participants to their patients. However, there may be new APMs for 
which CMS would have limited quality measures to choose from

[[Page 77417]]

that are reliable, valid and have an evidence-based focus. For example, 
models that target specific patient populations or a subset of services 
may have few relevant measures available. We believe the flexibility 
included in our proposed criteria will allow us to include measures 
that meet this requirement and continue to develop and implement new 
APMs in support of HHS' goals. Furthermore, most APMs include many 
types of measures that meet several of the criteria we proposed for 
Advanced APM ``comparable to MIPS measures.'' These measures come from 
a variety of sources including other CMS programs, and the NQF list of 
endorsed measures and in some instances were vetted by external 
stakeholders and technical expert panels to ensure they were suitable 
for use in the APM.
    Comment: One commenter asked for clarification as to whether non-
MIPS measures approved for use in a QCDR qualify as MIPS comparable 
quality measures. A few commenters supported the use of QCDR measures 
for Advanced APMs.
    Response: Yes, measures that are already approved by CMS for use in 
a QCDR may also be used to meet this Advanced APM criterion as long as 
the non-MIPS QCDR measure is reliable, valid, and has an evidence-based 
focus.
    Comment: One commenter requested clarification regarding submission 
methods available to APMs and Advanced APMs because the commenter 
believes that QCDRs and qualified registries should be available for 
submission of quality data. The commenter noted that the CMS Web 
Interface uses a sample of patients that represents a fraction of the 
APM Entity's overall patient population whereas QCDRs and qualified 
registries would be able to consolidate and submit a statistically 
relevant population of patients, that is, up to 90 percent of all 
patients across all payers. The commenter believes this would allow 
Advanced APMs and eligible clinicians in Advanced APMs to more 
accurately report on their population and compare themselves to MIPS 
eligible clinicians for purposes of finding actionable areas for 
quality improvement. The commenter also believes that QCDRs would be 
able to assist with development of measures specific to the goals of 
APMs and Advanced APMs.
    Response: As proposed, QCDR measures are considered to be MIPS-
comparable measures as long as the QCDR measure used in the APM is also 
evidence-based, reliable and valid. There may be some QCDR measures 
that do not meet the requirements to be reliable, valid, or have an 
evidence-based focus, and therefore, would not be considered comparable 
to MIPS quality measures for purposes of identifying Advanced APMs. 
When CMS designs new APMs, we must select specific submission method(s) 
for quality data within the policy and operational context of a given 
APM as well as the resources and systems available at CMS. 
Historically, this has included registry submission for some APMs. We 
hope that QCDRs will continue to develop new measures that both MIPS 
and other CMS programs can use to assess quality performance and 
appreciate their efforts to expand the inventory of measures available 
to our programs.
    Comment: One commenter stated concern that the proposal creates an 
additional process for assessing quality measures when there are 
already other established processes that determined whether measures 
are evidence-based, reliable, and valid, such as the National Quality 
Forum (NQF) Measures Application Partnership (MAP).
    Response: This proposal does not change the processes that are used 
by CMS to adopt measures for use in CMS programs. Rather the inclusion 
of an Innovation Center internal review process is to assess whether 
the measure meets the criteria to be a MIPS-comparable measure for 
purposes of identifying Advanced APMs. For example, there may be 
instances where CMS may elect to use a quality measure in the design of 
an APM to meet the MIPS-comparable measure criterion, and that measure 
is not currently included in the final list of MIPS measures for use in 
MIPS. Our proposed policy provides CMS the flexibility to identify a 
measure used in an APM as MIPS-comparable even if the measure is not 
used in MIPS as long as it meets the requirement that it is reliable, 
valid and has an evidence-based focus.
    Comment: One commenter encouraged CMS to urge private payers to 
also adopt core measure sets, and other commenters requested that CMS 
consider appropriate Medicare Advantage quality measures. Commenters 
urged CMS to streamline and standardize its quality measures to focus 
on a core set of measures that are nationally endorsed and not overly 
burdensome to administer, and another commenter suggested that CMS have 
one process to determine acceptability of both APM measures and QCDR 
measures. Another commenter encouraged CMS to seek guidance from NQF in 
order to maintain a rigorous level of measure assessment. Several 
commenters suggested that CMS use measures developed by other entities, 
including the Core Quality Measure Collaborative, Qualified Clinical 
Data Registries (QCDRs) and NQF. One commenter indicated that measures 
in APMs vary widely and that there is no consistency across APMs in 
obtaining stakeholder feedback on the quality measure sets; the 
commenter suggested the Measure Application Partnership (MAP) might be 
such a venue for obtaining stakeholder feedback in the future.
    Response: We believe the proposed criteria for the MIPS-comparable 
measures used in Advanced APMs does not prevent an APM from using a 
core measure set or using measures developed and included in other CMS 
programs, but instead provides the criteria for what constitutes a 
MIPS-comparable measure to meet the Advanced APM requirement. As noted 
above, not all quality measures upon which an APM bases payment are 
required to be MIPS-comparable, and not all payments under the APM must 
be based on MIPS-comparable measures. However, at least some payments 
must be tied to MIPS-comparable measures, regardless of whether those 
measures are the only ones the APM uses. We agree with the commenters 
that the Core Quality Measure Collaborative, led by America's Health 
Insurance Plans (AHIP) is an excellent source of measures for inclusion 
in Advanced APMs and other CMS programs. We also agree that identifying 
a core set of measures to be used in Advanced APMs would have 
advantages, but recognize the need to allow for inclusion of measures 
that are appropriate to assess performance for the specific patient 
population, for which the Advanced APM participants are providing care. 
We have heard repeatedly from clinicians that they need specific 
measures that address their patient population and a single core set 
used by all Advanced APMs may not meet that goal. Because CMS typically 
identifies measures that are appropriate for use in APMs by first 
looking at measures used in other CMS programs we do not believe there 
needs to be a separate process for identifying measures for use in APMs 
that there is the need to obtain additional input from other entities 
such as the MAP. Consequently, we do not believe we need to establish 
additional reviews by external organizations to vet MIPS-comparable 
measures as these processes are already established for measures used 
in MIPS and other CMS programs, and not all measures used in the 
Advanced APM need to be MIPS-comparable measures.
    Comment: Several commenters supported measurement innovation and

[[Page 77418]]

recommended engaging stakeholders in the development of quality 
measures. One commenter suggested that meeting measure requirements 
should not be tied to reporting a certain number of metrics. Some 
commenters also addressed specific types of APMs or potential APMs. For 
example, two commenters urged that CMS make modifications to BPCI so 
that it could become an Advanced APM. One commenter urged CMS to 
broaden the definition of how payments can be based on quality 
measures, which would allow for additional Advanced APMs. Specifically, 
the commenter referred to the CMS fact sheet that CMS is ``committed to 
ensuring beneficiaries receiving care from providers participating in 
BPCI receive high quality care,'' which supports the case that BPCI 
meets this criterion. Some commenters suggested new APMs and the 
development of relevant measures, such as palliative and end-of-life 
care and anesthesia.
    Response: We appreciate the commenters' support for emphasizing 
innovation in the development of quality measures and have already 
included this type of innovation in some of our new APMs, such as the 
Comprehensive Primary Care Plus (CPC+) model. We plan to develop one or 
more patient-reported outcome measures in CPC+ after it is implemented 
in 2017. We agree with the commenter that there is no need to specify 
the number of measures, and our proposed criteria for MIPS-comparable 
measures do not specify that a particular number of measures be used. 
We thank the commenters for their specific APM and measure suggestions, 
and remind readers of the PTAC, as described in section II.F.10. of 
this final rule with comment period. We also note that ideas for new 
APMs can be submitted directly to the CMS Innovation Center. Regarding 
BPCI, episode payments are based solely on episode spending 
performance, although we expect that reductions in spending would 
generally be linked to improved quality through reductions in hospital 
readmissions and complications. Building on the BPCI initiative, the 
Innovation Center is considering new episode payment models that could 
meet the Advanced APM criteria, including the requirement to provide 
for payment based on MIPS-comparable quality measures, potentially 
including a new voluntary bundled payment model for CY 2018. The 
following is a summary of the comments we received regarding our 
proposal to establish an Innovation Center quality measure review 
process for those measures that are not NQF-endorsed or included on the 
final MIPS measure list to assess whether the quality measures have an 
evidence-based focus, are reliable, and are valid.
    Comment: A few commenters supported the proposal to create an 
Innovation Center quality measure review process for measures that are 
not NQF-endorsed or on the final MIPS measure list.
    Response: We appreciate the commenters' support of the proposal to 
create an Innovation Center quality measure review process for measures 
that are not NQF-endorsed or on the final MIPS measure list.
    Comment: One commenter requested that, to the extent that CMS moves 
forward with the proposed Innovation Center quality measure review 
process, the Agency should identify the details of the process (for 
example, timelines, standards for consideration/approval, and 
opportunities for stakeholder input), and allow stakeholders the chance 
to comment on those details before the process is finalized.
    Response: We do not believe a formal mechanism for public input is 
necessary or appropriate in this case. We note that this process is 
intended merely to make a factual determination of whether a measure 
meets the Advanced APM criterion articulated in this final rule. This 
process will not determine which measures are included in APMs, nor 
will it determine how these measures will be linked to payment under an 
APM. Those determinations will be made and communicated through APM 
documents. In the case of APMs that are mandatory for participants, 
these decisions will continue to be made through rulemaking with 
opportunity for public comment.
    The following is a summary of the comments we received regarding 
our proposal to require that an Advanced APM must include at least one 
outcome measure if an appropriate measure is available on the MIPS list 
of measures for that specific QP Performance Period, as determined at 
the time when the APM is first established.
    Comment: Commenters generally supported the proposal to require at 
least one outcome measure. One commenter requested we delay this 
requirement until future years of the program. One commenter supported 
flexibility in allowing those designing the Advanced APM to select and/
or design the most appropriate outcome measures for that Advanced APM. 
Another commenter expressed support for not requiring an outcome 
measure if no applicable measures are available at the time an Advanced 
APM is established. Alternatively, two commenters suggested that at 
least one outcome measure be included even if there was no applicable 
outcome measure on the MIPS final list of measures.
    Response: We thank commenters for their support of the proposal to 
include the requirement for one outcome measure in the Advanced APM if 
an appropriate measure is available on the MIPS list of measures for 
that specific QP Performance Period at the time the APM is first 
established. We proposed that if no appropriate outcome measure is 
available on the MIPS list at the time the APM is established, the APM 
does not need to include an outcome measure. Furthermore, if there is a 
MIPS outcome measure available on the MIPS list for that specific QP 
Performance Period, but CMS determines there is another more 
appropriate non-MIPS outcome measure, the non-MIPS outcome measure can 
be used. Given the dearth of appropriate outcome measures for some 
specialties, we believe it is reasonable at this time to maintain the 
policy as proposed requiring inclusion of an outcome measure in 
Advanced APMs only if there is an appropriate measure included on the 
MIPS final measure list at the time the APM is first established.
    We are finalizing as proposed that to be an Advanced APM, an APM 
must base payment on quality measures that are evidence-based, 
reliable, and valid; and that at least one such measure must be an 
outcome measure unless there is not an applicable outcome measure on 
the MIPS quality measure list at the time the APM is developed. The 
required outcome measure does not have to be one of those on the MIPS 
quality measure list. We are also finalizing the proposal to establish 
an internal Innovation Center quality measure review process for 
measures that are not NQF-endorsed or on the final MIPS measure list in 
order to assess whether the measures meet these criteria.
(3) Financial Risk for Monetary Losses
(a) Overview
    The third criterion that an APM must meet to be an Advanced APM is 
that it must either be a Medical Home Model expanded under section 
1115A(c) of the Act as described below, or the APM Entities under the 
APM must bear financial risk for monetary losses under such APM that 
are in excess of a nominal amount. We refer to the latter criterion as 
the ``financial risk criterion.'' The correlating financial risk 
criterion for Other Payer Advanced

[[Page 77419]]

APMs is described in section II.F.7. of this final rule with comment 
period along with the requirements for consideration under the All-
Payer Combination Option that is applicable in payment years 2021 and 
later.
    The financial risk criterion we proposed for Advanced APMs would 
apply to the design of the APM financial risk arrangement between CMS 
and the participating APM Entity. If the structure of the arrangement 
meets the proposed financial risk requirements, then this criterion 
would be met. This proposal would not impose any additional performance 
criteria related to bearing financial risk. For example, eligible 
clinicians under the Advanced APM Entity would not need to bear 
financial risk under the APM so long as the APM Entity bears that risk. 
Furthermore, an APM Entity would not need to actually achieve savings 
or other metrics for success under the APM in order for the APM to meet 
this criterion.
    In describing our proposal, we divided the discussion into two main 
topics: (1) what it means for an APM Entity to bear financial risk for 
monetary losses under an APM; and (2) what levels of risk we would 
consider to be in excess of a nominal amount. In developing our 
proposed policies we prioritized keeping these standards consistent 
across different types of APMs, including Other Payer Advanced APMs as 
described in section II.F.7.b.(6) of this final rule with comment 
period. We believe that keeping these standards consistent to the 
extent possible would make it easier for stakeholders, APM Entities, 
and eligible clinicians to understand the type of financial risk 
required for an APM to be an Advanced APM. However, we proposed to 
specify small variations in the requirements to accord with the 
differing characteristics of certain types of APMs.
(b) Bearing Financial Risk for Monetary Losses
    We proposed a generally applicable financial risk standard for 
Advanced APMs and a unique standard that would apply only for Advanced 
APMs that are identified as Medical Home Models.
(i) Generally Applicable Advanced APM Standard
    First, we proposed that the generally applicable financial risk 
standard for Advanced APMs would be that an APM must include provisions 
that, if actual expenditures for which the APM Entity is responsible 
under the APM exceed expected expenditures during a specified 
performance period, we can:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians; or
     Require the APM Entity to owe payment(s) to CMS.
    The proposed financial risk standard for Advanced APMs reflected 
our interpretation of the statutory requirement that Advanced APM 
Entities must bear financial risk for monetary losses to encompass 
``losses'' that could be incurred through either direct repayments to 
CMS or reductions in payments for services. The former would cover two-
sided risk arrangements such as shared savings initiatives in which an 
Advanced APM Entity may receive shared savings or be liable for shared 
losses. The latter would cover a range of alternative methods for 
linking performance to payment, such as payment withholds subject to 
successful performance, or discounts in payment rates retrospectively 
applied at reconciliation similar to those in many episode-based 
bundled payment models.
    We solicited comments on how we could potentially create an 
objective and meaningful financial risk criterion that would define 
financial risk for monetary losses differently.
    The following is a summary of the comments we received regarding 
our proposal for the generally applicable Advanced APM financial risk 
standard.
    Comment: Many commenters expressed support for the proposed 
generally applicable Advanced APM financial risk standard as meaningful 
and appropriate. In particular, commenters supported that the standard 
only captures APMs with downside financial risk. Some commenters 
believe that all APMs should have downside risk or capitation-style 
payment arrangements in order to spur greater transformation and better 
value to consumers. Other commenters agreed with that sentiment, but 
believed that movement to downside risk takes time and requires an on-
ramp or path for clinicians to move to greater levels of risk. Some 
commenters also supported our proposal to focus the financial 
relationship between CMS and the APM Entity, rather than downstream 
risk relationships between the APM Entity and its participants, when 
assessing whether an APM satisfies the financial risk standard.
    Some commenters suggested that we increase the rigor of the 
financial risk standard so that Advanced APM performance is considered 
in addition to its financial risk design. For instance, an Advanced APM 
would have to demonstrate that its payment model is driving care 
delivery improvements for better outcomes and patient experience. They 
also suggested design changes for APMs such as enhancing consumer 
protections as APMs expand in scope or allowing sharing savings with 
beneficiaries.
    Response: We appreciate the general support for the design of the 
generally applicable financial risk standard. We agree that downside 
risk is an important distinction and an aspect of APM design that can 
contribute to improved costs and outcomes for beneficiaries. We also 
recognize that developing risk-bearing capacity is a long-term 
undertaking and that entities are currently at different states of 
readiness for bearing risk. Therefore, as we discuss throughout this 
final rule, we have emphasized technical assistance for small and rural 
practices and intend to offer an array of APMs and Advanced APMs so 
that clinicians can find the right fit for their practice now and in 
the future.
    For suggestions that we add more layers of requirements for an APM 
to become an Advanced APM, we do not believe that is the purpose of the 
APM incentive. In particular, as stated in our principles under section 
II.F.1. of this final rule with comment period, we believe the APM 
Incentive Payment is a time-limited incentive (with the combination of 
the favorable fee schedule update and the potential rewards inherent to 
APMs being the long-term incentives) intended to encourage movement 
into the most challenging and potentially most rewarding APMs available 
as defined by the three Advanced APM criteria described in this 
section. Each APM has many unique characteristics other than those 
involving CEHRT use, quality measurement, and financial risk, and we 
believe that it is important to support rather than constrain 
flexibility in APM design to the extent feasible. Additionally, we 
assess all of our APMs continuously, and the measurable success of an 
APM will determine our ability to expand it in the future, not whether 
the APM is determined to be an Advanced APM. Moreover, the ultimate 
evaluation of APM success is: (1) Retrospective in nature, so that if 
Advanced APM status were to hinge on such results, an APM's status 
would be uncertain until several years after its launch; and (2) 
distinct from the challenge of participating in a model with CEHRT use 
requirements, payment based on MIPS-comparable quality measures, and 
more than nominal financial risk.

[[Page 77420]]

    Regarding the comments on consumer protections, just as each APM 
has its own set of requirements and rewards, it also has its own set of 
program integrity protections, in addition to those for the overall 
Medicare program, in which we operate rigorous monitoring programs for 
each APM.
    Comment: Conversely, other commenters expressed their desire for 
CMS to consider costs not explicitly part of the financial risk 
arrangement of an APM as financial risk for purposes of this standard. 
The APM status of Track 1 of the Shared Savings Program was 
particularly salient for commenters in this respect. For instance, two 
commenters believe that CMS should consider Track 1 ACOs that have 
demonstrated high quality of care with quality performance scores of 86 
percent or greater and generated cost savings that exceed their minimum 
savings rate to be participating in an Advanced APM. Many commenters 
cited up-front costs or investments in infrastructure and care redesign 
related to the pursuit of success under the APM incurred by ACOs 
participating under Track 1. Some of these ``business risk'' costs can 
include IT acquisition, hiring of care coordination and case management 
personnel, business and clinical process development, population 
management analytics, and other administrative costs. Some commenters 
believe that any operational costs related to APM participation should 
be considered risk. One commenter suggested that CMS consider Track 1 
ACOs in Maryland that are subject to the Maryland All-Payer Model to be 
bearing downside risk.
    Some commenters similarly suggested that uncompensated care costs 
be considered financial risk. Other commenters suggested that we use 
the Medical Home Model financial risk standard for all APMs, such that 
the Track 1 adjustment to shared savings based on quality scores would 
be considered financial risk. Another commenter recommended that APMs 
that do not have downside risk be considered Advanced APMs for the 
first 2 years of the Quality Payment Program.
    One commenter submitted research suggesting that there is limited 
uptake and performance in ACOs with downside risk in comparison to 
Track 1 of the Shared Savings Program, and recommended that CMS 
recognize the shortcomings of the current two-sided ACO risk models and 
develop a new APM that includes more appropriate levels of risk. One 
commenter believes the proposed financial risk standard is inconsistent 
with the statutory intent to encourage proliferation of, and 
participation in, Advanced APMs. One commenter suggested that the focus 
of the financial risk standard should be on the motivation of APM 
participants to reduce costs rather than whether or not they bear 
financial risk.
    Response: We appreciate the comments suggesting broadening the 
scope of the Advanced APM financial risk standard, which appear to be 
largely driven by the desire to identify Track 1 of the Shared Savings 
Program as an Advanced APM. We recognize the substantial time and money 
commitments that APM Entities invest to become successful APM 
participants. However, we disagree with commenters that costs not 
encompassed by an APM's financial risk arrangements should be 
considered when assessing financial risk under the APM. First, we do 
not believe we can objectively and accurately assess business risk 
without exceptional administrative burden on both CMS and APM Entities 
to quantify such expenditures and verify that they were made solely for 
participation in a particular APM. Any such assessment would be at risk 
of being methodologically unsound because we do not believe we could 
set simple, clear standards for which expenditures would be included as 
``business risk'' for the purposes APM participation and not also of 
benefit to other activities that a practice may engage in.
    Second, although the cited activities and investments may be geared 
toward success in an APM, we believe the same activities and 
investments are likely to be aligned with success under any value-based 
payment system such as MIPS.
    Third, business risk is generally a sunk cost that is unrelated to 
performance-based payment under an APM. No matter how well or poorly an 
APM Entity performs, those costs are not reduced or increased 
correspondingly. Therefore, business ``risk'' is not analogous to 
performance risk in the APM context because those activities and 
investments are simply costs that are not incorporated into the 
financial calculations of an APM. In fact, we believe the placement of 
any objective monetary standard for how much investment could be 
considered more than nominal would inherently offer an incentive for 
excessive or wasteful investment that might be unrelated to 
performance.
    We also believe that maintaining a clear distinction between APMs 
and Advanced APMs is consistent with the statute, which did not 
envision that all APMs would meet this standard. We believe that 
section 1833(z) of the Act recognizes that not all APMs would meet this 
criterion. We believe the purpose of the APM incentives is to provide a 
boost for participation in the most challenging APMs, not to provide 
funding for infrastructure support for participation in any APM. 
Several APMs such as the ACO Investment Model, Next Generation ACO 
Model, and CPC+ model have those investment funds built into the APM.
    In addition, we have a stated interest in encouraging movement from 
one-sided risk arrangements to two-sided risk arrangements, that is, 
for example from Track 1 to Track 2 or 3 of the Shared Savings Program. 
Designating a Track 1 ACO as an Advanced APM by permitting business 
risk to meet the financial risk standard would provide no additional 
incentive for Track 1 ACOs to transition to two-sided risk models.
    With respect to uncompensated care, we do not wish to downplay the 
financial impact of uncompensated care, but we believe that addressing 
such costs in the context of APMs is beyond the scope of this final 
rule with comment period. We do not believe that such costs can be 
considered as financial risk under an APM in any systematic, 
quantifiable manner. Even more than with business risk, we do not 
believe uncompensated care can be considered ``monetary losses under 
such alternative payment model'' as stated in section 
1833(z)(3)(D)(ii)(I) of the Act. Further, we do not believe that an APM 
Entity that provides uncompensated care and also participates in an APM 
that does not meet the financial risk criterion should be considered to 
be participating in an Advanced APM. Losses resulting from the 
provision of uncompensated care would be unrelated to the performance 
requirements under the APM.
    With respect to the Medical Home Model financial risk standard, we 
believe that it is important to maintain the distinction between 
Medical Home Models and other APMs because we believe that Medical Home 
Models are categorically different than other types of APMs, as 
supported by specific provisions in the statute enabling unique 
treatment of Medical Home Models. Also, Medical Home Model participants 
tend to be smaller in size and have lower Medicare revenues relative to 
total Medicare spending than other APM Entities, which affects their 
ability to bear substantial risk, especially in relation to total cost 
of care. We believe that the meaning of nominal financial risk varies 
according to context, and that smaller practices participating in 
Medical Home Models, as a category, experience risk differently than 
much larger, multispecialty-

[[Page 77421]]

focused organizations do. To date, Medical Home Model participants have 
not been required to bear financial risk, which means the assumption of 
any financial risk presents a new challenge for these entities. We are 
providing special standards for Medical Home Models that are exceptions 
to the generally applicable standards because of these unique 
characteristics.
    Comment: Many commenters suggested two additional interrelated 
policies to improve access to Advanced APMs. First, many commenters 
requested that we amend the Shared Savings Program regulations so that 
ACOs may move from Track 1 to either Track 2 or Track 3 prior to the 
completion of their 3-year agreement period in order to allow ACOs to 
accept downside risk and participate in an Advanced APM sooner than 
they otherwise would be able. Some commenters suggested that this be a 
one-time opportunity in order to allow ACOs the chance to move ``up'' 
to a higher track. Other commenters requested an extension of the 
application cycle for 2017 participation in the Shared Savings Program.
    Several commenters suggested that we create a new Shared Savings 
Program track that closely aligns with the finalized Advanced APM 
nominal amount standard in this final rule so that there is an option 
for ACOs, particularly ACOs with relatively low revenue or small 
numbers of participating eligible clinicians, to participate in an 
Advanced APM without accepting the higher degrees of risk involved in 
Tracks 2 and 3. Commenters believe this would be an attractive and 
meaningful middle path between Tracks 1 and 2 and would be a viable on-
ramp for assuming greater amounts of risk in the future. Commenters 
suggested this opportunity should be coupled with the ability for Track 
1 ACOs to move into this new ``Track 1.5'' before the end of their 
current agreement periods. Another commenter specifically suggested an 
asymmetrical ACO model with a low marginal risk rate for losses, such 
as 25-30 percent of shared losses, and a higher marginal risk rate for 
savings, such as 70-75 percent of shared savings, with no minimum 
savings rate or minimum loss ratio.
    Response: We thank the commenters for their suggestions and 
comments regarding how to align the Shared Savings Program rules with 
the Quality Payment Program and enhance the opportunities for ACOs to 
participate in an Advanced APM. In the November 2011 final rule 
establishing the Shared Savings Program (76 FR 67909) as updated in the 
June 2015 final rule (80 FR 32692), we have created three tracks in 
which ACOs can choose to participate: A one-sided risk model (Track 1) 
that incorporates the statutory payment methodology under section 
1899(d) of the Act; and two, two-sided models (Tracks 2 and 3) that are 
also based on the payment methodology under section 1899(d) of the Act 
but incorporate performance-based risk using the authority under 
section 1899(i)(3) of the Act to use other payment models. We explained 
that offering a choice of tracks would create an ``on-ramp'' for the 
program to attract both providers and suppliers that are new to value-
based purchasing, as well as more experienced entities that are ready 
to share performance-based risk. We stated our belief that the one-
sided model would have the potential to attract a large number of 
participants to the program and introduce value-based purchasing 
broadly to providers and suppliers, many of whom may never have 
participated in a value-based purchasing initiative before. Another 
reason we included the option for a one-sided track with no downside 
risk was that this model would be accessible to and attract small, 
rural, safety net, and physician-only ACOs.
    However, we also noted that although a one-sided model could 
provide incentives for participants to improve quality, it might not be 
sufficient incentive for participants to improve the efficiency and 
cost of health care delivery (76 FR 67904 and 80 FR 32759). Therefore, 
we have used our authority under section 1899(i)(3) of the Act to 
create two performance-based risk options, Track 2 and Track 3, where 
ACOs are not only eligible to share in savings, but also must share in 
losses. We believe performance-based risk options have the advantage of 
providing more experienced ACOs an opportunity to enter a sharing 
arrangement that provides greater reward for greater responsibility, 
and we have designed our policies for the Shared Savings Program to 
offer a pathway for ACOs to transition from the one-sided model to 
performance risk-based arrangements. Therefore, we require that ACOs 
that elect to enter the Shared savings Program under Track 1 can remain 
in Track 1 for no longer than 2 agreement periods, and must transition 
to Track 2 or Track 3 for all subsequent agreement periods. We believe 
this approach increases interest in the Shared Savings Program by 
providing a gentler on-ramp while maintaining the flexibility for more 
advanced ACOs to take on greater performance-based risk in return for a 
greater share of savings immediately upon entering the program.
    Many of the program requirements that apply to ACOs in Tracks 1, 2, 
and 3 are the same but there are some significant differences that 
encourage progression along the risk continuum. For example, the 
financial reconciliation methodology was designed so that ACOs that 
accept performance-based risk under Track 2 or Track 3 have the 
opportunity to earn a greater share of savings, in exchange for their 
willingness to accept performance-based risk. Specific differences 
between the tracks are summarized in the June 2015 final rule at (80 FR 
32811 through 32812).
    In June 2016, we issued a final rule (81 FR 37950) to incorporate 
regional FFS expenditures into the methodology for establishing, 
adjusting, and updating the benchmarks of ACOs that continue their 
participation in the Shared Savings Program after an initial 3-year 
agreement period. In an effort to continue to provide a pathway to 
increasing performance-based risk, the June 2016 final rule also added 
a participation option to encourage ACOs to transition to performance-
based risk arrangements. Specifically, in the June 2016 final rule, we 
finalized a policy to give ACOs that participate in Track 1 for their 
first agreement period an additional option when they apply to renew 
for a second agreement period under a two-sided model (Track 2 or Track 
3). If the ACO's renewal request is approved, the ACO may request that 
its initial participation agreement under Track 1 be extended for an 
additional year (that is, the ACO would enter a fourth performance year 
under Track 1). As a result of this deferral, we will also defer 
rebasing the ACO's benchmark for 1 year. At the end of this fourth 
performance year under Track 1, the ACO will transition to the selected 
performance-based risk track for a three-year agreement period. This 
option became available beginning with the 2017 application cycle.
    However, even with this pathway to performance-based risk, we have 
heard from stakeholders, as exemplified by the comments above, that we 
should consider offering ACOs an even more gradual transition to 
performance-based risk. In the June 2016 final rule, we signaled that 
we are committed to facilitating entry and continued participation in 
the Shared Savings Program by ACOs with varying levels of experience 
with accountable care models and differing degrees of readiness to take 
on performance-based risk, and to encourage ACOs to transition to 
performance-based risk

[[Page 77422]]

tracks. Given that the overwhelming majority of ACOs still participate 
in the one-sided model, we continue to explore how to move ACOs to 
performance-based risk more quickly.
    Therefore, we are considering using our authority under section 
1115A of the Act to develop and test a ``Medicare ACO Track 1+ Model'' 
starting for the 2018 performance year. The Track 1+ Model would test a 
payment model that incorporates more limited downside risk than is 
currently present in Tracks 2 or 3 of the Shared Savings Program in 
order to encourage more rapid progression to performance-based risk. In 
other words, this potential Track 1+ Model is envisioned as an on-ramp 
to Tracks 2 or 3. The model could be open to Track 1 ACOs that are 
within their current agreement period, initial applicants to the Shared 
Savings Program, and Track 1 ACOs renewing their agreement that meet 
model eligible criteria. The model would be voluntary for organizations 
currently participating in Track 1 or seeking to participate in the 
Shared Savings Program. For Track 1 ACOs that have renewed their 
agreements, the benchmark that would apply under the model could also 
incorporate a regional benchmark adjustment consistent with the timing 
and phase-in of the regional benchmark adjustment as outlined in the 
June 2016 final rule for the Shared Savings Program. We will announce 
additional information about the Track 1+ Model in the future.
    We are finalizing the Advanced APM financial risk standard as 
proposed. To be an Advanced APM, an APM must provide that, if actual 
expenditures for which an APM Entity is responsible under the APM 
exceed expected expenditures during a specified performance period, CMS 
can:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians; or
     Require the APM Entity to owe payment(s) to CMS.
    We note that this generally applicable financial risk standard does 
not include reductions in otherwise guaranteed payments made under the 
terms of the APM--such as care management fees that vary based on 
quality performance--whereas, as described below, the Medical Home 
Model financial risk standard does take into consideration reductions 
in otherwise guaranteed payments under certain circumstances. As such, 
one-sided risk arrangements would not meet this financial risk 
criterion.
(ii) Medical Home Model Financial Risk Standard
    We proposed to adopt a slightly different financial risk standard 
for Medical Home Models. For a Medical Home Model to be an Advanced 
APM, it must include provisions that CMS:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians;
     Require the APM Entity to owe payment(s) to CMS; or
     Cause the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments, if either:
    ++ Actual expenditures for which the APM Entity is responsible 
under the APM exceed expected expenditures during a specified 
performance period; or
    ++ APM Entity performance on specified performance measures does 
not meet or exceed expected performance on such measures for a 
specified performance period.
    With regard to the proposed financial risk standard for Medical 
Home Models, we believe that the Medical Home Model is a unique type of 
APM that is treated differently under both the MIPS and APM programs. 
For example, under the MIPS clinical practice improvement activity 
performance category, as described in section II.E.3.f. of this final 
rule with comment period, eligible clinicians participating in medical 
homes receive an automatic 100 percent score, whereas eligible 
clinicians participating in other APM Entities receive a minimum of a 
50 percent score. Additionally, Medical Home Models are distinct from 
other APMs in that, if they are models tested under section 1115A of 
the Act, there is the possibility of having an alternate pathway to 
meet the financial risk criterion through expansion under section 
1115A(c) of the Act; and the presence of Medicaid Medical Home Models 
in a state can affect whether Medicaid payments or patients are 
excluded in the All-Payer Combination Option for QP determinations (see 
sections 1833(z)(2)(B)(ii)(I)(bb) and (iii)(II)(cc)(BB), 
1833(z)(2)(C)(ii)(I)(bb) and (iii)(II)(cc)(BB), 1833(z)(3)(C)(ii)(II), 
and 1848(q)(5)(C)(i) of the Act). Medical Home Models and their 
participating APM Entities (medical homes) are different from other 
APMs and their respective APM Entities in that: (1) Medical homes tend 
to be smaller in size and have lower Medicare revenues relative to 
total Medicare spending than other APM Entities, which affects their 
ability to bear substantial risk, especially in relation to total cost 
of care; and (2) to date, neither publicly nor commercially-sponsored 
medical homes have been required to bear the risk of financial loss, 
which means the assumption of any financial risk presents a new 
challenge for medical homes. For example, a common group practice in 
the Comprehensive Primary Care (CPC) initiative may consist of less 
than 20 individuals, including physicians, non-physician practitioners, 
and administrative staff. Making large lump sum loss payments or going 
without regular payment for a substantial period of time could put such 
practices out of business, whereas large ACOs may comprise an entire 
integrated delivery system with sufficient financial reserves to 
weather direct short-term losses.
    We therefore believe that the unique characteristics of Medical 
Home Models warrant the application of a financial risk standard that 
reflects these differences to provide incentives for participation in 
the most advanced financial risk arrangements available to medical 
homes practitioners.
    The proposed financial risk standard for Medical Home Models is 
similar to the generally applicable Advanced APM standard in its first 
three conditions. The difference is in the inclusion of the fourth 
condition for the proposed financial risk standard for Medical Home 
Models, which would allow a performance-based forfeiture of part or all 
of a payment under an APM to be considered a monetary loss. For 
example, a Medical Home Model would meet this standard if it conditions 
the payment of some or all of a regular care management fee to APM 
Entities upon meeting specified performance standards. Because the APM 
does not require any direct payment or repayment to us, a medical home 
penalized in such a manner would not necessarily be in a weaker 
financial position than it had been prior to the decreased payment; 
however, it would be in a comparatively worse position in the future 
than it otherwise would have been had it met performance standards. We 
believe that this financial risk standard respects the unique 
challenges of medical homes in bearing risk for losses while 
maintaining a more rigorous standard than business risk.
    We solicited comment on the proposed standards set forth for both 
Advanced APM Medical Home Models and for all other APMs, including any 
comments on alternative standards suggested by the public that could 
achieve our stated goals and the

[[Page 77423]]

statutory requirements. We also solicited comment on types of financial 
risk arrangements that may not be clearly captured in this proposal.
    The following is a summary of the comments we received regarding 
our proposal for a unique Advanced APM financial risk standard for 
Medical Home Models.
    Comment: Many commenters believe that Medical Home Models should 
not have any financial risk requirement in order to be an Advanced APM. 
As with the generally applicable financial risk standard, commenters 
cited up-front costs related to participation. Some commenters also 
stated a belief that the proposed rule inappropriately imposes 
financial risk upon clinicians and could have unintended consequences 
for those serving vulnerable populations. Other commenters believe that 
instead of a separate risk standard for Medical Home Models, we should 
more generally focus on developing APMs for small organizations and 
consider targeted accommodations for rural practices.
    Response: As with the comments suggesting that we consider expenses 
and investments related to the APM, we appreciate the desire to expand 
the availability of Advanced APMs but ultimately believe that 
considering these as financial risk would not respect the statutory 
distinction between APMs and Advanced APMs. However, the Medical Home 
Model financial risk standard acknowledges that risk under the terms of 
an APM can be structured uniquely for smaller entities participating in 
Medical Home Models in a way that offers the potential for losses 
without threatening their financial viability.
    We disagree with comments stating that the statute supports no 
financial risk for Medical Home Model participants. Section 
1833(z)(3)(D)(ii)(II) of the Act is clear that a Medical Home Model 
must be actually expanded under section 1115A(c) of the Act to meet the 
financial risk criterion without requiring APM Entities to bear more 
than nominal financial for monetary losses. The expanded Medical Home 
Model aspect of the financial risk criterion is described in full below 
in section II.F.4.(b) of this final rule with comment period.
    We also disagree that our financial risk criterion for Medical Home 
Models to be Advanced APMs imposes undue risk on clinicians. This 
financial risk requirement only pertains to how a Medical Home Model 
must generally be structured in order to be an Advanced APM. There is 
no requirement that all Medical Home Models be Advanced APMs, and, to 
date, we have not created any mandatory Medical Home Models. Clinicians 
receive substantial credit under MIPS in the improvement activities 
performance category for participation in Medical Home Models or 
receiving certain certified patient-centered medical home 
certifications, regardless of whether they participate in an Advanced 
APM.
    In fact, the financial risk policy that we finalize here for 
Medical Home Models is an exception to the generally applicable rule in 
recognition that Medical Home Models are categorically different than 
other types of APMs. However, we do not have the authority to dispense 
with the statutory requirement that an Advanced APM is one in which 
participating APM Entities bear more than nominal financial risk for 
monetary losses unless the APM is a Medical Home Model expanded as 
permitted under section 1115A(c).
    Lastly, we agree with commenters that we should focus on improving 
APM and Advanced APM participation opportunities for small and rural 
practices. However, we do not believe that pursuing those goals is 
mutually exclusive with creating Advanced APM participation 
opportunities through the Medical Home Model financial risk standard.
    Comment: Some commenters expressed their support for the separate 
Medical Home Model financial risk standard as placing a high value on 
the provision of primary care, and offered suggestions for further 
improvements such as improving the Relative Value Unit system that 
undergirds payment under the PFS even as we move away from entirely FFS 
payment. Other commenters supported the Medical Home Model financial 
risk standard but suggested that the entire financial risk criterion 
not apply to Medical Home Models until the 2018 QP Performance Period.
    Response: We thank the commenters for their support of the proposed 
policy, but note that modifying the RVU system under the PFS is beyond 
the scope of this final rule with comment period. We also appreciate 
the suggestion to delay the application of the financial risk criterion 
but do not believe that we have the authority to set aside the 
statutory criterion. Nevertheless, a delay in the assessment of the 
financial risk criterion for Medical Home Models to be considered 
Advanced APMs would not change any risk requirements imposed by the 
Medical Home Models. Risk is a component of the design of the APMs 
themselves, not something imposed by the Quality Payment Program. For 
instance, the financial risk for participants under the CPC+ model will 
be the same regardless of whether or not the model meets the Advanced 
APM financial risk criterion.
    We are finalizing the Advanced APM financial risk standard for 
Medical Home Models as proposed. For a Medical Home Model to be an 
Advanced APM, it must include provisions such that CMS could:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians;
     Require the APM Entity to owe payment(s) to CMS; or
     Cause the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments,
    if either:
     Actual expenditures for which the APM Entity is 
responsible under the APM exceed expected expenditures during a 
specified performance period; or
     APM Entity performance on specified performance measures 
does not meet or exceed expected performance on such measures for a 
specified performance period.
(4) Nominal Amount of Risk
    If the APM risk arrangement meets the proposed financial risk 
standard, we would then consider whether the amount of the risk is in 
excess of a nominal amount in order for this Advanced APM criterion to 
be met. We believe the statutory requirement that an APM Entity bear 
risk under an APM in excess of a nominal amount (which we would term 
the ``nominal amount standard'') relates to a particular quantitative 
risk value at which we would consider the risk arrangement to involve 
potential losses of more than a nominal amount. Similar to the 
financial risk portion of this assessment, we proposed to adopt a 
generally applicable nominal amount standard for Advanced APMs and a 
unique nominal amount standard for Medical Home Models. Under the 
proposed generally applicable nominal amount standard, the total risk 
percentages are of the APM Entity benchmark or, in the case of episode 
payment models, the target price, which is the amount of Medicare 
expenditures (which can vary as to the involvement of Parts A and B 
depending on the APM) above which an APM Entity owes losses and below 
which an APM Entity earns savings. In the case of Medical Home Models, 
the proposed risk percentages for Medical Home Models are based on 
Medicare Parts A and B revenue. As an alternative, we considered 
assessing total risk under the generally applicable nominal amount

[[Page 77424]]

standard (for APMs other than episode payment models) in relation to 
the APM Entity's Parts A and B revenue instead of in relation to the 
APM benchmark. We note that the ratio between entity revenue and the 
expenditures reflected in an APM's benchmark may vary across different 
types of entities, such as when the APM benchmark is based on total 
cost of care. We did not propose, but we sought comment on, the 
alternative of basing the generally applicable standard on Parts A and 
B revenue. We were concerned that assessing total risk based on an APM 
Entity's revenue instead of the APM benchmark could require case-by-
case determinations at the APM Entity level that could change from year 
to year, and would set meaningfully different standards for different 
types of entities regarding the extent to which they must be held 
financially responsible if expenditures exceed the benchmark. That 
said, we understand that setting the total risk standard too high could 
create challenges for smaller organizations for which a total cost of 
care benchmark represents more risk in relation to revenue than it does 
for larger organizations.
(a) Advanced APM Nominal Amount Standard
    In general, we believe that the meaning of ``nominal'' is, as plain 
language implies, minimal in magnitude. However, in the context of 
financial risk arrangements, we do not believe it to be a mere 
formality. For instance, we do not believe the law was intended to 
consider one dollar of risk to be more than nominal. That would create 
an arbitrary distinction between an APM that has only upside reward 
potential and one that has the same upside reward potential with a 
fractional and relatively meaningless downside risk. Therefore, in 
arriving at the proposed values, we sought amounts that would be 
meaningful for the entity but not excessive. As reference points to 
anchor the proposed values, we used the percentage amounts of MIPS 
adjustments in the MACRA and surveyed current APM risk arrangements, 
including those in Tracks 2 and 3 of the Shared Savings Program, the 
Pioneer ACO Model, and the Bundled Payments for Care Improvement (BPCI) 
Initiative. We considered the potential losses and marginal risk rates 
of those initiatives to be optimal in that they have been vetted 
through the APM development process and determined to be the 
appropriate amount of risk for each initiative such that, in the 
context of the APM, it is anticipated that the amount of risk would 
motivate the desired changes in care patterns to reduce costs and 
improve quality. As stated previously, we believe that the term 
``nominal'' is clearly an amount that is lower than optimal but 
substantial enough to drive performance. In other words, we are 
confident that risk levels in current APMs with downside risk are 
sufficient for a wide variety of providers and suppliers, but in 
certain circumstances, we would want to encourage participation in APMs 
with slightly lower levels of risk, though not levels of risk that are 
so low that an APM becomes no more effective at motivating desired 
changes than APMs with no downside risk.
    Except for risk arrangements described under section II.F.4.b.(4) 
of this final rule with comment period, we proposed to measure three 
dimensions of risk described in this section to determine whether an 
APM meets the nominal amount standard: (a) Marginal risk, which is a 
common component of risk arrangements--particularly those that involve 
shared savings--that refers to the percentage of the amount by which 
actual expenditures exceed expected expenditures for which an APM 
Entity would be liable under the APM; (b) minimum loss rate (MLR), 
which is a percentage by which actual expenditures may exceed expected 
expenditures without triggering financial risk; and (c) total potential 
risk, which refers to the maximum potential payment for which an APM 
Entity could be liable under the APM. Except for risk arrangements 
described under section II.F.4.b.(3) of this final rule with comment 
period, we proposed that for an APM to meet the nominal amount standard 
the specific level of marginal risk must be at least 30 percent of 
losses in excess of expected expenditures, and a minimum loss rate, to 
the extent applicable, must be no greater than 4 percent of expected 
expenditures, and total potential risk must be at least 4 percent of 
expected expenditures. As described in greater detail in section 
II.F.7. of this final rule with comment period, the proposed Other 
Payer Advanced APM nominal amount standard paralleled the proposed 
standard described here for Advanced APMs. In general, we proposed to 
define expected expenditures to be the level of expenditures reflected 
in the APM benchmark. However, for episode payment models, we proposed 
to define expected expenditures to be the level of expenditures 
reflected in the target price.
    To determine whether an APM satisfies the marginal risk portion of 
the nominal amount standard, we would examine the payment required 
under the APM as a percentage of the amount by which actual 
expenditures exceeded expected expenditures. We proposed that we would 
require that this percentage exceed the required marginal risk 
percentage regardless of the amount by which actual expenditures 
exceeded expected expenditures. APM arrangements with less than 30 
percent marginal risk would not meet the nominal amount standard. We 
believed that meaningful risk arrangements can be designed with 
marginal risk rates of greater than 30 percent. We believed that any 
marginal risk below 30 percent could create scenarios in which the 
total risk could be very high, but the average or likely risk for an 
APM Entity could actually be very low. We also proposed that the 
payment required by the APM could be smaller when actual expenditures 
exceed expected expenditures by enough to trigger a payment greater 
than or equal to the total risk amount required under the nominal 
amount standard. This was essentially an exception to the marginal risk 
requirement so that the standard would not effectively require APMs to 
incorporate total risk greater than the amount required by the total 
risk portion of the standard.
    We proposed a maximum allowable ``minimum loss rate'' (MLR) of 4 
percent in which the payment required by the APM could be smaller than 
the nominal amount standard would otherwise require when actual 
expenditures exceed expected expenditures by less than 4 percent; this 
exception accommodates APMs that include zero risk with respect to 
small losses but otherwise satisfy the marginal risk standard. If 
actual expenditures exceed expected expenditures by an amount exceeding 
the MLR, then all excess expenditures (including excess expenditures 
within the MLR) would be subject to the marginal risk requirements. For 
example, ACOs participating in performance-based risk arrangements 
under Tracks 2 and 3 of the Shared Savings Program are permitted to 
choose their own minimum savings rate (MSR) and MLR between zero and 
2.0 percent or a variable MSR and MLR up to 3.9 percent based on the 
number of assigned beneficiaries as long as the MSR and MLR are 
symmetrical. If losses do not exceed the chosen MLR, the ACO is not 
held responsible for losses. If the ACO has a very large MLR, there may 
be little to no risk with respect to losses below a certain percentage 
of the benchmark. Therefore, we believed it was appropriate to propose 
a maximum allowable MLR. We

[[Page 77425]]

recognize that there may be instances where an APM could satisfy the 
marginal risk portion of the nominal amount standard even with a high 
MLR. Therefore, we also proposed a process through which we could 
determine that a risk arrangement with an MLR higher than 4 percent 
could meet the nominal amount standard, provided that the other 
portions of the nominal amount standard are met. In determining whether 
such an exception would be appropriate, we proposed to consider: (1) 
whether the size of the attributed patient population is small; (2) 
whether the relative magnitude of expenditures assessed under the APM 
is particularly small; and (3) in the case of a test of limited size 
and scope, whether the difference between actual expenditures and 
expected expenditures would not be statistically significant even when 
actual expenditures are 4 percent above expected expenditures. We noted 
that we would grant such exceptions rarely, and we would expect APMs 
considered for such exceptions to demonstrate that a sufficient number 
of APM Entities are likely to incur losses in excess of the higher MLR. 
In other words, the potential for financial losses based on 
statistically significant expenditures in excess of the benchmark must 
remain meaningful for participants.
    To determine whether an APM satisfies the total risk portion of the 
nominal amount standard, we would identify the maximum potential loss 
an APM Entity could be required to incur as a percentage of expected 
expenditures under the APM. If that percentage exceeded the required 
total risk percentage, then the APM would satisfy the total risk 
portion of the nominal amount standard.
    In evaluating both the total and marginal risk portions of the 
nominal amount standard, we would not include any payments the APM 
Entity or its eligible clinicians would make to us under the APM if 
actual expenditures exactly matched expected expenditures. In other 
words, payments made to us outside the risk arrangement related to 
expenditures would not count toward the nominal amount standard. This 
requirement ensures that perfunctory or pre-determined payments do not 
supersede incentives for improving efficiency. For example, an APM that 
simply requires an APM Entity to make a payment equal to 5 percent of 
the APM benchmark at the end of the year, regardless of actual 
expenditure performance, would not satisfy the nominal amount standard.
    In particular, the financial risk an Advanced APM Entity would bear 
under an Advanced APM need not take a shared savings structure in which 
the financial risk increases smoothly based on the amount by which an 
Advanced APM Entity's actual expenditures exceed expected expenditures. 
Examples of a risk arrangement based on shared savings are Tracks 2 and 
3 of the Shared Savings Program, where the greater the losses in 
relation to the expenditure benchmark, the greater the potential amount 
of shared losses an ACO would be required to repay us. On the other 
hand, an Advanced APM could require APM Entities to pay a penalty based 
on expenditure targets, regardless of the degree to which the APM 
Entity actually exceeded those expenditure targets, provided that the 
payments are otherwise structured in a way that satisfies both the 
marginal and total risk requirements under the nominal amount standard.
    We solicited comment on appropriate levels for the allowable 
minimum loss rate and the parameters we should consider when 
determining whether a risk arrangement should warrant an exception from 
the minimum loss rate portion of the nominal amount standard.
    We solicited comment on the Advanced APM nominal amount standard. 
In particular, we solicited comment on whether the Advanced APM 
benchmark or the Advanced APM Entity revenue is a more appropriate 
basis for assessing total risk and on the proposed amounts of total 
potential risk, marginal risk, and maximum allowable minimum loss rate. 
In particular, we solicited comment on whether 30 percent is a 
sufficient level of marginal risk to be considered ``more than 
nominal.'' We also solicited comment on whether there could be a 
meaningful standard that we could adopt that only includes total and 
marginal risk without the minimum loss rate component. Finally, we 
solicited comment on a tiered nominal risk structure in which different 
levels of marginal risk could be paired with different levels of total 
risk.
    In commenting on possible alternatives, we encouraged commenters to 
refer to the policy principles articulated in section II.F.1. of this 
final rule with comment period and to consider the extent to which 
their proposed alternatives would be more or less consistent with those 
principles.
    The following is a summary of the comments we received regarding 
our proposal to set the generally applicable nominal amount standard 
such that, to be an Advanced APM, an APM must have total risk of at 
least 4 percent of expected expenditures, marginal risk of at least 30 
percent, and, if applicable, a minimum loss rate (MLR) of no more than 
4 percent, for which we would also have a process to determine whether 
a higher MLR is appropriate for particular APMs.
    Comment: The comments on the nominal amount standard split into 
three main themes--complexity, magnitude of risk, and basis of the 
percentage of risk--but all three elements are closely related. Most 
commenters expressed their belief that the generally applicable nominal 
amount standard is excessively complex and should be simplified. In 
particular, several commenters thought the inclusion of marginal risk 
and minimum loss ratio components to be especially complicated.
    Many commenters also believe that the proposed standard's amount of 
risk was too high because 4 percent of total cost of care could equate 
to upwards of 20 percent of an entity's revenue depending on the 
composition of the APM Entity, and discourages all but the most highly-
resourced organizations from Advanced APM participation. Some 
commenters suggested starting at a lower amount of total risk and 
increasing over time. Many commenters believe that between 1 and 3 
percent of Parts A and B revenue would be a reasonable definition of 
``more than nominal,'' particularly in light of not including up-front 
or investment costs in the determination. Some commenters recommended 
tailoring risk standards based on various factors or adjusting marginal 
risk and total risk in relation to one another to the degree that 
marginal risk could be paired with lower total risk. One commenter 
stated that level of risk is too high because clinicians would not have 
access to information on the expenditures outside an APM Entity until 
the end of a given year. One commenter was concerned that the nominal 
amount standard would be burdensome for rural practices and potentially 
reduce access to care in rural settings. Some commenters requested that 
CMS make the generally applicable nominal risk definition more like 
that proposed for medical homes.
    Finally, many commenters stressed that basing the nominal amount 
standard on APM Entity revenue, rather than expected expenditures as 
proposed, would be a more meaningful standard that allows for tailoring 
risk to the size of APM Entities. Several commenters suggested values 
of between 2 and 15 percent of eligible clinician or APM Entity revenue 
would be an appropriate standard. Some commenters noted that this would 
also make the standard more comparable to MIPS.

[[Page 77426]]

    Response: We appreciate the response to this proposed policy. With 
respect to the marginal risk and MLR portions of the standard, we 
understand commenters' concerns that, despite being technically robust, 
these aspects of the standard are complex enough to require additional 
time to understand. For that reason, we are not finalizing the marginal 
risk and MLR requirements as proposed for year 1. We also believe that 
marginal risk and MLR components are not necessary to explicitly 
include in the nominal amount standard because we are committed to 
creating Advanced APMs with strong financial risk designs that 
incorporate risk adjustment, benchmark methodologies, sufficient stop-
loss amounts, and sufficient marginal risk; and that all APMs involving 
financial risk that we operate now or in the future will meet or exceed 
the proposed marginal risk and MLR requirements. In section 
II.F.7.b.(6) of this final rule with comment, we are finalizing these 
marginal risk and MLR requirements with respect to Other Payer Advanced 
APMs for QP Performance Period in 2019 and later, as we believe such 
requirements are important to preventing possible engineering of the 
nominal amount standard for payment arrangements designed by other 
payers via manipulation of marginal risk, MLRs, or attribution 
methodologies in order to make the possibility of reaching a stop-loss 
cap very unlikely. We believe that this additional time will help 
mitigate commenters' concerns about complexity.
    Regarding the total risk portion of the proposed standard, we agree 
with commenters that the meaning of ``nominal'' can be relative and 
that for many APM Entities, 4 percent of a total cost of care benchmark 
could represent a significant fraction of an APM Entity's revenue. We 
believe such amounts of risk would be more than nominal for all APM 
Entities, but much more substantial for some APM Entities. We recognize 
that a revenue-based standard would provide an alternative approach 
under the nominal amount standard that would be particularly meaningful 
to practices of certain sizes. However, we caution that a revenue-based 
standard is not easily applied to most current APMs, which tend to base 
risk arrangements on expenditure benchmarks that are unrelated to a 
particular APM Entity's revenue. We believe that total cost of care 
benchmarks are optimal for many APMs, and those will continue to 
represent the preferred standard for assessing performance in terms of 
cost. We also caution that, under a revenue-based standard, certain 
types of APM Entities may have a significant probability of incurring 
losses outside the stop loss and thus bear no responsibility for 
increases in expected expenditures beyond that point, which may 
undermine the ability of such APMs to drive performance for those APM 
Entities. In seeking a risk standard that is meaningful but not 
excessive, we sought to balance these considerations.
    In deciding on the policy that we finalize below, we considered 
several alternatives. For instance, we considered setting the revenue-
based standard at up to 15 percent of revenue or setting the revenue-
based standard at 10 percent so long as risk is at least equal to 1.5 
percent of expected expenditures for which an APM Entity is responsible 
under an APM. While we are finalizing lower revenue-based standards for 
the first two QP Performance Periods in 2017 and 2018, we intend to 
increase the standard to one of the alternatives discussed above for 
the QP Performance Period in 2019 and later years. We will weigh public 
comments on this final rule with comment period and assess the impact 
of this standard, particularly on the design of Other Payer Advanced 
APMs by non-Medicare payers, in establishing the nominal amount 
standard for the QP Performance Period in 2019 and later. We 
particularly seek comments on a standard that tailors the level of risk 
to particular APM Entities' circumstances while also ensuring that APMs 
include strong incentives to improve performance and coordinate care 
across clinician types. In addition, we will consider the amount of 
risk taken in APM contracts (with Medicare and other payers) and seek 
comment on trends in those amounts and other factors that may inform 
the nominal risk standard for 2019.
    Finally, although we are finalizing a policy that is responsive to 
these comments in that we are not finalizing marginal risk components 
and we are generally reducing the requisite total risk for an APM to be 
an Advanced APM, we encourage commenters and other stakeholders to 
understand that, based on our preliminary analysis, all APMs that could 
be Advanced APMs for 2017 would have higher levels of risk than would 
be required under the proposed or the finalized standard. We also point 
out that reducing the standard for what constitutes a more than nominal 
amount of risk for losses for purposes of deciding whether an APM is an 
Advanced APM would not reduce the level of risk under any particular 
APM, nor is it likely to change the list of Advanced APMs in 2017. 
Rather, it opens the opportunity for future APMs to be considered 
Advanced APMs with lower levels of risk than those currently identified 
as potential Advanced APMs. However, as discussed above, we intend that 
such future APMs will meet the proposed marginal risk and minimum loss 
rate standards.
    Comment: Some commenters supported the proposed nominal amount 
standard but also suggested that we develop a more thorough strategy 
for helping practices develop the tools and capacity to manage risk and 
move into higher levels of risk over time. One commenter requested 
clarification as to when the nominal risk definition applies.
    Response: We appreciate these comments and agree that in addition 
to offering more Advanced APM opportunities, we also need to guide 
clinicians in being successful in APMs and Advanced APMs. We refer 
commenters to the discussion of technical assistance for APM adoption 
in section II.F.2. of this final rule with comment period. Regarding 
timing, we will publish a list of APMs that meet the finalized Advanced 
APM standards, as described in section II.F.4.a. of this final rule 
with comment. To be clear, the nominal amount standard we are 
finalizing in this final rule with comment period is the standard we 
will use in determining whether an APM is an Advanced APM. The actual 
risk participants bear is defined through the APM itself according to 
the APM's unique terms and timeframe.
    Comment: Some commenters asked whether or not PPS and bundled 
payments were considered in calculating risk.
    Response: To determine the amount of risk borne by an APM Entity in 
an APM, we will look at the specific risk arrangement under the APM, 
which may include bundled payments that are prospective or 
retrospective in nature, but would not include regular methods of 
Medicare payments for services. We will only assess financial risk that 
is under the APM; in other words, only risk arrangements that are part 
of the terms and conditions of the APM itself, not the underlying 
payment system or systems that the APM may modify. As expressed in the 
proposed rule and the finalized policy, we will assess total potential 
losses in relation to the target price for episode payment models.
    Comment: Some commenters requested clarification of what we meant 
in the proposed rule by stating that any payments made by an APM Entity 
to CMS outside the risk

[[Page 77427]]

arrangement would not be counted toward the nominal amount 
consideration.
    Response: Payments made ``outside'' of a risk arrangement mean that 
the payments are not related to cost performance under the terms of the 
APM. For instance, an APM Entity could be required to pay CMS a flat 
fee of $1,000 or take a 1 percent discount on payments. No matter how 
well the APM Entity performs, those amounts are fixed under the APM. It 
is those types of payments that would not be considered at risk but 
rather a cost of APM participation.
    We are finalizing two ways that an APM can meet the Advanced APM 
nominal amount standard. An APM would meet the nominal amount standard 
if, under the terms of the APM, the total annual amount that an APM 
Entity potentially owes us or foregoes is equal to at least: (1) For QP 
Performance Periods in 2017 and 2018, 8 percent of the average 
estimated total Medicare Parts A and B revenues of participating APM 
Entities (the ``revenue-based standard''); or (2) for all QP 
Performance Periods, 3 percent of the expected expenditures for which 
an APM Entity is responsible under the APM (the ``benchmark-based 
standard''). For episode payment models, expected expenditures means 
the target price for an episode. We note that we are only finalizing 
the amount of the revenue-based nominal amount standard for the first 
two QP Performance Periods at this time. However, we intend to increase 
the revenue-based nominal amount standard for the third and subsequent 
QP Performance Periods. We seek comment on the amount and structure of 
the revenue-based nominal amount standard for QP Performance Periods in 
2019 and later. Specifically, we seek comment on: (1) Setting the 
revenue-based standard for 2019 and later at up to 15 percent of 
revenue; or (2) setting the revenue-based standard at 10 percent so 
long as risk is at least equal to 1.5 percent of expected expenditures 
for which an APM Entity is responsible under an APM.
    The standard we are finalizing for the 2017 and 2018 QP Performance 
Periods is a change from the proposed nominal amount standard. Under 
this final standard, we would not assess marginal risk or MLRs. 
Additionally, instead of replacing the proposed benchmark-based total 
risk standard with the revenue-based standard, we are adopting the 
revenue-based standard as an additional option. Therefore, if an APM's 
financial design meets either of the two nominal amount standards, we 
would consider the nominal amount standard to be met. This makes the 
finalized standard more accommodating of the increasing variety of 
financial designs in APMs. For instance, current APMs that have total 
cost of care benchmarks, such as the Next Generation ACO Model, would 
be easily assessed as to whether they meet the benchmark-based standard 
because the standard and the APM design use the same metric. Other 
potential APM designs might be more easily assessed under the revenue-
based standard. The nominal amount standard we are finalizing for the 
2017 and 2018 QP Performance Periods further increases flexibility 
because, in the event that an APM using a total cost of care benchmark 
does not meet the benchmark-based standard, we would still assess it 
under the revenue-based standard by calculating the total potential 
risk as a percentage of the average estimated Medicare Parts A and B 
revenue of the participating APM Entities.
    Although we are finalizing a standard based in part on revenue, for 
episode payment models we believe the standard based on the target 
price is most relevant, as target price is the focal point for risk 
under such APMs. Using a revenue-based standard for episode payment 
models would likely disqualify most potential episode payment models 
from becoming Advanced APMs because their relatively narrow scope makes 
the amount at risk a smaller percentage of APM Entity revenue when 
compared to APMs like ACO initiatives.
    As discussed above, our intention in setting a revenue-based 
nominal amount standard is to tailor the level of risk an APM Entity 
must bear relative to the resources available to it. In instances where 
an APM Entity is one component of a larger health care provider 
organization, we believe that the revenue of the larger organization is 
a more accurate measure of the resources available to the APM Entity 
and should be the basis for setting the revenue-based nominal amount 
standard, even if only a portion of the organization is participating 
in the APM Entity.
    However, we believe that it will not be operationally feasible to 
apply the nominal amount standard in this fashion during the first two 
QP Performance Periods, so this final rule sets the revenue-based 
nominal amount standard based solely on the revenue of the APM Entity. 
Nevertheless, ideally, the nominal amount standard would take into 
consideration the resources available to an APM Entity using a measure 
such as revenue for the parent organization. We are evaluating the 
feasibility of implementing such a measure in lieu of APM Entity 
revenue for the third year of the program and later years. Under such 
an approach, we would anticipate basing the revenue-based nominal 
amount standard on the total Medicare Parts A and B revenues across the 
APM Entity, any parent organizations, any subsidiary organizations, and 
any subsidiaries of parent organizations for all eligible clinicians 
and groups who are participants of an APM Entity. We seek comment on 
this approach and how such an approach could be implemented while 
minimizing burden on participants.
(b) Medical Home Model Standard
    We proposed that for Medical Home Models, the total annual amount 
that an Advanced APM Entity potentially owes us or foregoes under the 
Medical Home Model must be at least the following amounts in a given 
performance year:
     In 2017, 2.5 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2018, 3 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2019, 4 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2020 and later, 5 percent of the APM Entity's total 
Medicare Parts A and B revenue.
    We believe the statute's explicit discussion of medical homes gives 
us unique latitude to separately set financial risk and nominal amount 
standards for Medical Home Models that fall below an amount we consider 
sufficient to be ``more than nominal'' in the context of other types of 
APMs. We also believe that the meaning of the term ``nominal'' depends 
on the situation in which it is applied, so we believe it is 
appropriate to consider the characteristics of the APM Entities in 
Medical Home Models in setting the nominal amount standard for Medical 
Home Models. As we noted in discussing the financial risk standard, few 
APM Entities in Medical Home Models have had experience with financial 
risk, and many would be financially unable to provide sufficient care 
or even remain a viable business in the event of substantial 
disruptions in revenue. As such, we believe we should base the nominal 
amount standard on the APM Entity's total Medicare Parts A and B 
revenues and also avoid a potentially excessive level of risk for such 
entities. Our proposal set forth a gradually increasing but achievable 
long-term amount of risk that would apply in subsequent years. In 
general, we believe that this scheme allows

[[Page 77428]]

Medical Home Models to craft incentive designs that allow participants 
in Medical Home Models to succeed through care transformation and the 
provision of high-value care while not threatening the ability of small 
practices to function.
    Even more than for participants in non-Medical Home Models, basing 
the Medical Home Model nominal amount standard on percentage of risk in 
relation to a total cost of care benchmark would mean that participants 
would be required to bear greater total risk in relation to their 
revenues than other entities, which we believe would be undesirable in 
light of the special characteristics of Medical Home Models.
    For the Medical Home Model nominal amount standard, we solicited 
additional comment on the length of the proposed multi-year ``ramp up 
period'' and the magnitude of the total risk amounts during such a 
period. We also solicited comment on the potential addition of a 
marginal risk amount to the extent applicable and on whether the 
Advanced APM benchmark or Advanced APM Entity revenue is the most 
appropriate standard for measuring total risk.
    In commenting on possible alternatives, we encouraged commenters to 
refer to the policy principles articulated in section II.F.1. of this 
final rule with comment period and to consider the extent to which 
their proposed alternatives would be more or less consistent with those 
principles.
    The following is a summary of the comments we received regarding 
our proposal for the Advanced APM nominal amount standard for Medical 
Home Models.
    Comment: Several commenters stated that 2.5 percent of Medicare 
Parts A and B revenue is an appropriate standard for the minimum total 
risk a Medical Home Model must require to be an Advanced APM and 
believe that we should not increase that requirement to 5 percent over 
time. Some commenters note that such a quick increase, set 
prospectively, is unwise because there is little experience with risk 
in the Medical Home Model context for all stakeholders involved. Some 
commenters expressed concern that this standard is too limiting in that 
too few clinicians will have access to an Advanced APM in 2017 or 2018.
    Response: We understand commenters' concerns that a programmed 
increase from 2.5 percent to 5 percent of revenue over several years is 
too great in magnitude and premature. However, we believe that an 
ultimate Medical Home Model nominal amount standard of 5 percent is 
appropriate, and that setting the standard at 5 percent of Parts A and 
B revenue strikes the appropriate balance to reflect the meaning of 
``nominal'' in the Medical Home Model context. We do not believe the 
proposed increase in risk over time would be unmanageable. Instead, we 
consider the incremental increases in the standard over several years 
from 2.5 percent to 5 percent to be a recognition that the earliest 
adopters of risk in the Medical Home Model context might initially 
consider any losses to be substantial while acclimating to bearing 
risk, but with successive years of experience, gain comfort and 
confidence in assuming higher risk levels.
    We also reiterate, as we note for the generally applicable nominal 
amount standard, that the terms and conditions in the particular APM 
govern the actual risk that participants experience; the nominal amount 
standard we are setting in this final rule with comment period merely 
sets a floor on the level of risk required to be an Advanced APM. 
Therefore, we do not believe that this nominal amount standard for 
Medical Home Models will in itself limit Advanced APM participation 
opportunities. Rather, we believe that developing more APMs, amending 
existing APMs, expanding successful APMs, and reopening applications 
for certain APMs could result in increased opportunities to participate 
in Advanced APMs in the near future.
    We are finalizing the Medical Home Model nominal amount standard as 
proposed.
    To be an Advanced APM, a Medical Home Model must require that the 
total annual amount that an Advanced APM Entity potentially owes us or 
foregoes under the Medical Home Model be at least the following amounts 
in a given performance year:
     In 2017, 2.5 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2018, 3 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2019, 4 percent of the APM Entity's total Medicare 
Parts A and B revenue.
     In 2020 and later, 5 percent of the APM Entity's total 
Medicare Parts A and B revenue.
    Also, parallel with the generally applicable nominal amount 
standard, if the financial risk arrangement under the Medical Home 
Model is not based on revenue (for example, it is based on total cost 
of care or a per beneficiary per month dollar amount), we will make a 
determination for the APM based on the risk under the Medical Home 
Model compared to the average estimated Parts A and B revenue of its 
participating APM Entities using the most recently available data.
    We believe that, given the unique financial risk and nominal amount 
standards we proposed for Medical Home Models, it would be appropriate 
to impose size and composition limits for the Medical Home Models to 
which the unique standards would apply to ensure that the focus is on 
organizations with a limited capacity for bearing the same magnitude of 
financial risk as larger APM Entities do. We proposed that, beginning 
in the second QP Performance Period (proposed to be 2018), the Medical 
Home Model financial risk standard and nominal amount standard, 
described in section II.F.4.b.(4) of this final rule with comment 
period, would only apply to APM Entities that participate in Medical 
Home Models and that have 50 or fewer eligible clinicians in the 
organization through which the APM Entity is owned and operated. Thus, 
in a Medical Home Model that meets the criteria to be an Advanced APM, 
the proposed Medical Home Model financial risk and nominal amount 
standards would only apply to those APM Entities owned and operated by 
organizations with 50 or fewer eligible clinicians. We believe it is 
appropriate to use the number of eligible clinicians as the basis, 
rather than physicians, for this threshold because the number of 
eligible clinicians reflects organizational resources and capacity, and 
also may fluctuate widely around a specific number of physicians. We 
also believe that the size threshold of 50 eligible clinicians is 
appropriate because organizations of that size have demonstrated the 
capacity and interest in taking on higher levels of two-sided risk 
either by themselves or by joining with other organizations. In the 
event that a Medical Home Model happens to meet the generally 
applicable financial risk and nominal amount standards, this 
organizational size limitation would not be applicable. We proposed the 
same restriction on Medicaid Medical Home Models as discussed in 
section II.F.7 of this final rule with comment period.
    Measuring organizational size based on the size of the ``parent 
organization'' differs from measuring it based on the size of the APM 
Entity. Collecting accurate information on the number of eligible 
clinicians affiliated with a parent organization would require 
additional, but we believe achievable, reporting by APM Entities. We 
believe that size of the organization is generally a better indication 
of risk-bearing

[[Page 77429]]

capacity than APM Entity size. For instance, an APM Entity may be very 
small if it represents one practice site, but that practice site may be 
one of many affiliated with a health system or independent physician 
association of substantial size. We believe that the proposed limits on 
the types and sizes of entities that can be Advanced APM Entities under 
Medical Home Models would encourage larger organizations to move into 
Advanced APMs with greater levels of risk than the smaller levels that 
could enable Medical Home Models to become Advanced APMs. This is 
consistent with our goals that the incentives for Advanced APM 
participation should reward commitment to challenging models. However, 
we do not intend to imply that participation in Medical Home Models is 
necessarily inappropriate for larger organizations. We recognize that 
Medical Home Models differ from other APMs, such as ACO initiatives, 
because Medical Home Models focus on improving primary care through 
much more targeted and intensive interventions than those commonly 
found in other APMs. We hope to encourage participation in Medical Home 
Models for all organizations that can derive value from their designs, 
not just those that are too small to join ACO initiatives and other 
higher risk APMs.
    We proposed to implement this size limitation for Advanced APMs 
that are Medical Home Models beginning in the second year of the 
Quality Payment Program (2018 QP Performance Period) because we 
understand that applications for many APMs would be due to us prior to 
this final rule, precluding APM Entities from having time to 
substantially adjust their APM participation strategies for the 2017 QP 
Performance Period. We proposed that we would make a determination of 
whether an APM Entity meets the size limitation prospectively before a 
QP Performance Period, and that the determinations would not 
subsequently change based on changes in organizational size during or 
after the QP Performance Period (although changes in organizational 
size would, as applicable, affect determinations for subsequent QP 
Performance Periods).
    We solicited comment on this proposal, particularly with regard to 
the use of the count of eligible clinicians in the parent organization 
of the APM Entity as the metric of organizational size for Medical Home 
Models, and whether setting the limit at 50 for the number of eligible 
clinicians in the organization would constitute a reasonable threshold 
to distinguish between organizations that we could expect to have the 
financial capability to join APMs, such as ACO initiatives, that have 
two-sided risk. We also solicited comment on an alternative option to 
establish the size limitation based on the number of eligible 
clinicians in the entire Medical Home Model, rather than on number of 
eligible clinicians in a particular APM Entity's organization.
    The following is a summary of the comments we received regarding 
our proposal to, starting in the second QP Performance Period, restrict 
the Medical Home Model financial risk and nominal amount standards 
applicable only to APM Entities with 50 or fewer eligible clinicians in 
their parent organizations. Comments regarding our proposal to apply 
the same restriction on Medicaid Medical Home Models are also included.
    Comment: Many commenters expressed opposition to this policy. 
Commenters cited deterrence of participation by larger organizations in 
Medical Home Models that are Advanced APMs because of the inability to 
earn the APM Incentive Payment, difficulties in creating attractive 
multispecialty Medical Home Models, and disadvantages for large 
organizations competing for eligible clinicians. They believe that the 
APM Incentive Payment is a strong incentive, and that the presence or 
absence of the opportunity to earn it will be a driving factor in 
eligible clinician and APM Entity decision-making.
    Some commenters believe that our proposed size criterion of 50 
eligible clinicians in the organization is an arbitrary cutoff that 
does not accurately represent a distinction between organizations that 
can and cannot reasonably assume downside risk, and some asked for 
clarification for why the cutoff was set at 50. Some suggested that if 
we do not eliminate the size limit, we should increase it to 100 or 200 
clinicians. Other clinicians suggested that the limit be applied to APM 
Entities rather than parent organizations.
    Response: We appreciate the many comments on this topic, and 
understand that the organization size limit creates an additional 
consideration for entities looking to participate in an Advanced APM. 
In many ways, it is consistent with our goal that entities move toward 
robust, performance-based APMs. Creating a unique Medical Home Model 
financial risk criterion reflects what we believe is a reasonable goal 
for smaller entities' risk-bearing capacity. We also believe that 
organization size is a meaningful proxy for potential risk-bearing 
capacity. In arriving at the magnitude of the limit, we compared the 
sizes of Shared Savings Program ACOs across tracks of the program to 
the organizational sizes of CPC practices and found that the vast 
majority of CPC practices fell below this number and the vast majority 
of ACOs were above this number. We believe that this supports using 
eligible clinician counts as a proxy for risk-bearing capacity and for 
selecting 50 as the cutoff that differentiates between use of the 
Medical Home Model or the generally applicable financial risk 
criterion. Therefore, we believe that our proposed policy is sound, 
especially because there is no limit in the first year, and 
organizations will have the time to consider their options accordingly.
    We also believe that a Medical Home Model such as CPC+ offers many 
inherent benefits to its participants regardless of the opportunity to 
earn the APM Incentive Payment. The 5 percent APM Incentive Payment 
will be one benefit to certain Advanced APM participants, but the 
opportunities within APMs themselves should be the primary drivers of 
participation decisions because those risks and rewards within the APMs 
can outweigh the 5 percent APM Incentive Payment. Therefore, we 
encourage organizations with both greater and fewer than 50 clinicians 
to consider the ability of Medical Home Models such as CPC+ to help 
develop care infrastructure and transform practices to be more patient-
centered and value-oriented.
    Comment: Some commenters suggested that instead of using the number 
of eligible clinicians we use clinician revenue or the size of the APM 
Entity's patient panel or attributed beneficiary list in order to draw 
a distinction between organizations' risk-bearing capacity.
    Response: We appreciate the idea of using alternative methods of 
setting the size limit for a Medical Home Model Advanced APM such as 
patient panel size or revenue. Attribution and revenue have much 
greater variability across APM Entities than number of eligible 
clinicians, which would make the setting of a meaningful number more 
challenging. Further, for any APM Entity, attribution numbers can vary 
significantly from year to year, partly in relation to the number of 
eligible clinicians, but also due in part to uncontrollable factors 
such as beneficiary behavior and the presence of multiple APM Entities 
in the same region that vie for the attribution of a similar pool of 
beneficiaries. Finally, several APMs require that an APM Entity have a 
minimum number of attributed beneficiaries in order to be eligible to 
participate. We have data on APM Entity attribution numbers, but

[[Page 77430]]

because we are pursuing an appropriate proxy for the risk-bearing 
capacity of a parent organization, we do not believe that we could 
accurately obtain patient panel data for entire organizations without 
imposing a substantial administrative burden of such organizations. 
Therefore, we continue to believe that the best metric available to us 
at this time is the number of eligible clinicians in the organization.
    Comment: Some commenters expressed concern that the Medical Home 
Models that are Advanced APMs offer an incentive for clinicians to 
enter Advanced APMs with lower levels of risk than they would otherwise 
bear. A commenter stated that this could cause the Advanced APMs to 
compete with one another, and that the lowest risk option that is an 
Advanced APM will be the most attractive to many clinicians.
    Response: The concern expressed by these commenters is what led us 
to propose this policy. We believe that organizations capable of taking 
on significant downside risk should have the incentives align to 
encourage them to assume the amount of risk that matches their 
capabilities. However, for many smaller organizations, a high degree of 
risk such as that required in the ACO initiatives is not a viable 
option. We believe participation in a Medical Home Model such as CPC+ 
represents the most risk some smaller organizations can handle at this 
time, and such APMs offer invaluable support for transforming practices 
to achieve our delivery system reform goals. That is, the balance we 
try to strike in this policy is to provide incentives for participation 
in Advanced APMs but also encouragement for each APM Entity to 
participate in the best ``fit'' APM for them.
    We are finalizing as proposed the limitation on applicability of 
the Medical Home Model financial risk and nominal amount standard to 
APM Entities with fewer than 50 eligible clinicians in their parent 
organizations. This limitation would not apply to the first QP 
Performance Period that begins in 2017. Therefore, any APM Entity 
participating in a Medical Home Model that meets the unique Medical 
Home Model Advanced APM standards will be considered to be 
participating in an Advanced APM and have the opportunity to become a 
QP for purposes of payment year 2019. Starting in the QP Performance 
Period that begins in 2018, the Medical Home Model Advanced APM 
financial risk standard would not apply for APM Entities that are owned 
and operated by organizations with greater than 50 eligible clinicians. 
As such, participation in a Medical Home Model Advanced APM by such an 
Advanced APM Entity would not offer the opportunity to attain QP status 
through that Medical Home Model unless the Medical Home Model meets the 
generally applicable Advanced APM financial risk criterion. Beginning 
for the QP Performance Period starting in 2018, we will make this size 
limit determination for APM Entities in relevant Medical Home Models 
prior to a QP Performance Period using the most recently available 
information from the year prior to the QP Performance Period. 
Therefore, the first determinations of organization size will take 
place in 2017 using information gathered in 2017. We intend to collect 
the necessary information through the Medical Home Model operations and 
will issue guidance on how and when we will do so.
(5) Capitation
    We proposed that full capitation risk arrangements would meet the 
Advanced APM financial risk criterion. We proposed that, for purposes 
of this rulemaking, a capitation risk arrangement means a payment 
arrangement in which a per capita or otherwise predetermined payment is 
made to an APM Entity for all items and services furnished to a 
population of beneficiaries, and no settlement is performed for the 
purpose of reconciling or sharing losses incurred or savings earned by 
the APM Entity. We also reiterated that Medicare Advantage and other 
private plans paid to act as insurers on the Medicare program's behalf 
are not Advanced APMs.
    We believe that capitation risk arrangements, as defined here, 
involve full risk for the population of beneficiaries covered by the 
arrangement, recognizing that it might require no services whatsoever 
or could require exponentially more services than were expected in 
calculating the capitation rate. The APM Entity bears the full downside 
and upside risk in this regard. Thus, we believe capitation 
arrangements inherently require an APM Entity to bear financial risk 
for monetary losses in excess of a nominal amount. We proposed that, 
where payment is made to participating entities in an APM using a 
capitation risk arrangement, the APM and participating entities would 
meet the criterion under section 1833(z)(3)(D)(ii)(I) of the Act.
    In implementing this proposed policy, it is important to 
distinguish capitation as a risk arrangement from capitation as only a 
cash flow mechanism. A capitation risk arrangement adheres to the idea 
of a global budget for all items and services to a population of 
beneficiaries during a fixed period of time. Cash flow mechanisms that 
make payments in predetermined amounts that are later reconciled or 
adjusted based on actual services are not necessarily a full risk 
arrangement. For example, an APM Entity has a capitation arrangement 
under an APM that pays $1,000 per beneficiary per month for a 
population of 100 beneficiaries, totaling $1.2 million per year. If 
expenditures for services actually furnished to these beneficiaries 
would have totaled $1.3 million if paid on a FFS basis, a payment 
mechanism without risk might make a reconciliation payment of $100,000 
to the entity. In that case, the APM Entity is not bearing any 
financial risk for monetary losses under the APM. If there is partial 
reconciliation, the arrangement would not meet the proposed capitation 
risk arrangement definition but still may meet the financial risk and 
nominal amount standards through the assessments described in this 
section above. In contrast, if this arrangement is a capitation risk 
arrangement, there would be zero reconciliation for those losses. Under 
our proposal, we would categorically accept that a capitation risk 
arrangement under an APM would meet the Advanced APM financial risk 
criterion.
    We solicited comment on our proposal for the categorical acceptance 
of capitation risk arrangements as satisfying the Advanced APM 
financial risk criterion and on our proposed definition of a capitation 
risk arrangement. We also solicited comment on other types of 
arrangements that may be suitable for such treatment for purposes of 
this financial risk criterion. Finally, we solicited comment on 
potential limits or qualifications to the capitation standard to 
prevent potential abuse or incentives that are not consistent with the 
provision of high value care.
    The following is a summary of the comments we received regarding 
our proposal to consider full capitation risk arrangements to meet the 
Advanced APM financial risk criterion.
    Comment: Several commenters expressed support for considering full 
capitation payment arrangements to meet the Advanced APM financial risk 
criterion. Some commenters requested that we further clarify what we 
would consider full capitation and how we would treat partial 
capitation arrangements. In particular, we received suggestions that 
full capitation be in reference to all ``agreed upon items and

[[Page 77431]]

services'' rather than ``all items and services.'' Finally, some 
commenters requested that we not limit this policy to arrangements 
without reconciliation for savings or losses. One commenter cautioned 
that an over-abundance of capitation arrangements in a market could 
fuel consolidation and restrict the diversity of practice types and 
sizes, and one commenter wanted assurance that capitation would be 
accompanied by appropriate quality measurement to mitigate a focus only 
on cost.
    Response: We appreciate the general support for this policy. With 
respect to defining full capitation, we believe that the structure as 
proposed is neither too broad nor too narrow. In our preamble language, 
we described full capitation as a ``global budget for all items and 
services to a population of beneficiaries during a fixed period of 
time.'' We believe that that is a key distinction between full and 
partial capitation. An ``agreed upon'' set of items and services could 
be relatively small compared to all items and services in the payment 
arrangement between parties. Therefore, we believe that this standard 
should only apply to ``full'' capitation. Similarly, as described in 
the proposed rule, reconciliation of settlement of savings and losses 
mitigates and removes the risk aspect of capitation. This is the 
difference between a risk arrangement, in which there is no 
reconciliation, and a cash flow mechanism, in which the ultimate 
payment amount is adjusted after the fact to account for variations in 
utilization.
    For payment arrangements that do not meet this definition of full 
capitation, we would still assess the arrangement under the applicable 
financial risk criterion. Therefore, partial capitation arrangements 
could meet the criterion so long as the magnitude of the payments at 
risk involved in the arrangement meets the nominal amount standard and 
the arrangement is actually a risk arrangement rather than a cash flow 
mechanism.
    Finally, we appreciate the commenter's concern that a high 
prevalence of capitation arrangements without sufficient quality 
performance requirements could misplace incentives for delivering high 
value care. We will monitor the impact of Advanced APMs with capitation 
arrangements in the future, especially as the All-Payer Combination 
Option becomes available beginning in payment year 2021. We also 
believe that this concern is mitigated in part by the Advanced APM 
MIPS-comparable quality measure requirement, described earlier in this 
section, because Advanced APMs must also base payment at least in part 
on meaningful quality measures instead of entirely on cost performance.
    We are finalizing the policy that full capitation arrangements 
would meet the Advanced APM financial risk criterion. All other payment 
arrangements would be assessed against the applicable nominal amount 
standards set forth in this final rule.
(6) Medical Home Expanded Under Section 1115A(c) of the Act
    Section 1833(z)(3)(D)(ii)(II) of the Act states that an Advanced 
APM must either meet the financial risk criterion or be a Medical Home 
Model expanded under section 1115A(c) of the Act. We refer to the 
latter criterion as the expanded Medical Home Model criterion. We 
proposed that a Medical Home Model that has been expanded under section 
1115A(c) of the Act would meet the expanded Medical Home Model 
criterion and thus would not need to meet the Advanced APM financial 
risk criterion as described above. Under this proposal, an APM would 
have to both be determined to be a Medical Home Model as defined in 
this rulemaking and in fact be expanded using the authority under 
section 1115A(c) of the Act. Such expansion is contingent upon whether, 
for an APM tested under section 1115A(b) of the Act:
     The Secretary determines that such expansion is expected 
to reduce spending under the applicable title without reducing the 
quality of care; or improve the quality of patient care without 
increasing spending;
     CMS' Chief Actuary certifies that such expansion would 
reduce (or would not result in any increase in) net program spending 
under the applicable titles; and
     The Secretary determines that such expansion would not 
deny or limit the coverage or provision of benefits under the 
applicable title for applicable individuals. In determining which 
models or demonstration projects to expand under the preceding 
sentence, the Secretary shall focus on models and demonstration 
projects that improve the quality of patient care and reduce spending.
    We note that the expanded Medical Home Model criterion cannot be 
met unless a Medical Home Model has been expanded under section 
1115A(c). Merely satisfying expansion criteria would not be sufficient 
to meet this Advanced APM criterion. This expanded Medical Home Model 
criterion is directly related to a similar criterion addressed in the 
proposed rule for Medicaid Medical Home Models, which addresses how 
such APMs can meet the Other Payer Advanced APM financial risk 
criterion by having criteria comparable to an expanded Medical Home 
Model. We requested comments on the proposed requirements for this and 
all proposed Advanced APM criteria.
    The following is a summary of the comments we received regarding 
our proposal that Medical Home Models that are expanded under section 
1115A(c) of the Act would meet the Advanced APM financial risk 
criterion.
    Comment: Several commenters urged us to assess the Comprehensive 
Primary Care (CPC) initiative in order to expand it under section 
1115A(c) authority as soon as possible. Some commenters also stated 
that this criterion was very narrow and limits the future Medical Home 
Model opportunities for Advanced APM participation. Some commenters 
believe that this is not aligned with Congressional intent to enable 
Medical Home Models to become Advanced APMs without meeting the 
financial risk criteria.
    Response: Expansion of the CPC initiative is outside the scope of 
this final rule with comment period. We will continue to consider 
whether CPC meets the statutory expansion criteria. As with CPC, we 
will closely monitor the results of CPC+ in order to determine whether 
it meets the statutory criteria for expansion in the future.
    With respect to the narrowness of this policy, we believe that we 
do not have the statutory authority to broaden the standard to include 
Medical Home Models that have not actually been expanded. Section 
1833(z)(3)(D)(ii)(II) of the Act is quite clear in its reference to 
expansion under section 1115A(c) of the Act.
    We are finalizing the expanded Medical Home Model policy as 
proposed. An APM that is determined to be a Medical Home Model and has 
in fact been expanded using the authority under section 1115A(c) of the 
Act meets the Advanced APM financial risk criterion.
(7) Application of Criteria to Current and Recently Announced APMs
    In the proposed rule, we used the proposed Advanced APM criteria to 
identify the current APMs that we anticipate would be Advanced APMs for 
the first QP Performance Period. The list of proposed Advanced APMs was 
based on the application of criteria in the proposed rule and did not 
preclude any changes to the list based on: (1) any changes made to the 
proposed criteria or their application in this final rule; (2) any 
modifications to the design of

[[Page 77432]]

current APMs; or (3) any new APMs announced after publication of the 
proposed rule. Consistent with our finalized policy to post an official 
determination of which APMs would meet the final Advanced APM criteria 
prior to the beginning of the first QP Performance Period, we will 
publish such materials on the CMS Web site following the publication of 
this final rule with comment period.
    The following is a summary of the comments we received on the 
preliminary assessment of which current APMs meet the Advanced APM 
criteria.
    Comment: Many commenters responded to the publication of the 
preliminary list of Advanced APMs by suggesting additional candidates 
to be Advanced APMs. Several commenters supported the indication that 
certain APMs, such as Shared Savings Program Tracks 2 and 3, the 
Oncology Care Model, and the Next Generation ACO Model, would be 
Advanced APMs based on the proposed criteria. Other commenters stated 
their belief that the Shared Savings Program Track 1, BPCI, and the 
proposed Part B Drug Payment Model should be Advanced APMs as well. 
Some commenters suggested that the current Maryland All-Payer Model 
should be classified as an Advanced APM, and that participating 
Maryland hospitals and hospital-based clinicians should be considered 
Advanced APM Entities because they will be primarily responsible for 
the cost and quality of care provided to beneficiaries. Commenters 
cited that participants in such APMs currently represent some of the 
most innovative and dedicated organizations interested in driving 
delivery system reform goals. Other commenters generally stated that 
the current list of Advanced APMs is quite limited and that there 
should be more Advanced APMs, specifically for hospitals and 
specialties.
    Response: We thank the commenters for their thoughts on which APMs 
should or should not be Advanced APMs. We are finalizing criteria and 
discuss the rationale for such decisions earlier in this section, and 
we highlighted the many ways in which we are planning to expand the 
opportunities for Advanced APM participation. For instance, concurrent 
with the release of this rule, we explain our strategy to: (1) Reopen 
certain APMs for additional application rounds; (2) amend the design of 
certain APMs so that they meet the Advanced APM criteria; (3) and 
engage in development of new APMs that could be Advanced APMs, 
potentially including APMs based on recommendations from the PTAC. 
Finally, we encourage the commenters to examine the final Advanced APM 
determinations for 2017 that we will publish no later than January 1, 
2017. These determinations will identify which Advanced APM criteria 
each APM meets or does not meet.
    Comment: Some commenters responded to the proposed list of APMs by 
submitting ideas for the design of new APMs.
    Response: We thank the commenters for providing input on the design 
of potential future APMs. We note that soliciting comment on the design 
of potential future APMs is outside of the scope of this final rule 
with comment period. However, we remind commenters of the PTAC, as 
described in section II.F.10. of this final rule with comment period, 
and note that commenters can submit proposals for the design of new 
APMs directly to the Innovation Center.
    Comment: Some commenters urged CMS to identify a Medical Home Model 
that would be an Advanced APM and stated their belief that it was 
Congress' intent to have a Medical Home Model that is an Advanced APM.
    Response: We thank the commenters for emphasizing the importance of 
making Medical Home Models available as Advanced APMs. As stated in 
section II.F.4.6. of this final rule with comment period, the unique 
statutory path specified for Medical Home Models to become Advanced 
APMs explicitly requires expansion under section 1115A(c) of the Act, 
which is something that has not yet occurred for any Medical Home 
Model. In the absence of a Medical Home Model that has been expanded 
under section 1115A(c) of the Act, the Medical Home Model financial 
risk criterion could allow a Medical Home Model to be an Advanced APM 
without meeting the expansion pathway set forth in the law.
    In the proposed rule, we noted that the CJR model did not meet the 
proposed Advanced APM criteria. We solicited comment on how we might 
change the design of CJR through future rulemaking to make it an 
Advanced APM, and we solicited comment on how to include eligible 
clinicians in CJR for purposes of the QP determination as described in 
section II.F.5. of this final rule with comment period.
    The following is a summary of the comments we received regarding 
our request for comments on how to redesign the CJR model to make it an 
Advanced APM.
    Comment: Many commenters urged CMS to modify existing programs, 
such as the CJR model, Track 1 of the Shared Savings Program, and BPCI, 
to make them meet the criteria for Advanced APMs and to create an 
Advanced APM ``on-ramp'' for interested participants. Specifically, 
many commenters recommended that CJR and BPCI be modified to require 
the use of CEHRT, and that steps be taken to enable BPCI to include 
quality measures that will satisfy the Advanced APM quality criterion. 
One commenter expressed the view that CJR currently meets the 
requirements of an Advanced APM. Commenters recommended rewarding 
clinicians with improvement activities credit for participating in CJR 
and BPCI programs that satisfy the Advanced APM criteria. Some 
commenters suggested that CMS either allow all tracks of the CEC model 
to be an Advanced APM or to offer an option for non-Large Dialysis 
Organization (LDO) participations in the CEC model to assume downside 
risk to be in an Advanced APM. One commenter suggested that CMS 
consider the Maryland All-Payer Model to be an Advanced APM.
    Response: To be considered an Advanced APM, an APM must meet the 
three criteria described in this section through the terms of its 
arrangement with APM Entities. It is not sufficient that an APM Entity, 
independent of an obligation under the APM, meets the standards.
    We agree with commenters that one way for CMS to encourage more 
participation in Advanced APMs is to assess and modify existing APMs to 
meet the criteria for Advanced APMs. We considered this in developing 
proposed amendments to CJR (81 FR 50793), and we are considering 
implementing a new voluntary bundled payment APM for CY 2018 that could 
meet the Advanced APM criteria.
    Comment: One commenter requested that any APM in which CMS takes a 
direct discount off of FFS payments, such as CJR, regardless of whether 
or not it meets the Advanced APM criteria outlined in the Proposed 
Rule, should qualify for the APM Incentive Payment. Another commenter 
requested that we deem CJR an Advanced APM regardless of modifications 
to the model.
    Response: We believe we have defined the statutory criteria 
appropriately, consistent with the terms of the statute. As such, 
Advanced APMs are limited to those that meet the final criteria.
    Comment: A few commenters suggested that CMS make the following 
changes to CJR: (1) Restructure CJR by replacing the hospital as the 
APM Entity with MIPS eligible clinicians; (2) replace CJR's 
retrospective

[[Page 77433]]

reimbursement with a prospective payment; and (3) include outpatient 
services in CJR. Another commenter recommended that CMS use its own 
data to determine which CJR hospitals meet the Meaningful Use 
requirements and relay this information to affiliated clinicians, or, 
in the alternative, add a measure similar to the Shared Savings Program 
measure that assesses the use of CEHRT by certain eligible clinicians. 
Another commenter suggested that CMS ask CJR hospitals to voluntarily 
provide a list of eligible clinicians who treat patients in the 
hospital for any of the CJR procedures to satisfy the Advanced APM 
Participation List requirement. Also, to satisfy the CEHRT requirement, 
commenter suggested that CMS either use the Advancing Care Information 
domain data submitted by eligible clinicians in CJR to assess whether 
the eligible clinicians are meaningful users of CEHRT or count a 
hospital's participation in the EHR Incentive Program. Another 
commenter suggested the following changes to CJR: (1) Make physician 
assumption of risk mandatory, rather than place the risk on hospitals; 
and (2) include medical device manufacturers in the pool of CJR 
collaborators.
    Response: We thank the commenters for their ideas. We considered 
these comments informally in developing proposed amendments to CJR (see 
81 FR 50793). We will consider public comments on these proposed 
amendments in the separate rulemaking process for those proposed 
amendments.
5. Qualifying APM Participant (QP) and Partial QP Determination
    The QP determination process is specified under section 1833(z)(2) 
of the Act, in which QPs are defined as those eligible clinicians who 
meet the specified threshold(s). We proposed a process for determining 
which eligible clinicians would be QPs or Partial QPs for a given 
payment year through their participation in Advanced APMs during a 
corresponding QP Performance Period. Per sections 1833(z)(2) and 
1848(q)(1)(C)(ii)(I) and (II) of the Act, an eligible clinician would 
become a QP or Partial QP for a payment year if they are determined at 
the end of the performance period to be eligible clinicians in an 
Advanced APM Entity that collectively meets the threshold values for 
participation in an Advanced APM during the corresponding QP 
Performance Period, and starting in 2021, the threshold values for 
participation in an Other Payer Advanced APM as proposed here. We 
proposed to determine each year whether an eligible clinician achieved 
the threshold level of participation to become a QP or Partial QP 
during the corresponding QP Performance Period. We would make this 
assessment independent of QP or Partial QP determinations made in 
previous years and accounting for Advanced APMs that begin or end on 
timeframes that do not align precisely with the QP Performance Period. 
The following would apply to an eligible clinician whom CMS determines 
to be a QP for a particular year:
     For payment years 2019-2024, the QP will receive a lump 
sum payment equal to 5 percent of the estimated aggregate payment 
amounts for Medicare Part B covered professional services for the prior 
year, as described in section II.F.8. of this final rule with comment 
period;
     The QP will be excluded from MIPS payment adjustments, as 
described in section II.E.3. of this final rule with comment period; 
and
     For payment years 2026 and later, payment rates under the 
Medicare PFS for services furnished by the eligible clinician will be 
updated by the 0.75 percent qualifying APM conversion factor as 
specified in sections 1848(d)(1)(A) and (d)(20) of the Act.
    Through the APM Entity group determination described in section 
II.F.5.b. of this final rule with comment period, we would identify 
eligible clinicians who do not meet the QP Threshold but reach the 
Partial QP Threshold for a year to be Partial QPs. Partial QPs would 
not be eligible for the 5 percent APM Incentive Payment for years from 
2019 through 2024 or, beginning for 2026, the qualifying APM conversion 
factor. However, Partial QPs would have an opportunity to decide 
whether they wish to be subject to a MIPS payment adjustment, which 
could be positive or negative.
    The statute requires that we use two options to determine whether 
an eligible clinician is a QP or a Partial QP for a payment year--one 
is the Medicare Option and, beginning in 2021, the other is the All-
Payer Combination Option. While these are the terms based on statutory 
language that we have chosen to use for the purposes of describing the 
process by which we can calculate an eligible clinician's Threshold 
Score, we note that the use of the word ``option'' does not imply that 
an eligible clinician will have the ability to choose between the two. 
We further outlined in the proposed rule our proposed process by which 
we will assess eligible clinicians under both options (beginning in 
2021) to the extent that sufficient data is submitted to us.
    The Medicare Option focuses on participation in Advanced APMs, and 
we would make determinations under this option based on Medicare Part B 
covered professional services attributable to services furnished 
through an Advanced APM Entity. The Medicare Option is the only option 
available for QP determinations during the first 2 years of this 
program (payment years 2019-2020). The All-Payer Combination Option, 
described in section II.F.7. of this final rule with comment period, is 
applicable beginning in the third payment year (2021) and would allow 
us to make determinations based on participation in both Advanced APMs 
and Other Payer Advanced APMs. The All-Payer Combination Option would 
not replace or supersede the Medicare Option; instead, it would allow 
eligible clinicians to become QPs by meeting a relatively lower 
threshold based on Medicare Part B covered professional services 
through Advanced APMs and an overall threshold based on services 
through both Advanced APMs and Other Payer Advanced APMs. With our QP 
Threshold Score methodologies finalized in this rule, we generally 
interpret payments ``through'' an Advanced APM Entity to mean payments 
made by us for services furnished to attributed beneficiaries, who are 
the beneficiaries for whose costs and quality of care an Advanced APM 
Entity is responsible under the Advanced APM. Under section 
1848(q)(1)(C)(iii) of the Act, the calculations used for Partial QP 
determinations are the same, but the threshold percentages to be a 
Partial QP for each year are lower than those required to be a QP.
    The QP and Partial QP Thresholds under the Medicare Option are 
shown in Tables 32 and 34 of this final rule with comment period. The 
QP and Partial QP Threshold values under the All-Payer Combination 
Option are shown in Tables 33 and 35 of this final rule with comment 
period. We will determine an eligible clinician's QP status for a 
payment year by calculating an eligible clinician's Threshold Score, 
and comparing the eligible clinician's Threshold Score (either based on 
payment amounts or patient counts) to the relevant QP Threshold or 
Partial QP Threshold. In addition, we discussed our proposal to make QP 
determinations at a group level based on an entire Advanced APM Entity 
in section II.F.5.b of the proposed rule (81 FR 28319-28321).
    According to section 1833(z)(2)(D) of the Act, the Secretary may 
base the determination of whether an eligible

[[Page 77434]]

clinician is a QP or a Partial QP by using counts of patients in lieu 
of using payment amounts and using the same or similar percentage 
criteria as those used for the payment amount method, as the Secretary 
determines is appropriate. For QP and Partial QP determinations using 
patient count calculations, we proposed to use the percentage values 
displayed in Tables 34 and 35 of this final rule with comment period. 
The purpose of the proposed design of the Medicare patient count method 
is to make QP determinations accessible to entities and individuals who 
are clearly and significantly engaged in delivering value-based care 
through participation in Advanced APMs.
    By performing preliminary analyses using our proposed QP 
determination methodologies with historical APM data, we found that the 
proposed QP and Partial QP Patient Count Thresholds are similar in 
magnitude and trajectory to those specified in the statute for the 
payment-based calculations. Due to varying attribution and 
organizational characteristics, we anticipate that using our proposed 
thresholds, the method--payment amount or patient count--that results 
in the most favorable QP status will likely vary across different 
Advanced APMs and Advanced APM Entities. We believe that each eligible 
clinician should have every opportunity to reach the QP threshold for 
each year, and do not intend to limit this opportunity by preemptively 
selecting one method over another.

                                                 Table 32--QP Payment Amount Thresholds--Medicare Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Medicare Option--Payment Amount Method
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               2019            2020            2021            2022            2023       2024 and later
                      Payment year                           (percent)       (percent)       (percent)       (percent)       (percent)       (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Payment Amount Threshold.............................              25              25              50              50              75              75
Partial QP Payment Amount Threshold.....................              20              20              40              40              50              50
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                                                                          [GRAPHIC] [TIFF OMITTED] TR04NO16.009
                                                                                                                                          

                                                 Table 34--QP Patient Count Thresholds--Medicare Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Medicare Threshold Option--Patient Count Method
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               2019            2020            2021            2022            2023       2024 and later
                      Payment year                           (percent)       (percent)       (percent)       (percent)       (percent)       (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
QP Patient Count Threshold..............................              20              20              35              35              50              50
Partial QP Patient Count Threshold......................              10              10              25              25              35              35
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 77435]]


Part II--Continued






[[Page 77436]]

[GRAPHIC] [TIFF OMITTED] TR04NO16.010

    We solicited comment on the proposed QP Patient Count Threshold and 
Partial QP Patient Count Threshold percentage values for both the 
Medicare Option and the All-Payer Combination Option.
    The following is a summary of the comments we received regarding 
our proposed QP Patient Count Thresholds and Partial QP Patient Count 
Thresholds.
    Comment: A few commenters did not support the proposed QP Patient 
Count Thresholds because they are lower than the correlating QP Payment 
Amount Thresholds. They stated that this would increase the number of 
QPs in the absence of a strong connection between performance and 
reward.
    Response: We believe that what appear to be the lower QP Patient 
Count Thresholds actually represent a parallel to the QP Payment Amount 
Thresholds and that both reflect increasing rigor over time. We believe 
the QP Patient Count and Payment Amount Thresholds represent the same 
overall level of rigor by taking into account factors that cause the 
payment amount and patient count Threshold Scores to vary for an 
Advanced APM Entity group. These factors include, in addition to the 
obvious patient counts or payment amounts, characteristics of the 
markets in which APM Entities operate, the APMs' attribution 
methodologies, and the participation of different types of eligible 
clinicians such as specialists and non-physician practitioners. In 
addition to excluding payment amounts and patient counts that are 
categorically impossible to be in the numerator from the denominator of 
Threshold Score calculations, we believe that the thresholds (payment 
amount and patient count) should have the same overall level of rigor 
in order to effectuate the intent of the law to have thresholds that 
reward committed participation in Advanced APMs. Regarding the concern 
that a lower QP Patient Count Threshold would increase the number of 
eligible clinicians who are QPs without a connection between 
performance and reward, we believe that the Advanced APMs themselves 
are the drivers of cost and quality performance through their unique 
incentive designs. The QP thresholds are not replacements for those 
performance measurements in Advanced APMs. However, we believe that 
having a sufficient amount of payments or patients flowing through an 
Advanced APM contributes to ensuring eligible clinicians have a 
meaningful incentive to deliver high-value care across their entire 
practice. We also do not believe that we should aim to produce a 
particular number of QPs by calibrating the QP Patient Count Threshold. 
We want the QP thresholds to be meaningful and attainable independent 
of how many eligible clinicians ultimately become QPs.
    Comment: Many commenters supported the proposed QP Patient Count 
Thresholds, although some expressed a degree of concern about the 
difficulty of meeting the higher percentage thresholds we proposed for 
future performance periods.
    Response: We thank the commenters for their support. We believe 
that the higher thresholds in future years will be challenging but 
attainable for eligible clinicians in Advanced APMs. We also believe it 
is appropriate for increases in the QP Patient Count Threshold over the 
next several performance periods to parallel those for the QP Payment 
Amount Threshold.
    Comment: Some commenters stated their belief that in order to 
become QPs, participants in Advanced APMs should be held to a high 
performance standard--for instance, demonstrated cost and quality 
improvements in the Advanced APM--that increases over time. Conversely, 
other commenters believe that becoming a QP should be based upon 
participation in Advanced APMs and not on the actual performance within 
the Advanced APMs.
    Response: We thank commenters for their input on how to achieve QP 
status. We do not believe that we have the legal authority to tie QP 
status to performance within the Advanced APMs. The statute specifies 
that becoming a QP is based on reaching the QP thresholds, which are 
based on the percentage of payments or patients provided services 
through an Advanced APM, not on other performance metrics such as cost 
and quality.
    Comment: Many commenters stated that the QP thresholds--both 
payment amount and patient count--were too high, especially for certain 
types of Advanced APM Entities that have high ratios of specialists or 
act as referral centers, resulting in substantial amounts of care 
delivered to non-attributed beneficiaries. Some commenters stated that 
if such Advanced APM Entities cannot meet the QP thresholds, we would 
essentially be discouraging participation and penalizing them for 
fulfilling their missions of treating a wide range of beneficiaries and 
for utilizing their expertise as broadly as possible. Therefore, 
several commenters suggested that CMS further reduce the QP thresholds, 
both payment amount and patient count, to ensure participation is 
appropriately incentivized. Other commenters suggested that the QP 
thresholds be reduced differentially depending on the Advanced APM in 
order to tailor the thresholds to the particular context of an Advanced 
APM. Some commenters

[[Page 77437]]

requested that we monitor the issue in the early years of 
implementation so that we can adjust our thresholds or methodologies 
for the later years if necessary.
    Response: We thank the commenters for their thoughts on the QP 
thresholds. First, we reiterate that the payment amount thresholds are 
set by the statute and that we do not have the authority to change them 
in this final rule. Second, based on our preliminary analyses of 
historical participation in APMs, we believe that QP thresholds in the 
first years under both the payment amount and patient count thresholds 
are highly attainable by Advanced APM participants. We will closely 
monitor the results and consider whether the finalized patient count 
thresholds accurately represent participants' level of commitment to 
Advanced APMs in a manner similar to the payment amount thresholds. We 
understand that there may be some natural differences in Threshold 
Scores depending on the characteristics of a particular Advanced APM or 
its participants, but we believe the statute contemplates a single QP 
threshold for each performance period, and that it is preferable to 
have a single, simple set of QP thresholds applicable to all Advanced 
APM participants. We believe our proposed set of QP Patient Count 
Thresholds adhere to the statutory directive that we use percentage 
criteria for the QP Patient Count Thresholds that are similar to those 
for the QP Payment Amount Threshold.
    After considering the public comments, we are finalizing the QP 
Patient Count Thresholds and Partial QP Patient Count Thresholds as 
proposed, and we are finalizing the QP Payment Amount Threshold and 
Partial QP Payment Amount Thresholds as specified in statute.
    We proposed that, beginning with payment year 2021, we would 
conduct the QP determination sequentially so that the Medicare Option 
is applied before the All-Payer Combination Option. We proposed to 
apply the All-Payer Combination Option only to an Advanced APM Entity 
group of eligible clinicians or eligible clinicians who do not meet 
either the QP Payment Amount or Patient Count Threshold under the 
Medicare Option but who do meet the lower Medicare threshold for the 
All-Payer Combination Option. This process is illustrated in Figures C 
and D of this final rule with comment period, which show that the first 
assessment is whether the Medicare QP Threshold has been met under 
either the Medicare Option or the All-Payer Combination Option.
    Because in addition to being a standalone path to QP status, the 
Medicare Option (either based on payment amounts or patient counts) is 
also a component of the All-Payer Combination Option, and because all 
eligible clinicians must reach at least a minimum Threshold Score 
through Advanced APMs to be QPs, we believe that this sequential 
approach streamlines the analytic and operational requirements to make 
QP determinations under the All-Payer Combination Option. Figure C 
illustrates the proposed process for making QP determinations under the 
Medicare Option for 2019 and 2020. Figure D illustrates the process 
proposed for making QP determinations under both the Medicare and All-
Payer Combination Options for payment years 2021-2024. Figure E 
provides an example of the proposed process for making QP 
determinations in payment years 2023-2024. Figures C, D, and E only 
illustrate the payment amount method, but a similar process would apply 
for the patient count method.
[GRAPHIC] [TIFF OMITTED] TR04NO16.011


[[Page 77438]]


[GRAPHIC] [TIFF OMITTED] TR04NO16.012

    The following is a summary of the comments we received regarding 
our proposal to assess Advanced APM Entities sequentially under the 
Medicare Option and, only if necessary, under the All-Payer Combination 
Option.
    Comment: A few commenters expressed support for the sequential 
determination of QPs and Partial QPs in the Medicare Option and then 
the All-Payer Combination Option.
    Response: We thank the commenters for their support.
    We are finalizing the policy as proposed. Beginning with payment 
year 2021, we will conduct the QP determination sequentially so that 
the Medicare Option is applied before the All-Payer Combination Option. 
We will apply the All-Payer Combination Option only to an Advanced APM 
Entity group of eligible clinicians who do not meet either the QP 
Payment Amount or Patient Count Thresholds under the Medicare Option 
but who do meet the lower Medicare threshold for the All-Payer 
Combination Option.
    The following is a summary of comments regarding the QP 
determination process generally.
    Comment: A few commenters expressed that the QP determination is 
too complex and that clinicians will not understand what is required to 
attain QP status. They recommended that we establish a more transparent 
and simple approach. Other commenters suggested that any level of 
participation in an Advanced APM should suffice for receiving the APM 
Incentive Payment. One commenter requested that CMS be more flexible in 
granting QP status.
    Response: We are required by statute to apply payment amount or 
patient count thresholds in order to identify which eligible clinicians 
receive the APM Incentive Payment and are excluded from MIPS 
adjustments. We understand that this is a new process with certain 
inherent complexities, but we believe that in our proposed policies we 
have balanced the interests of simplicity and the need to accurately 
apply standards to an increasingly diverse array of Advanced APMs now 
and in the future. We will be providing education and technical 
assistance to

[[Page 77439]]

help eligible clinicians understand the requirements to attain QP 
status.
    Comment: Some commenters believe that the QP determination process 
discourages participation in Advanced APMs due to the uncertainty of 
the results of the Threshold Score. Similarly, one commenter suggested 
that those eligible clinicians and entities that have already invested 
heavily and currently participate in Advanced APMs should have an 
easier path to QP determination that those who are new participants.
    Response: We take seriously any potential incentives that could 
work against this program's purpose of increasing Advanced APM 
participation. Although we do not agree that our proposed and final QP 
determination policies will discourage participation, we intend to 
provide information and preliminary assessments based on historical 
data to help Advanced APM participants understand what their Threshold 
Scores would likely be in order to mitigate uncertainty about their 
likely QP status.
    We disagree with the commenter that current APM participants should 
have an easier path to QP status than APM participants who have never 
previously participated in APMs. While we greatly appreciate the early 
adopters of Advanced APMs, we find no policy justification for making 
it relatively more difficult for those who have never participated in 
an Advanced APM to achieve QP status because, as stated above, a core 
purpose of this program is to increase Advanced APM participation.
a. Group Determination and Lists
(1) Group Determination
    The statute consistently refers to an eligible clinician throughout 
section 1833(z) of the Act and clearly identifies that the QP 
determinations are to be made for an eligible clinician, whom we 
identify by a unique NPI. Thus, an eligible clinician is a person who 
may have multiple TIN/NPI combinations but only one NPI. In section 
1833(z)(3)(B) of the Act, the definition of an eligible clinician 
includes a group of such clinicians.
    We proposed, in general, to make the QP determination at a group 
level. As a result, the QP determination for the group would apply to 
all the individual eligible clinicians who are identified as part of an 
Advanced APM Entity. If that eligible clinician group's collective 
Threshold Score meets the relevant QP threshold, all eligible 
clinicians in that group would receive the same QP determination, 
applied to their NPI, for the relevant year. The QP determination 
calculations described in the proposed rule would be aggregated using 
data for all eligible clinicians participating in the Advanced APM 
Entity during the QP Performance Period.
    We believe that this policy promotes administrative simplicity and 
collaboration among group members instead of promoting barriers, and 
while many beneficiaries are attributed to an APM Entity based on the 
services rendered by one eligible clinician, many of the eligible 
clinicians participating in the APM Entity may play a role in the 
actual diagnosis, treatment, and management of many beneficiaries in 
the APM Entity population. Each of these individual eligible clinicians 
could potentially view themselves as being instrumental in providing 
quality care to the beneficiary that is in line with the objectives of 
the APM, regardless of whether their individual services are counted 
towards APM-specific attribution methods.
    An Advanced APM Entity faces the risks and rewards of participation 
in an Advanced APM as a single unit, and is responsible for performance 
metrics that are aggregated to the level of that entity. This policy is 
based on the premise that positive change occurs when entire 
organizations commit to participating in an Advanced APM and focusing 
on its cost and quality goals as a whole. It also mitigates situations 
in which individual eligible clinicians who practice together in an 
Advanced APM Entity receive different QP determinations and thus are 
treated differently for purposes of APM Incentive Payments, MIPS 
payment adjustments, and eventually, differential fee schedule updates 
under the PFS. We believe that such discrepancies could potentially 
lead to confusion and lack of cohesion among eligible clinicians and 
Advanced APM Entities and place additional burdens on eligible 
clinicians and organizations to track these differences. Additionally, 
we wish to avoid any additional burden, confusion, and operational 
difficulties for both eligible clinicians and CMS that would result 
from allowing eligible clinicians or Advanced APM Entities to elect 
whether to be assessed at the Advanced APM Entity level. We believe 
that a simple, overarching rule is preferable to adding extra variables 
to the already complex processes under this program.
    The following is a summary of the comments we received regarding 
our proposal to make the QP determination at the Advanced APM Entity 
group level.
    Comment: Most commenters expressed support for performing the 
Threshold Score calculations in this section at a group level defined 
by the Advanced APM Entity. Commenters stated that this was supportive 
of care coordination, organization cohesiveness, and the different 
clinician types supporting an Advanced APM Entity regardless of whether 
or not their services are tied directly to attribution. Some commenters 
were supportive but cautioned that this approach might be difficult to 
apply in certain Advanced APMs with Advanced APM Entities that have 
partial TINs or span multiple TINs.
    Response: We thank the commenters for their support of this 
approach and agree that it aligns with the goals of Advanced APMs. We 
believe that this accommodates the various organizational structures 
across Advanced APMs because it relies upon the lists maintained under 
each APM and its particular rules.
    Comment: One commenter stated that the exclusionary criteria under 
MIPS (first year of Medicare participation and low-volume threshold) 
should also apply to QP eligibility.
    Response: We disagree with the commenter. Although the statute 
specified exclusionary criteria for MIPS, we find no statutory basis or 
policy rationale to exclude such eligible clinicians from QP 
determinations.
    Comment: A few commenters recommended that the QP determinations be 
made at the TIN or NPI level instead of the Advanced APM Entity level. 
One commenter favored TIN level assessment in order to parallel the 
MIPS group reporting option and enable a greater degree of accuracy in 
a group's financial estimates.
    Response: We appreciate the potential advantages in certain 
scenarios for QP determinations to be made at TIN or NPI levels, but we 
continue to believe that QP determination at the Advanced APM Entity 
group level aligns with the goals of the Advanced APMs themselves and 
ultimately is more beneficial for a wider range of eligible clinicians 
who might not have an opportunity to be QPs individually or in smaller 
groups. We want to reinforce the collective responsibility of an 
Advanced APM Entity. However, as outlined below, we finalize two 
exceptions for situations in which we believe it is more appropriate to 
make the QP determination at the individual NPI level: (1) For 
individuals participating in multiple Advanced APM Entities, none of 
which meet the QP threshold as a group, and (2) for eligible clinicians 
on an Affiliated Practitioner List when that list is used for the QP 
determination because there are no eligible clinicians on a 
Participation List for the Advanced

[[Page 77440]]

APM Entity. For the former exception, we believe that participation in 
multiple Advanced APMs demonstrates particular commitment to Advanced 
APMs. We believe it will be rare that all of an eligible clinician's 
multiple Advanced APM Entities would fail to meet the QP thresholds, 
but in such cases, the Threshold Scores of those Advanced APM Entities 
may not be indicative of the degree to which the eligible clinician has 
dedicated his or her practice to Advanced APMs. For the latter 
exception, eligible clinicians on an Affiliated Practitioner List, 
particularly those in episode payment models, do not necessarily have 
the same organizational relationship with one another as eligible 
clinicians who are on a Participation List. Unlike APM Entities that 
are defined as a group of eligible clinicians, affiliated practitioners 
may have no common connection to each other aside from their mutual 
relationship with a facility.
    Comment: One commenter did not support the proposal to apply QP 
status to an eligible clinician's NPI rather than the TIN/NPI 
combination associated with an Advanced APM Entity.
    Response: We disagree with the commenter and believe that applying 
QP status at the TIN/NPI level instead of at the NPI level as proposed 
would do a disservice to QPs. An eligible clinicians identified by an 
NPI may have reassigned billing to multiple TINs, resulting in multiple 
TIN/NPI combinations being associated with one eligible clinician 
(NPI). If QP status was only applied to one of an eligible clinician's 
multiple TIN/NPI combinations, an eligible clinician who is a QP for 
only one TIN/NPI combination might still have to report under MIPS for 
another TIN/NPI combination. Further, under that approach, the APM 
Incentive Payment would be based on only a fraction of the eligible 
clinician's covered professional services instead of, as we believe is 
the most logical reading of the statute, all those services furnished 
by the individual eligible clinician, as represented by an NPI. 
Therefore, we do not believe that applying QP status only to a specific 
TIN/NPI combination is supportive of the program's goals to reward 
individuals for commitment to Advanced APM participation.
    Except as explained further below, we are finalizing the proposed 
policy to make QP determinations collectively using the group of 
eligible clinicians in an Advanced APM Entity. We are finalizing two 
exceptions to this policy. First, if the eligible clinicians are 
identified on an Affiliated Practitioner List rather than a 
Participation List, as described in this section below, we will perform 
the QP determination individually for each eligible clinician on the 
Affiliated Practitioner List. We believe that eligible clinicians on 
Affiliated Practitioner Lists are unlike eligible clinicians on 
Participation Lists because, although they may have similar 
relationships with the Advanced APM Entity, they may not have any 
relationship with one another and do not represent a single 
organization unified in APM-related goals. Therefore, we believe 
considering these eligible clinicians individually is the most 
appropriate approach. We finalize the other exception regarding 
eligible clinicians participating in multiple Advanced APMs in section 
II.F.5.a.3. of this final rule with comment period.
    We understand that, as with any group assessment, there will be 
some situations in which individual Threshold Scores would differ from 
group Threshold Scores if assessed separately. This could lead to some 
eligible clinicians becoming QPs when they would not have met the QP 
Threshold individually (a ``free-rider'' scenario) or, conversely, some 
eligible clinicians not becoming QPs within an Advanced APM Entity when 
they might have qualified individually (a dilution scenario). We 
believe that through the methodology we are finalizing for QP 
determinations in this final rule, the magnitude of such discrepancies 
will be relatively small compared to the value of maintaining Advanced 
APM Entity cohesion.
(2) Groups Used for QP Determination
    We proposed that the group of eligible clinicians used for a 
collective QP determination would consist of all the eligible 
clinicians participating in an Advanced APM Entity during a QP 
Performance Period. This would be defined by an Advanced APM Entity's 
Participation List provided to CMS. We proposed that the Participation 
List for each Advanced APM Entity would be compiled from CMS-maintained 
lists that identify each eligible clinician by a unique TIN/NPI 
combination attached to the identifier of the Advanced APM Entity.
    We proposed two exceptions to this rule. One exception is for 
Advanced APMs that do not identify eligible clinicians on a 
Participation List. In certain Advanced APMs, a Participation List may 
not include eligible clinicians. For example, in an APM where all 
Advanced APM Entities are hospitals, the Advanced APM Entity may not 
have eligible clinicians identified by a unique TIN/NPI combination 
attached to the identifier of the Advanced APM Entity on a 
Participation List. On the other hand, in certain Advanced APMs, an 
Advanced APM Entity may have a list (Affiliated Practitioner List) of 
other entities, including eligible clinicians, who are affiliated with 
and support the Advanced APM Entity in its participation in the 
Advanced APM but are not on the Participation List. For example, an 
Affiliated Practitioner List comprised of gainsharers under an APM 
might include eligible clinicians whereas a Participation List may only 
include hospitals.
    Where there is a Participation List that can be used to identify 
eligible clinicians, we proposed that it be the only list that is 
considered for the QP determination. We proposed that for Advanced APMs 
where the Participation List does not identify eligible clinicians, but 
there is an Affiliated Practitioners List of eligible clinicians who 
have a contractual relationship with the Advanced APM Entity based at 
least in part on supporting the Advanced APM Entity's quality or cost 
goals under the Advanced APM, we would use the eligible clinicians on 
the Affiliated Practitioner List for purposes of the QP determination. 
Where there is both a Participation List and an Affiliated Practitioner 
List that can be used to identify eligible clinicians under an Advanced 
APM, we proposed to only use the Participation List for purposes of the 
QP determination.
    This proposed policy was developed to capture the group or groups 
of eligible clinicians who are the most closely associated with the 
performance of the Advanced APM Entity under an Advanced APM and to 
recognize their role in supporting the Advanced APM Entity. We believe 
this policy provides for flexibility in the design of Advanced APMs 
while providing the APM Incentive Payment to those eligible clinicians 
who are the most engaged in the Advanced APM.
    We solicited comment on our proposals to define the eligible 
clinician group for QP determination based on the Participation List 
and the exception to use the Affiliated Practitioners List for Advanced 
APMs in which there are not eligible clinicians on the Participation 
List. We also solicited comment on whether to limit the proposed policy 
to the Medicare Option, as it may be less likely that Affiliated 
Practitioners support the Advanced APM Entity in Other Payer Advanced 
APMs and may be more difficult for us to distinguish based on 
information submitted to CMS by Advanced APM Entities. Because there 
may be Advanced APMs in the future that have

[[Page 77441]]

multiple lists of Affiliated Practitioners, we sought comment on 
approaches for grouping those separate lists for purposes of the QP 
determination.
    The following is a summary of the comments we received regarding 
our proposals pertaining to defining the eligible clinician groups for 
QP determination.
    Comment: Several commenters requested clarification on which list, 
the Participation List or Affiliated Practitioner List, would be used 
when an Advanced APM has both. One commenter requested clarification of 
the definition of the Participation List and another commenter 
requested clarification regarding the definition of Affiliated 
Practitioner, specifically if the definition varies by Advanced APM. 
Several commenters recommended that when an Advanced APM has both a 
Participation List and an Affiliated Practitioner List, the lists 
should be reconciled in order to include a broader group of eligible 
clinicians for purposes of the QP determination. Some commenters 
supported the distinction between participants on a Participation List 
and Affiliated Practitioners on an Affiliated Practitioner List for 
purposes of the QP determination.
    A few commenters made specific comments on how the proposed policy 
relates to episode payment models. Some commenters suggested that if 
BPCI or CJR become Advanced APMs, CMS should accept a hospital's 
Affiliated Practitioner List for the QP determination. A commenter 
suggested that CMS create a process for APM Entities in episode payment 
models to report their Affiliated Practitioners out of concern that 
ACOs will exclude specialists so that their primary care physicians 
will as a group be QPs.
    Response: A Participation List is a CMS-maintained list that 
includes the most central participants in an APM. Affiliated 
Practitioners are eligible clinicians who are more loosely affiliated 
with an Advanced APM Entity than those on a Participation List, and 
have a contractual relationship with the Advanced APM Entity based at 
least in part on supporting the Advanced APM Entity's quality or cost 
goals under the Advanced APM. The definitions of Participation List and 
Affiliated Practitioner List are located at Sec.  414.1305. If the 
terms of an Advanced APM do not require a Participation List to 
identify eligible clinicians but do allow for eligible clinicians to be 
identified on an Affiliated Practitioner List, we would use the 
Affiliated Practitioner List for purposes of the QP determination. If 
an Advanced APM has both a Participation List and an Affiliated 
Practitioner List, we will only look at the Participation List for 
purposes of the QP determination, with the following exception.
    In response to the comment requesting that we identify Affiliated 
Practitioners for the QP determination in BPCI, we are finalizing an 
exception that would allow for the appropriate identification of 
eligible clinicians in APMs that, like BPCI, have multiple types of 
participating APM Entities. Under this exception, we will use either 
the Participation List or the Affiliated Practitioner List depending on 
the type of APM Entity. This exception applies to Advanced APMs, such 
as some episode payment models, in which different types of APM 
Entities participate and some Advanced APM Entities may identify 
eligible clinicians on a Participation List, and others may have only 
an Affiliated Practitioner List. For these models, we will identify the 
eligible clinicians for QP determinations based on the composition of 
the Advanced APM Entity instead of at the Advanced APM level. 
Specifically, for these episode payment model Advanced APMs, we will 
determine which eligible clinicians will be included in the QP 
determination as follows: (1) For Advanced APM Entities that include 
and identify eligible clinicians on a Participation List, that 
Participation List will be used to define the Advanced APM Entity 
group, regardless of whether or not there is also an Affiliated 
Practitioner List or other list of eligible clinicians, and we will 
make QP determinations at the APM Entity group level; (2) for Advanced 
APM Entities that do not include and identify eligible clinicians on a 
Participation List and there is an Affiliated Practitioner List that 
identifies eligible clinicians, that Affiliated Practitioner List will 
be used to identify the eligible clinicians for purposes of QP 
determination, and those eligible clinicians will be assessed 
individually. The structure of BPCI serves as a useful example to show 
how we would apply this policy. In a model like BPCI, when the APM 
Entity is a physician group practice that identifies eligible 
clinicians on a Participation List, we would use that list for purposes 
of the QP determination, even if there is also an Affiliated 
Practitioner List. When the APM Entity is a hospital that does not 
identify eligible clinicians on a Participation List, but it identifies 
eligible clinicians on an Affiliated Practitioner List, we would use 
that list for purposes of identifying eligible clinicians for the QP 
determination, and those eligible clinicians would be evaluated 
individually. While this policy is responsive to comments about APMs 
like BPCI, this policy does not change the design of the models within 
BPCI. We are also considering implementing a new voluntary APM that is 
an episode payment model for CY 2018 that could meet the criteria for 
this exception (81 FR 50793).
    We believe this exception to making QP determinations at a group 
level appropriately identifies the eligible clinicians with the closest 
supporting role to the Advanced APM Entity in episode payment models. 
We would assess affiliated practitioners individually because 
affiliated practitioners do not necessarily have the same 
organizational relationship with one another as eligible clinicians on 
a Participation List have with one another. Unlike APM Entities that 
are defined as a group of eligible clinicians, affiliated practitioners 
may have no common connection to each other aside from their mutual 
relationship with a facility. Therefore, we believe that the rationale 
for group assessments does not apply to these individual eligible 
clinicians.
    Comment: Several commenters requested that CMS develop a way to 
identify individual eligible clinicians who are employed by an Advanced 
APM Entity in an episode payment model and involved in episodes of care 
or require that the Advanced APM Entity provide CMS with a list of such 
clinicians. One commenter recommended that in addition to using 
Participation Lists and Affiliated Practitioner Lists for purposes of 
QP determination, CMS should also use all eligible clinicians under a 
single TIN as a group of eligible clinicians, regardless of inclusion 
on one of these lists. Another commenter suggested that it may be 
preferable to only count eligible clinicians who can be used for 
beneficiary attribution in the Advanced APM. Another commenter 
suggested that eligible clinicians working with a partner teaching 
hospital that is an Advanced APM Entity should receive credit for 
participation in the Advanced APM, even if they do not have a formal 
arrangement with the Advanced APM Entity.
    Response: We believe that the policy to use Participation Lists and 
Affiliated Practitioner Lists, when applicable, for purposes of the QP 
determination, captures the eligible clinicians who are most closely 
associated with the performance of the Advanced APM Entity under the 
Advanced APM. We do not believe that including clinicians for whom we 
have no other record of participation in an Advanced APM would be an 
accurate and equitable

[[Page 77442]]

representation of the eligible clinicians that could become QPs through 
an Advanced APM. CMS defines an eligible clinician's role in an APM 
through his or her inclusion on specific CMS-maintained lists defined 
in each APM's terms and conditions or regulation or law, and we cannot 
verify relationships for which we do not maintain records. Further, we 
do not believe it would be useful to merge the Participation Lists with 
Affiliated Practitioner Lists to identify eligible clinicians for QP 
determinations because the clinicians on these lists have different 
relationships with an Advanced APM Entity.
    The policy we are finalizing addresses which eligible clinicians, 
those on a Participation List or those on an Affiliated Practitioner 
List, will be considered for the QP determination. We believe that we 
should only capture those eligible clinicians affirmatively identified 
as the most central participants supporting an Advanced APM Entity for 
purposes of the QP determination. Many APMs have multiple ``tiers'' of 
eligible clinicians who may play different roles for an APM Entity, and 
the policy we are finalizing reflects those tiers so that only the 
eligible clinicians most responsible for the requirements of the 
Advanced APM relative to other tiers of eligible clinicians will be 
considered the central participants of an Advanced APM Entity. Where 
Advanced APM Entities have eligible clinicians identified on a 
Participation List, those eligible clinicians are the most central 
participants. Where Advanced APM Entities do not have eligible 
clinicians identified on a Participation List, but they do have 
eligible clinicians on an Affiliated Practitioner List, those eligible 
clinicians are the most central participants.
    Comment: One commenter suggested that CMS provide some protections, 
flexibility, or an appeals process for those eligible clinicians who 
find themselves to be on what they believe to be the wrong list, 
especially during the first few years of adjusting to the Quality 
Payment Program.
    Response: We understand that ensuring list accuracy can be a 
difficult process for organizations and clinicians to manage. List 
management takes place with the APMs themselves, and we are not 
developing any universal standards for how each APM collects, updates, 
and maintains its lists. However, because of the important implications 
in list management, we will closely monitor this issue in the first 
years of the Quality Payment Program, and on an ongoing basis.
    We are finalizing the proposed policy with certain modifications, 
as follows:
     For Advanced APMs for which there is a Participation List 
that identifies eligible clinicians, that Participation List will be 
used to define the Advanced APM Entity group, regardless of whether 
there is also an Affiliated Practitioner List or other list of eligible 
clinicians associated with the Advanced APM. QP determinations will be 
made at the Advanced APM Entity group level.
     For Advanced APMs for which there is not a Participation 
List that identifies eligible clinicians and there is an Affiliated 
Practitioner List that identifies eligible clinicians, that Affiliated 
Practitioner List will be used to identify the eligible clinicians for 
purposes of QP determinations. Eligible clinicians on an Affiliated 
Practitioner List will be assessed individually, unlike eligible 
clinicians on a Participation List who are assessed as a group.
     For Advanced APMs, such as episode payment models, in 
which there are some Advanced APM Entities that include eligible 
clinicians on a Participation List and other Advanced APM Entities that 
identify eligible clinicians only on an Affiliated Practitioner List, 
we will identify eligible clinicians for QP determinations based on the 
composition of the Advanced APM Entity: (1) For Advanced APM Entities 
that include and identify eligible clinicians on a Participation List, 
that Participation List will be used to define the Advanced APM Entity 
group, regardless of whether or not there is also an Affiliated 
Practitioner List or other list of eligible clinicians, and those 
eligible clinicians will be assessed as a group; (2) for Advanced APM 
Entities that do not include and identify eligible clinicians on a 
Participation List and there is an Affiliated Practitioner List that 
identifies eligible clinicians, that Affiliated Practitioner List will 
be used to identify the eligible clinicians for purposes of QP 
determinations, and those eligible clinicians will be assessed 
individually.
    As discussed in our response to comments above, we believe the 
relationship between eligible clinicians and APM Entities in APMs such 
as episode payment models can vary and that eligible clinicians on an 
Affiliated Practitioner List can be engaged in the goals of the 
Advanced APM in a similar manner as eligible clinicians on a 
Participation List depending on the characteristics of the Advanced APM 
Entity.
    We are finalizing these policies on the identification of eligible 
clinicians for purposes of QP determinations only for the Medicare 
Option. We did not receive public comment on whether to extend this 
policy to the All-Payer Combination Option and believe it is prudent to 
first apply this policy in the Medicare Option before considering 
whether to apply it in the All-Payer Combination Option through future 
rulemaking.
(3) Exception for Participation in Multiple Advanced APMs
    We proposed an exception to making QP determinations at the group 
level. Some eligible clinicians may participate in multiple Advanced 
APMs. For instance, an eligible clinician could participate in an ACO 
under the Shared Saving Program and an episode payment model with 
another entity, both of which have been determined to be Advanced APM 
Entities. In such a case, we proposed the following (81 FR 28320):
     Consistent with the general policy proposed above, if one 
or more of the Advanced APM Entities in which the eligible clinician 
participates meets the QP threshold, the eligible clinician becomes a 
QP.
     If none of the Advanced APM Entities in which the eligible 
clinician participates meet the QP threshold, CMS proposes to assess 
the eligible clinician individually, using combined information for 
services associated with that individual's NPI and furnished through 
all such eligible clinician's Advanced APM Entities during the QP 
Performance Period. We would adjust to assure that services are not 
double-counted (for example, a surgeon participating in an episode 
payment model, in which some of the procedures are performed on 
patients affiliated with an ACO that the surgeon is also a part of, 
would only have payments or patients from those procedures count once 
towards the QP determination).
    We believe that this policy maintains the general simplicity of the 
Advanced APM Entity-level QP determination while acknowledging 
individual eligible clinicians who are participating in multiple 
advanced initiatives that support CMS goals. This also complements the 
policy described under the All-Payer Combination Option for QP 
determinations in which an eligible clinician may submit information on 
participation in Other Payer Advanced APMs to be assessed as an 
individual under that option in the event that the APM Entity or 
Entities in which the eligible clinician participates do not submit 
sufficient information.

[[Page 77443]]

    We solicited comment on the proposal for exceptions to making QP 
determinations at the Advanced APM Entity level. In particular, we 
solicited comment on the merits of making all determinations at the 
individual eligible clinician level versus through some alternative 
grouping methodology. We also solicited comment on our proposal to 
assess an eligible clinician who participates in multiple Advanced APM 
Entities, and any other potential exceptions to the proposed general 
policy to make QP determinations at the Advanced APM level.
    The following is a summary of the comments we received regarding 
our proposal to assess an eligible clinician individually for purposes 
of a QP determination in the event that the eligible clinician 
participates in multiple Advanced APM Entities, none of which meet the 
QP thresholds as a group.
    Comment: Many commenters supported our proposal to evaluate the 
individual eligible clinician participating in multiple Advanced APMs 
if the individual is not determined to be a QP based on participation 
in any single Advanced APM. Some commenters suggested that for at least 
the first year, we allow any individuals or TINs within an Advanced APM 
Entity to be QPs if they reach the QP threshold independent of their 
Advanced APM Entities in order to ensure that as many eligible 
clinicians become QPs as possible.
    Response: With respect to the alternative of allowing individual 
TINs or NPIs within an Advanced APM Entity to be assessed separately 
and to apply the most favorable result, we do not believe that approach 
would best reflect the collective participation toward shared goals 
that is fostered under APMs, and in particular, Advanced APMs. Like the 
APM Entity's performance under the APM, we believe group level 
determinations in the APM context involve collective and consistent 
responsibility for results, including QP determinations. We will have 
instances in which eligible clinicians are assessed as a group and 
instances in which they are assessed as individuals, but we believe 
individual evaluation should be used only to address exceptional 
circumstances. The approach suggested by the commenters would 
effectively apply an individual assessment with a floor determined by 
the group performance. Such an alternative would erode the cooperative 
purpose of a group determination, and we continue to believe, as stated 
in the proposed rule, that APM participation is focused on collective 
responsibility for the cost and quality of care for Medicare 
beneficiaries.
    Comment: One commenter requested clarification on how we would 
average or weight participation across multiple Advanced APMs.
    Response: We appreciate the questions regarding how individuals 
would be assessed in the case of an eligible clinician participating in 
multiple Advanced APMs. Because we will make QP determinations using 
claims analyses, which enables us to connect services for beneficiaries 
to an eligible clinician's NPI, we would only need to add the numerator 
and denominator values together, and adjust for any duplication in the 
numerator or denominator. The formulas would be the same as if 
calculated for the group but based on the individual eligible 
clinician's activity at the NPI level.
    We are finalizing the policy as proposed. If an eligible clinician 
participates in multiple Advanced APM Entities during a QP Performance 
Period, and is not determined to be a QP based on participation in any 
of those Advanced APM Entities, then we will assess the eligible 
clinician individually using combined information for services 
associated with that individual's NPI and furnished through all the 
eligible clinician's Advanced APM Entities during the QP Performance 
Period. This includes all Advanced APM Entities for which the eligible 
clinician is represented on either a Participation List or Affiliated 
Practitioner List that CMS uses for QP determinations in accordance 
with the identification policies described in this section of the final 
rule with comment period. We will make adjustments to ensure that 
patients and payments for services that may be counted in the QP 
calculations for multiple Advanced APM Entities (for example, payments 
for services furnished to a beneficiary attributed to an ACO that are 
also part of an episode in an episode payment model) are not double-
counted for the individual.
    We believe that this policy maintains the general principles behind 
Advanced APM Entity-level QP determinations while acknowledging the 
broader commitment of individual eligible clinicians who are 
participating in multiple Advanced APMs. We believe considering these 
eligible clinicians individually is the most reasonable approach to 
capturing the multiple potential permutations of participation in 
Advanced APMs and providing eligible clinicians an equitable 
opportunity to become a QP.
(4) Timing of Group Identification for Eligible Clinicians
    We proposed that we would identify the eligible clinician group for 
each Advanced APM Entity at a specified point in time for each QP 
Performance Period. We proposed that this point-in-time assessment will 
occur on December 31 of each QP Performance Period.
    We solicited comments on our proposal to define the Advanced APM 
Entity group based on the Participation List for each Advanced APM 
Entity at a specified point in time during the QP Performance Period. 
We also solicited comment on the proposed date of the Participation 
List assessment, and whether this date should be earlier in the QP 
Performance Period or should instead be a range of time (81 FR 28320).
    The following is a summary of the comments we received regarding 
our proposal to define the Advanced APM Entity group for purposes of 
the QP determination by take a point-in-time snapshot of eligible 
clinicians in an Advanced APM Entity according to Participation Lists 
on December 31 of the QP Performance Period.
    Comment: Many commenters expressed concerns with the proposed 
policy of a December 31 snapshot of Participation Lists in order to 
determine the Advanced APM Entity group for QP determinations and, if 
applicable, MIPS reporting and scoring under the APM scoring standard. 
Some commenters stated that December 31 captures APMs that start or 
allow additions to Participation Lists during the calendar year, but 
for APMs such as the Next Generation ACO Model in which Participation 
Lists are set at the beginning of the year and can only be reduced 
during the year, December 31 does not necessarily capture the entity as 
it operates throughout the year. Similarly, commenters noted that the 
proposed policy both does not incentivize participation during the 
early part of a year and is not fair to eligible clinicians who may 
have been part of the Advanced APM Entity for large portions of the QP 
Performance Period but not on the Participation List on the last day of 
the year. Finally, many commenters stressed that because not being on 
an Advanced APM Entity's Participation List means that the eligible 
clinician must make arrangements for MIPS reporting for the services 
furnished under the TIN/NPI combination associated with the Advanced 
APM Entity, and learning that late in the year would make the necessary 
preparations to perform well under MIPS in a limited amount of time 
very difficult.

[[Page 77444]]

    Response: We agree with commenters that a single snapshot on 
December 31 or the last day of the QP Performance Period may create 
some potentially inequitable or burdensome situations. Therefore, as 
described in this section, we are finalizing a policy that moves away 
from a single, end of year snapshot to instead use several snapshots 
through the year that we believe better represent eligible clinician 
participation in Advanced APMs over the course of a year for purposes 
of QP determinations.
    Comment: A few commenters suggested that we use a range of time 
during which presence on a Participation List would be sufficient to be 
included in the group. Similarly, some commenters suggested that 
presence on the list for a certain number of consecutive days (that is, 
on the Participation List for 60 days) should result in inclusion in 
the group.
    Response: We thank the commenters for the suggestion. These ideas 
both have merit, and we considered them carefully. We are finalizing a 
different policy because, under these suggested options, we believe APM 
list management will be more difficult. We want the list used for 
purposes of an APM and for purposes of the Quality Payment Program to 
be as consistent as possible so that APM Entities may easily understand 
how list changes have impacts across programs. Under the commenters' 
proposals, at any single point in time, there will likely be 
inconsistencies between the APM Entity's Participation List and the 
list we would use for QP determinations, which would be very 
challenging to explain and to manage for both CMS and Advanced APM 
Entities. Specifically with regard to the proposal to have a range of 
time during which anyone on the Participation List would be included in 
the APM Entity group, many APM Entities make changes to their 
Participation Lists at certain times of the year, especially during the 
first quarter, and we do not want to include eligible clinicians in the 
APM Entity group if they were only on a list fleetingly during a period 
of administrative transitions. We believe that the minimum length of 
time proposal ensures that eligible clinicians participate sufficiently 
before being included in an APM Entity group, but APM Entities would 
not have the ability on a given date to know which eligible clinicians 
will be included in the group because some may leave at staggered 
points in time prior to participating for the necessary number of days.
    Comment: Several commenters suggested that we allow each Advanced 
APM Entity to submit a list, which may vary from the one used under the 
Advanced APM, for purposes of the QP determination in order to 
accurately reflect what the entity believes is the most recent and 
salient representation of its group of eligible clinicians 
participating in the Advanced APM Entity. Other commenters suggested 
that each Advanced APM select its own snapshot based on its particular 
operations or change its Participation List rules to allow adjustments 
in preparation for this snapshot date. On the other hand, several 
commenters expressed a desire for as much automation as possible, such 
as through claims analyses and use of PECOS data, to avoid 
administratively burdensome list submission and avoid potential list 
inaccuracies and inconsistencies.
    Response: We thank the commenters for their suggestions. We 
understand that allowing a distinct list submission solely for QP 
determinations purposes or selecting a snapshot date would maximize the 
control an Advanced APM Entity has over the group's Threshold Score. 
However, we believe these options would be ripe for potential gaming 
and could result in inconsistencies between the group of eligible 
clinicians actually responsible for performance under the Advanced APM 
according to CMS records and the list the Advanced APM might identify 
for the QP determination. We believe it is most appropriate to align QP 
determinations with records of participation under the Advanced APMs 
themselves. Although changing how any particular APM manages 
participation by eligible clinicians and APM Entities is beyond the 
scope of this final rule with comment period, we understand how certain 
changes could be made in Advanced APMs to help Advanced APM Entities 
sync up with the Quality Payment Program goals. Finally, we agree with 
commenters in principle that automation of the identification process 
for eligible clinicians in Advanced APMs is a valuable goal. We do not 
want to create additional administrative tasks, such as maintaining and 
submitting a unique Participation List, when we can use available 
information in CMS systems.
    Comment: Many commenters expressed support for a December 31 
snapshot date because the fluid nature of participation during a year 
may result in eligible clinicians joining and leaving an Advanced APM 
Entity in relatively short periods of time during the year.
    Response: We thank the commenters for their support of the proposed 
policy, but because of the issues raised by other commenters, we are 
finalizing a policy that we believe retains many of the benefits of an 
end-of-year or end-of-QP Performance Period snapshot while trying to 
provider greater certainty earlier in the year.
    To address the comments we received, especially the concerns 
regarding eligible clinicians not knowing whether they are part of an 
Advanced APM Entity for purposes of QP determinations until the end of 
the calendar year, we are finalizing a modified process for identifying 
the APM Entity group (individual eligible clinicians in the case of an 
Affiliated Practitioner List) to use a series of three ``snapshots'' of 
an APM Entity's Participation List (or Affiliated Practitioner List) 
during the QP Performance Period. Each snapshot may add eligible 
clinicians to the APM Entity group or capture new affiliated 
practitioners who were not previously identified as part of the group 
or as individuals in the Advanced APM, but once determined to be a 
participant in an APM Entity for the QP Performance Period at any of 
the three snapshots, an eligible clinician will be considered by CMS 
for QP determinations as part of an APM Entity group, or as an 
individual, as appropriate, regardless of whether they are included on 
a Participation List or Affiliated Practitioner List in later 
snapshots. The first snapshot will be on March 31 of the QP Performance 
Period, the second snapshot will be on June 30 of the QP Performance 
Period, and the third snapshot will be on the August 31, which will be 
the last day of the QP Performance Period.
    Each of these snapshots will establish and then add to the APM 
Entity group used for purposes of the QP determinations made for the QP 
Performance Period described in this section. In the event that the APM 
Entity participates in a MIPS APM and is not excluded from MIPS, the 
final APM Entity group after the third snapshot will be also be the APM 
Entity group used for purposes of MIPS group reporting and scoring 
under the APM scoring standard described in section II.e.3.h. of this 
final rule with comment period.
    We believe that this final policy accommodates the variety of 
policies in different models regarding the adding or dropping of APM 
participants so that we capture the eligible clinicians who have 
meaningfully participated in an Advanced APM Entity during a QP 
Performance Period. Most importantly, we believe that, in combination 
with the final policy on the QP Performance Period, this policy allows 
for substantially greater certainty at an earlier point in time of an 
eligible clinician's status, first as a participant or

[[Page 77445]]

affiliated practitioner in an Advanced APM or MIPS APM, and then as a 
QP or MIPS eligible clinician, as compared to the proposed policy. 
Figure F illustrates the three additive snapshots we will use to 
identify the participants in an APM Entity.
    We acknowledge that use of point-in-time snapshots may result in 
some eligible clinicians being captured on Participation Lists or 
Affiliated Practitioner Lists when they have only been on such a list 
for a short period of time. Although we believe that most APMs have 
list management rules to inhibit potential manipulation and that large 
numbers of additions to a Participation List may reduce an Advanced APM 
Entity's Threshold Score, we will monitor whether APM Entities 
systematically construct their lists in a manner that inappropriately 
affects the assessment of participation in Advanced APMs. In response, 
we may modify our policy through future rulemaking to address any such 
issues.
[GRAPHIC] [TIFF OMITTED] TR04NO16.013

b. QP Performance Period
    According to section 1833(z)(2) of the Act, we are required to 
determine QP and Partial QP status based on payment amounts or patient 
counts during the most recent period for which data are available, 
which may be less than a year. We proposed that the QP Performance 
Period is the full calendar year that aligns with the MIPS performance 
period (for instance, 2017 would be the QP Performance Period for the 
2019 payment year). We believe that having a QP Performance Period that 
concludes 1 year and one day before the payment year would enable us to 
provide all eligible clinicians participating in Advanced APMs the best 
opportunity to monitor their performance through the Advanced APM and 
make the most informed decisions regarding their decision whether to 
not to be subject to MIPS in the event that they become a Partial QP. 
We solicited comment on this proposal and any alternative QP 
Performance Period timeframes that would both enable meaningful QP 
assessment and ensure operational alignment with MIPS.
    The following is a summary of the comments we received regarding 
our proposal that the QP Performance Period would be the full calendar 
year 2 years prior to the payment year.
    Comment: Many commenters expressed concern that under the proposed 
QP Performance Period, participants in Advanced APMs would not know 
their QP status until after the end of the MIPS submission period. As a 
result, prudent Advanced APM participants would proactively report to 
MIPS in order to ensure that, in the event they do not reach the QP 
thresholds, they have an opportunity to fare well under MIPS. Most of 
these commenters suggested that QP determinations be made earlier so 
that QPs know their status in sufficient time to avoid unnecessary MIPS 
reporting. Whereas most of these commenters agreed generally that the 
determinations should be completed during the QP Performance Period in 
order to avoid the administrative task of reporting to MIPS, some 
commenters suggested that QP determinations be made as early as the 
spring of the QP Performance Period in order to prevent as much 
unnecessary MIPS-related activity as possible, such as the performance 
necessary for the improvement activities and advancing care information 
performance categories. Other commenters went further and stated that 
QP determinations should be completed prior to or at the very beginning 
of the QP Performance Period. To enable these very early 
determinations, commenters recognized that the calculations would have 
to be made using historical data from 2016 or by issuing presumptive 
determinations with MIPS adjustment accommodations in the event that 
actual results differed from those predicted. Several commenters 
requested that we at least mitigate the issue by providing as much 
preliminary data as possible so that Advanced APM participants may 
clearly understand their possible and likely outcomes.
    Response: Although we designed the APM scoring standard in section 
II.E.3.h. of this final rule with comment period to reduce the 
reporting burden, we agree with commenters that it is only part of the 
solution. We disagree with commenters who recommended using 2016 as the 
QP Performance Period or implied that we should use 2016 data by 
suggesting that we make QP determinations for 2019 at the beginning of 
2017. First, such a proposal would further remove the performance 
timeframe from the corresponding reward; second, the purpose of a 
performance period is to base a determination on actual participation 
in Advanced APMs during that period, and the applicable ``performance'' 
to attain QP status is participation in Advanced APMs; third, a 
performance period of 2016 would severely restrict access to QP status 
because there were fewer opportunities to participate in APMs that 
could be considered Advanced APMs in 2016 than in 2017; and fourth, it 
is very important to base these determinations on robust, reliable data

[[Page 77446]]

instead of historical abstractions or future predictions.
    That said, we agree in principle that earlier notification of QP 
status is optimal and would prevent wasted time and resources. Our 
analyses indicate that one calendar quarter's data is sufficiently 
reliable and consistent with full year results to make early final QP 
determinations using those data. Thus, we are modifying our proposed 
policy in this final rule, as explained more fully below, to 
incorporate QP determinations during the calendar year based on data 
from less than the full QP Performance Period. Any such QP 
determination made during the QP Performance Period will be considered 
final. QP determinations may be rescinded in the event that an Advanced 
APM Entity is terminated from an Advanced APM, voluntarily or 
involuntarily, prior to August 31 of the QP Performance Period, or in 
the event of eligible clinician or Advanced APM Entity program 
integrity violations, as described in section II.F.9. of this final 
rule with comment period. We also intend to provide preliminary 
information to eligible clinicians participating in an Advanced APM 
early in the QP Performance Period in order to help participants assess 
their likelihood of becoming a QP for a year. For the first performance 
year, we will calculate hypothetical Threshold Scores based on 
historical claims data and current attribution data that represent an 
approximation of QP status as if the eligible clinicians had 
participated in an Advanced APM in 2016.
    Comment: Many commenters suggested that CMS include a later time 
period for the QP Performance Period so that there is a smaller gap in 
time between the QP Performance Period and the payment year (for 
example, 2018 Advanced APM participation would determine QP status for 
the 2019 payment year). Commenters expressed a desire to have an 
opportunity following the publication of this final rule with comment 
period to join an Advanced APM and receive the first APM Incentive 
Payment. Some commenters suggested keeping the QP Performance Period as 
proposed but adjusting the Participation List snapshot date to January 
1 of the year after the QP Performance in order to capture new 
participants in Advanced APMs for inclusion in the QP determination. 
Other commenters generally urged us to use 2018 Advanced APM 
participation to make QP determinations for the 2019 payment year.
    Response: In isolation, we agree that a QP Performance Period 
during the calendar year immediately prior to the payment year would 
provide certain advantages over one that is during the calendar year 2 
years prior to the payment year. However, using 2018 Advanced APM 
participation information to make QP determinations for the 2019 
payment year would raise several significant complications. First, we 
do not believe we should ``double-count'' performance for two different 
payment years because we believe the APM Incentive Payment is intended 
to reflect and reward Advanced APM participation for a specific, 
delineated period that should logically align with common APM 
operational functions and timelines. Crossing calendar years would lead 
to highly unreliable and disjointed data because Participation Lists 
often change substantially between calendar years, and we cannot assume 
that the performance of a previous year's group of participants would 
be replicated in a new year with different participants and different 
attributed beneficiaries. Second, as stated in the previous response 
regarding a 2016 QP Performance Period for the 2019 payment year, we 
believe it is paramount that we use actual Advanced APM participation 
information rather than proxies for participation, which would be the 
case for new entrants into an Advanced APM on January 1 under the first 
commenter's proposal. We also believe that we need data from at least 
one calendar quarter of activity in order to consider the data 
reliable, so we do not believe that one day of Advanced APM 
participation is sufficient to reliably calculate a Threshold Score for 
eligible clinicians; any 2017 data would be derived from performance 
while such new Advanced APM participants were not Advanced APM 
participants. Finally, the relationship between QP determinations and 
MIPS reporting drives the need for determinations based on an earlier 
timeframe, and earlier QP determinations rather than later 
determinations. At the very latest, we need to ensure that all QPs for 
a year are removed from the MIPS eligible clinician cohort in 
sufficient time for us to make the requisite budget neutrality 
calculations, which in turn drives the calculation of MIPS payment 
adjustments for a year. We are also modifying our proposals to be 
responsive to many commenters who want to know as early as possible 
whether or not they will need to report under MIPS, and if so, which 
groups and reporting mechanisms they will use for reporting.
    Comment: One commenter requested that the first QP Performance 
Period start on July 1, 2017 instead of January 1, 2017, because of the 
close proximity of January 1 to the publication of this final rule with 
comment period.
    Response: We disagree with the commenter and note that the QP 
determination described in this section is different in nature from 
MIPS. Unlike with MIPS, the QP determination requires no reporting or 
directed activity by Advanced APM participants beyond what is required 
in the Advanced APMs themselves. We believe that starting the QP 
Performance Period later in 2017 would actually do a disservice to 
Advanced APM participants because they potentially would not be able to 
receive due credit for their participation early in the year. We also 
do not believe a later start for the QP Performance Period would 
provide a meaningfully greater opportunity to eligible clinicians to 
join an Advanced APM in the event that they were not part of one at the 
beginning of 2017.
    We are modifying our proposals for the QP Performance Period and 
the timing of QP determinations. Instead of the proposed policy, we are 
finalizing a QP Performance Period that runs from January 1 through 
August 31 of the calendar year that is 2 years prior to the payment 
year. During that QP Performance Period, we will make QP determinations 
at three separate times, each of which would be a final determination 
for the eligible clinicians who are determined to be QPs. The QP 
Performance Period and the three separate QP determinations apply 
similarly for both the group of eligible clinicians on a Participation 
List and the individual eligible clinicians on an Affiliated 
Practitioner List.
    The first QP determination of the QP Performance Period will be 
made for all eligible clinicians who are identified as Advanced APM 
participants eligible to be QPs, either through a Participation List or 
Affiliated Practitioner List as described above, as of March 31 using 
data for that Advanced APM Entity group from January 1 through March 31 
of that year. If the APM Entity group meets the QP threshold under this 
first assessment, then all eligible clinicians in the Advanced APM 
Entity group will be QPs for purposes of the respective payment year 
unless the Advanced APM Entity's participation in the Advanced APM is 
voluntarily or involuntarily terminated prior to the end of the QP 
Performance Period, or in the event of eligible clinician or Advanced 
APM Entity program integrity violations, as described in section 
II.F.9. of this final rule with comment period. These same procedures 
apply to the first QP determination made for individual eligible 
clinicians on an Advanced APM

[[Page 77447]]

Entity's Affiliated Practitioner List or individual eligible clinicians 
in multiple Advanced APMs whose Advanced APM Entity groups did not meet 
the QP threshold.
    In the event that the Advanced APM Entity group did not meet the QP 
threshold at the first QP determination, or if the Advanced APM Entity 
group includes eligible clinicians who were not part of the Advanced 
APM Entity group at the first QP determination, we will make a second 
QP determination for all eligible clinicians in the Advanced APM Entity 
at the first QP determination plus any additional eligible clinicians 
who are on the Participation List as of June 30 using data for that 
Advanced APM Entity group from January 1 through June 30 of that QP 
Performance Period. If the Advanced APM Entity group meets the QP 
threshold, then all eligible clinicians in the Advanced APM Entity 
group will be QPs for the payment year unless the Advanced APM Entity's 
participation in the Advanced APM is voluntarily or involuntarily 
terminated prior to the end of the QP Performance Period, or in the 
event of eligible clinician or Advanced APM Entity program integrity 
violations, as described in section II.F.9. of this final rule with 
comment period. If the Advanced APM Entity group does not meet the QP 
threshold at the second determination but did meet the QP threshold at 
the first determination, CMS would not revise the QP status of the 
eligible clinicians who were previously determined to be QPs, but any 
additional eligible clinicians who were in the Advanced APM Entity 
group at the second determination would not be QPs for the payment year 
through the group determination. If an Advanced APM Entity group meets 
the threshold in both the first and second determination, but some 
eligible clinicians no longer remain on the Participation List for the 
second determination, those eligible clinicians will still be 
considered QPs. These same procedures apply to the second QP 
determination made for individual eligible clinicians on the Advanced 
APM Entity's Affiliated Practitioner List or individual eligible 
clinicians in multiple Advanced APMs whose Advanced APM Entity groups 
did not meet the QP threshold.
    In the event that the Advanced APM Entity group did not meet the QP 
threshold under the first or second QP determination or if the Advanced 
APM Entity group includes eligible clinicians who were not part of the 
Advanced APM Entity group at the second QP determination, we will make 
a third QP determination for all eligible clinicians on the Advanced 
APM Entity's Participation List from the first and second QP 
determinations plus any additional eligible clinicians who are on the 
Participation List as of August 31 using data for that Advanced APM 
Entity group from January 1 through August 31 of that QP Performance 
Period. If the Advanced APM Entity group meets the QP thresholds, then 
all eligible clinicians in the Advanced APM Entity group will be QPs 
for the payment year unless the Advanced APM Entity's participation in 
the Advanced APM is voluntarily or involuntarily terminated prior to 
the end of the QP Performance Period. If the Advanced APM Entity group 
does not meet the QP threshold at the third determination but did meet 
the QP threshold at a previous determination, CMS would not revise the 
QP status of the eligible clinicians who were previously determined to 
be QPs, but any additional eligible clinicians who were only in the 
Advanced APM Entity group at the third QP determination would not be 
QPs for the payment year. If an Advanced APM Entity group meets the QP 
threshold in both the third determination and a previous determination, 
but some eligible clinicians no longer remain in the Advanced APM 
Entity at the third determination, those eligible clinicians will still 
be considered QPs. These same procedures apply to the third QP 
determination made for individual eligible clinicians on the Advanced 
APM Entity's Affiliated Practitioner List or individual eligible 
clinicians in multiple Advanced APMs whose Advanced APM Entity groups 
did not meet the QP threshold.
    For each of the three QP determinations, we will allow for 3 
months' claims run-out before calculating the Threshold Scores so that 
the three QP determinations will be made approximately 4 months after 
the end of that determination time period. Therefore, the last of these 
three QP determinations will take place on or around January 1 of the 
subsequent calendar year, which is the year immediately prior to the 
payment year. This way, eligible clinicians will know of their QP 
status prior to or near the beginning of the MIPS data submission 
period and know whether they should report to MIPS for the applicable 
year. Additionally, for purposes of this policy, we do not consider the 
ending of an Advanced APM's operations to be the voluntary or 
involuntary termination of an Advanced APM Entity. We consider an 
Advanced APM's end to be the natural and scheduled close rather than a 
``dropping out'' of participants from the Advanced APM.
    Figure G illustrates the three QP determinations during a QP 
Performance Period and the associated period of claims data used for QP 
determination (A), the Participation List or Affiliated Practitioner 
List snapshot date (B), the claims run-out period (C), and the 
estimated completion date of the QP determination (D).
[GRAPHIC] [TIFF OMITTED] TR04NO16.014


[[Page 77448]]


c. Partial QP Election To Report to MIPS
    Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the 
definition of MIPS eligible clinician an eligible clinician who is a 
Partial QP for a year. However, under section 1848(q)(1)(C)(vii) of the 
Act, an eligible clinician who is a Partial QP for a year and reports 
on applicable measures and activities as required under the MIPS is 
considered to be a MIPS eligible clinician for the year. To carry out 
these provisions, we proposed to require that each Advanced APM Entity 
must make an election each year on behalf of all of its identified 
participating eligible clinicians on whether to report under MIPS in 
the event that the eligible clinicians participating in the Advanced 
APM Entity are determined as a group to be Partial QPs for a year. We 
proposed that the Advanced APM Entity could change its election for a 
year at any time during the QP Performance Period, but the election 
would become permanent at the close of the QP Performance Period. We 
believe that this is consistent with our proposed general policy to 
make QP determinations at the Advanced APM Entity level, and with 
related MIPS policies described in section II.E.3.h. of this final rule 
with comment period, under which we proposed that each APM Entity would 
be considered a group for purposes of MIPS reporting. Therefore, we 
believe that the decision of whether to report and subsequently be 
subject to MIPS adjustments should also be made at the group level. We 
solicited comment on whether the Advanced APM Entity or each individual 
eligible clinician should make the Partial QP MIPS reporting election.
    As discussed in section II.E.3.h. of this final rule with comment 
period, we recognize that the Shared Savings Program eligible 
clinicians participate as a complete TIN such that all of the eligible 
clinician participants in the participant billing TIN participate in 
the Shared Savings Program. Therefore, we also solicited comment on an 
alternative approach for Shared Savings Program APM Entities in which 
each individual billing TIN participating in the APM Entity would make 
the Partial QP election on behalf of its individual eligible clinicians 
and that election would be applied to all eligible clinicians in that 
individual billing TIN, as opposed to having the APM Entity (ACO) make 
the Partial QP election. We stated that we would only undertake this 
alternative paired with determining a MIPS final score for each TIN 
within an APM Entity (ACO) at the TIN level, an alternative discussed 
under the APM scoring standard in the proposed rule.
    Our proposal that Partial QPs may choose whether to report to MIPS 
has two additional interactions with other proposed policies. First, 
because we proposed unique MIPS scoring policies for MIPS eligible 
clinicians participating in certain APMs, the election by the APM 
Entity not to report under MIPS is in effect a decision to tell us not 
to score the information submitted by the APM Entity under MIPS. Under 
our proposal, that decision would be made at the APM Entity level. APM 
Entities and eligible clinicians would continue to report to their 
respective APMs as required under the terms of their participation 
agreements with us.
    Second, given the proposed timeframe for QP determinations under 
section II.F.5.a. of the proposed rule (81 FR 28313), our proposed 
treatment of claims run-out, claims adjustments, supplemental service 
payments, and alternative payment methods for purposes of QP 
determination (further detailed in section II.F.8 of the proposed rule 
(81 FR 28339)), and the and subsequent notification of QP 
determinations proposed under section II.F.5.d. of the proposed rule 
(81 FR 28322), eligible clinicians who become Partial QPs would not 
receive notification of this status until after the proposed timeframe 
for the MIPS reporting period will have closed. Although the 
information necessary for MIPS reporting would already be prepared in 
our systems by the time the Partial QP determination is made, a 
prospective election by the Advanced APM Entity to not be scored under 
MIPS and receive a MIPS payment adjustment would signal us to not 
transfer information from our reporting system to the MIPS scoring 
system in the event of a Partial QP determination, and that any 
submitted information is not to be used for purposes of a MIPS 
assessment or payment adjustment. Thus, by choosing not to report under 
MIPS, those Advanced APM Entities and eligible clinicians determined to 
be Partial QPs would be exempted from the MIPS payment adjustment for 
that year. We solicited comment on the timing and process for Advanced 
APM Entities to elect whether to be subject to MIPS in the event of a 
Partial QP determination.
    The following is a summary of the comments we received regarding 
our proposal for Advanced APM Entities to determine whether or not to 
be subject to MIPS in the event that their eligible clinicians are 
determined to be Partial QPs.
    Comment: Several commenters expressed opinions about the level at 
which the Partial QP decision is made of whether or not to report to 
MIPS. Most of these commenters stated strong support for the proposed 
policy that the decision be made at the APM Entity level in order to 
reinforce the collective nature of APM participation, and, in the event 
the group is subject to MIPS through a Partial QP election or missing 
the Partial QP and QP thresholds, the use of the APM Entity as the 
defining group for MIPS scoring. Other commenters stated support for 
QPs to make the decision at a TIN level in order to align with billing, 
other activities outside the APM context, and the TIN-based structure 
of the Shared Savings Program. A few commenters expressed that the 
decision should be made individually by each eligible clinician.
    Response: We agree that although there could be some advantages to 
TIN-level Partial QP decisions, it is most appropriate to retain 
consistency within the Quality Payment Program in which eligible 
clinicians in APMs are primarily assessed at the APM Entity level. In 
the cases for which we make the Partial QP determination at the 
individual eligible clinician level, those individual eligible 
clinicians would accordingly make the Partial QP election of whether to 
be subject to MIPS payment adjustments at an individual level.
    Comment: Some commenters expressed general support for the Partial 
QP election policy because it enables a degree of flexibility and 
choice to recognize those who participate in Advanced APMs to some 
extent, despite the fact that the eligible clinicians did not reach the 
QP threshold.
    Response: We thank the commenters for their support.
    Comment: Several commenters expressed concern about the timing of 
the Partial QP determinations. They stated that, as proposed, Partial 
QPs would not be able to make a fully-informed decisions because they 
would make their decision of whether or not to be subject to MIPS prior 
to knowing their ultimate QP status; therefore, Partial QP 
determinations should be made earlier to avoid prospective decisions.
    Response: We agree with commenters that Partial QP decisions 
regarding MIPS should not be made without any information regarding a 
group's QP status. We believe that we resolve this issue through the 
finalized QP Performance Period policy so that all Advanced APM 
participants will know if they are Partial QPs by the beginning

[[Page 77449]]

of the MIPS submission period and will not need to make MIPS decisions 
as Partial QPs prior to that point in time.
    Comment: Some commenters were concerned that Partial QPs would not 
have enough information to made decisions about whether to report to 
MIPS.
    Response: We note that no eligible clinicians, regardless of 
whether they are Partial QPs, will be able to know their MIPS payment 
adjustments until they are actually announced just before the payment 
year, so a Partial QP decision to report to MIPS does carry with it 
some unavoidable uncertainty. Each Advanced APM Entity will need to 
weigh its options of the burden of reporting and likelihood of positive 
MIPS adjustments with the certainty of choosing exclusion from MIPS 
payment adjustments, which could be upward, neutral, or downward 
adjustments for the payment year.
    Comment: Some commenters suggested alternatives to the consequences 
of Partial QP status. One commenter recommended that Partial QPs 
receive a partial bonus payment. Another commenter recommended that 
Partial QPs who report MIPS data should receive the higher amount of 
the MIPS adjustments or the neutral payment adjustment. In other words, 
the commenter suggested that MIPS adjustments should apply if positive 
but not apply if negative.
    Response: We appreciate the ideas for Partial QP policies, but we 
do not believe the statute provides for the kinds of Partial QP 
incentives suggested by the commenter.
    In consideration of the comments and the modifications we are 
making to the proposed QP Performance Period policies, we are not 
finalizing the proposed policy that Advanced APM Entities would make 
prospective elections regarding whether or not to score their MIPS data 
in the event that they are determined to be Partial QPs. Instead, we 
are finalizing a modified policy such that, following a final 
determination that eligible clinicians in an Advanced APM Entity group 
are Partial QPs for a year, the Advanced APM Entity will make an 
election whether to report to MIPS, thus making all eligible clinicians 
in the Advanced APM Entity group subject to MIPS reporting requirements 
and payment adjustments for the year; if the Advanced APM Entity elects 
not to report, all eligible clinicians in the APM Entity group will be 
excluded from MIPS adjustments. In the cases where the QP determination 
is made at the individual eligible clinician level, if the eligible 
clinician is determined to be a Partial QP, the eligible clinician will 
make the election whether to report to MIPS and then be subject to MIPS 
reporting requirements and payment adjustments.
    A Partial QP who elects not to report to MIPS, whether based on the 
decision of the APM Entity or the individual eligible clinician, 
similar to QPs, is excluded from MIPS across all TINs associated with 
that Partial QP's NPI. Partial QPs do not under any circumstance 
receive the APM Incentive Payment.
    Under this finalized policy, only Partial QPs must make this 
election after the Partial QP determination is made. The finalized QP 
Performance Period and QP determination policies apply to Partial QP 
determinations and enable Partial QP determinations to be made in a 
timeframe that makes the proposed prospective elections unnecessary. 
This means that Advanced APM Entities do not make a Partial QP decision 
on behalf of their constituent eligible clinicians unless and until 
that group actually is determined to be a Partial QP. Similarly, 
eligible clinicians for whom we make individual QP determinations do 
not elect whether to report to MIPS unless and until the eligible 
clinician is determined to be a Partial QP for the year.
    We also clarify how we consider the absence of an explicit 
election. For situations in which the APM Entity is responsible for 
making the determination on behalf of all eligible clinicians in the 
APM Entity group, the group of Partials QPs will not participate in 
MIPS unless the APM Entity opts the group into MIPS participation so 
that no actions other than the APM Entity's election for the group to 
participate in MIPS would result in MIPS participation. We believe that 
this default minimizes the possibility of unexpected participation in 
MIPS and also recognizes that most APM Entity groups in this situation 
would be scored collectively under the APM scoring standard in MIPS, 
thus necessitating group decision-making.
    For situations in which an eligible clinician is determined to be a 
Partial QP individually, we will use the eligible clinician's actual 
reporting activity to determine whether to exclude the Partial QP from 
MIPS in the absence of an explicit election. Therefore, if an eligible 
clinician determined as an individual to be Partial QP submits 
information to MIPS (which does not include information automatically 
populated or calculated by CMS on the Partial QP's behalf), we will 
consider the Partial QP to have reported and thus be participating in 
MIPS. Likewise, if an eligible clinician determined as an individual to 
be a Partial QP does not take any action to submit information to MIPS, 
then we will consider the Partial QP to have elected to be excluded 
from MIPS.
    We anticipate that there will be relatively few Partial QPs, 
especially in the first few years of the Quality Payment Program; 
therefore, we believe that this finalized policy will reduce 
administrative burden on Advanced APM participants and operate most 
smoothly with our finalized policies for QP determinations.
d. Notification of QP Determination
    We proposed to notify both Advanced APM Entities and their 
participating eligible clinicians of their QP or Partial QP status as 
soon as we have made the determination and performed all necessary 
validation of the results. We proposed that this notification would be 
made directly to the Advanced APM Entity and eligible clinician, and 
made in combination with a general public notice on the CMS Web site 
that such determinations have been completed for the applicable QP 
Performance Period. We proposed that this notification would also 
contain other necessary and useful information, such as what actions, 
if any, an Advanced APM Entity or eligible clinician may or should take 
with respect to MIPS.
    We solicited comment on our proposals to make the QP and Partial QP 
status notifications. We also solicited comment on other methods and 
media for the notification of QP and Partial QP status. We also 
solicited comment on the content of such notifications so that they may 
be as clear and useful as possible.
    The following is a summary of the comments we received regarding 
our proposal to make notifications regarding the results of QP and 
Partial QP determinations.
    Comment: Many commenters suggested that CMS notify Advanced APM 
participants of their QP status as soon as possible so that they can 
know whether or not they should report to MIPS. Several commenters 
specifically stated that notification should be made during the QP 
Performance Period or by February 1 or March 1 of the year following 
the QP Performance Period.
    Response: We agree that timely notification is important, and we 
understand that much of the concern for receiving timely notifications 
is related primarily to the QP Performance Period timeframe. We can 
only notify Advanced APM participants of their QP status as soon as 
such status is finalized, and as proposed, that notification could

[[Page 77450]]

not have occurred prior to April or May of the year following the QP 
Performance Period. However, under the finalized QP determination 
timeframe, we will be able to complete QP determinations at three 
separate times during the QP Performance Period, thus enabling 
significantly earlier notifications than proposed.
    Comment: Several commenters stated the need for clear communication 
and offered suggestions on the types of content that should be 
contained in the notifications. Some commenters recommended that we 
provide Advanced APM participants with comprehensive information on 
their Threshold Scores using both the payment amount and patient count 
methods so that they can see precisely where they stand in relation to 
the QP thresholds. Other commenters stated that we should send 
preliminary information to Advanced APM participants before the actual 
QP determinations so that they can predict their QP status. Finally, 
some commenters requested that we send reports with data sufficient for 
Advanced APM Entities to replicate and verify the Threshold Score 
calculations. Finally, one commenter requested that we include an 
appeals process following notification of the QP determinations.
    Response: We agree that supplying useful information about 
Threshold Scores under the different methods in concert with the QP 
determination is a valuable goal. We will take all of these comments 
into account as we develop the notification format and content. We also 
plan to supply Advanced APM participants with preliminary analyses 
based on their historical claims to help them understand their 
likelihood of meeting the QP thresholds were they to practice in the 
Advanced APM similarly to how they have done previously. Finally, 
section 1833(z)(4) of the Act explicitly excludes administrative or 
judicial review of the QP determinations, but we will ensure that the 
calculations undergo a rigorous quality assurance process prior to 
finalization.
    Comment: Some commenters provided suggestions as to which parties 
should receive notifications of QP status. One commenter suggested that 
we send notifications to the Advanced APM Entity and the eligible 
clinicians in writing or via email and that we publicly post the 
determinations on the CMS Web site. One commenter stated that the 
Advanced APM Entity should receive the notification instead of TINs 
that may be part of the Advanced APM Entity.
    Response: We thank the commenters for their suggestions, and we 
agree that it is important to ensure that the appropriate parties are 
properly notified of their status. We will take these comments into 
consideration when developing our notification processes.
    We are finalizing the proposal to notify Advanced APM Entities and 
eligible clinicians of their QP or Partial QP status as soon as we have 
made the determination and performed all necessary validation of the 
results. This notification process will occur for each of the three QP 
determinations that we will perform during a QP Performance Period. We 
will provide additional information on the format of such notifications 
and the data we will include as part of our public communications 
following this final rule with comment period.
6. Qualifying APM Participant Determination: Medicare Option
a. In General
    Under the Medicare Option, we proposed to calculate a Threshold 
Score for an Advanced APM Entity--or eligible clinician in the cases of 
an exception described in section II.F.5.b. of the proposed rule (81 FR 
28319)--based on participation in an Advanced APM by analyzing claims 
for Medicare Part B covered professional services. Under the 
alternative calculation using patient counts in lieu of payments 
(patient count method), we proposed to similarly calculate a Threshold 
Score for the Advanced APM Entity based on patient attribution as 
described in the proposed rule. Under either the payment amount or 
patient count method, only Medicare Part B covered professional 
services under the PFS will count toward the numerator and denominator 
of the Threshold Score calculation.
    Section 1833(z)(2)(A), (B)(i) and (C)(i) of the Act describes the 
QP determination using the Medicare payment method as follows: A QP is 
an eligible clinician whose payments under this part for covered 
professional services furnished by such professional during the most 
recent period for which data are available (which may be less than a 
year) were attributable to such services furnished under this part 
through an Advanced APM Entity. Section 1833(z)(2)(D) of the Act 
describes the basis for the patient count method.
(1) Attributed Beneficiaries
    In section II.F.3. of the proposed rule (81 FR 28295), we proposed 
two definitions that would apply specifically for the purposes of QP 
determination: Attributed beneficiary and attribution-eligible 
beneficiary. Each term describes a particular relationship between an 
Advanced APM Entity and the beneficiaries for whose cost and quality of 
care the participating eligible clinicians are held accountable. These 
terms are the foundation for how we propose to count services furnished 
through an Advanced APM Entity.
    We proposed that ``attributed beneficiary'' be defined as a 
beneficiary attributed to the Advanced APM Entity on the latest 
available list of attributed beneficiaries during the QP Performance 
Period based on each APM's respective attribution rules. There are some 
natural advantages to using this term for the purposes of QP 
determination because it is consistent with how many APMs--including 
the Shared Savings Program (assigned beneficiaries), Next Generation 
ACO Model (aligned beneficiaries), and BPCI Model (attributed 
beneficiaries)--identify the beneficiaries whose outcomes and costs are 
included in an APM Entity's assessment. We believe that using the same 
construct also coordinates the incentives under the Advanced APM with 
the incentives under the MACRA by addressing the same beneficiary 
population.
    In most episode payment models, such as the CJR Model, attribution 
is defined by the beneficiaries who trigger the defined episode of care 
under the model, often by presenting with a specific condition at the 
location of a participating APM Entity. In many attribution-based APMs, 
such as ACO initiatives or the Comprehensive Primary Care Initiative, 
CMS attributes beneficiaries to APM Entities through claims-based 
algorithms that identify the APM Entity with the plurality of 
evaluation and management visits for a beneficiary. In addition, most 
APMs do not allow beneficiaries to be attributed to more than one APM 
Entity. This means that the greater the APM Entity density in a market, 
the lower the attributed population for a given APM Entity will be as a 
percent of its total beneficiaries. We solicited comment on the 
proposed methodology for defining the attributed beneficiary 
population, including comment on alternative methods for capturing the 
most meaningful cohort of attributed beneficiaries.

[[Page 77451]]

    Under these plurality-based approaches, typically only 30-50 
percent of an Advanced APM Entity's total population of beneficiaries 
for whom its eligible clinicians furnish services are actually 
attributed to the Advanced APM Entity for a performance period. These 
percentages reflect a combination of CMS' design decisions, 
beneficiaries' underlying care patterns, and the fact that 
beneficiaries in Medicare FFS retain freedom of choice to select 
clinicians. These percentages reflect conditions that are not entirely 
under the control of the APM Entity or its eligible clinicians. Thus, 
we recognize that because Advanced APMs have different attribution 
methodologies, using the specific Advanced APM attributed beneficiary 
as the definition may create a standard that advantages or 
disadvantages participation in certain Advanced APMs relative to others 
simply based on the specific attribution policies.
    We proposed to use the attributed beneficiaries on Advanced APM 
attribution lists generated by each Advanced APM in making QP 
determinations. We also proposed that the attributed beneficiary list 
would be taken from the Advanced APM's latest available list at the end 
of the QP Performance Period prior to making the QP determinations. For 
episode payment models, attributed beneficiaries would be those 
beneficiaries who trigger episodes of care under the terms of the APM.
    We believe that this approach to attribution lists maintains 
consistency with the panel of beneficiaries for whom Advanced APM 
Entities are responsible under their respective Advanced APMs during 
the QP Performance Period. Therefore, we believe that such lists would 
be appropriate for use in QP determinations. Advanced APM Entities are 
already accustomed to providing care for the panel of beneficiaries 
represented by their APM Entity-specific list. We believe that our 
proposal to link attribution for QP determination to Advanced APM 
attribution lists further strengthens the goals of the Advanced APMs in 
which these Advanced APM Entities participate. By using the same 
beneficiary population for QP determination purposes, Advanced APM 
Entities may continue focusing on the care they furnish to the same 
panel of attributed beneficiaries, instead of shifting focus and 
changing practice patterns to reach a QP threshold. As stated in our 
principles in section II.F.1. of the proposed rule (81 FR 28293), we 
intend for the QP determination process to seamlessly reward 
participation in Advanced APMs, not to create a new set of performance 
standards distinct from the goals of APMs.
    We solicited comment on our proposal for determining which 
beneficiaries are considered attributed to an Advanced APM Entity.
    The following is a summary of the comments we received regarding 
our proposal to define the attributed beneficiary population based on 
actual Advanced APM attribution and to use the latest available 
attribution list at the end of the QP Performance Period for QP 
determinations.
    Comment: We received several comments related to attribution more 
generally, such as how to improve attribution in APMs, enable 
attribution across multiple entities or APMs, allow for review and 
modification of attribution lists, and requests for clarification of 
how attribution is performed in APMs.
    Response: We thank the commenters for their input. However, these 
issues are beyond the scope of this final rule with comment period.
    We are finalizing the definition of attributed beneficiary as 
proposed. We are finalizing that we would identify the attributed 
beneficiaries for an Advanced APM Entity based on the latest available 
attribution list at the time of a QP determination. This differs 
slightly from the proposed policy in order to align with the finalized 
QP Performance Period policies in this section and enable QP 
determinations to be made earlier in the QP Performance Period.
(2) Attribution-Eligible Beneficiaries
    Consistent with our proposed definition of attributed beneficiary, 
our proposed definition for an attribution-eligible beneficiary would 
allow us to be consistent across Advanced APMs in how we consider the 
population of beneficiaries served by an Advanced APM Entity for the 
purposes of QP determination. To be attributed to an Advanced APM 
Entity in an Advanced APM, a beneficiary is first required to meet 
certain eligibility criteria. Specifically, for purposes of QP 
determinations, we propose that an attribution-eligible beneficiary 
would be one who:
    (1) Is not enrolled in Medicare Advantage or a Medicare cost plan.
    (2) Does not have Medicare as a secondary payer.
    (3) Is enrolled in both Medicare Parts A and B.
    (4) Is at least 18 years of age.
    (5) Is a United States resident.
    (6) Has a minimum of one claim for evaluation and management 
services by an eligible clinician or group of eligible clinicians 
within an APM Entity for any period during the QP Performance Period.
    An attribution-eligible beneficiary may or may not be an attributed 
beneficiary. Attributed beneficiaries are a subset of attribution-
eligible beneficiaries. Much like the term ``attributed beneficiary,'' 
the term attribution-eligible beneficiary is generally consistent with 
the attribution methodologies used in most current APMs to identify the 
beneficiaries who could potentially be attributed to an APM Entity. 
Although the factors we proposed for the definition of an attribution-
eligible beneficiary in this context would only apply for the purposes 
of QP determinations, and would not change APM-specific methodologies, 
we believe that the factors in the proposed definition are 
representative of the methodologies most current APMs use to perform 
attribution. Therefore, we believe it would serve as a practical common 
set to apply in QP threshold calculations.
    The purpose of using the attribution-eligible construct is to 
ensure that the denominator of QP determination calculations described 
in this section only includes payments for services furnished to 
patients who could potentially be attributed to an Advanced APM Entity 
under the Advanced APM, and thus could also appear in the numerator of 
the QP determination calculations. We believe that including amounts in 
the denominator that could not possibly be included in the numerator 
would be arbitrarily punitive toward certain Advanced APM Entities that 
furnish services to a substantial population of non-attribution-
eligible beneficiaries.
    We note that specialty-focused or disease-specific APMs may have 
attribution methodologies that are not based on evaluation and 
management services. Therefore, we anticipate needing targeted 
exceptions, especially related to the sixth factor of the definition of 
attribution-eligible beneficiary, for such APMs so that the attributed 
beneficiary population is truly a subset of the attribution-eligible 
population. Such exceptions would be made either through rulemaking or 
using available waiver authority and would be announced when the APM is 
announced.
    For example, under the CEC Model, one criterion, among others, to 
be an aligned beneficiary requires that the beneficiary receive 
maintenance dialysis services. In the event that the CEC Model were 
determined to be an Advanced APM, we would consider

[[Page 77452]]

attribution-eligible beneficiaries for the APM Entities participating 
in the CEC Model to be beneficiaries that meet the first five criteria 
outlined above and that have had at least one maintenance dialysis 
service billed through the Advanced APM Entity during the QP 
Performance Period. We would make this exception for the CEC Model to 
ensure that the denominator of QP determination calculations described 
in this section only includes payments for services furnished to 
patients who could potentially be attributed to an Advanced APM Entity 
under the Advanced APM.
    Although the availability of such exceptions, as outlined above, 
would create multiple standards for the beneficiaries that are 
attribution-eligible, we believe this slightly more complex approach is 
more appropriate and equitable because it is consistent with the design 
of APMs. An alternative approach could be to have a simple standard 
that includes in the denominator all beneficiaries who are furnished 
any Medicare Part B covered professional service by eligible clinicians 
participating in the Advanced APM Entity.
    We solicited comment on the proposed general definition of 
attribution-eligible beneficiary and on our proposal to use of APM-
specific standards as necessary to fulfill our expressed goals for 
specialty- or disease-focused APMs that may use alternative attribution 
methodologies.
    The following is a summary of the comments we received regarding 
our proposal to define attribution-eligible beneficiaries.
    Comment: Many commenters stated support for altering the definition 
of attribution-eligible in circumstances when an Advanced APM does not 
base attribution on evaluation and management services in order to 
support disease- and specialty-focused APMs, such as BPCI, CJR, OCM, 
and CEC, with the assumption that these APMs would be Advanced APM. 
Some commenters requested that we explain how such exceptions will be 
made and that stakeholders have input in defining the rules.
    Response: We do not believe that there should be a formal 
application process for these exceptions because we operate both the 
Quality Payment Program and Advanced APMs. Therefore, we will make 
assessments appropriate to the interactions between programs. As we 
explained, we would for the CEC Model, consider whether the evaluation 
and management service basis for the definition of attribution-eligible 
beneficiary is appropriate for assessing eligible clinicians' 
participation in an Advanced APM. If evaluation and management services 
are significantly at odds with actual attribution and the evaluation of 
performance on the cost and quality of beneficiary care under an 
Advanced APM, we may consider a different basis for the attribution-
eligible beneficiary definition that takes into consideration 
attribution within the Advanced APM. In that case, we would make an 
exception either through rulemaking or by using available waiver 
authority that would be announced in connection with notifications for 
the APM.
    Comment: In direct response to our solicitation on defining 
attribution-eligible beneficiaries in the context of the CEC 
initiative, several commenters suggested that only patients on dialysis 
be included in the attribution-eligible definition, which would exclude 
those patients with CKD or a kidney transplant unless and until the CEC 
initiative expands to include responsibility for CKD or kidney 
transplant patients.
    Response: We appreciate the detailed input commenters offered in 
response to our solicitation regarding the CEC initiative and agree 
that these are important components to appropriately defining the 
attribution-eligible population. We will take these responses into 
account as needed to develop the basis for attribution-eligible 
beneficiaries for CEC.
    We are finalizing the definition of attribution-eligible to mean a 
beneficiary who:
     Is not enrolled in Medicare Advantage or a Medicare cost 
plan.
     Does not have Medicare as a secondary payer.
     Is enrolled in both Medicare Parts A and B.
     Is at least 18 years of age.
     Is a United States resident.
     Has a minimum of one claim for evaluation and management 
services by an eligible clinician or group of eligible clinicians 
within an APM Entity for any period during the QP Performance Period.
    We are also finalizing that, for Advanced APMs that do not base 
attribution on evaluation and management services and for which 
attributed beneficiaries are not, in fact, a subset the attribution-
eligible beneficiary population based on the requirement to have at 
least one claim for evaluation and management services furnished by an 
eligible clinician who is in the APM Entity for any period during the 
QP Performance Period, then we will modify the definition of 
attribution-eligible beneficiary for that Advanced APM only in order to 
identify the appropriate attribution-eligible population based upon the 
attribution methodology of the Advanced APM (for example, a combination 
of evaluation and management services and/or other Part B covered 
professional services). We will announce these exceptions to the extent 
applicable in a manner consistent with the Advanced APM notification 
process under section II.F.4. of this final rule with comment period.
    For example, we would develop such an exception for the CEC Model 
to the extent it is determined to be an Advanced APM to ensure that the 
denominator of QP determination calculations described in this section 
only includes payments for services furnished to patients who could 
potentially be attributed to ESRD Seamless Care Organizations (ESCOs).
b. Payment Amount Method
    This section describes how we will calculate a Threshold Score for 
the eligible clinician group in an Advanced APM Entity--or individual 
eligible clinician in the exception situations under section II.F.6. of 
this final rule with comment period--using the payment amount method, 
which would then be compared to the relevant QP Payment Amount 
Threshold and Partial QP Payment Amount Threshold to determine if the 
eligible clinician meets the QP status for a payment year.
(1) Claims Methodology and Adjustments
    For the payment amount method, sections 1833(z)(2)(A), (B)(i) and 
(C)(i) of the Act requires that we use payments for Medicare Part B 
covered professional services to make QP determinations. Covered 
professional services are defined under section 1848(k)(3)(A) of the 
Act as services for which payment is made under, or based on, the PFS. 
The payment amounts discussed in this proposal only include payments 
for Medicare Part B services under, or based on, the PFS, even if an 
Advanced APM bases attribution and/or financial risk on payments other 
than or in addition to Medicare Part B payments.
    We proposed to use all available Medicare Part B claims information 
generated during the QP Performance Period. Additionally, we propose 
that CMS will treat claims run-out, claims adjustments, supplemental 
service payments, and alternative payment methods in the same manner 
for purposes of calculating both the Threshold Score and for 
determining the APM Incentive Payment amount. We further detailed our 
proposals to account for claims run-out, claims

[[Page 77453]]

adjustments, non-claims-based payments, and alternative payment methods 
in section II.F.8. of the proposed rule (81 FR 28339).
    We believe it is appropriate to maintain consistency across the QP 
determination and the incentive payment calculation in order to support 
internal CMS operational consistencies. It also ensures that any unique 
payment mechanisms within an Advanced APM do not affect the opportunity 
for an eligible clinician to reach the QP threshold.
    We solicited comment on whether the claims methodology we use under 
the Medicare payment method should align with the proposed claims 
methodology for purposes of calculating the estimated aggregate payment 
amount for the APM Incentive Payment.
    The following is a summary of the comments we received regarding 
our proposal for the QP payment amount method to use all available 
claims information for Medicare Part B covered professional services 
during the QP Performance Period and to treat claims run-out, claims 
adjustments, supplemental service payments, and alternative payment 
methods in the same manner as that used for the APM Incentive Payment 
calculation.
    Comment: Several commenters expressed general support for the QP 
determination methodologies in this section, including our 
interpretation of which payments and patients are considered 
``through'' an Advanced APM and that we will use the same treatment of 
claims for calculating the Threshold Scores in this section and the APM 
Incentive Payment in section II.F.8. of this final rule with comment 
period.
    Response: We thank the commenters for their support of our approach 
to QP determination methodologies.
    Comment: Some commenters were uncertain about how ``incident to'' 
items and services would be considered in QP calculations.
    Response: We would consider ``incident to'' billing for covered 
professional services to be covered professional services when 
calculating the Threshold Scores, as long as the NPI billing for the 
``incident to'' claims is identified as a participant in the Advanced 
APM Entity. We further clarify that this would exclude ``incident to'' 
payment for drugs, biologics, and devices covered under Medicare Part B 
because those are not covered professional services.
    Comment: One commenter requested that we use the Medicare paid 
amount instead of the allowed amount when calculating the Threshold 
Score.
    Response: We do not believe it would be appropriate to use the 
Medicare paid amount instead of the allowed amount when calculating 
Threshold Scores. The Medicare paid amount reflects any reductions from 
the Medicare PFS amount for beneficiary co-payments or coinsurance 
requirements, and also reflects any payment adjustments that are 
applied to fee schedule payments, such as positive or negative payment 
adjustments from the PQRS, MU, VM, or MIPS programs. Including these 
adjustments is inconsistent with our proposal to exclude payment 
adjustments from these programs that we finalized in section II.F.8. of 
this final rule with comment period.
    We are finalizing that for the QP payment amount method we will use 
all available claims information for Medicare Part B covered 
professional services during the applicable QP determination period as 
described in this section of the final rule with comment period.
(2) Threshold Score Calculation
    In general, our method for deriving a Threshold Score for an 
Advanced APM Entity is to divide the value described under paragraph 
(a) in this section by the value described under paragraph (b) of this 
section. This calculation will result in a percent value that CMS will 
compare to the QP Payment Amount Threshold and the Partial QP Payment 
Amount Threshold to determine the QP status for all eligible clinicians 
in the Advanced APM Entity for the payment year.
(a) Numerator
    We proposed that the numerator for this calculation would be the 
aggregate of all payments for Medicare Part B covered professional 
services furnished by the eligible clinicians in the Advanced APM 
Entity to attributed beneficiaries during the QP Performance Period.
    We believe that this method is the most logical reading of the 
statute and is reflective of the population of beneficiaries for whom 
an Advanced APM Entity is responsible for cost and quality. Therefore, 
we believe that counting payments for covered professional services 
furnished to attributed beneficiaries is the most suitable metric for 
payments that are attributable to services furnished ``through'' an 
Advanced APM Entity. In episode payment models, because a beneficiary 
is considered attributed during the course of an episode, the payments 
included in the numerator for this calculation are those for Medicare 
Part B covered professional services furnished to an attributed 
beneficiary by eligible clinicians in the Advanced APM Entity during 
the course of an episode.
    One program integrity concern is that an Advanced APM Entity might 
meet the higher QP Payment Amount Threshold in later years by providing 
substantially disproportionate amounts of care for attributed 
beneficiaries relative to all others. However, because of the financial 
risk an Advanced APM Entity bears, which is usually based on 
expenditures, we believe that the relatively large potential loss under 
the Advanced APM would outweigh the advantage of any overutilization 
geared toward abusing Threshold Score calculations. We solicited 
comment on any alternative numerators we could use for purposes of the 
Medicare payment method that meaningfully meet statutory requirements, 
are understandable, and operationally feasible.
    The following is a summary of the comments we received regarding 
our proposal to calculate the numerator of the Threshold Score under 
the QP payment amount method using the aggregate of all payments for 
Medicare Part B covered professional services furnished by the eligible 
clinicians in the Advanced APM Entity to attributed beneficiaries 
during the QP Performance Period.
    Comment: We received few comments regarding the numerators for QP 
determinations, but most commenters were generally supportive of its 
basis in services furnished to an Advanced APM Entity's attributed 
beneficiary population. One commenter suggested that we essentially 
include all physician payments in the numerator for which a physician 
is listed as an attending physician because the commenter stated that 
hospitalists are ultimately responsible for all spending for a patient.
    Response: We thank the commenters for their general support of our 
approach. We do not believe it is meaningful or consistent with the 
statute to design numerators that are mathematically the same as, or 
potentially larger than, denominators. Although we understand that 
Advanced APM participation may have valuable spillover effects into 
other aspects of clinical practice, we must base the calculations in 
terms of direct Advanced APM participation, not any activity that 
appears similar in nature to Advanced APM activity.
    We are finalizing the numerator of the Threshold Score under the QP 
payment amount method to be the aggregate of all payments for Medicare 
Part B covered professional services furnished by the

[[Page 77454]]

eligible clinicians in the Advanced APM Entity to attributed 
beneficiaries during the timeframe used for QP determination.
    This is identical to the proposed policy except that the applicable 
range of service dates will vary depending on which of the three QP 
determinations during a QP Performance Period is being performed in 
accordance with the finalized QP Performance Period policy in this 
section and illustrated in Figure G.
(b) Denominator
    We proposed that the denominator in the Medicare payment method 
would be the aggregate of all payments for Medicare Part B covered 
professional services furnished by the eligible clinicians in the 
Advanced APM Entity to attribution-eligible beneficiaries during the QP 
Performance Period. We proposed that when the QP determination is made 
at the eligible clinician level as described in section II.F.5. of the 
proposed rule (81 FR 28313), the denominator would be the total of all 
payments for Medicare Part B covered professional services furnished to 
attribution-eligible beneficiaries by the eligible clinician. In 
episode payment models, the payments included in the denominator for 
this calculation as proposed would be those for Medicare Part B covered 
professional services furnished to any attribution-eligible beneficiary 
by eligible clinicians in the Advanced APM Entity. This would include 
all such services to all attribution-eligible beneficiaries whether or 
not such services occur during the course of an episode under the 
Advanced APM.
    Including payment for services furnished only to attribution-
eligible beneficiaries standardizes the denominator to ensure fairness 
across types of eligible clinicians and geographic regions. By using 
the attribution-eligible population, the denominator will not penalize 
entities for furnishing services to beneficiaries who could not 
possibly be in the numerator through attribution under an Advanced APM. 
For example, an ACO's eligible clinicians may furnish services to a 
large population of beneficiaries with Medicare as a secondary payer. 
Those beneficiaries may not be eligible for attribution to the ACO, and 
could never be included in the numerator. Therefore, we believe that 
this methodology focuses on factors for which Advanced APM Entities 
have some control rather than those for which they may have no control 
or that disadvantage certain organizational structures or types of 
APMs. We solicited comment on alternative methods that are consistent 
with the statutory language.
    The following is a summary of the comments we received regarding 
our proposal to calculate the denominator of the Threshold Score for 
the QP payment amount method using the aggregate of all payments for 
Medicare Part B covered professional services furnished by the eligible 
clinicians in the Advanced APM Entity to attribution-eligible 
beneficiaries during the QP Performance Period.
    Comment: Several commenters expressed support for the basis of the 
denominator being tied to attribution-eligible beneficiaries because it 
meaningfully limits the denominator to those beneficiaries that could 
potentially be in the numerator. Some commenters recommended that we 
consider adjusting the denominator to ensure that episodes are treated 
appropriately in the numerator and the denominator. For instance, one 
commenter suggested that the last element of the attribution-eligible 
definition be tied to all beneficiaries with the specific disease, 
condition, or episode to whom the Advanced APM Entity eligible 
clinicians furnished services for Medicare Part B covered professional 
services.
    Response: We thank the commenters for their support and agree that 
the attribution-eligible construct is a meaningful way to define the 
denominator. We also believe that evaluation and management services 
remain a consistent standard that identifies the population of 
beneficiaries whom eligible clinicians can consider their patients, 
even though some APMs base attribution on services other than 
evaluation and management services. The narrow focus of some APMs, 
primarily episode payment models, may make it relatively difficult for 
participants to reach the QP thresholds in comparison to APMs that are 
based upon a more comprehensive assessment of beneficiary care. 
Nonetheless, we believe that the QP thresholds will still be attainable 
by episode payment model participants who have a significant portion of 
their practice focused on the services upon which the APM is based. 
Customizing the denominator to the particular services upon which an 
APM is focused could, in many cases, reduce the denominator so much 
that it would not be meaningfully representative of an eligible 
clinician's business under Medicare Part B. Under such an approach, the 
5 percent APM Incentive Payment, which is based on an eligible 
clinician's payments for Part B covered professional services, could 
exceed the entire denominator value in many cases. Therefore, we 
continue to believe that the proposed policy as applied to episode 
payment models is appropriate and representative of an eligible 
clinician's degree of Part B-related participation in an Advanced APM.
    Comment: A few commenters expressed concern that the denominator 
will be difficult for APM participants to estimate, thus causing 
uncertainty about their likely QP status. Most APMs currently provide 
APM Entities only with an attributed beneficiary list, not an 
attribution-eligible beneficiary list.
    Response: We appreciate the feedback on the inability to precisely 
predict an Advanced APM Entity's Threshold Score because this is a new 
calculation without historical scores or readily available information 
on beneficiaries considered attribution-eligible. Each APM manages the 
beneficiary attribution rules and lists provided to participants. 
However, we believe that the preliminary Threshold Score information we 
plan to send to Advanced APM participants near the beginning of a QP 
Performance Period will mitigate these concerns. We welcome input for 
the future on particular types of data that Advanced APM participants 
would find helpful in their analyses.
    Comment: Several commenters expressed concern about the potential 
difficulty of attaining high Threshold Scores based on the proposed 
denominator. In particular, commenters cited specialists, who in most 
cases may participate in only one ACO but often see a broad range of 
patients across many networks, most of whom are not attributed to the 
specialist's particular ACO. Commenters stated that this could result 
in a dilution of the denominator and be detrimental to the entire APM 
Entity's ability to meet the higher QP thresholds, creating an 
inadvertent incentive to remove specialists from Participation Lists in 
the future. Some commenters requested that we find a way other than 
attribution to define the denominator or to separately evaluate non-
primary care practitioners so that the relative breadth of their 
practices is not a detriment to the Threshold Score. One commenter 
suggested that we extend the QP threshold increases so that the higher 
thresholds are further in the future. One commenter stated that it is 
unfair to have a metric for which attaining a 100 percent score is 
often not possible, particularly for specialty practice groups. Another 
commenter suggested that we simply use attributed beneficiaries in the 
denominator instead of attribution-eligible beneficiaries, 
acknowledging that this would

[[Page 77455]]

essentially give a 100 percent score to all Advanced APM Entities. Some 
commenters suggested that we exclude from attribution-eligible category 
any beneficiaries who are actually attributed to other Advanced APM 
Entities in order to address the issue of attribution competition over 
beneficiaries in regions with a high density of Advanced APM Entities. 
Finally, some commenters recommended that we include service area 
adjustments to account for mobile beneficiary populations that may only 
reside in an area for a portion of a year.
    Response: We understand the commenters' concerns about the 
denominator being a key factor in reaching the higher QP thresholds. We 
agree and have developed the attribution-eligible definition in 
response to otherwise unrealistic thresholds for many organizations. 
That said, we do not believe it is necessary to make a 100 percent 
Threshold Score attainable to all Advanced APM participants because 
this is, as the name implies, a metric based on reaching a threshold. 
Once the threshold is met, no additional benefit accrues to those with 
higher Threshold Scores. With respect to the suggestion of removing 
beneficiaries attributed to other Advanced APM Entities from the 
denominator, we appreciate the idea and agree that it would have the 
effect of shrinking the denominator. However, we believe it is 
important to provide an incentive for Advanced APM Entities to strive 
to expand their attributed population. It is consistent with our goals 
that, within their capabilities, Advanced APM Entities are responsible 
for the cost and quality of as many beneficiaries as possible. With 
respect to service area adjustments, we believe that this would add a 
high degree of complexity to this calculation with very minimal 
positive impact on Threshold Scores.
    We will closely monitor Threshold Scores, particularly with respect 
to the impact of specialist participation, the fragmentation of where 
beneficiaries seek their care, or circumstances such as high rates of 
``snowbird'' patients affecting the denominator. We will monitor 
Threshold Scores at both the APM Entity and individual levels to 
understand how group Threshold Scores may vary based on characteristics 
of attributed beneficiary populations and the eligible clinicians in an 
Advanced APM Entity.
    We believe that ACOs, which on average have specialist 
representation on their Participation Lists approximately 
representative of the specialist distribution nationally, will 
generally be able to meet the QP thresholds. We also believe that 
participation in any episode payment models that are Advanced APMs 
could be an opportunity, consistent with the relatively narrow scope of 
many episode payment models, for eligible clinicians to become a QP.
    Comment: A few commenters believe that the attribution-eligible 
construct for the denominator could inadvertently create an incentive 
to not provide necessary services or to select patients for purposes of 
meeting the QP thresholds.
    Response: We appreciate the consideration for program integrity 
concerns. We take these concerns seriously, and, as described in 
section II.F.9. of this final rule with comment period, we will be 
monitoring the program for patterns of behavior with unintended 
negative consequences.
    We are finalizing the denominator of the Threshold Score under the 
QP payment amount method to be the aggregate of all payments for 
Medicare Part B covered professional services furnished by the eligible 
clinicians in the Advanced APM Entity to attribution-eligible 
beneficiaries during the timeframe used for QP determination. This is 
identical to the proposed policy except that the applicable range of 
service dates will vary depending on which of the three QP 
determinations during a QP Performance Period is being performed in 
accordance with the finalized QP Performance Period policy in this 
section.
c. Patient Count Method
    Similar to the Medicare payment amount method, this section 
describes our proposal for calculating a Threshold Score for the 
eligible clinicians participating in an Advanced APM Entity--or 
eligible clinician in situations under section II.F.6. of this final 
rule with comment period--using the Medicare patient count method, 
which would then be compared against the relevant QP Patient Count 
Threshold and Partial QP Patient Count Threshold to determine the QP 
status of an eligible clinician for the year. Given our authority under 
section 1833(z)(2)(D) of the Act to use patient counts in lieu of 
payments ``as the Secretary determines appropriate,'' we are 
interpreting the patient count method to offer a more flexible 
alternative to the payment method. As previously mentioned, the purpose 
of the proposed design of the Medicare patient count method is to make 
QP status determinations accessible to entities and individuals who are 
clearly and significantly engaged in delivering value-based care 
through participation in Advanced APMs.
(1) Unique Beneficiaries
    We proposed that when counting the number of beneficiaries under 
this method, we may count a given beneficiary in the numerator and 
denominator for multiple different Advanced APM Entities or eligible 
clinicians.
    We proposed that we would not count any beneficiary more than once 
for any single Advanced APM Entity or eligible clinician. In other 
words, for each Advanced APM Entity or eligible clinicians, we would 
count each unique beneficiary no more than one time in the numerator 
and one time in the denominator.
    We believe that counting beneficiaries this way retains the 
integrity of the Threshold Scores by preventing double counting of 
beneficiaries within an Advanced APM Entity while recognizing the 
reality that beneficiaries often have relationships with multiple 
different organizations.
    To be consistent with the Medicare payment method, we proposed that 
beneficiary counts would be based on any beneficiary for whom the 
eligible clinicians within an Advanced APM Entity receive payments for 
Part B covered professional services, or professional services 
furnished at an RHC or FQHC as described in this section, even if an 
Advanced APM bases its attribution and/or financial risk on both Parts 
A and B. We proposed that for this Threshold Score calculation, we 
would use any and all available Part B claims information generated 
during the QP Performance Period. We received no specific comments 
regarding our proposals to enable a beneficiary to be counted for 
multiple APM Entities but to count a beneficiary no more than once per 
APM Entity.
    We are finalizing the policy for the Medicare patient count method 
to enable a beneficiary to be counted in the numerator and denominator 
for multiple APM Entities or eligible clinicians but to count a 
beneficiary no more than once in the numerator and once in the 
denominator per APM Entity or eligible clinician. We are also 
finalizing the policy to base patient counts on any beneficiary for 
whom the eligible clinicians within an Advanced APM Entity receive 
payments for Part B covered professional services, or professional 
services furnished at an RHC or FQHC as described in this section, and 
to use any and all available Part B claims information generated during 
the QP Performance Period.

[[Page 77456]]

(2) Threshold Score Calculation
    We proposed that the Threshold Score would be calculated under the 
Medicare patient count method as a percent by dividing the value 
described under paragraph (a) of this section by the value described 
under paragraph (b) of this section. We include the formula and 
examples in the summary equation below.
(a) Numerator
    We proposed that the numerator would be the number of unique 
attributed beneficiaries to whom eligible clinicians in the Advanced 
APM Entity furnish Medicare Part B covered professional services during 
the QP Performance Period. For episode payment models, this would 
include the number of attributed beneficiaries furnished Medicare Part 
B covered professional services, or professional services at an RHC or 
FQHC as described in this section, by eligible clinicians in the 
Advanced APM Entity during the course of an episode under the Advanced 
APM.
    We did not receive any comments uniquely responding to our proposal 
for the numerator in the patient count method that were not also 
applicable to the payment amount method. Therefore, relevant comments 
were addressed in the payment amount numerator section.
    We are finalizing the policy that the numerator of the Threshold 
Score for the QP patient count method will be the number of unique 
attributed beneficiaries to whom eligible clinicians in the Advanced 
APM Entity furnish Medicare Part B covered professional services, or 
professional services at an RHC or FQHC as described in this section, 
during the QP determination timeframe. For episode payment models, the 
numerator will be the number of attributed beneficiaries furnished 
Medicare Part B covered professional services by eligible clinicians in 
the Advanced APM Entity during the course of an episode under the 
Advanced APM. This policy is identical to the proposed policy except 
that the applicable range of service dates will vary depending on which 
of the three QP determinations during a QP Performance Period is being 
performed in accordance with the finalized QP Performance Period policy 
in this section.
(b) Denominator
    We proposed that the denominator would be the number of 
attribution-eligible beneficiaries to whom eligible clinicians in the 
Advanced APM Entity furnish covered professional services during the QP 
Performance Period. For episode payment models, this would include the 
number of attribution-eligible beneficiaries furnished Medicare Part B 
covered professional services by eligible clinicians in the Advanced 
APM Entity group at any point during the QP Performance Period, 
irrespective of whether such services occur during the course of an 
episode.
    We solicited comment on alternative approaches to the patient count 
method that would achieve our goal of a simple and meaningful Threshold 
Score calculation.
    We did not receive any comments uniquely responding to our proposal 
for the denominator in the patient count method that were not also 
applicable to the payment amount method. Therefore, relevant comments 
were addressed in the payment amount denominator section.
    We are finalizing the denominator of the Threshold Score under the 
QP patient count method to be the number of attribution-eligible 
beneficiaries to whom eligible clinicians in the Advanced APM Entity 
furnish covered professional services during the timeframe used for QP 
determination.
    This is identical to the proposed policy except that the applicable 
range of service dates will vary depending on which of the three QP 
determinations during a QP Performance Period is being performed in 
accordance with the finalized QP Performance Period policy in this 
section. In general, we believe that through consistency with the 
payment amount method, this approach balances our interests of relative 
simplicity and having a meaningful standard that recognizes the common 
aspects of attribution and accountability under Advanced APMs. Similar 
to the payment amount method, the patient count method represents a 
proportion of the patients for whom an Advanced APM Entity is 
accountable under the Advanced APM with respect to all patients who 
could potentially be attributed to the Advanced APM Entity under the 
Advanced APM.
(3) APM Entity Participation in Multiple Advanced APMs
    We proposed that if the same Advanced APM Entity participates in 
multiple Advanced APMs and if at least one of those Advanced APMs is an 
episode payment model, we would add the number of unique beneficiaries 
in the numerator of the episode payment model Advanced APM Entity to 
the numerator(s) for non-episode payment models in which the Advanced 
APM Entity participates. For example, if an Advanced APM Entity is an 
ACO in Track 3 of the Shared Savings Program and also in the OCM 
(assuming these are both Advanced APMs for purposes of this example), 
we would add the entity's unique attributed beneficiaries in OCM to the 
numerator for its Shared Savings Program Track 3 Threshold Score 
calculation. We proposed that for purposes of the APM incentive, 
Advanced APM Entities would be considered the same if we determine that 
the eligible clinician Participation Lists are the same or 
substantially similar, or if the Advanced APM Entity participating in 
one Advanced APM is the same as, or is a subset of, the other.
    The purpose of this proposal was to allow the logical combination 
of activities under multiple Advanced APMs where appropriate. We 
believe that the purpose of the incentives for Advanced APM 
participation is to capture the degree of Advanced APM participation 
generally, not simply the degree of participation within a single 
Advanced APM. Where relevant and operationally feasible, we want this 
program to encourage participation in multiple Advanced APMs. The 
counterfactual where we would not account for a single Advanced APM 
Entity's participation in multiple Advanced APMs could be seen as 
punitive. For instance, an Advanced APM Entity could serve the vast 
majority of its beneficiaries through several Advanced APMs, but unless 
that participation is aggregated, the entity could end up with several 
lower Threshold Scores that are below the QP Patient Count Threshold 
and not indicative of its broader participation.
    We understand the difficulty associated with determining whether 
two Advanced APM Entities are in fact the same organization. It is 
highly unlikely that their Participation Lists would be exactly the 
same. Therefore, we solicited comment on how best to make a 
determination of substantial similarity, which includes, for example, 
matching organizational information, aligning TINs, and comparing 
Participation Lists. We also solicited comment on percentages of 
Participation List or TIN similarity that would be sufficient for APM 
Entities to be considered under this policy.
    The following is a summary of the comments we received regarding 
our proposal that if the same Advanced APM Entity participates in 
multiple Advanced APMs and if at least one of those Advanced APMs is an 
episode payment model, we would add the number of unique beneficiaries 
in the numerator of the episode payment model Advanced APM Entity to 
the

[[Page 77457]]

numerator(s) for non-episode payment models in which the Advanced APM 
Entity participates.
    Comment: Several commenters supported this proposed policy, and one 
commenter suggested that we define ``substantially similar'' so that 
either of the Advanced APM Entity Participation Lists must have at 
least a specified percentage of the eligible clinicians participating 
in the other Advanced APM Entity.
    Response: We agree that it would be optimal to have a clear 
percentage of similarity standard that could apply across all APMs and 
APM Entities. However, many episode payment models construct 
Participation Lists or Affiliated Practitioner Lists differently than 
those in other APMs so the amount by which the individual eligible 
clinicians overlap is highly variable rates depending upon the 
entities.
    After considering the comments and the difficulty of implementing 
this policy as proposed, we are not finalizing the proposed policy to 
combine the numerators of Advanced APM Entities that participate in 
multiple Advanced APMs with substantially similar Participation Lists. 
We do not believe that we have a reliable, precise mechanism for 
determining substantial similarity of Participation Lists. Further, we 
believe that the policy we finalized earlier in this section regarding 
how we would assess eligible clinicians who are in multiple Advanced 
APMs serves the intended purpose of this proposed policy because it 
gives an eligible clinician the opportunity to become a QP in the event 
that the eligible clinician does not become a QP through any one of the 
multiple Advanced APMs in which the eligible clinician participates. 
Therefore, we do not believe that our reconsideration of this policy 
will limit the opportunity of eligible clinicians to become QPs, and we 
believe that not finalizing this policy will promote operational and 
conceptual simplicity.
d. Use of Methods
    We proposed that we would calculate Threshold Scores for eligible 
clinicians in an Advanced APM Entity under both the payment amount and 
patient count methods for each QP Performance Period. We also proposed 
that we would assign QP status using the more advantageous of the 
Advanced APM Entity's two scores.
    We believe that both the payment amount and patient count methods 
produce valid Threshold Scores, even as there may be cases in which 
Threshold Scores vary enough that different QP determinations could 
result depending on which is used. In such an event, we do not believe 
that prioritizing the Threshold Score using one calculation over the 
other would yield an appropriate, non-arbitrary result. By using the 
more advantageous of the Threshold Scores achieved, we hope to promote 
simplicity in QP determinations and to maximize the number of eligible 
clinicians that attain QP status each year. We solicited comment on the 
use of the payment and patient count methods for the Medicare Option.
    The following is a summary of the comments we received regarding 
our proposal to calculate for each Advanced APM Entity of eligible 
clinician the Threshold Score using both the payment amount and patient 
count methods and use the more advantageous of the two scores.
    Comment: Many commenters expressed support for the use of the 
patient count method, for not double-counting beneficiaries, and for 
using the more favorable of the payment amount or patient count methods 
for each Advanced APM Entity because it reduces potential variations in 
Threshold Scores across practice patterns, certain specialty types, and 
the costs of services. Some supportive commenters recommended that we 
monitor results to potentially take action to ensure year-to-year 
stability in Threshold Scores. One commenter was concerned that the 
patient count methodology might be easier to game to meet the QP 
thresholds and encouraged CMS to consider whether this might create 
problematic incentives.
    Response: As commenters suggest, we will monitor the results of QP 
determinations to see if there are cases of large disparities between 
the two methods that may indicate gaming.
    We are finalizing the policy as proposed. We will calculate 
Threshold Scores for each Advanced APM Entity or eligible clinician 
using both the payment amount and patient count methods and apply the 
more advantageous QP result.
    To clarify the meaning of ``more advantageous,'' we mean that a QP 
determination takes precedence over a Partial QP determination, which 
takes precedence over not meeting either threshold. Therefore, if one 
method results in a QP determination and the other results in a Partial 
QP determination, we would apply the QP determination and disregard the 
Partial QP determination. We note that this is distinct from the 
numerical score, which is not directly comparable across the payment 
amount and patient count methods due to the different percentage 
thresholds for the respective methods. A lower numerical patient count 
Threshold Score may actually result in a more advantageous QP result 
than a relatively higher numerical payment amount Threshold Score.
e. Services Furnished Through CAHs, FQHCs, and RHCs
(1) Critical Access Hospitals (CAHs)
    We proposed that professional services billed by CAHs under section 
1834(g)(2)(B) of the Act (Method II CAH professional services) would 
count towards the QP determination threshold calculations for both the 
Medicare payment amount and patient count methods in both the numerator 
and the denominator, as applicable. These services would constitute 
``covered professional services'' under section 1848(k)(3) of the Act 
because they are furnished by an eligible clinician and payment is 
based on the Medicare PFS. This policy is consistent with our treatment 
of payments for Method II CAH professional services for purposes of the 
EHR Incentive Program and PQRS adjustments under sections 1848(a)(7) 
and (8) of the Act, respectively. Under section 1848(a)(7) and (8) of 
the Act, the PQRS and EHR Incentive Program adjustments are applied to 
payments for covered professional services furnished by an eligible 
clinician in a Method II CAH.
    CAHs were established under the Balanced Budget Act (BBA) of 1997 
as a separate provider type with a distinct set of Medicare Conditions 
of Participation and their own payment methodology. CAHs are not 
subject to the Medicare Inpatient Prospective Payment System (IPPS) or 
the Medicare Outpatient Prospective Payment System (OPPS). Instead, 
CAHs are generally paid based on 101 percent of reasonable costs for 
inpatient services and are paid for outpatient services under one of 
two methods: the Standard Payment method outlined in section 1834(g)(1) 
of the Act (Method I), or the Optional Payment Method outlined in 
section 1834(g)(2) of the Act (Method II). A CAH is paid under Method I 
unless it elects to be paid under Method II.
    Under Method I, for cost reporting periods beginning on or after 
January 1, 2004, payments to CAHs are made for outpatient CAH facility 
services at 101 percent of reasonable costs. Physicians and 
practitioners receive payment for professional services under the 
Medicare PFS. A CAH may elect Method II billing, under which the CAH 
bills Medicare for both facility services and professional services 
furnished to its outpatients by a physician or

[[Page 77458]]

practitioner who has reassigned his or her billing rights to the CAH. 
Even if a CAH makes this election, each physician or practitioner who 
furnishes professional services to CAH outpatients can choose to 
either: (1) reassign his or her billing rights to the CAH, agree to be 
included under the Method II billing, attest in writing that he or she 
will not bill Medicare for professional services furnished in the CAH 
outpatient department, and receive payment from the CAH for the 
professional services; or (2) elect to file claims for his or her 
professional services with Medicare for standard payment under the 
Medicare PFS.
    As of January 1, 2004, payment for a physician's professional 
services provided at a CAH billing under Method II is 115 percent of 
the allowed amount, after applicable deductions, under the Medicare 
PFS. For a non-physician practitioner's professional services, the 
payment amount is 115 percent of the amount that otherwise would be 
paid for the practitioner's professional services, after applicable 
deductions, under the Medicare PFS.
(2) Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    RHCs and FQHCs are facilities that furnish services that are 
typically furnished in an outpatient clinic setting. They are located 
in areas that have been designated as underserved or health 
professional shortage areas (HPSAs), and meet other requirements.
    Under section 1833(a)(3) of the Act, RHCs are paid an all-inclusive 
rate (AIR) based on reasonable costs, subject under section 1833(f) of 
the Act to a maximum payment per visit that is established by Congress 
and updated annually based on the percentage change in the Medicare 
Economic Index (MEI) and subject to annual reconciliation. The per-
visit limit does not apply to RHCs determined to be an integral and 
subordinate part of a hospital with fewer than 50 beds. Laboratory 
tests (excluding venipuncture) and technical components of RHC services 
are paid separately. The RHC payment limit per visit for CY 2016 is 
$81.32, effective January 1, 2016, through December 31, 2016.
    The FQHC Medicare benefit was added when section 1861(aa) of the 
Act was amended by section 4161 of the Omnibus Budget Reconciliation 
Act of 1990. FQHCs are paid according to the FQHC PPS set out under 
section 1834(o) of the Act, in which Medicare pays a national 
encounter-based rate per beneficiary per day, with some adjustments. 
The unadjusted 2016 PPS rate is $160.60.
    We proposed that professional services furnished at RHCs and FQHCs 
that participate in ACOs, and are reimbursed under the RHC AIR or FQHC 
PPS (respectively), be counted towards the QP determination 
calculations under the patient count method but not under the payment 
amount method.
    In certain Medicare ACO APMs, RHC and FQHC services can be counted 
for purposes of attributing beneficiaries to an ACO. Therefore, we 
proposed to include beneficiaries attributed to an Advanced APM Entity 
in full or in part because of services furnished by RHCs or FQHCs in 
the patient counts used for QP determination calculations.
    As previously stated, section 1833(z)(2)(D) of the Act permits us 
to use patient counts in lieu of payments when determining whether an 
eligible clinician is a QP ``as the Secretary determines appropriate.'' 
Our proposal to include the professional services furnished by eligible 
clinicians at RHCs and FQHCs in the QP threshold calculations for the 
patient count method is essential to assure consistency with this 
program and existing APM attribution methodologies. An Advanced APM 
Entity is responsible for the cost and quality of care for all 
beneficiaries attributed to an APM Entity, including all professional 
services furnished to such beneficiaries, regardless of whether or not 
attribution was based on services furnished by an eligible clinician or 
by an RHC or FQHC. We believe such beneficiaries are clearly served 
through the Advanced APM Entity, and it would be potentially confusing 
to eligible clinicians and Advanced APM Entities to track this 
distinction strictly for purposes of QP determination. We also believe 
that it would be unduly burdensome and impractical for us to develop 
and maintain a separate list of beneficiaries aligned to each Advanced 
APM Entity from the full list of beneficiaries for whom an Advanced APM 
Entity is responsible under an Advanced APM.
    Because professional services furnished by eligible clinicians at 
RHCs and FQHCs are not reimbursed under, or based on, the Medicare PFS, 
professional services furnished in these settings do not constitute 
``covered professional services'' under section 1848(k)(3)(A) of the 
Act. In the Medicare Payment Amount Method, where payments for 
specified covered professional services are summed, only payments for 
covered professional services can be included.
    We believe that our proposal will continue to encourage the 
development of APMs that span rural and/or underserved areas. We 
solicited comment on this proposal.
    The following is a summary of the comments we received regarding 
our proposal to (1) include payments for Method II CAH professional 
services furnished by eligible clinicians in an Advanced APM Entity in 
the numerator of the Threshold Score for the payment amount method and 
(2) to allow Method II CAH professional services furnished by eligible 
clinicians in an Advanced APM Entity and professional services 
furnished by eligible clinicians in an Advanced APM Entity at RHCs and 
FQHCs to place a beneficiary in the numerator of the Threshold Score 
for the patient count method.
    Comment: A few commenters expressed support for the treatment of 
CAH, RHC, and FQHC services to enable them to be a factor in the 
patient count method. One commenter stated that FQHC clinicians should 
be eligible for the APM Incentive Payment.
    Response: If clinicians in RHCs or FQHCs meet the definition of 
eligible clinician set forth in section II.F.3. of this final rule with 
comment period and participate in an Advanced APM, then they will be 
considered for QP determination as part of the Advanced APM Entity 
along with all the other eligible clinicians in the group. The 
calculation of the APM Incentive Payment amount for an eligible 
clinician that practices at an RHC or FQHC will be subject to the 
specific criteria, which are based on Part B covered professional 
services, for calculating the APM Incentive Payment amounts outlined in 
section II.F.8.c. of this final rule with comment period.
    We are finalizing the policy as proposed. We will include payments 
for Method II CAH professional services furnished by eligible 
clinicians in an Advanced APM Entity in the numerator of the Threshold 
Score for the payment amount method. We will also count a beneficiary 
in the numerator of the Threshold Score for the patient count method if 
the beneficiary receives Method II CAH professional services furnished 
by eligible clinicians in an Advanced APM Entity and professional 
services furnished by eligible clinicians in an Advanced APM Entity at 
RHCs and FQHCs.

[[Page 77459]]

7. Combination All-Payer and Medicare Payment Threshold Option
a. Overview
    Beginning in 2021, in addition to the Medicare Option, eligible 
clinicians may alternatively become QPs through the All-Payer 
Combination Option, described under section 1833(z)(2)(B)(ii) and 
(C)(ii) of the Act as the Combination All-Payer and Medicare Payment 
Threshold Option. Thus, there will be two avenues for eligible 
clinicians to become QPs--the Medicare Option and the All-Payer 
Combination Option. An eligible clinician need only meet the QP 
threshold under one of the two options to be a QP for the payment year. 
The All-Payer Combination Option provides an incentive for eligible 
clinicians to participate in payment arrangements with payers other 
than Medicare Part B that have payment designs similar to Advanced 
APMs. The All-Payer Combination Option uses both the methods described 
in the Medicare Option and methods that calculate payments for all 
services from all payers, with certain exceptions, that are 
attributable to participation in both Advanced APMs and Other Payer 
Advanced APMs.
    Although the statutory QP threshold for an eligible clinician to be 
a QP (the QP Payment Amount Threshold) under the Medicare Option 
increases from 25 percent in 2019 and 2020 under section 1833(z)(2)(A) 
of the Act, to 50 percent in 2021 and 2022 under section 
1833(z)(2)(B)(i) of the Act, to 75 percent beginning in 2023 under 
section 1833(z)(2)(C)(i) of the Act, the All-Payer Combination Option 
allows eligible clinicians with lower levels of participation in 
Advanced APMs to become QPs through sufficient participation in Other 
Payer Advanced APMs with payers such as State Medicaid programs and 
commercial payers, including Medicare Advantage plans. Section 
1833(z)(2)(D) of the Act also allows the QP determination to be based 
on payment amount or on counts of patients in lieu of payments using 
the same or similar percentage criteria. These QP thresholds are 
presented in Tables 36 and 37 of this final rule with comment, and the 
process for the payment amount method is shown in Figures H and I of 
this final rule with comment. We may reassess the QP Patient Count 
Thresholds in future years based on the experience gained during the 
first years of operations.
    In summary, in addition to becoming QPs through the Medicare 
Option, eligible clinicians may alternatively become QPs through the 
All-Payer Combination Option if the following steps occur as described 
in the associated sections of the proposed rule: (1) the eligible 
clinician submits to CMS sufficient information on all relevant payment 
arrangements with other payers; (2) based upon that information CMS 
determines that at least one of those payment arrangements is an Other 
Payer Advanced APM; (3) the eligible clinician meets the relevant QP 
thresholds by having sufficient payments or patients attributed to a 
combination of participation in Other Payer Advanced APMs and Advanced 
APMs.

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[[Page 77461]]


[GRAPHIC] [TIFF OMITTED] TR04NO16.016

    Sections 1833(z)(2)(B)(ii) and (C)(ii) of the Act describe the 
payment amount method for making the QP determination under the All-
Payer Combination Option. For purposes of making a QP determination 
under this option, a QP is an eligible clinician for whom it is 
determined that items and services furnished by such a professional 
during the most recent period for which data are available (which may 
be less than a year) and where the specified percent of the sum of 
combined Medicare payments and all other payments regardless of payer 
are through Advanced APMs and Other Payer Advanced APMs that meet the 
criteria set forth in this section.
    The following is a summary of the comments we received regarding 
our overall approach to the All-Payer Combination Option.
    Comment: Several commenters supported aligning policies for the 
All-Payer Combination Option with those for the Medicare Option and 
emphasized the value of consistent models, measures, and reporting 
mechanisms across payers. One commenter appreciated our recognition of 
eligible clinicians engaging in APMs with payers other than Medicare 
and recommended that CMS minimize administrative burdens associated 
with such eligible clinicians demonstrating their participation in 
Other Payer Advanced APMs. Another commenter supported the proposal to 
implement the All-Payer Combination Option beginning in 2021.
    By contrast, one commenter expressed concern about extending 
Advanced APMs to other payer arrangements by identifying Other Payer 
Advanced APMs. Another commenter noted we have historically emphasized 
the importance of engaging multiple payers in payment reform, but has 
never suggested that commercial payers must offer identical 
arrangements to those CMS offers or replicate CMS payment models. One 
commenter opposed using the same criteria to determine both Advanced 
APM and Other Payer Advanced APMs, noting that these criteria would 
require large-scale renegotiation of payer contracts, which may not be 
within an organization's control. One commenter recommended CMS abandon 
the All-Payer

[[Page 77462]]

Combination Option. Two commenters suggested that the All-Payer 
Combination Option be made effective earlier than payment year 2021, 
preferably payment year 2019. Another commenter encouraged CMS to 
accept risk-based non-Medicare contracts as Other Payer Advanced APMs 
beginning in payment year 2019. The commenter stated that clinicians 
who have invested in the transition to value-based care with many of 
their payers should not have to wait until 2021 to be rewarded.
    Response: We appreciate the support for our proposed approach. We 
recognize that the All-Payer Combination Option will require 
adjustments and transitions. However, the All-Payer Combination Option 
is required by the statute, and we believe that it represents a 
promising opportunity for those participating in certain other payer 
arrangements to participate in the Advanced APM framework. The statute 
specifies the criteria for Other Payer Advanced APMs, and that those 
criteria generally mirror the Advanced APM criteria. However, the Other 
Payer Advanced APM criteria only address certain aspects of payment 
arrangements, leaving substantial room for flexibility. Just as they do 
for Advanced APMs, the criteria allow for exploration and testing of 
alternative payment arrangements that can improve quality and reduce 
cost. Finally, the statute does not allow us to make the All-Payer 
Combination Option effective prior to payment year 2021.
    Comment: A commenter suggested CMS clearly define the process for 
determining whether a payment arrangement is an Other Payer Advanced 
APM. One commenter encouraged CMS to be flexible in the application of 
Other Payer Advanced APM criteria in order to encourage other payers to 
innovate. One commenter noted that among the 24 APMs reviewed by CMS, 
only six met all of the proposed criteria to be an Advanced APM, and 
that given these limitations, the commenter did not believe CMS has the 
flexibility to bring as many physicians as possible into Advanced APMs. 
As a result, this commenter believes Other Payer Advanced APMs and 
PFPMs might become more important to CMS goals, and recommended 
offering flexibility in the Other Payer Advanced APM criteria. One 
commenter recommended CMS provide additional flexibility to recognize 
as Other Payer Advanced APMs private payer reimbursement arrangements 
that accomplish high quality and efficient care but may not meet the 
Other Payer Advanced APM criteria. Another commenter recommended that 
the approach to assessing whether a payment arrangement will qualify as 
an Other Payer Advanced APM should be phased in so that initially, 
participation in any payment arrangement that meets some of the 
criteria could be considered an Other Payer Advanced APM, and then all 
three criteria would apply at a later time.
    Response: We appreciate the comments and the widespread desire to 
make as many Other Payer Advanced APMs available as possible. The 
statute requires us to use the three criteria discussed in section 
II.F.7.b. of this final rule with comment period as the basis for 
determining whether a payment arrangement is an Other Payer Advanced 
APM. We believe our proposed and final policies adhere to the statute 
as well as to our principles and reflect the commenters' suggestions to 
allow substantial flexibility in the design of payment arrangements 
when implementing the Quality Payment Program.
    Comment: Several commenters stated that CMS should include a 
thorough proposal of the criteria for Other Payer Advanced APMs in the 
CY 2018 PFS and/or issue subregulatory guidance.
    Response: We appreciate the comments. We are not sure at this time 
the exact vehicles through which we will establish policies and publish 
more information in the future, but we intend to inform the public 
regarding developments in the All-Payer Combination Option and Other 
Payer Advanced APM criteria through future rulemaking and subregulatory 
guidance.
    Comment: One commenter believes that the inclusion of all-payer 
data in APMs was the most important provision of the proposed rule and 
stated that the number of different measures and incentives across all 
payers created unnecessary burden and would be difficult to compare 
across APMs and payers. The same commenter recommended a standardized 
attribution model to ensure equitable treatment of models across 
payers. Some commenters requested to have additional guidance on the 
data collection requirements and the determination of Other Payer 
Advanced APMs as soon as practicable. Another commenter expressed 
concern that the proposed All-Payer Combination Option extends the CMS 
collection of, and access to, data beyond those of Medicare patients. 
One commenter supported multi-payer engagement but was concerned about 
the willingness of commercial payers to support value-based 
arrangements. This commenter implored CMS to mandate that commercial 
payers share full claims data sets to allow clinicians to manage risk 
and patient populations.
    Response: We do not believe that we are creating an unnecessary 
burden, but rather that we are proposing an approach to implementing 
the statute that is clear and flexible enough to be applicable to the 
diversity of payment arrangements. We do not believe a standardized 
attribution model is appropriate at this stage given the breadth of 
payment arrangements across payers. We are not sure at this time the 
exact vehicles through which we will establish policies and publish 
more information in the future, but we intend to inform the public 
regarding developments in the All-Payer Combination Option and Other 
Payer Advanced APM criteria through future rulemaking and subregulatory 
guidance.
    Comment: Several commenters requested that some flexibility be 
provided to states in assessing their models. One commentator said that 
the three Other Payer Advanced APM criteria are broadly reflective of 
the direction states are seeking to move. One commenter noted that 
states and clinicians are at different points along a continuum towards 
their ability to meet the criteria, and states are implementing changes 
in a manner that reflects local health care markets and the Medicaid 
populations they serve. The commenter stated that recognition of the 
variation among states in the development and implementation of APMs is 
essential to accommodate Medicaid APMs, given the unique needs of 
Medicaid beneficiaries, different health care provider risk-bearing 
capacity, and health care provider infrastructure issues that states 
may confront. Specifically, the commenter recommended that there should 
be a clear optional pathway for states to contact CMS in order to have 
Other Payer Advanced APMs be identified or deemed as such. Some 
commenters suggested that Medicaid APMs developed under the CPC+ model 
or the State Innovation Models (SIM) should be considered Other Payer 
Advanced APMs.
    Another commenter recommended that CMS establish a process to 
approve state-operated APMs so that clinicians can be aware of which 
payment arrangements will be Other Payer Advanced APMs. One commenter 
believes CMS needs to clearly articulate a process for how it will 
determine Other Payer Advanced APMs in states that are engaged with CMS 
in the development of Other Payer Advanced APMs.

[[Page 77463]]

    Response: We acknowledge that there is variation among Medicaid 
programs in the development and implementation of alternative payment 
models, which is in part due to varying state circumstances. We seek 
comment and input on the potential creation of a separate pathway to 
determine whether Medicaid APMs are Other Payer Advanced APMs prior to 
a QP Performance Period for the All-Payer Combination Option.
    Comment: One commenter supported the proposed definition for 
Medicaid APMs stating that it provides some flexibility for states to 
implement new payment models and align core requirements for Medicaid 
APMs with the broader Advanced APM and Other Payer Advanced APM 
criteria. One commenter requested additional flexibility and 
consideration for state models, such as population-based payment 
models.
    One commenter supported the proposal to assess Medicaid APMs under 
the Other Payer Advanced APM criteria and to include the Medicaid APM 
as part of the All-Payer Combination Option. This commenter agreed that 
CMS should generally defer to states in their design of these payment 
arrangements. The commenter also agreed with the proposal that if a 
state does not offer a Medicaid APM that meets the Other Payer Advanced 
APM criteria, then Medicaid payments and patients would be excluded 
from the All-Payer Combination Option calculations. Another commenter 
supported the criteria for Other Payer Advanced APMs and recommended 
including Medicare Advantage and state programs created through the 
Medicaid Health Home State Plan Option in the All-Payer Combination 
Option calculations.
    Response: We appreciate the comments and support for our proposals. 
We believe that the Other Payer Advanced APM criteria allow for 
flexibility in the design of Medicaid APMs that can be considered Other 
Payer Advanced APMs. However, as discussed in this section, we are 
interested in conducting further analysis and seeking further comment 
on the appropriate criteria for certain payers.
    Comment: One commenter encouraged CMS to work with stakeholders in 
creating and streamlining a process for assessing Other Payer Advanced 
APMs given the inherent complexity of these arrangements. Some 
commenters also encouraged CMS to work with state Medicaid agencies on 
a parallel process to approve state-supported models, whether through 
their FFS program or managed care arrangements. Another commenter 
believes that clinicians will have difficulty determining which of 
their contracts count as Other Payer Advanced APMs in time for them to 
know if they should try to alter a contract to make it an Other Payer 
Advanced APM. To resolve this, the commenter suggested that CMS have a 
process whereby payers submit models to CMS for basic approval of the 
specifications as Other Payer Advanced APMs in advance of parties 
finalizing contracts. Two commenters suggested CMS work with the Health 
Care Payment Learning and Action Network (LAN) to support this process.
    Response: We appreciate the comments. We seek public comment on the 
possibility of establishing a process to prospectively engage in design 
and review of payment arrangements to determine if they meet the 
criteria for being Other Payer Advanced APMs, particularly regarding 
the assessment of Medicaid APMs. In addition, we will continue to 
communicate our work to the LAN.
    After considering public comments, we are finalizing our overall 
approach to the All-Payer Combination Option as proposed. We are 
seeking additional comments on the creation of an optional pathway for 
states to seek a determination from CMS on whether a Medicaid payment 
arrangement is an Other Payer Advanced APM. We are also seeking 
additional comments on the overall process for reviewing payment 
arrangements in order to determine whether they are Other Payer 
Advanced APMs.
b. Other Payer Advanced APM Criteria
(1) In General
    According to section 1833(z)(2)(B)(iii) of the Act, a payment 
arrangement is an Other Payer Advanced APM if it meets three criteria:
     CEHRT is used;
     Quality measures comparable to measures under the MIPS 
quality performance category apply; and
     The payment arrangement either: (1) requires APM Entities 
to bear more than nominal financial risk if actual aggregate 
expenditures exceed expected aggregate expenditures; or (2) for 
beneficiaries under title XIX, is a Medicaid Medical Home Model that 
meets criteria comparable to Medical Home Models expanded under section 
1115A(c) of the Act.
    Payment arrangements under any payer other than traditional 
Medicare, including Medicare Advantage and other Medicare-funded 
private plans, will be Other Payer Advanced APMs if they meet all three 
criteria.
(2) Medicaid APMs
    We proposed to define a Medicaid APM as a payment arrangement under 
title XIX that meets the criteria to be an Other Payer Advanced APM as 
proposed. States can choose from different authorities in title XIX 
when implementing new payment models. We believe this proposal would 
provide some flexibility for States but align the core requirements for 
Medicaid APMs with the broader Advanced APM and Other Payer Advanced 
APM criteria. Otherwise, we intend to generally defer to states in 
their design of payment arrangements.
(3) Medicaid Medical Home Models
    We proposed that a Medicaid Medical Home Model is a Medical Home 
Model that is operated under title XIX instead of under section 1115A 
of the Act. We specifically identified Medicaid Medical Home Models 
because section 1833(z) of the Act mentions both medical homes 
generally and medical homes for beneficiaries under title XIX several 
times, but does not define the terms. Medicaid Medical Home is also not 
defined in title XIX or in Medicaid laws or regulations. Therefore, we 
needed to define the terms because of their importance in the Quality 
Payment Program. This definition of Medicaid Medical Home Model applies 
only for the purposes of the Quality Payment Program. We proposed that 
a Medicaid Medical Home Model must have the following elements at a 
minimum:
     Model participants include primary care practices or 
multispecialty practices that include primary care physician and 
practitioners and offer primary care services, and
     Empanelment of each patient to a primary clinician.
    In addition to these elements, we proposed that a Medicaid Medical 
Home Model must have at least four of the following elements:
     Planned chronic and preventive care.
     Patient access and continuity.
     Risk-stratified care management.
     Coordination of care across the medical neighborhood.
     Patient and caregiver engagement.
     Shared decision-making.
     Payment arrangements in addition to, or substituting for, 
FFS payments (for example, shared savings, population-based payments).
    This definition of Medicaid Medical Home Model applies only for the 
purposes of the Quality Payment Program, and could be defined 
differently for other purposes. To define these terms, we reviewed 
existing and

[[Page 77464]]

past Medical Home Models CMS developed under section 1115A of the Act, 
including the Comprehensive Primary Care Initiative (CPC). In addition, 
we reviewed a variety of other sources including several from the 
National Committee for Quality Assurance, the Joint Principles of the 
Patient-Centered Medical Home (a joint statement by the American 
Academy of Family Physicians, the American Academy of Pediatrics, the 
American College of Physicians, and the American Osteopathic 
Association), and the Agency for Healthcare Research and Quality. Our 
proposed definition of Medicaid Medical Home Model uses common elements 
from these sources. We believe that using a common set of elements 
ensures general comparability between Medical Home Models and Medicaid 
Medical Home Models while maintaining flexibility for the states under 
title XIX. We did not propose adhering to any particular organization's 
accreditation process for Medical Home Models or Medicaid Medical Home 
Models. We believe that such a policy would provide limited additional 
benefit while unnecessarily restricting state innovation. However, it 
is possible that accredited models, such as those certified by the 
National Committee on Quality Assurance, may also meet the definition 
of a Medicaid Medical Home Model. Medicaid Medical Home Models can be 
Other Payer Advanced APMs if they meet the criteria.
    We solicited comment on the proposed definitions of Medicaid APMs 
and Medicaid Medical Homes Models.
    The following is a summary of the comments we received regarding 
our definitions of Medicaid APMs and Medicaid Medical Home Models. 
Additional comments on the definition of Medicaid Medical Home Models 
were considered as part of the response to the definition of Medical 
Home Models in section II.F.3. of this final rule with comment period.
    Comment: One commenter applauded CMS for developing an appropriate, 
physician-friendly, and patient-centered framework for Medicaid Medical 
Home Models, and agreed with CMS' proposal not to mandate a specific 
method or accreditation process for recognizing Medicaid Medical Home 
Models. Another commenter supported the proposal regarding Medicaid 
Medical Home Models.
    Several commenters believed CMS should provide states flexibility 
in designing and implementing their Medicaid Medical Home Models. One 
commenter suggested the rule should enable states to deem and define 
their own patient-centered medical home programs and determine if it is 
a Medicaid Medical Home Model. Another commenter recommended that Other 
Payer Advanced APMs should include state-sponsored patient-centered 
medical home models that have demonstrated improvements in cost, 
quality, and patient experience through an evaluative process. Another 
commenter recommended CMS permit greater flexibility in enabling 
Medicaid Medical Home Models to qualify as Other Payer Advanced APMs. 
One commenter recommended state-based medical homes models should be 
considered Other Payer Advanced APMs.
    One commenter recommended CMS recognize robust regional programs 
when assigning credit for nationally recognized medical home models. 
Another commenter recommended that the proposed Medicaid Medical Home 
Model definition be expanded to include partnerships across sectors 
designed to improve population health and achieve health equity.
    One commenter recommended that CMS require Other Payer Advanced 
APMs to meet all of the proposed primary care practice criteria and 
characteristics required of Medical Home Models.
    Response: We appreciate these comments. We believe the proposed 
definition of Medicaid Medical Home Model provides states with 
significant flexibility for implementation. Nothing in the definition 
precludes states from deeming and defining their own medical home 
programs. As proposed, the rule does not endorse any specific 
certification process for Medicaid Medical Home Models. However, we 
retain the authority to determine whether any payment model under title 
XIX meets our criteria to be a Medicaid Medical Home Model or Other 
Payer Advanced APMs. We do not believe at this time that it is 
appropriate to create additional criteria for Other Payer Advanced APMs 
beyond those set forth in the statute. We are adopting a definition for 
Medicaid Medical Home Model because it is necessary to interpret an 
undefined term used in the statute and identifies a subset of payment 
arrangements that are treated slightly different under the Other Payer 
Advanced APM criteria.
    Comment: Some commenters requested CMS consider options for 
categorizing IHS, Tribal, and Urban Indian health programs as Other 
Payer Advanced APMs. One commenter questioned how the financial risk 
requirement will impact IHS, Tribal, and Urban Indian facilities.
    Response: We support the pursuit of developing Other Payer Advanced 
APMs under a variety of health care payment programs. Payment 
arrangements not included under Medicare Part B could potentially 
qualify as Other Payer Advanced APMs for QP Performance Periods in 2019 
and later.
(4) Use of Certified Electronic Health Record Technology
    To be an Other Payer Advanced APM, as described under section 
1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act, 
payments must be made under arrangements in which CEHRT is used. This 
requirement is slightly different than the requirement for Advanced 
APMs that ``requires participants in such model to use certified EHR 
technology (as defined in section 1848(o)(4) of the Act),'' as 
specified in section 1833(z)(3)(D)(i)(I) of the Act. Although the 
statutory requirements are phrased slightly differently, we believe 
that there is value in keeping the two standards--for Advanced APMs and 
Other Payer Advanced APMs--as similar as possible.
    We proposed that payment arrangements would meet this Other Payer 
Advanced APM criterion under sections 1833(z)(2)(B)(iii)(II)(bb) and 
(z)(2)(C)(iii)(II)(bb) of the Act by requiring participants to use 
CEHRT as defined for MIPS and APMs under Sec.  414.1305. This approach 
is consistent with the approach for Advanced APMs as described in 
section II.F.4.b.(1) of this final rule with comment period. In the 
2015 EHR Incentive Programs final rule (80 FR 62872 through 62873), we 
established the definition of CEHRT for EHR technology that must be 
used by eligible clinicians to meet the meaningful use objectives and 
measures in specific years. In the proposed rule, we proposed to adopt 
the specifications from within the current definition of CEHRT in our 
regulation at Sec.  414.1305 for eligible clinicians participating in 
MIPS or in APMs. This definition is identical to the definition for use 
by eligible hospitals and CAHs and Medicaid eligible clinicians in the 
EHR Incentive Programs.
    In accordance with section 1833(z)(2)(C)(iii)(II) of the Act, we 
proposed that an Other Payer Advanced APM must require at least 75 
percent of eligible clinicians in each participating APM Entity (or 
each hospital if hospitals are the APM participants) to use the 
certified health IT functions outlined in the proposed definition of 
CEHRT to document and communicate

[[Page 77465]]

clinical care with patients and other health care professionals.
    We solicited comment on the proposed definition of CEHRT for 
Advanced APMs and Other Payer Advanced APMs and whether they should be 
the same for both. We solicited comment on the proposed method for 
Other Payer Advanced APMs to meet the CEHRT use criterion.
    The following is a summary of the comments we received regarding 
our proposal to require a payment arrangement to use CEHRT in order to 
become an Other Payer Advanced APM.
    Comment: One commenter agreed with the importance of leveraging 
EHRs and clinical data to improve the coordination of care and improved 
outcomes through APMs. The same commenter encouraged CMS to use the 
full extent of its regulatory authority to build on existing efforts to 
support adoption and use of HIT among behavioral health and Long Term 
Support Service (LTSS) providers. The commenter appreciated the steps 
CMS has already taken to encourage investment in the HIT infrastructure 
for key Medicaid providers and suppliers, including behavioral health 
and LTSS providers.
    An additional commenter stated CMS should not dictate which edition 
of CEHRT must be included in a third party contract. Likewise, the 
commenter stated that CMS should not lock in a level of participation 
at this time, but instead monitor the performance and make a 
determination in a later rule. Another commenter expressed concern 
about an increased EHR burden on clinicians because of the cost of 
implementing the technology. One commenter recommended a requirement 
that Other Payer Advanced APMs meet all measures that currently exist 
in Meaningful Use standards, including access to discrete records, 
reference disease registries, receive care alerts, provide decision 
support, have access to lab results, and support a patient portal.
    Response: We appreciate the comments. Sections 
1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act 
specifies that to be an Other Payer Advanced APM, the arrangement must 
be one in which CEHRT is used. By aligning this requirement with the 
CEHRT requirements in the advancing care information and Advanced APM 
sections of this rule, this criterion avoids adding different EHR-
related requirements that Other Payer Advanced APMs must place on their 
participants. Under this CEHRT criterion, we believe there is 
significant flexibility for other payers to tailor HIT requirements to 
their particular populations and goals. We do not believe any 
additional requirements are warranted.
    Comment: One commenter agreed the definitions for CEHRT should be 
the same for both Advanced APMs and Other Payer Advanced APMs. One 
commenter supported CMS' proposal to align the definition of CEHRT for 
purposes of MIPS, Advanced APMs, and other payer arrangements so as not 
to place undue burden on eligible clinicians participating in Other 
Payer Advanced APMs. The commenter requested CMS clarify the proposed 
method for Other Payer Advanced APMs to meet the CEHRT use criterion. 
The commenter also requested confirmation that, as with Advanced APMs, 
the requirements relate to the terms of the payment arrangement, not 
directly to the performance of each APM Entity or eligible clinician. 
One commenter suggested that other payers should be able to require 
that clinicians in any APM Entity using CEHRT use the functionality of 
the CEHRT so that they can report on applicable objectives and measures 
specified for the advancing care information performance category under 
MIPS. Another commenter expressed that EHR systems generally do not 
communicate well between physicians, laboratories, and hospitals, and 
believes that eligible clinicians should not be penalized for these 
system problems.
    Response: We appreciate the comments and support for alignment of 
criteria between Advanced APMs and Other Payer Advanced APMs. Regarding 
the method for meeting this criterion, we confirm for commenters that 
the CEHRT requirement in this final rule--like all Other Payer Advanced 
APM criteria--is of the payment arrangement. Payment arrangements, not 
clinicians or entities, are determined to be Other Payer Advanced APMs. 
Therefore, a payer retains the flexibility to specify the use of CEHRT 
in a variety of ways that may be more stringent that this criterion 
requires, and would still meet this criterion to be an Other Payer 
Advanced APM so long as it ascertains that the required percentage of 
eligible clinicians in each APM Entity use CEHRT. Accordingly, we do 
not penalize individual clinicians for performance under this 
criterion. These requirements exist only to determine whether the 
structure of a payment arrangement meets the Other Payer Advanced APM 
criteria. These topics are discussed in more depth in section 
II.F.4.b.(1) of this final rule with comment.
    Comment: One commenter objected to our proposal to require a 
threshold for CEHRT use as is required for Advanced APMs, and thought 
that a threshold for CEHRT use was supported less by the statute in the 
case of the Other Payer Advanced APMs. Another commenter recommended 
that CMS relax the requirement that 75 percent of the clinicians use 
CEHRT to instead allow for glide paths that are tailored to each Other 
Payer Advanced APM's particular needs and capabilities. For example, 
the commenter suggested that payers should be required to reach 75 
percent within the first 3 to 6 years of implementation. One commenter 
requested that states have the ability to set the CEHRT use percent 
criterion that defines participation in Other Payer Advanced APMs. They 
believed that a 75 percent threshold is too high given the lack of 
CEHRT uptake among key Medicaid clinicians.
    Response: We appreciate the comments. As part of the alignment with 
CEHRT requirements across the Quality Payment Program, we are reducing 
the level of CEHRT use that an Other Payer Advanced APM must require of 
eligible clinicians in each APM Entity from 75 percent to 50 percent.
    After considering public comments, we are modifying our proposal 
and finalizing that to be an Other Payer Advanced APM, a payment 
arrangement must require at least 50 percent of participating eligible 
clinicians in each APM Entity to use CEHRT to document and communicate 
clinical care.
(5) Application of Quality Measures Comparable to Those Under the MIPS 
Quality Performance Category
    Sections 1833(z)(2)(B)(ii)(II)(aa) and (C)(iii)(II)(aa) of the Act 
specify that, to be an Other Payer Advanced APM, a payment arrangement 
must apply quality measures comparable to those under the MIPS quality 
performance category. We proposed that the quality measures on which 
the Other Payer Advanced APM bases payment must include at least one of 
the following types of measures provided that they have an evidence-
based focus and are reliable and valid:
    (1) Any of the quality measures included on the proposed annual 
list of MIPS quality measures;
    (2) Quality measures that are endorsed by a consensus-based entity;
    (3) Quality measures developed under section 1848(s) of the Act;
    (4) Quality measures submitted in response to the MIPS Call for 
Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or

[[Page 77466]]

    (5) Any other quality measures that CMS determines to have an 
evidence-based focus and are reliable and valid.
    We proposed that not all quality measures in an APM are required to 
be ``MIPS comparable'' and not all payments under the APM must be based 
on comparable measures. This approach is similar to the requirement for 
Advanced APMs as described in section II.F.4.b.(2) of this final rule 
with comment period. We believe that under the proposed policy, Other 
Payer Advanced APMs would retain sufficient freedom to innovate in 
paying for services and measuring quality. In other words, this 
criterion only sets standards for payments tied to quality measurement, 
not other methods of payment. Conversely, a payment arrangement may 
test new quality measures that do not fall into the MIPS-comparable 
standard. So long as the payment arrangement meets the requirements set 
forth in this criterion, there is no additional prescription for how 
the payment arrangement tests additional measures that may or may not 
meet the standards under this criterion.
    We want to encourage the use of outcome measures for quality 
performance assessment in Other Payer Advanced APMs, so we also 
proposed that an Other Payer Advanced APM must include at least one 
outcome measure if an appropriate measure (that is, the measure 
addresses the specific patient population and is specified for the 
participants' clinical setting) is available on the MIPS list of 
measures for that specific QP Performance Period.
    We believe that this framework will provide other payers the 
flexibility needed to ensure that their quality performance metrics 
meet their unique goals. We solicited comment on this proposed 
criterion.
    The following is a summary of the comments we received regarding 
our proposal that an Other Payer Advanced APM must provide for payment 
for covered professional services to include quality measures 
comparable to MIPS measures under the performance category.
    Comment: One commenter agreed with the proposed flexibility in 
selecting quality measures that are evidence-based, reliable and valid. 
One commenter supported the proposal for Other Payer Advanced APMs to 
require eligible clinicians to report at least one quality measure 
comparable to measures included in the MIPS measures list. Another 
commenter stated CMS should consider Medicaid Core Measures to be MIPS-
comparable and incorporate a review of private payer measures. The same 
commenter stated CMS should require an outcome measure, regardless of 
whether it is a measure included in the MIPS measure list. Another 
commenter also stated that an outcome measure should be required 
regardless of whether an appropriate measure included in the MIPS 
measure list. A different commenter opposed an approach that would 
require physicians to report on a complex set of measures that do not 
impact or influence the quality of care provided to patients. The 
commenter believes all measures used in MIPS and APMs must be 
clinically relevant, harmonized among all public and private payers, 
and minimally burdensome to report. In addition, commenters recommended 
CMS use the core measure sets by the multi-stakeholder Core Quality 
Measures Collaborative.
    Response: We believe that the proposal provides a balance between 
the flexibility for implementing payment arrangements that payers need 
while also ensuring that the statutory requirement for MIPS-comparable 
quality measures is met. For example, based on our review, we believe 
the proposed criteria for an Other Payer Advanced APM allows for the 
use of Medicaid Core Measures because they are comparable to MIPS 
quality measures. We also agree with the commenters that the Core 
Quality Measure Collaborative, may be a valuable source of measures for 
inclusion in Other Payer Advanced APMs. We continue to believe that the 
requirement for an outcome measure is appropriate. Given the dearth of 
appropriate outcome measures for some specialties, we believe it is 
reasonable at this time to maintain the policy as proposed, which only 
requires the use of an outcome measure if there is an applicable one 
available on the MIPS list of quality measures. In addition, we believe 
that when quality measures are tied to payments, they do have an impact 
on the quality of care patients receive. Further discussion of quality 
measures and their comparability to MIPS can be found in section 
II.F.4.b.(2) of this final rule with comment period.
    After considering public comments, we are finalizing our proposal 
without changes. To be an Other Payer Advanced APM, a payment 
arrangement must base payment on quality measures that are evidence-
based, reliable, and valid. At least one such measure must be an 
outcome measure unless there is not an applicable outcome measure on 
the MIPS quality measure list for the QP Performance Period. The 
outcome measure used does not have to be one of those on the MIPS 
quality measure list.
(6) Financial Risk for Monetary Losses
    As described in sections 1833(z)(2)(B)(iii)(II)(cc) and 
(C)(iii)(II)(cc) of the Act, the third criterion that a payment 
arrangement must meet to be an Other Payer Advanced APM is that under 
the arrangement, the APM Entity must either bear more than nominal 
financial risk if actual aggregate expenditures exceed expected 
aggregate expenditures or the arrangement is a Medicaid Medical Home 
Model that meets criteria comparable to Medical Home Models expanded 
under section 1115A(c) of the Act.
    The financial risk standard under this criterion is similar to the 
criterion we are finalizing for Advanced APMs. For purposes of 
determining whether the payment arrangement is an Other Payer Advanced 
APM, this proposal does not impose any additional performance criteria, 
such as actual achievement of savings, on APM Entities in other payer 
arrangements. As with all of the Advanced APM criteria, this 
requirement pertains to the payment arrangement structure, not to the 
performance of the participants within the payment arrangement.
    This section is divided into two main parts: (1) What it means for 
an APM Entity to bear financial risk if actual aggregate expenditures 
exceed expected aggregate expenditures under a payment arrangement; and 
(2) what amounts of risk are considered to be more than nominal.
(a) Bearing Financial Risk for Monetary Losses
    We proposed a generally applicable standard for Other Payer 
Advanced APMs and a slightly different standard for Medicaid Medical 
Home Models. We want to be consistent with and comparable to the 
Advanced APM financial risk standard within the limits of the statute.
(i) Generally Applicable Other Payer Advanced APM Financial Risk 
Standard
    We proposed that the generally applicable financial risk standard 
for Other Payer Advanced APMs would be that a payment arrangement must, 
if APM Entity actual aggregate expenditures exceed expected aggregate 
expenditures during a specified performance period:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;

[[Page 77467]]

     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians; or
     Require direct payments by the APM Entity to the payer.
    We believe this financial risk criterion best distinguishes most 
payment arrangements from those that are focused on challenging 
physicians and practitioners to assume risk and provide high value 
care. We expect that an increasing proportion of other payer 
arrangements will meet that bar over time. This proposal is based on 
the statutory requirement that the APM Entity bear risk if aggregate 
actual expenditures exceed aggregate expected expenditures under the 
model, and is consistent with our proposal for the corresponding 
criterion proposed for Advanced APMs. We understand that many 
stakeholders believe that business risk should be sufficient to meet 
this Advanced APM criterion. We do not intend to minimize the 
substantial time and financial commitments that APM Entities invest to 
become successful APM participants. We note that there is also 
difficulty in creating an objective and enforceable standard for 
determining whether an entity's business risk exceeds a nominal amount, 
and that the statutory framework for the APM Incentive Payment 
recognizes that not all alternative payment arrangements will meet the 
criteria to be considered for purposes of the QP determination. We 
solicited comments regarding the proposed standard and whether there 
are other types of arrangements that should be incorporated into the 
standard.
    The following is a summary of the comments we received regarding 
our proposal to set a generally applicable Other Payer Advanced APM 
financial risk standard.
    Comment: One commenter supported using similar criteria to those 
proposed for Advanced APM criteria to assess the financial risk in the 
payment arrangement. A few commenters recommended CMS consider broad 
financial risk requirements so that clinicians can meet the Other Payer 
Eligible APM criteria. One commenter noted that it may be difficult to 
design Other Payer Advanced APMs that both meet the proposed financial 
risk standards and are attractive to eligible clinicians, and requested 
CMS to consider adding flexible arrangements that meet the spirit of 
the statute while not necessarily meeting the exact criteria that 
eligible clinicians share risk. Another commenter recommended that CMS 
give Other Payer Advanced APMs more flexibility in defining risk 
standards and not require complete alignment of risk definitions, as 
payers need a period of flexibility in tailoring risk arrangements 
depending on the type or maturity of the APM model, its population 
characteristics, and unique market conditions. Specifically, the 
commenter recommended that CMS give other payers the same flexibility 
to align, not match perfectly, their risk models under Other Payer 
Advanced APMs as under the Comprehensive Primary Care Plus (CPC+) 
model. Another commenter opposed the proposed financial risk standard 
for Other Payer Advanced APMs because the commenter stated that it 
places an arbitrary imposition of financial risk upon clinicians and 
violates the intent of the law.
    Response: We appreciate the comments. We believe that in order to 
implement the statute, it is important to have a meaningful financial 
risk standard. We believe the proposed elements are well established. 
And while they are intended to be challenging, they also provide for 
flexibility in the design of Other Payer Advanced APMs. We also believe 
that the financial risk standard provides flexibility to states and 
private payers in the design of their payment arrangements.
    Comment: Another commenter said there are opportunities and 
challenges with a federally-set benchmark for risk that would be 
applied to Medicaid APMs, and further understanding of these issues is 
needed before the rule is finalized. This commenter opined states are 
working to incorporate shared accountability for quality and outcomes 
with eligible clinicians through both FFS and capitated managed care 
models. However, there are both merits and challenges in setting a 
federal benchmark for the level of risk that Medicaid APMs must assume 
to be considered Other Payer Advanced APMs.
    Response: We appreciate the comments. We agree that further 
research and analysis on the level of nominal risk would be 
appropriate, particularly for Medicaid APMs, which is why we are 
seeking additional comments on setting specific levels for nominal risk 
as discussed in section II.F.7.(b) of this final rule with comment 
period.
    After considering public comments, we are finalizing our proposal 
to set a generally applicable Other Payer Advanced APM financial risk 
standard, as proposed, without changes. The generally applicable 
financial risk standard for Other Payer Advanced APMs is that, if the 
APM Entity's actual aggregate expenditures exceed expected aggregate 
expenditures during a specified performance period, the payer will:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians; or
     Require direct payments by the APM Entity to the payer.
(ii) Medicaid Medical Home Model Financial Risk Standard
    We proposed that for a Medicaid Medical Home Model to be an Other 
Payer Advanced APM if the APM Entity's actual aggregate expenditures 
exceed expected aggregate expenditures, the Medicaid Medical Home Model 
must:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians;
     Require direct payment by the APM Entity to the Medicaid 
program; or
     Require the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments.
    For instance, a Medicaid Medical Home Model would meet our proposed 
financial risk criterion if it conditions the payment of some or all of 
a regular care management fee to medical home APM Entities upon 
expenditure performance in relation to a benchmark. Because the 
arrangement would require no direct payment as a consequence for 
failure to meet expenditure standards, such a medical home would not 
necessarily be worse off than it had been prior to the decreased 
payment. However, it would be worse off in the future than it otherwise 
would have been had it met expenditure standards. Similarly, a Medicaid 
Medical Home Model that offers expenditure and quality performance 
payments in addition to payment withholds that can be earned back for 
meeting minimum requirements would also meet this criterion. Consistent 
with the treatment of Medical Home Models under the statute, this 
proposal acknowledges the unique challenges of medical homes in bearing 
risk for losses while maintaining a more rigorous standard than mere 
business risk.
    We believe that because Medicaid Medical Home Models are unique 
types of Medicaid APMs and because they are identified and treated 
differently under the statute, it is appropriate to establish a unique 
standard for bearing financial risk that reflects these differences and

[[Page 77468]]

remains consistent with the statutory scheme, which is to provide 
incentives for participation by eligible clinicians in advanced APMs.
    Similar to Medical Home Model standards for Advanced APMs, which 
are discussed in II.F.4.b.(3) of this final rule with comment period, 
we believe that it would be appropriate to impose size and composition 
limits for Medicaid Medical Home Models to ensure that the focus is on 
organizations with a limited capacity for bearing the same magnitude of 
financial risk as larger organizations do, namely, small primary care-
focused organizations. We proposed that this limit would only apply to 
APM Entities that participate in Medicaid Medical Home Models and that 
have 50 or fewer eligible clinicians in the organization through which 
the APM Entity is owned and operated. Thus, in a Medicaid Medical Home 
Model that is an Other Payer Advanced APM, only those APM Entities that 
are part of a parent organization with 50 or fewer eligible clinicians 
would be APM Entities. We believe it is appropriate to use eligible 
clinicians, rather than physicians, when setting this threshold as the 
number of eligible clinicians both reflects organizational resources 
and capacity and also may differ substantially across organizations 
with the same number of physicians.
    We also believe that this size threshold of 50 eligible clinicians 
is appropriate as organizations of that size have demonstrated the 
capacity and interest in taking on risk, and organizations may also 
join together to take on risk collectively, for example, in an ACO. In 
the event that a Medicaid Medical Home Model happens to have criteria 
that meet the Advanced APM financial risk criterion that is generally 
applicable to all Other Payer Advanced APMs, this organizational size 
limitation would be moot.
    There are several unique aspects of Medicaid Medical Home Models, 
which statute specifically singles out for unique treatment, and their 
participating APM Entities (medical homes) that support the need for a 
separate standard to assess financial risk if actual expenditures 
exceed expected expenditures. Medical homes are generally more limited 
in their ability to bear financial risk than other entities because 
they tend to be smaller and predominantly include primary care 
practitioners, whose revenues are a smaller fraction of the 
beneficiaries' total cost of care than those of other eligible 
clinicians. Moreover, Medicaid medical home practices serve low income 
populations and those with significant health disparities; due to the 
method of payment for care for these populations, Medicaid medical home 
practices often have relatively low revenues. Lastly, Medicaid Medical 
Home Models to date have not required participants to bear substantial 
downside risk, and including such a requirement under this program 
would create a significant challenge for medical homes to serve their 
patients.
    We solicited comment on the proposed financial risk standard set 
forth for Medicaid Medical Home Models and on alternative standards 
that would be consistent with the statute and could achieve our stated 
goals. We also solicited comment on types of financial risk 
arrangements that may not be clearly captured in this proposal.
    The following is a summary of the comments we received regarding 
our proposal for the Medicaid Medical Home Model financial risk 
standard. Comments on the 50 eligible clinician size limit are 
aggregated in the comments on the correlating Medical Home Model 
financial risk criterion in section II.F.4. of this final rule with 
comment period.
    Comment: One commenter agreed with our proposed approach. One 
commenter believed CMS should remove the proposed financial risk 
standard from the proposed rule and that APM Entities in Medicaid 
Medical Home Models should not be subject to any financial risk 
requirement.
    Another commenter recommended that Medicaid Medical Home Models not 
be subjected to downside risk unless and until it can be clearly 
demonstrated generally that they are capable or caring for patients 
without any decrease in access or quality under the limited payments 
provided by Medicaid in most states. An additional commenter 
recommended CMS eliminate the nominal risk requirements for Medicaid 
Medical Home Models. By definition, physicians who treat Medicaid and 
dual eligible patients are assuming more than nominal financial risk, 
given the very low reimbursement rates.
    One commenter stated that the financial risk standard needs to be 
revised to ensure that Medicaid medical homes serving vulnerable 
populations are not forced to assume financial risks that would 
jeopardize patients' access to care. Another commenter agreed that APM 
Entities should bear the financial risk, but noted that special 
considerations may be appropriate for Medicaid Medical Home Models 
depending on size as some FQHCs, RHCs, and Tribal 638 safety net 
clinics may be smaller with more diverse group of primary care 
practitioners. The same commenter noted that CMS has historically 
allowed states to implement APMs for FQHC/RHCs from the traditional PPS 
method, and requested CMS specifically address how states' models that 
include FQHCs and RHCs would be assessed to meet the Other Payer 
Advanced APM criteria.
    Response: We appreciate the comments and concerns about applying 
the financial risk standard to Medicaid Medical Home Models. Section 
1833(z)(2)(B)(iii) of the Act requires that in order to meet the Other 
Payer Advanced APM criteria, the APM Entities must bear more than 
nominal financial risk if actual aggregate expenditures exceed expected 
aggregate expenditures or be in a Medicaid Medical Home Model that 
meets criteria comparable to Medical Home Models expanded under section 
1115A(c) of the Act. Because there are currently no expanded Medical 
Home Models, we do not believe there is a way to evaluate whether a 
Medicaid Medical Home Model meets criteria comparable to expanded 
Medical Home Models. As such, in order to be determined an Other Payer 
Advanced APM, a Medicaid Medical Home Model must require its 
participating APM Entities to bear more than nominal financial risk. If 
a Medical Home Model is expanded in the future under section 1115A(c) 
of the Act, we will address how Medicaid Medical Home Models that have 
comparable criteria will meet the financial risk portion of this 
criterion. We are already providing special consideration for the risk 
that Medicaid Medical Home Models must bear by proposing separate 
financial risk and nominal amount standards.
    We are also finalizing certain provisions at section II.F.6.d. of 
this final rule with comment period to ensure that CAH, RHC and FQHC 
participation in Advanced APMs is considered to the extent applicable 
when calculating Threshold Scores under the patient count method.
    After considering public comments, we are finalizing our proposal 
for the Medicaid Medical Home Model financial risk standard without 
changes. The Medicaid Medical Home Model financial risk standard is 
that, if the APM Entity's actual aggregate expenditures exceed expected 
aggregate expenditures during a specified performance period, the payer 
will:
     Withhold payment for services to the APM Entity and/or the 
APM Entity's eligible clinicians;
     Reduce payment rates to the APM Entity and/or the APM 
Entity's eligible clinicians;

[[Page 77469]]

     Require direct payment by the APM Entity to the Medicaid 
program; or
     Require the APM Entity to lose the right to all or part of 
an otherwise guaranteed payment or payments.
(b) Nominal Amount of Risk
    When an other payer risk arrangement meets the proposed financial 
risk standard, we would then consider whether the risk is of a more 
than nominal amount such that it meets this nominal amount standard. 
Similar to the financial risk portion of this assessment, we proposed 
to adopt a generally applicable nominal amount standard for Other Payer 
Advanced APMs and a unique nominal amount standard for Medicaid Medical 
Home Models.
    We proposed to measure three dimensions of risk to determine 
whether a payment arrangement meets the nominal amount standard: (a) 
Marginal risk, which is a common component of risk arrangements--
particularly those that involve shared savings--that refers to the 
percentage of the amount by which actual expenditures exceed expected 
expenditures for which an APM Entity would be liable under a payment 
arrangement; (b) minimum loss rate (MLR), which is a percentage by 
which actual expenditures may exceed expected expenditures without 
triggering financial risk; and (c) total potential risk, which refers 
to the maximum potential payment for which an APM Entity could be 
liable under a payment arrangement. An example of marginal risk is an 
ACO that has a sharing rate, or marginal risk, of 50 percent and 
exceeds its benchmark (expected expenditures) by $1 million, the ACO 
would be liable for $500,000 of those losses. The marginal risk could 
also vary with the amount of losses.
    To determine whether a payment arrangement satisfies the total risk 
portion of the nominal amount standard, we would identify the maximum 
potential payment an APM Entity could be required to make as a 
percentage of the expected expenditures under the payment arrangement. 
If that percentage exceeded the required total risk percentage, then 
the arrangement would satisfy the total risk portion of the nominal 
amount standard.
    To determine whether a payment arrangement satisfies the marginal 
risk portion of the nominal amount standard, we would examine the 
payment required under the payment arrangement as a percentage of the 
amount by which actual expenditures exceeded expected expenditures. We 
proposed that we would require that this percentage exceed the required 
marginal risk percentage regardless of the amount by which actual 
expenditures exceeded expected expenditures, with two exceptions.
    First, we proposed a maximum allowable ``minimum loss rate'' (MLR) 
of 4 percent in which the payment required by the payment arrangement 
could be smaller than the nominal amount standard would otherwise 
require when actual expenditures exceed expected expenditures by less 
than 4 percent; this exception accommodates payment arrangements that 
include zero risk for small losses but otherwise satisfy the marginal 
risk standard. We also proposed a process through which we could 
determine that a risk arrangement with an MLR higher than 4 percent 
could meet the nominal amount standard, provided that the other 
portions of the nominal amount standard are met. In determining whether 
such an exception would be appropriate, we would consider: (1) Whether 
the size of the attributed patient population is small; (2) whether the 
relative magnitude of expenditures assessed under the payment 
arrangement is particularly small; and (3) in the case of test of 
limited size and scope, whether the difference between actual 
expenditures and expected expenditures would not be statistically 
significant even when actual expenditures are 4 percent above expected 
expenditures. We note that we would grant such exceptions rarely, and 
we would expect APMs considered for such exceptions to demonstrate that 
a sufficient number of APM Entities are likely to incur losses in 
excess of the higher MLR. In other words, the potential for financial 
losses based on statistically significant expenditures in excess of the 
benchmark remains meaningful for participants.
    Second, we proposed that the payment required by the payer could be 
smaller when actual expenditures exceed expected expenditures by enough 
to trigger a payment greater than or equal to the total risk amount 
required under the nominal amount standard. This exception ensures that 
the marginal risk requirement does not effectively require payers to 
incorporate total risk greater than the amount required by the total 
risk portion of the standard to become Other Payer Advanced APMs.
    In evaluating both the total and marginal risk portions of the 
nominal amount standard, we would not include any payments the APM 
Entity or its participating eligible clinicians would make to the other 
payer if actual expenditures exactly matched expected expenditures. In 
other words, payments made to a payer outside the risk arrangement 
related to expenditures would not count toward the nominal amount 
standard. This requirement ensures that perfunctory or pre-determined 
payments do not supersede incentives for improving efficiency. For 
example, a payment arrangement that simply requires an APM Entity to 
make a payment equal to 5 percent of the payment arrangement benchmark 
at the end of the year, regardless of actual expenditure performance, 
would not satisfy the nominal amount standard.
    Finally, we proposed that the amounts described in this section 
need not take a shared savings structure in which financial risk 
increases smoothly based on the amount by which an APM Entity's actual 
expenditures exceed expected expenditures. The risk arrangement must be 
tied to expenditures, but the amount of that risk would not have to be 
directly proportional to expenditures. For instance, an APM Entity 
could be required to pay the payer a flat amount or an amount tied to 
the number of attributed beneficiaries in the case of exceeding an 
expenditure benchmark, provided that these amounts are otherwise 
structured in a way that satisfies the nominal amount standard.
(i) Generally Applicable Other Payer Advanced APM Nominal Amount 
Standard
    Except for risk arrangements described under the Medicaid Medical 
Home Model Standard, we proposed that for a payment arrangement to meet 
the nominal amount standard the specific level of marginal risk must be 
at least 30 percent of losses in excess of the expected expenditures 
and total potential risk must be at least four percent of the expected 
expenditures.
    In establishing the proposed criteria for Other Payer Advanced 
APMs, we kept the approach to nominal risk as consistent as possible 
with the approach for the proposed Advanced APM criteria. The statute 
specifies that the Advanced APM Entity must bear more than nominal 
financial risk if actual aggregate expenditures exceed expected 
aggregate expenditures. We believe it is important, to the extent 
possible and consistent with the statute, to adopt consistent financial 
risk standards with the Advanced APM standard as described in section 
II.F.4.a of the proposed rule, so that eligible clinicians can base 
their decisions on participation in these Other Payer Advanced APMs on 
a consistent set of criteria. The Advanced APM nominal amount standard 
section of the proposed rule,

[[Page 77470]]

II.F.4.a, describes the process by which we arrived at the proposed 
values.
    For Medicaid APMs we proposed the same standard as for Other Payer 
Advanced APMs. However, we recognize that Medicaid practitioners may be 
less able to bear substantial financial risk because they serve low-
income populations and those with significant health disparities. 
Therefore, we solicited comment and supporting evidence on whether the 
proposal offered identifies the appropriate amounts of nominal risk for 
Medicaid APMs.
    The following is a summary of the comments we received regarding 
our proposal to set a generally applicable Other Payer Advanced APM 
nominal amount standard.
    Comment: Several commenters believed the nominal amount standard is 
overly complicated and encouraged CMS to simplify the standard. One 
suggested CMS include only the MLR and total potential risk requirement 
proposed in the regulation. This commenter further requested that CMS 
modify the total potential risk to include an entity's Part A and B 
revenue to provide the assurance that an entity is not assuming more 
risk than their potential revenues. One commenter requested 
clarification regarding what those participating in the All-Payer 
Combination Option will have to do in order to satisfy the nominal 
amount standard.
    An additional commenter requested that the nominal amount standard 
initially mirror the medical home approach so that it is assessed 
through APM Entity revenue or a choice between APM Entity revenue and 
Advanced APM benchmarks, and has low requirements with phased increases 
mirroring the approach taken with Medicaid Medical Home Models.
    Response: As we noted in the section of the rule discussing the 
nominal amount standard for Advanced APMs, we understand commenters' 
concerns that these aspects of the standard are complex enough to 
require additional time to understand. We note, however that these 
standards will not take effect until QP Performance Periods beginning 
in 2019 and later; we believe that this time will help mitigate 
commenters' concerns about complexity. Moreover, we believe that using 
these measures of risk will ensure the program integrity of the All-
Payer Combination Option so that payment arrangements between other 
payers and APM Entities cannot be engineered in such a way as to 
provide an avenue to QP status that meets the financial risk criterion 
but makes the actual likelihood of losses based on performance very 
low. This could potentially result in payment of the APM Incentive 
Payment to APM Entities in payments arrangements that do not adhere to 
our principles of setting meaningful financial risk standards.
    We put these protections in place for Other Payer Advanced APMs and 
not Advanced APMs because we have direct control over the design of 
Advanced APMs but not of payment arrangements of other payers We must 
act in the interest of the Medicare Trust Funds when designing Advanced 
APMs, but other payers do not have the same obligation and thus may be 
interested in assisting APM Entities to receive the APM Incentive 
Payment. Although states design and implement Medicaid APMs that are 
generally subject to federal approval processes such as state plan 
amendment approvals, we have no direct or indirect control over the 
payment arrangements of private payers. Including marginal risk as a 
component of the nominal amount standard prevents the consideration of 
payment arrangement designs that could contribute to the attainment of 
QP status through arrangements far less rigorous than those in Advanced 
APMs. There may be other ways of achieving the same program integrity 
goals and we seek comment on this policy. For instance, we are 
considering ways to issue guidance or design federal approval processes 
to promote Medicaid APMs focused on high value care to Medicaid 
beneficiaries that also align with our program integrity objectives.
    Comment: A few commenters expressed concern that, if not set 
correctly, the level of risk under the nominal amount standard might 
jeopardize Medicaid clinicians' abilities to provide effective care. 
One commenter, in commenting on the nominal amount standard for 
Advanced APMs, stated that practices should be encouraged to serve 
Medicaid and dual eligible patients, but the risk requirements are 
likely to have the opposite effect. The commenter stated that simply 
providing care to Medicaid and dual eligible patients could be 
considered to involve more than nominal risk for monetary losses due to 
the very low payment rates in most Medicaid programs. Another commenter 
expressed concern about ongoing cuts states are making in Medicaid 
reimbursement rates, and believed CMS should promulgate rules that 
prevent damaging reimbursement and encourage exploration of innovative 
care delivery options. Another commenter said that any adjustment in 
payments must take into account socio-demographic factors such as 
income, race and educational attainment.
    Response: We understand that Medicaid clinicians may have less 
risk-bearing capacity than other clinicians, particularly in cases in 
which they serve a relatively high proportion of high-risk patients. We 
believe the proposed nominal amount standard allows Medicaid APMs and 
Medicaid Medical Home Models to create meaningful incentives for 
improving the care for their populations. However, we seek additional 
comments on the structure and levels of risk in the nominal amount 
standard as applied to Medicaid APMs.
    Comment: One commenter stated that there are both merits and 
challenges in setting a standard for the level of risk that Medicaid 
payment arrangements must meet to be considered Medicaid APMs. This 
commenter said there is significant variation among Medicaid 
clinicians' ability and willingness to assume risk, especially given 
the vulnerable and complex population Medicaid clinicians serve. The 
commenter also stated that state Medicaid directors are cautious to 
apply risk where it seems inappropriate or premature. However, the 
commenter also stated that a federal risk standard might support 
movement toward risk-based models in many states. The commenter 
expressed that this is a critical aspect of the regulation that 
warrants further engagement with states and urged CMS to evaluate 
state-specific situations where Medicaid clinicians are assuming risk 
and to further engage states on this issue.
    Response: We acknowledge the potential benefits and challenges of 
setting a nominal amount standard that applies to other payers, 
including state Medicaid programs, and believe we have taken the 
considerations into account in our finalized policy. We have engaged 
with stakeholders on this issue and will continue to do so. We realize 
that although the All-Payer Combination Option does not go into 
effective until the 2019 QP Performance Period for the 2021 payment 
year, Medicaid programs and other payers may begin their work 
developing payment arrangements that meet the Other Payer Advanced APM 
criteria. For this reason, we believe it is important to establish 
these policies now, even though there may be subsequent modifications 
through future rulemaking.
    Comment: One commenter generally supported the proposal regarding 
standards for nominal risk, but stated that the standard for Medicaid 
APMs that are not Medicaid Medical Home Models be set lower, at 3 
percent. Another commenter supports the

[[Page 77471]]

simplification of the nominal risk amount and requested CMS lower the 
proposed loss sharing limit for Other Payer Advanced APMs from 4 
percent to a more reasonable threshold, such as 10 percent of 
physicians' payments for covered Part B professional services, or 1 
percent of total Parts A and B target costs, whichever is lower.
    One commenter recommended that CMS use risk corridors across 
programs to allow APMs to align their operations and financial 
approach, while reducing administrative overhead. One commenter 
suggested a 30 percent marginal risk threshold, with a 1-2 percent 
minimum loss rate, and recommended that CMS consider using the full-
risk structure within the Next Generation ACO model as a framework when 
assessing nominal risk.
    Response: We believe that the meaning of ``nominal'' can be 
relative and that for many APM Entities, 4 percent of a total cost of 
care benchmark could be substantially more than nominal. We discuss the 
nominal amount standard in depth in section II.F.4.a of this final rule 
with comment period. Depending on the size and clinician composition of 
an APM Entity, a total risk cap of 4 percent of a total cost of care 
benchmark could mean risk for losses that are up to or greater than 100 
percent of some APM Entities' revenue from a payer. Therefore, we 
recognize that a revenue-based standard would provide an alternative 
approach under the nominal amount standard that is particularly 
meaningful to practices of certain sizes. However, we caution that a 
revenue-based standard is not easily applied to many current payment 
arrangements, which tend to base risk arrangements on expenditure 
benchmarks that are unrelated to a particular APM Entity's revenue. We 
believe that total cost of care benchmarks are optimal for many APMs, 
and those will continue to represent the preferred standard for 
assessing performance in terms of cost. We also caution that, under a 
revenue-based standard, certain types of APM Entities may have a 
significant probability of incurring losses outside the stop loss and 
thus bear no responsibility for increases in expected expenditures 
beyond that point, which may undermine the ability of such APMs to 
drive performance for those APM Entities. In seeking a risk standard 
that is meaningful but not excessive, we sought to balance these 
considerations.
    After considering the comments, we are finalizing the proposed 
policy with modifications. First, we are finalizing the marginal risk 
and MLR components as proposed. To meet the Other Payer Advanced APM 
nominal amount standard, a payment arrangement's level of marginal risk 
must be at least 30 percent of losses in excess of the expected 
expenditures, and the maximum allowable MLR must be 4 percent. We seek 
additional comments on this approach for Other Payer Advanced APMs and 
additional information on other approaches that ensure payment 
arrangements are not engineered to meet the financial risk criterion 
but avoid the likelihood of APM Entities experiencing losses based on 
their performance.
    Second, we are finalizing that a payment arrangement must require 
APM Entities to bear financial risk for at least 3 percent of the 
expected expenditures for which an APM Entity is responsible under the 
payment arrangement. For episode payment models, expected expenditures 
means the target price for an episode. We also note that we intend to 
establish through future rulemaking a total risk standard based on the 
revenue of the APM Entity from the payer in a manner that would 
parallel the standard we are finalizing in the Advanced APM nominal 
amount standard under section II.F.4.b.(4) of this final rule with 
comment period. Therefore, we seek comment for future consideration on 
the amount and structure of the revenue-based nominal amount standard 
for QP Performance Periods in 2019 and later. Specifically, we seek 
comment on: (1) Setting the revenue-based standard for 2019 and later 
at up to 15 percent of revenue; or (2) setting the revenue-based 
standard at 10 percent so long as risk is at least equal to 1.5 percent 
of expected expenditures for which an APM Entity is responsible under 
an APM. We expect to apply the same percentage standards for Other 
Payer Advanced APMs as for Advanced APMs; however, we seek comment on 
how and why this standard could differ for Medicaid APMs relative to 
the generally applicable Other Payer Advanced APM standard.
    Our intention in setting a revenue-based nominal amount standard is 
to tailor the level of risk an APM Entity must bear relative to the 
resources available to it. In instances where an APM Entity is one 
component of a larger health care provider organization, we believe 
that the revenue of the larger organization is a more accurate measure 
of the resources available to the APM Entity and should be the basis 
for setting the revenue-based nominal amount standard, even if only a 
portion of the organization is participating in the APM Entity.
    However, we do not believe that applying the nominal amount 
standard at a level other than the APM Entity is operationally feasible 
at this point in time, and doing so in the other payer context may pose 
unique challenges relative to those we face under Medicare. 
Nevertheless, ideally, the nominal amount standard would take into 
consideration the resources available to an APM Entity using a measure 
such as revenue for the parent organization. We are evaluating the 
feasibility of implementing such a measure in lieu of APM Entity 
revenue for the third year of the program and later years. Under such 
an approach, we would anticipate basing the revenue-based nominal 
amount standard on the total revenues from a payer across the APM 
Entity, any parent organizations, any subsidiary organizations, and any 
subsidiaries of parent organizations for all eligible clinicians and 
groups who are participants of an APM Entity. We seek comment on this 
approach and how such an approach could be implemented while minimizing 
burden on participants.
(ii) Medicaid Medical Home Model Nominal Amount Standard
    For Medicaid Medical Home Models, we proposed that the minimum 
total annual amount that an APM Entity must potentially owe or forego 
to be considered an Other Payer Advanced APM must be at least:
     In 2019, 4 percent of the APM Entity's total revenue under 
the payer.
     In 2020 and later, 5 percent of the APM Entity's total 
revenue under the payer.
    We believe that because few Medicaid Medical Home Model 
participants have experience with financial risk, and because they tend 
to be smaller in size, both in terms of the number of clinicians and 
revenue, than other APM Entities, we should not include a potentially 
excessive nominal amount for such entities in the first year of the 
program. We have also taken into account that the statute explicitly 
highlights Medical Home Models for special treatment under the Quality 
Payment Program. We generally have less information on Medicaid Medical 
Home Models and their performance to date compared to our information 
on Medical Home Models. Medicaid Medical Home Models are still 
developing, and we believe the introduction of a nominal amount 
standard that is not currently widely represented in the marketplace 
should be approached in a measured manner. We therefore believe that 
the unique characteristics of Medicaid Medical Home Models warrant the 
application of

[[Page 77472]]

a nominal amount standard that reflects these differences.
    We solicited comment on the proposed nominal amount standard. We 
also solicited comment on the potential inclusion of a marginal risk 
amount in the standard and the extent to which it would be applicable.
    The following is a summary of the comments we received regarding 
our proposal to set a Medicaid Medical Home Model nominal amount 
standard.
    Comment: One commenter supported the lower risk amount for Medicaid 
Medical Home Models. Another commenter expressed concern that CMS' 
proposed nominal amount standard for Medicaid Medical Homes Models of 4 
percent of the APM Entity's total Medicaid revenue in 2019 and 5 
percent in 2020 and thereafter is too high to encourage medical 
practices to serve Medicaid and dual eligible patients. This commenter 
said providing care to Medicaid and dual eligible patients would be 
considered by most physicians to involve more than nominal risk of 
financial losses due to the very low payment rates in most Medicaid 
programs.
    Response: We understand the concern that the proposed nominal 
amount standard may be too high and could serve as a deterrent to the 
development of and participation in Medicaid Medical Home Models. 
However, we believe that, as with Medical Home Models under Medicare, 
the proposed values are appropriate for those entities that are 
interested in assuming risk and participating in the Quality Payment 
Program. We also believe that the finalized Advanced APM financial risk 
criterion for Medicaid Medical Home Models, combined with this nominal 
amount standard, allows for payment arrangement designs that motivate 
improvements in the cost and quality of care while not deterring 
practices from participating in the program. We are finalizing the 
standard as proposed to be consistent with the Advanced APM nominal 
amount standard for Medical Home Models as discussed in section 
II.F.4.b.(3) of this final rule with comment. Setting the standard that 
starts at 4 percent of revenue and increases to 5 percent of revenue 
represents the meaning of ``nominal'' in the Medicaid Medical Home 
Model context.
    After considering public comments, we are finalizing the Medicaid 
Medical Home Model nominal amount standard as proposed. In order to be 
an Other Payer Advanced APM, the minimum total annual amount that a 
Medicaid Medical Home Model must require an APM Entity to potentially 
owe or forego must be at least:
     In 2019, 4 percent of the APM Entity's total revenue under 
the payer.
     In 2020 and later, 5 percent of the APM Entity's total 
revenue under the payer.
(c) Capitation
    We proposed that full capitation risk arrangements would meet the 
Other Payer Advanced APM financial risk criterion. We proposed that for 
purposes of this rulemaking, a capitation risk arrangement means a 
payment arrangement in which a per capita or otherwise predetermined 
payment is made to an APM Entity for services furnished to a population 
of beneficiaries, and no settlement is performed for the purpose of 
reconciling or sharing losses incurred or savings earned by the APM 
Entity. Our rationale for this policy is the same as the rationale on 
capitation for Advanced APMs described in section II.F.4.b.(3) of this 
final rule with comment period. As such, we reiterated that full 
capitation risk arrangements are not simply a cash flow mechanism.
    We solicited comment on our proposal that capitation risk 
arrangements would meet the financial risk criterion for Other Payer 
Advanced APMs and on our proposed definition of a capitation risk 
arrangement. We also solicited comment on other types of arrangements 
that may be suitable for such treatment for purposes of this financial 
risk criterion.
    The following is a summary of the comments we received regarding 
our proposal that full capitation risk arrangements will automatically 
meet the Other Payer Advanced APM financial risk criterion.
    Comment: One commenter supported the proposal that capitation 
automatically satisfies the financial risk criterion, but requested CMS 
to explicitly include partial capitation as well if it meets the 
nominal risk criteria. Another commenter recommended existing 
arrangements, such as capitation, be included in the proposed rule 
definition of Other Payer Advanced APMs that bear more than nominal 
risk, because the commenter believes that such arrangements require the 
organization to absorb costs that exceed expected expenditures. This 
commenter requested clarification on whether tertiary care centers 
would be considered Other Payer Advanced APMs when these centers have 
capitated arrangements with other clinicians, and where patients' 
primary care clinicians are not directly affiliated with the tertiary 
care center.
    One commenter supported the proposal that that full capitation risk 
arrangements meet the financial risk criterion for APM Entities with 
full downside risk, but noted that some entities are in the middle of 
transforming their practices. The commenter stated that risk during 
transition could be mitigated through risk corridors and other methods 
that could be used while payers are obtaining and improving data 
necessary to improve the appropriateness of rates to health plans and 
clinicians.
    Response: Partial capitation arrangements can satisfy the financial 
risk criterion, but will not do so automatically. They will be assessed 
according to the nominal amount standard. We appreciate the suggested 
payment methodology, but we are not prescribing any specific 
methodology for such arrangements. We also remind commenters of the 
Physician-Focused Payment Model Technical Advisory Committee described 
in section II.F.10. of this final rule with comment period.
    After considering public comments, we are finalizing our proposal 
that full capitation risk arrangements will automatically meet the 
Other Payer Advanced APM financial risk criterion and our proposal to 
define capitation risk arrangement without changes.
(d) Criteria Comparable to Expanded Medical Home Models
    In accordance with sections 1833(z)(2)(B)(iii)(II)(cc)(BB) and 
(C)(iii)(II)(cc)(BB) of the Act, we proposed that Medicaid Medical Home 
Models that meet criteria comparable to a Medical Home Model expanded 
under section 1115A(c) of the Act would meet the Other Payer Advanced 
APM financial risk criterion. We proposed that we would specify in 
subsequent rulemaking the criteria of any Medical Home Model that is 
expanded under section 1115A(c) of the Act that would be used for 
purposes of making this comparability assessment. We believe that the 
expanded Medical Home Model criteria can only be used for comparison 
when a Medical Home Model is, in fact, expanded as described in section 
II.F.4.b.(6) of the proposed rule, not merely by satisfying the 
expansion criteria under section 1115A(c) of the Act. If no such 
Medical Home Model has actually been expanded under section 1115A(c) of 
the Act, we would not have any criteria for comparison. In the absence 
of any expanded Medical Home Model to which we could draw comparisons, 
Medicaid Medical Home Models must meet the financial risk criterion 
through the other provisions (the financial risk and nominal amount

[[Page 77473]]

standards) to be an Other Payer Advanced APM. We solicited comment on 
how to determine the criteria of an expanded Medical Home Model that 
could be used for comparison, and on how similar the Medicaid Medical 
Home Model criteria must be to the expanded Medical Home Model criteria 
in order to be considered ``comparable.''
    The following is a summary of the comments we received regarding 
our proposal to address criteria comparable to expanded Medicaid 
Medical Home Models in future rulemaking.
    Comment: One commenter appreciated that CMS plans for future 
rulemaking in this area, and agrees that no current models meet the 
expansion criteria.
    Response: We appreciate the comment.
    We are finalizing our proposal that Medicaid Medical Home Models 
that meet criteria comparable to a Medical Home Model expanded under 
section 1115A(c) of the Act would meet the Other Payer Advanced APM 
financial risk criterion. We will specify in future rulemaking the 
criteria for any Medical Home Model that is expanded under section 
1115A(c) of the Act, and specify how they would be used for purposes of 
making this comparability assessment.
(7) Medicare Advantage (MA)
    For the APM Incentive Payment, section 1833(z)(1)(A) of the Act 
states that the APM Incentive Payment is based on payments for Part B 
covered professional services, which do not include payments for 
services furnished to MA enrollees. For QP determination calculations, 
we believe it is important to note that Advanced APMs may involve MA 
plans and payers other than Medicare. Under the All-Payer Combination 
Option for QP determinations, eligible clinicians can meet the QP 
threshold based in part on payment amounts or patients counts 
associated with MA plans and other payers, provided that such 
arrangements meet the criteria to be considered Other Payer Advanced 
APMs. However, under sections 1833(z)(2)(A), (2)(B)(i), and (3)(B)(i) 
of the Act, payments under MA and other payer arrangements cannot be 
included in the QP determination calculations under the Medicare 
Option, which requires that we only consider payment amounts or patient 
counts for Medicare Part B covered professional services.
    Regardless of which option--Medicare or All-Payer Combination--is 
used to determine that an eligible clinician is a QP for a year, the 
APM Incentive Payment calculation will only be based upon payments for 
Medicare Part B covered professional services, which does not include 
payments for services furnished to MA enrollees.
    We recognize that MA contracts can include financial risk as well 
as quality performance standards, CEHRT, and other health IT 
requirements that support high-value care. We proposed to evaluate 
payment arrangements between eligible clinicians, APMs Entities, and MA 
plans according to the proposed Other Payer Advanced APM criteria. In 
the assessment of MA plans for the Other Payer Advanced APM criteria, 
it is important to note that the requirements refer to aspects of the 
payment arrangement between the MA plan and the participating APM 
Entity, and this includes the criterion for bearing more than a nominal 
amount of financial risk. We noted that we will not consider an 
arrangement in which the MA plan meets the CEHRT and quality measures 
criteria, but pays the APM Entity on a FFS basis, to be an Other Payer 
Advanced APM because there is no risk connected to actual cost of care 
exceeding projected cost of care. Because this arrangement would not be 
an Other Payer Advanced APM, it would not be considered for purposes of 
QP determinations. In addition, the financial relationship between CMS 
and the MA plan--even if the relationship is part of an APM--is not 
relevant to this assessment because there would not be a direct payment 
arrangement between CMS and the APM Entities or eligible clinicians.
    The following is a summary of the comments we received regarding 
how MA plans will be treated in the Medicare Option and the All-Payer 
Combination Option.
    Comment: Several commenters suggested that eligible MA contracts be 
compared to the Advanced APM criteria rather than the Other Payer 
Advanced APM criteria. A few commenters requested that CMS consider MA 
contracts when determining whether APM Entities are participating in 
Advanced APMs and include MA payments when calculating Threshold Scores 
under the Medicare Option. In addition, one commenter stated that 
focusing the Medicare Option on Part B and not including MA disregards 
the work of many clinicians to improve care for beneficiaries and to 
build the accompanying infrastructure required to carry out this work. 
Another commenter was concerned that MA participation will not be 
considered until payment year 2021 and that this could potentially 
limit eligible clinicians' ability to become QPs because they do not 
participate in Advanced APMs under Medicare Part B. The commenter 
expressed concern that this delay will disadvantage clinicians who have 
already taken the initiative to incorporate quality metrics, financial 
risk, and CEHRT in their care of beneficiaries.
    A few commenters stated that if CMS included MA under the Medicare 
Option, several high-performing plans would meet the Advanced APM 
criteria. The commenters stated that CMS could use its section 1115A 
authority to designate MA plans as Advanced APMs.
    Response: We appreciate the comments and suggestions. Under section 
1833(z)(2)(A) of the Act, it is clear that MA is not included in the QP 
determination calculations under the Medicare Option, which requires 
that we only consider payment amounts or patient counts for Medicare 
Part B covered professional services. The statute is clear that the 
All-Payer Combination Option will begin in payment year 2021, for which 
2019 is the QP Performance Period as finalized in this rule. We believe 
that MA plans can play an important role in the Quality Payment Program 
through the All-Payer Combination Option.
    Comment: One commenter recommended that CMS align MIPS and APM 
measures in traditional Medicare to the CMS MA Five Star Quality Rating 
System, which measures how well MA and prescription drug (Part D) plans 
perform in several areas including quality of care and customer 
service. Another commenter recommended that if an APM Entity's contract 
with an MA Organization includes ``more than nominal risk,'' and if the 
MA plan meets a threshold star rating (for example, 4 or greater), 
patients and payments through that MA plan should be included in the 
Medicare Option.
    Response: Establishing rules related to MA contracting are outside 
the scope of this rule. An Other Payer Advanced APM must meet all three 
of the criteria set forth in this final rule with comment. As discussed 
in this section of the final rule with comment period, the statute does 
not permit inclusion of MA plans or payments in the Medicare Option, 
regardless of an MA plan's Star Ratings. Although the Star Rating may 
reflect positive activities, the statute does not permit any substitute 
for the Advanced APM or Other Payer Advanced APM criteria.
    Therefore, we understand the value of aligning measures across 
payers. Although measures of health plans are beyond the scope of this 
rule and do not necessarily measure the same performance as measures 
used under MIPS and APMs, which relate directly to health care provider 
performance, we

[[Page 77474]]

recognize that there are many potential avenues for potential alignment 
in the selection of the MIPS quality measure set and in the design of 
specific APMs that engage multiple payers.
    Comment: One commenter proposed that information on the Quality 
Payment Program be made available to MA organizations and easily 
accessible by the general public. One commenter suggested CMS to use 
its leadership role in the LAN in order to align incentives, 
performance measures, and other components of value-based arrangements 
between public and private payers.
    Response: We agree with commenters that continuous communication 
and engagement are essential to the effective implementation of the 
Quality Payment Program. We intend to continue our strong emphasis on 
clinician outreach and education, and will continue to be receptive to 
new ideas for improving the Quality Payment Program in the future. We 
believe that the finalized criteria in this final rule with comment are 
sufficiently clear as to how an MA payment arrangement may become an 
Other Payer Advanced APM. Apart from defining the statutory criteria, 
we intentionally do not prescribe unnecessary details in our finalized 
policies in order to enable significant flexibility in the design of 
Other Payer Advanced APMs.
    Comment: Another commenter supported our proposal to consider MA 
plans under the All-Payer Combination Option beginning in the 2019 QP 
Performance Period and believes CMS should consider developing 
incentives for MA plan participation. One commenter believes that CMS 
should offer (or seek statutory changes that would allow CMS to offer) 
provider-affiliated MA plans to create Other Payer Advanced APMs 
because the commenter believes provider-affiliated MA plans already 
bear financial risk for care of Medicare beneficiaries. The commenter 
also believes that CMS should encourage MA plans to offer more APM-like 
options to the increasing number of MA enrollees, because commenter 
believes that patients in MA plans should benefit from improved care 
and payment reforms of APMs.
    Response: We appreciate the comments. As we mentioned above, we 
encourage diversity in Other Payer Advanced APMs, but we do not intend 
provide additional guidance or incentives in MA contracting as part of 
our implementation of the Quality Payment Program. We also note that 
the statute does not provide for special consideration for MA plans or 
additional or special incentives for the development of or 
participation in MA plan-operated Other Payer Advanced APMs. In 
addition, as discussed in a recent Report to Congress entitled, 
``Alternative Payment Models and Medicare Advantage,'' we have limited 
tools available to encourage Medicare Advantage Organizations (MAOs) to 
adopt APMs or similar payment arrangements, as the statutory non-
interference clause prohibits CMS from interfering in the development 
of contracts between MAOs and their network providers. We will continue 
to communicate with stakeholders, including MA plans, before the All-
Payer Combination Option takes effect for the performance period in 
2019.
    Comment: One commenter asked how PACE organizations will align with 
Other Payer Advanced APMs in the future, particularly as CMS considers 
options for Other Payer Advanced APMs, which may include MA payment 
arrangements. Another commenter suggested that CMS model future 
Advanced APMs after the most successful MA models.
    Response: We will evaluate each payment arrangement according to 
the Other Payer Advanced APM criteria. Again, we encourage diversity in 
Other Payer Advanced APMs and believe this rule provides flexibility in 
the design of innovative models.
    Comment: Some commenters requested information about how FFS 
payment adjustments under the Quality Payment Program, including MIPS 
adjustments and APM Incentive Payments, will impact the benchmark rates 
that are used to determine our monthly payments to MA plans. These 
commenters stated that we should address the effects of these 
adjustments on MA benchmarks before the release of our CY 2019 Advance 
Notice. Commenters also stated that CMS should have addressed the 
impacts of these FFS adjustments in the proposed rule's regulatory 
impact analysis.
    Response: CY 2019 is the first year that the MIPS payment 
adjustments will impact FFS payments and that the APM Incentive Payment 
will be made to QPs. We believe that it is more appropriate that we 
address our methodology for calculating CY 2019 MA benchmarks through 
the annual Advance Notice and Rate Announcement process, as set forth 
in section 1853(b) of the Act. Starting in CY 2017, the annual release 
of our Advance Notice will be followed by a comment period of no fewer 
than 30 days, which will provide MA organizations with sufficient 
opportunity to raise any concerns regarding proposed changes to our 
benchmark calculation methodology. MA rates are set through a separate 
process, and payment policies for CY 2019 will be addressed in the 
Advance Notice and Rate Announcement for that program.
c. Calculation of All-Payer Combination Option Threshold Score
(1) Use of Methods
    We may apply one or both of two different methods--using payment 
amounts or patient counts--to arrive at an eligible clinician's 
Threshold Score. We would compare the Threshold Score against the 
relevant QP Threshold or Partial QP Threshold to determine an eligible 
clinician's QP status for the year.
    We proposed that we would calculate Threshold Scores for eligible 
clinicians in an Advanced APM Entity under both the payment amount and 
patient count methods for each QP Performance Period. We also proposed 
that we would assign QP status using the more advantageous of the 
Advanced APM Entity's two scores.
    We believe that both the payment amount and patient count methods 
should be considered in order to produce Threshold Scores. As the two 
calculations differ there may be cases in which Threshold Scores vary 
enough that different QP determinations could result depending on which 
is used. In such an event, we do not believe that prioritizing the 
Threshold Score using one calculation over the other would yield an 
appropriate, non-arbitrary result. By using the greater of the 
Threshold Scores achieved, we hope to promote simplicity in QP 
determinations and to maximize the number of eligible clinicians that 
attain QP status each year. We solicited comment on the use of the 
payment and patient count methods for the All-Payer Combination Option.
    The following is a summary of the comments we received regarding 
our proposal to calculate the Threshold Score for eligible clinicians 
participating in Other Payer Advanced APMs by either the payment amount 
or patient count method.
    Comment: One commenter supported CMS' proposal to include and 
calculate both the revenue and patient count methodologies for QP 
determination, and use the most advantageous calculation.
    Response: We thank the commenter for supporting our proposal. We 
are finalizing our policy as proposed, and note that the policies for 
calculating Threshold Scores under the All-Payer Combination Option 
mirror those for the Medicare Option. Both options use

[[Page 77475]]

similarly defined numerators and denominators, and both apply the more 
advantageous result of the two methods for calculating the Threshold 
Score for purposes of QP determination. Section II.F.6. of this final 
rule with comment period contains a fuller discussion of the Medicare 
Option policy.
    We are finalizing our proposal to calculate Threshold Scores for 
eligible clinicians in an APM Entity under both the payment amount and 
patient count methods for each QP Performance Period. We will make QP 
determinations using the more advantageous of the APM Entity's two 
scores.
(2) Excluded Payments
    Section 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act specifies 
that the calculation under the All-Payer Combination Option is based on 
the sum of both payments for Medicare Part B covered professional 
services and, with certain exceptions, all other payments, regardless 
of payer. We proposed that we would include such ``all other'' payments 
in the numerator and the denominator, and we would exclude payments as 
specified in the statute. We also proposed to exclude patients 
associated with these excluded payments from the patient count method.
    The statute excludes payments made:
     By the Secretary of Defense for the costs of Department of 
Defense health care programs;
     By the Secretary of Veterans Affairs for the costs of 
Department of Veterans Affairs health care programs; and
     Under Title XIX in a state in which no Medicaid Medical 
Home Model or APM is available under the state plan.
    We proposed that title XIX payments or patients would be excluded 
in the numerator and denominator for the QP determination unless: (1) A 
state has at least one Medicaid Medical Home Model or Medicaid APM in 
operation that is determined to be an Other Payer Advanced APM; and (2) 
the relevant Advanced APM Entity is eligible to participate in at least 
one of such Other Payer Advanced APMs during the QP Performance Period, 
regardless of whether the APM Entity actually participates in such 
Other Payer Advanced APMs. This would apply to both the payment amount 
and patient count methods. We believe this Medicaid exclusion avoids 
penalizing eligible clinicians who do not have the possibility of 
participation in an Other Payer Advanced APM under Medicaid. We believe 
that failing to exclude such payments and/or patients would unduly 
disadvantage potential QPs by inflating denominators based on 
circumstances beyond their control. For example, if a state's Medicaid 
Medical Home Model is determined to be an Other Payer Advanced APM and 
is operated on a statewide basis, Medicaid payments would be included 
in the denominator for all eligible clinicians in that state assessed 
under the All-Payer Combination Option. However, if the state operates 
such an Other Payer Advanced APM at a sub-state level, and eligible 
clinicians who do not practice in the geographic area where the 
Medicaid Medical Home Model is available are not eligible to 
participate, Medicaid payments would not be included in such eligible 
clinicians' QP calculations. We plan to more fully develop the approach 
to identify Medicaid Medical Home Models and Medicaid APMs, as well as 
eligible clinicians participating in them, through subsequent 
rulemaking.
    We solicited comment on our proposals to determine payment 
exclusions and on how we could account for eligible clinician 
participation in Medicaid APM or Medicaid Medical Home Models, such as 
pilots where participation may be intentionally limited by the state.
    Comment: One commenter requested that CMS clarify this proposal. 
Another commenter requested clarification of what ``all other payments 
regardless of payer'' means, which establishes the basis for 
determining the payments in the denominator of the threshold 
calculations.
    Response: ``All other payments regardless of payer,'' described 
previously in this final rule, means the aggregate of all payments from 
all payers, except those explicitly excluded by statute.
    After considering the public comments, we are finalizing our 
proposal for determining exclusions of payments in the numerator and 
denominator for the QP determination without changes. The calculation 
under the All-Payer Combination Option is based on the sum of both 
payments for Medicare Part B covered professional services and, with 
certain exceptions, all other payments, regardless of payer. We will 
include such ``all other'' payments in the numerator and the 
denominator and exclude payments as specified in the statute. We will 
also exclude patients associated with these excluded payments from the 
patient count method, as proposed.
    The payments excluded are those made:
     By the Secretary of Defense for the costs of Department of 
Defense health care programs;
     By the Secretary of Veterans Affairs for the costs of 
Department of Veterans Affairs health care programs; and
     Under Title XIX in a state in which no Medicaid Medical 
Home Model or APM is available under the state plan.
(3) Payment Amount Method
    We proposed to calculate an All-Payer Combination Option Threshold 
Score for eligible clinicians in an Advanced APM Entity using the 
proposed payment amount method, which would then be compared to the 
relevant QP Payment Amount Threshold and Partial QP Payment Amount 
Threshold to make a QP determination.
(a) Threshold Score Calculation
(i) In General
    We proposed to calculate the All-Payer Threshold Score for eligible 
clinicians in an Advanced APM Entity (or an eligible clinician that 
participates in multiple APMs, as this exception was discussed in the 
proposed rule) by dividing the numerator value described under section 
II.F.7.c.(3)(a)(ii) of this final rule with comment period by the 
denominator value described under section II.F.7.c.(3)(a)(iii) of this 
final rule with comment period. This calculation would result in a 
percent value Threshold Score that we would compare to the QP Payment 
Amount Threshold and the Partial QP Payment Amount Threshold to 
determine the QP status of the eligible clinicians for the payment 
year. The calculations occur in two steps because there is a Medicare 
QP Threshold and an All-Payer QP Threshold.
(ii) Numerator
    We proposed that the numerator would be the aggregate of all 
payments from all other payers, except those excluded under sections 
1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM 
Entity's eligible clinicians--or the eligible clinician in the event of 
an individual eligible clinician assessment--under the terms of all 
Other Payer Advanced APMs during the QP Performance Period. Medicare 
Part B covered professional services will be calculated under the All-
Payer Combination Option in the same manner as it will be under the 
Medicare Option.
(iii) Denominator
    We proposed that the denominator would be the aggregate of all 
payments from all payers, except those excluded under sections 
1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM 
Entity's eligible clinicians--or the eligible clinician in the event of 
an

[[Page 77476]]

individual eligible clinician assessment--during the QP Performance 
Period. The portion of this amount that relates to Medicare Part B 
covered professional services will be calculated under the All-Payer 
Combination Option in the same manner as it is for the Medicare Option.
(b) Examples of Payment Amount Threshold Score Calculation
    In this example, an Advanced APM Entity participates in a Medicare 
ACO initiative, a commercial ACO arrangement, and a Medicaid APM. Each 
of the APMs is determined to be an Advanced APM. In the QP Performance 
Period for payment year 2021 (proposed in the proposed rule to be 
2019), the Advanced APM Entity receives the following payments:

                                Table 38--All-Payer Combination Option Example 1
----------------------------------------------------------------------------------------------------------------
                                                                               Total payments
                           Payer                            Payments through   from applicable   Threshold score
                                                                   ACO              payer              (%)
----------------------------------------------------------------------------------------------------------------
Medicare*.................................................           300,000         1,000,000                30
Commercial................................................           300,000           500,000                60
Medicaid..................................................            80,000           100,000                80
                                                           -----------------------------------------------------
    Total.................................................           680,000         1,600,000                43
----------------------------------------------------------------------------------------------------------------
* For Medicare Part B payments, the amount used for the All-Payer Combination Option will be the same as the
  amount tied to attribution-eligible beneficiaries used in the denominator of the calculation under the
  Medicare Option.

    In Table 38, the Advanced APM Entity meets the minimum Medicare 
threshold (30% > 25%) to be considered under the All-Payer Combination 
Option. However, it fell short of the QP Payment Amount Threshold (43% 
< 50%). In this case, the Advanced APM Entity would meet the Partial QP 
Payment Amount Threshold (43% > 40%).
    Another Advanced APM Entity in the same year receives the following 
payments:

                                Table 39--All-Payer Combination Option Example 2
----------------------------------------------------------------------------------------------------------------
                                                                               Total payments
                           Payer                            Payments through   from applicable   Threshold score
                                                                   ACO              payer
----------------------------------------------------------------------------------------------------------------
Medicare*.................................................           200,000           500,000                40
Commercial................................................           400,000           500,000                80
Medicaid..................................................           100,000           150,000                67
                                                           -----------------------------------------------------
    Total.................................................           700,000         1,150,000                61
----------------------------------------------------------------------------------------------------------------
* For Medicare Part B payments, the amount used for the All-Payer Combination Option will be the same as the
  amount tied to attribution-eligible beneficiaries used in the denominator of the calculation under the
  Medicare Option.

    In Table 39, the Advanced APM Entity meets the minimum Medicare 
threshold (40% > 25%) to be considered under the All-Payer Combination 
Option. It also exceeds the QP Payment Amount Threshold (61% > 50%). In 
this case, the eligible clinicians in the Advanced APM Entity would 
become QPs.
    We solicited comment on the payment amount method described in this 
proposal and any potential alternative approaches.
    The following is a summary of the comments we received regarding 
our payment amount method proposal.
    Comment: One commenter supported our proposal for using the payment 
amount method to calculate the All-Payer Combination Option Threshold 
Score. Another commenter supported the definition of the numerator 
because if a beneficiary is attributed to an ACO and sees a clinician 
outside that ACO, payments made to the non-ACO clinician will not count 
towards this numerator, even if the ACO is in an Other Payer Advanced 
APM.
    An additional commenter requested more details around how the data 
for the Threshold Score numerator and denominator under the All-Payer 
Combination Option would be collected and calculated. One commenter 
requested clarification as to whether 100 percent of a clinician's 
qualifying risk-based payments for Medicaid services from an Other 
Payer Advanced APM would be eligible to count towards the All Payer 
Combination Option.
    Response: We appreciate the comments. The collection and submission 
of data is described in section II.F.7.d. of this final rule with 
comment period, and we seek further comments on that topic. All of the 
payments an eligible clinician receives through an Other Payer Advanced 
APM, except for those excluded as detailed above, will count in the 
numerator of the Threshold Score.
    We are finalizing our proposal to calculate the All-Payer 
Combination Option Threshold Score for eligible clinicians in an 
Advanced APM Entity (or an eligible clinician that participates in 
multiple APMs) by dividing the numerator by the denominator value, as 
described above. This calculation will result in a percent value 
Threshold Score that we would compare to the QP Payment Amount 
Threshold and the Partial QP Payment Amount Threshold to determine the 
QP status of the eligible clinicians for the payment year. The 
calculations occur in two steps because there is a Medicare QP 
Threshold and an All-Payer QP Threshold. We are finalizing our proposal 
that the numerator is the aggregate of all payments from all other 
payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and 
(C)(ii)(I) of the Act, to the Advanced APM Entity's eligible 
clinicians--or the eligible clinician in the event of an individual 
eligible clinician

[[Page 77477]]

assessment--under the terms of all Other Payer Advanced APMs during the 
QP Performance Period.
    We are finalizing our proposal that the denominator is the 
aggregate of all payments from all payers, except those excluded under 
sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the 
Advanced APM Entity's eligible clinicians--or the eligible clinician in 
the event of an individual eligible clinician assessment--during the QP 
Performance Period.
(4) Patient Count Method
    We proposed to calculate a Threshold Score for the eligible 
clinician group in an Advanced APM Entity--or eligible clinician in the 
exception situations under sections II.F.5 and II.F.6 of the proposed 
rule--using the patient count method, which would then be compared 
against the relevant QP Patient Count Threshold and Partial QP Patient 
Count Threshold to determine the QP status of an eligible clinician for 
the year based on the higher of the two values.
(a) Threshold Score Calculation
(i) In General
    We proposed that the Threshold Score calculation for the patient 
count method would include patients for whom the eligible clinicians in 
an Advanced APM Entity furnish services and receive payment under the 
terms of an Other Payer Advanced APM, with certain exceptions as 
outlined in the previous section. This calculation would result in a 
percent value Threshold Score that CMS would compare to the QP Patient 
Count Threshold and the Partial QP Patient Count Threshold to determine 
the eligible clinicians' QP status for the payment year. The 
calculations occur in two steps as there is a Medicare Threshold 
requirement and an All-Payer Threshold requirement.
(ii) Unique Patients
    First, we proposed that, like the Medicare Option, the patient 
count method under the All-Payer Combination Option would only count 
unique patients, with multiple eligible clinicians able to count the 
same patient. Similarly, we proposed to count a single patient, where 
appropriate, in the numerator and denominator for multiple different 
Advanced APM Entities when counting the number of beneficiaries under 
this method section II.F.6 of the proposed rule. We also proposed that 
we would not count any patient more than once for any single Advanced 
APM Entity. In other words, for each Advanced APM Entity, we would 
count each unique patient one time in the numerator, and one time in 
the denominator.
    We believe that counting patients this way maintains integrity by 
preventing double counting of patients within an Advanced APM Entity 
while recognizing the reality that patients often have relationships 
with eligible clinicians in different organizations. We expect to avoid 
distorting patient counts for such overlap situations, especially in 
Advanced APM Entity-dense markets.
    We solicited comment on our proposal for counting unique patients 
for the patient count method.
(iii) Numerator
    We proposed that the numerator would be the number of unique 
patients to whom eligible clinicians in the Advanced APM Entity furnish 
services that are included in the measures of aggregate expenditures 
used under the terms of all of their Other Payer Advanced APMs during 
the QP Performance Period, plus the patient count numerator for 
Advanced APMs. A patient would count in the non-Medicare portion of 
this numerator only if, as stated in the proposed rule, the eligible 
clinician furnishes services to the patient and receives payment(s) for 
furnishing those services under the terms of an Other Payer Advanced 
APM.
(iv) Denominator
    We proposed that the denominator would be the number of unique 
patients to whom eligible clinicians in the Advanced APM Entity furnish 
services under all non-excluded payers during the QP Performance 
Period.
(b) Examples of Patient Count Threshold Score Calculation
    In the QP Performance Period for payment year 2021the Advanced APM 
Entity experienced the following patient counts:

                                Table 40--All-Payer Combination Option Example 3
----------------------------------------------------------------------------------------------------------------
                                                            Patients through   Total patients    Threshold score
                           Payer                                   ACO           from payer            (%)
----------------------------------------------------------------------------------------------------------------
Medicare*.................................................             3,000            10,000                30
Commercial................................................             1,000             5,000                20
Medicaid..................................................               800             1,000                80
                                                           -----------------------------------------------------
    Total.................................................             4,800            16,000                30
----------------------------------------------------------------------------------------------------------------
* For Medicare Part B patients, the amount used for the All-Payer Combination Option will be the same as the
  number of attribution-eligible beneficiaries used in the denominator of the calculation under the Medicare
  Option.

    In Table 40, the Advanced APM Entity meets the minimum Medicare 
threshold (30% > 20%) to be considered under the All-Payer Combination 
Option. However, it fell short of the QP Patient Count Threshold (30% < 
35%). In this case, the Advanced APM Entity would meet the Partial QP 
Patient Count Threshold (30% > 25%).
    Another Advanced APM Entity in the same year experienced the 
following patient counts:

                                Table 41--All-Payer Combination Option Example 4
----------------------------------------------------------------------------------------------------------------
                                                            Patients through   Total patients    Threshold score
                           Payer                                   ACO           from payer            (%)
----------------------------------------------------------------------------------------------------------------
Medicare*.................................................             2,000             5,000                40
Commercial................................................             4,000             5,000                80
Medicaid..................................................             1,000             1,500                67
                                                           -----------------------------------------------------

[[Page 77478]]

 
    Total.................................................             7,000            11,500                61
----------------------------------------------------------------------------------------------------------------
* For Medicare Part B patients, the amount used for the All-Payer Combination Option will be the same as the
  number of attribution-eligible beneficiaries used in the denominator of the calculation under the Medicare
  Option.

    In Table 41, the Advanced APM Entity meets the minimum Medicare 
threshold (40% > 20%) to be considered under the All-Payer Combination 
Option. It also exceeds the minimum QP Patient Count Threshold (61% > 
35%). In this case, the eligible clinicians in the Advanced APM Entity 
would become QPs.
    We solicited comment on the patient count method described above 
and any potential alternative approaches.
    We received no comments in response to our proposed patient count 
method. Section II.F.6.(c) of this final rule with comment has a 
detailed discussion of comments on this policy as it pertains to the 
Medicare Option.
    We are finalizing our proposal to calculate the All-Payer 
Combination Option Threshold Score for eligible clinicians in an 
Advanced APM Entity (or an eligible clinician that participates in 
multiple APMs) by dividing the numerator by the denominator value, as 
described above. This calculation will result in a percent value 
Threshold Score that we would compare to the QP Patient Count Threshold 
and the Partial QP Patient Count Threshold to determine the QP status 
of the eligible clinicians for the payment year. The calculations occur 
in two steps because there is a Medicare QP threshold and an All-Payer 
QP threshold. We are finalizing our proposal that the numerator is the 
number of unique patients to whom eligible clinicians in the Advanced 
APM Entity furnish services that are included in the measures of 
aggregate expenditures used under the terms of all of their Other Payer 
Advanced APMs during the QP Performance Period, plus the patient count 
numerator for Advanced APMs.
    We are finalizing our proposal that the denominator is the number 
of unique patients to whom eligible clinicians in the Advanced APM 
Entity furnish services under all non-excluded payers during the QP 
Performance Period.
d. Submission of Information for Assessment Under the All-Payer 
Combination Threshold Option
    Under sections 1833(z)(2)(B)(ii)(III) and (C)(ii)(III) of the Act, 
an eligible clinician can only become a QP using the All-Payer 
Combination Option by providing the Secretary such information as is 
necessary for the Secretary to determine whether a payment arrangement 
is an Other Payer Advanced APM and to determine the eligible 
clinician's Threshold Score.
    We have the necessary data to make QP determinations and an APM 
Incentive Payments for Advanced APMs because they are administered 
within the Medicare program. Because Other Payer Advanced APMs are 
administered outside of the Medicare program, CMS needs to collect 
analogous data from specific sources who have that data to make QP 
determinations and APM Incentive Payments to those participating in 
Other Payer Advanced APMs. In order for CMS to perform QP 
determinations using the All-Payer Combination Option, submissions must 
include specific payment and patient numbers for each payer from whom 
the eligible clinician has received payments during the QP Performance 
Period.
    We proposed that APM Entities or individual eligible clinicians 
must submit by a date and in a manner determined by us: (1) Payment 
arrangement information necessary to assess whether each payment 
arrangement is an Other Payer Advanced APM, including information on 
financial risk arrangements, use of certified EHR technology, and 
payment based on quality measures; and (2) for each payment 
arrangement, the amounts of revenues for services furnished through the 
arrangement, the total revenues from the payer, the numbers of patients 
furnished any service through the arrangement (that is, patients for 
whom the eligible clinician is at risk if actual expenditures exceed 
expected expenditures), and (3) the total number of patients furnished 
any service through the payer.
    If we do not receive sufficient information to complete our 
evaluation of all other payer arrangements to perform the QP threshold 
calculation, we would not evaluate the eligible clinicians under the 
All-Payer Combination Option. If sufficient information is submitted, 
we would then assess the characteristics of the other payer arrangement 
to determine if it is an Other Payer Advanced APM and would notify the 
APM Entities and/or eligible clinicians of the Other Payer Advanced APM 
determinations based on their submissions. Because we proposed that an 
Other Payer Advanced APM is required to have an outcome measure, we 
propose that if an Other Payer Advanced APM has no outcome measure, the 
Advanced APM Entity must attest that there is no applicable outcome 
measure on the MIPS list. We intend to establish specific requirements 
regarding the timing and manner of submission of such information 
through future rulemaking.
    We proposed that each payer attest to the accuracy of all submitted 
information including the reported payment and patient data. We 
proposed that if a payer does not attest to the accuracy of the 
reported payment and patient data, these data would not be assessed 
under the All-Payer Combination Option. However, we recognize that such 
a requirement leaves eligible clinicians dependent on a payer over 
which they may have limited control. We therefore solicited comment on 
alternatives to requiring payer attestation, such as addressing the 
scope and intensity of audits to verify the submitted data. For APM 
Entities and eligible clinicians participating in Medicaid, we would 
initiate a review and determine in advance of the QP Performance Period 
the existence of Medicaid Medical Home Models and Medicaid APMs based 
on information obtained from state Medicaid agencies and other 
authorities, such as professional organizations or research entities.
    We solicited comment from stakeholders on the specific types of 
payment arrangement information that would be necessary to assess 
whether payment arrangement is an Other Payer Advanced APM, and the 
format in which we could reasonably expect to receive this information. 
We solicited comment on the level of detail which we should require, 
and whether certain pieces of information would be most easily 
submitted directly from individual eligible clinicians or from an APM 
Entity. We also solicited comment on the timing of when we could expect 
to receive this information from individual eligible clinicians and APM

[[Page 77479]]

Entities for a performance year. In addition, we solicited comment on 
the proposed requirement that an Other Payer Advanced APM must have an 
outcome measure.
    We solicited comment on the possibility of receiving information on 
Other Payer Advanced APMs and their participants directly from other 
payers in order to minimize reporting burden for APM Entities and 
eligible clinicians. We solicited comment on the extent to which 
collecting voluntary submissions of data from other payers could reduce 
burden and increase program integrity through more accurate 
determinations of QP status based on payment or patient threshold 
calculations for Other Payer Advanced APMs. Likewise, we solicited 
comment on the extent to which such data collection is operationally 
feasible or could infringe upon other payers' interests in maintaining 
the confidentiality of their business practices.
    In addition, we proposed to make early Other Payer Advanced APM 
determinations on other payer arrangements if sufficient information is 
submitted at least 60 days before the beginning of a QP Performance 
Period. This would allow us to offer eligible clinicians advance notice 
of their prospects of achieving QP status in the event they are 
assessed under the All-Payer Combination Option. This early 
determination would be considered final for the QP Performance Period 
based on the payment arrangement information submitted. If new 
information is submitted based on a change in the payment arrangement 
during the QP Performance Period, the initial determination could be 
subject to review and revision. We also proposed that, to the extent 
permitted by federal law, we would maintain confidentiality of certain 
information that the APM Entities and/or eligible clinicians submit 
regarding Other Payer Advanced APM status to avoid dissemination of 
potentially sensitive contractual information or trade secrets. We 
proposed that, unlike our proposal for Advanced APM determinations, the 
Other Payer Advanced APM determinations would be made available 
directly to participating APM Entities and eligible clinicians rather 
than through public notice, and we would explain how and within what 
timeframes such notifications will occur in subregulatory guidance. We 
may consider publicly releasing information on Other Payer Advanced 
APMs on the CMS Web site with general and/or aggregate information on 
the payers involved and the scopes of such agreements.
    We solicited comment on the proposed timing and method of feedback 
to APM Entities and eligible clinicians regarding the status of Other 
Payer Advanced APMs for which they have submitted information and on 
the proposed early determination process and the ability of APM 
Entities and eligible clinicians to submit sufficient information prior 
to the beginning of a QP Performance Period. We also solicited comment 
on the types of information that contain potentially sensitive 
information.
    The information submitted to determine whether an eligible 
clinician is a QP under the All-Payer Combination Option may be subject 
to audit, and eligible clinicians and APM Entities will be required to 
maintain copies of any supporting documentation. If an audit reveals a 
material discrepancy in the information submitted to us, and such 
discrepancy affected the eligible clinician's QP status, the APM 
Incentive Payment may be recouped. Providing false information may 
reflect a false claim subject to investigation and prosecution. We may 
provide further details on the audit and recoupment process under the 
All-Payer Combination Option in future rulemaking.
    The following is a summary of the comments we received regarding 
our proposal to require APM Entities or eligible clinicians to submit 
information regarding their payment arrangements in order to be 
assessed under the All-Payer Combination Option.
    Comment: We received several comments on the requirements for 
submission of information. Many commenters suggested CMS to be mindful 
of the need to limit potential burden on clinicians and APM entities to 
collect information for calculation of the All-Payer Combination 
Option. Many commenters expressed concern that the validation process 
will be burdensome for both eligible clinicians and payers and 
requested CMS keep an open dialogue with all involved parties to design 
a process that is administratively feasible. Several commenters 
requested that the requirements for data requests be very specific and 
limited to protect sensitive and proprietary information, and that the 
process have safeguards in place to protect data.
    Several commenters expressed concern or opposition to CMS requiring 
APM Entities and eligible clinicians to submit information for CMS to 
assess whether other payer arrangements meet the Other Payer Advanced 
APM criteria. Some of these commenters stated that payers should be 
required to submit the information because clinicians may not have the 
necessary information readily available. One of these commenters stated 
that, in order to ensure that plans and clinicians can continue to 
focus on delivering high-quality care, CMS should minimize the 
reporting required under the All-Payer Combination Option. Another 
commenter expressed concern that eligible clinicians could be reluctant 
to share their non-Medicare payment information with CMS. One commenter 
opposed CMS requiring eligible clinicians to submit the entirety of a 
contract with another payer, particularly sections including negotiated 
fee schedule or payment rates.
    Response: We appreciate the comments. We understand that both 
eligible clinicians and payers are concerned with which parties will be 
responsible for the submission of information, the timing and method of 
submission, and who will be held accountable for the accuracy of the 
information submitted. We intend to implement a process that requires 
reporting the least amount of information needed to determine 
participation in Other Payer Advanced APMs and calculate Threshold 
Scores while ensuring the integrity of the program. Because these 
provisions of the statute will not be implemented until the 2019 QP 
Performance Period, we are seeking additional comments on these 
information submission requirements.
    Comment: Some commenters opposed requiring payers to verify or 
attest to the data being submitted by APM Entities or eligible 
clinicians. These commenters expressed that the task would be 
burdensome and that APM Entities or eligible clinicians should be 
responsible for all reporting requirements. One commenter stated some 
private payers have no relationship with CMS and the attestation would 
be a burden to establish. Several commenters believe the proposed rule 
provided insufficient detail regarding payer responsibility and 
recommended that CMS clearly explain payer responsibilities and 
expectations with regard to attestation of payment arrangements with 
physicians. One commenter stated that, as currently written, this 
provision of the proposed rule could include disclosure of proprietary 
contracting information that CMS does not have authority to collect. 
This may violate the contractual limitations between the payer and 
clinician. The same commenter said that without any appropriate 
guidance that set parameters around this requirement, operational 
implementation is likely to be overly burdensome. One commenter

[[Page 77480]]

requested CMS strike this requirement from the final rule and instead 
include a criteria checklist in the attestation. One commenter 
recommended CMS minimize administrative burdens for eligible clinicians 
to demonstrate their participation with these payers and looked forward 
to submitting more detailed comments when CMS proposes more specifics 
for how data will be handled and calculations will made under the All-
Payer Combination Option.
    Response: We appreciate the comments. We believe payer involvement 
in attesting to the accuracy of data submitted is essential to the 
integrity of the program. We do not believe the process poses an 
unreasonable burden, even for private payers who have no relationship 
with CMS. We intend to put in place guidelines that will ensure 
proprietary information is not disclosed. We seek additional comments 
on the process for submitting information.
    Comment: Several commenters recommended that CMS have a 
conversation with multiple stakeholders regarding how information will 
be submitted to CMS. Several commenters also suggested that CMS 
establish the detailed reporting requirements through a formal 
rulemaking process with an opportunity for interested parties to 
provide feedback on the requirements. Two commenters suggested that, 
rather than attend to the details through subregulatory guidance, CMS 
should include a thorough proposal in the CY 2018 PFS.
    One commenter recommended that CMS should consider the same 
approach for Other Payer Advanced APMs that is used for Medicare 
Advantage plans. However, the commenter suggested that if CMS believes 
a different standard should apply to MA plans because of their 
contractual relationship with CMS, then CMS should apply the 
reasonableness standard that is enforced through the Medicare Advantage 
program in which a health plan would acknowledge, to the best of its 
knowledge, information, and belief, that the reported payment and 
patient counts were accurate. The commenter recommended that CMS apply 
this standard in a way that minimizes the reporting burden on MA plans. 
Another commenter encouraged CMS to consider establishing a data 
submission process that would allow MA plans to submit data on their 
arrangements in lieu of attestation. One commenter requested more 
detailed requirements for MA contracts and an explanation for how ACOs 
can attest to participating in such contracts.
    Another commenter recommended CMS to consider expanding the third-
party data partners to include state all-payer claims databases (APCDs) 
as a data submitter for those payment arrangement electing to utilize 
the state aggregator for reporting. This option would also have the 
potential to enhance the analytic opportunities for the APM Entity to 
work with the APCD to implement analytic tools and data products that 
benefit the patient population and the APM Entity beyond Medicare 
reporting requirements.
    Response: We appreciate the comments and suggestions. We do intend 
to consult further with stakeholders about the process for submitting 
information. We will consider existing reporting rules and attestations 
with payers, such as MA plans, and adopt similar ones where 
appropriate. We intend to use future rulemaking to potentially make 
changes to our approach.
    After considering the public comments, we are finalizing our 
proposed information submission requirements with no changes, but seek 
further comments on the process for submitting information. APM 
Entities or individual eligible clinicians must submit by a date and in 
a manner determined by CMS: (1) payment arrangement information 
necessary to assess whether each payment arrangement is an Other Payer 
Advanced APM, including information on financial risk arrangements, use 
of certified EHR technology, and payment tied to quality measures; and 
(2) for each payment arrangement, the amounts of payments for services 
furnished through the arrangement, the total payments from the payer, 
the numbers of patients furnished any service through the arrangement 
(that is, patients for whom the eligible clinician is at risk if actual 
expenditures exceed expected expenditures), and (3) the total numbers 
of patients furnished any service through the payer.
    We are also finalizing our proposal that each payer attest to the 
accuracy of all submitted information including the reported payment 
and patient data. We proposed that if a payer does not attest to the 
accuracy of the reported payment and patient data, these data would not 
be assessed under the All-Payer Combination Option. We note that while 
we cannot require other payers to submit information, we could only be 
confident in the accuracy of information eligible clinicians submitted 
to us--and use such information in the All-Payer Combination Option--if 
other payers attest to the accuracy of that information.
8. APM Incentive Payment
    The APM Incentive Payment is specified under section 1833(z)(1) of 
the Act.
a. Amount of the APM Incentive Payment
    This section describes our proposal for calculating the amount of 
the APM Incentive Payment and accounts for the specific scenarios 
outlined under sections 1833(z)(1)(A)(i) and 1833(z)(1)(A)(ii) of the 
Act. This section also describes the process by which we proposed to 
disburse these APM Incentive Payments to QPs.
    In accordance with section 1833(z)(1)(A) of the Act, we would make 
an APM Incentive Payment for a year to eligible clinicians that achieve 
QP status for the year during years 2019 through 2024. In accordance 
with the statute, we proposed that this APM Incentive Payment must be 
equal to 5 percent of the estimated aggregate amounts paid for Medicare 
Part B covered professional services furnished by the eligible 
clinician from the preceding year across all billing TINs associated 
with the QP's NPI.
    The following is a summary of the comments we received in response 
to our proposals regarding the amount of the APM Incentive Payment.
    Comment: One commenter recommended that CMS delay the expiration of 
the APM Incentive Payment until eligible clinicians have meaningful 
opportunities to participate in an Advanced APM, specifically Advanced 
APMs that promote access to advanced illness and palliative care. The 
commenter noted that developing and implementing such a new Advanced 
APM would take time and investment.
    Response: The years for which the APM Incentive Payment is in 
effect are specified under section 1833(z)(1) of the Act. We do not 
believe we have authority to extend availability of the five percent 
APM Incentive Payment beyond the statutory timeframe. Additionally, we 
remind readers that after the APM Incentive Payments expire, QPs will 
continue to be excluded from MIPS reporting requirements and payment 
adjustments for each year that they meet the QP Thresholds. 
Additionally, beginning in 2026, QPs will receive a differential, 
higher PFS update each year.
    Comment: Several commenters suggested that CMS include payments 
made under MA plans when calculating the 5 percent APM Incentive 
Payment. We also received one comment suggesting that CMS include 
payments

[[Page 77481]]

made under the FQHC PPS and the RHC AIR when calculating the 5 percent 
APM Incentive Payment.
    Response: We thank commenters for their suggestions regarding the 
inclusion of payments made under Medicare Advantage, the FQHC PPS, and 
the RHC AIR plans when calculating the estimated aggregate payments 
made to eligible clinicians. However, section 1833(z)(1) of the Act 
stipulates that the APM Incentive Payment be equal to 5 percent of the 
estimated aggregate amounts paid only for Medicare Part B covered 
professional services, which do not include Medicare Advantage, FQHC 
PPS, and RHC AIR payments.
    Comment: One commenter requested clarification on how Medicare 
crossover payments would be taken into consideration for calculating 
the APM Incentive Payment.
    Response: A Medicare crossover claim occurs when Medicare is the 
primary payer for a beneficiary that has supplemental insurance 
coverage, including Medicaid. Under the crossover payment process, 
after the Medicare claim is adjudicated, the Medicare Administrative 
Contractor automatically sends the adjudicated claim to the designated 
insurer for payment. Medicare payments made under this process that are 
for Part B covered professional services will be included in our 
calculations when determining QP Thresholds using the Medicare Option 
and will also be included in the amount of the APM Incentive Payment.
    Comment: One commenter expressed concern that a 5 percent bonus on 
Part B payments may not be enough of an incentive to offset taking on 
risk for both Parts A and B expenditures for aligned beneficiaries, as 
is done in ACO initiatives with downside risk. Another commenter 
recommended that we set the APM Incentive Payment amounts to be at 
least the same amount as the maximum allowable MIPS bonus with the 
intent of further increasing participation in Advanced APMs. One 
commenter supported our belief that the APM Incentive Payment is based 
on participation in an Advanced APM, and is not based on performance in 
the APM. Conversely, we also received a comment that expressed concern 
for paying eligible clinicians a 5 percent incentive to participate in 
Advanced APMs that are not supported by strong evidence of success in 
controlling cost or improving quality, or both. The commenter stated 
that APM Incentive Payments should be provided only for those eligible 
clinicians in APM Entities proven to improve value for beneficiaries. 
The commenter believes that the relationship between guaranteed 
additional payment and payment at risk must be substantial enough so 
that eligible clinicians are motivated to improve their care processes 
and reduce unnecessary utilization.
    Response: We note that section 1833(z)(1) of the Act stipulates 
that the APM Incentive Payment be equal to 5 percent of the estimated 
aggregate amounts paid for Medicare Part B covered professional 
services. Likewise, as stated in section II.F.1. of this final rule 
with comment period, we believe that the process for determining 
whether an eligible clinician is a QP and receives the APM Incentive 
Payment should focus on the relative degree of participation by 
eligible clinicians in Advanced APMs, not on their performance within 
the APM. The Quality Payment Program does not alter how each particular 
APM, or Advanced APM, measures and rewards success within its design. 
Rather, it rewards a substantial degree of participation in Advanced 
APMs.
    Comment: We received one comment in support of our proposal that 
the amount of APM Incentive Payment be calculated across all billing 
TINs associated with the QP's NPI.
    Response: We thank commenters for their feedback and support of 
this proposal.
    Comment: One commenter requested feedback on how we would calculate 
the APM Incentive Payment if an APM Entity contract ends during the 
incentive payment base period.
    Response: QP Threshold Scores and APM Incentive Payments are 
calculated based on the data that CMS has available at the time of the 
calculations. We reiterate that our proposal is to calculate the APM 
Incentive Payment across all billing TINs during the incentive payment 
base period, which we are finalizing to be the calendar year preceding 
the payment year. As an example, using 2017 as the performance period 
for the 2019 payment year, we would calculate the amount of the APM 
Incentive Payment based on payments during CY 2018. Even if an APM 
Entity contract involving the QP ends during CY 2018, we would still 
base the amount of the APM Incentive Payment across all of a QP's 
billing TINs during the incentive payment base period.
    After considering public comments, we are finalizing our proposals 
regarding the calculation of the amount of the APM Incentive Payment as 
required by section 1833(z)(1)(A) of the Act. Specifically, we finalize 
our proposals that APM Incentive Payments will be made to eligible 
clinicians who are determined to be QPs during years 2019 through 2024. 
In accordance with the statute, we are finalizing our proposal that 
this APM Incentive Payment must be equal to 5 percent of the estimated 
aggregate payment amounts for Medicare Part B covered professional 
services furnished by the QP during the preceding year across all 
billing TINs associated with the QP's NPI.
(1) Incentive Payment Base Period
    The incentive payment base period is the range of dates that would 
be used to calculate the estimated aggregate payment amounts for the 
year preceding the QP payment year that would serve as the basis for 
the incentive payment. Section 1833(z)(1)(A) of the Act states that in 
calculating the amount that is equal to 5 percent of the estimated 
aggregate payment amounts for Medicare Part B covered professional 
services under this part for the preceding year, the payment amount for 
the preceding year may be an estimation for the full preceding year 
based on a period of such preceding year that is less than the full 
year. We believe this provision provides flexibility in determining the 
incentive payment base period. We proposed to use the full calendar 
year prior to the payment year as the incentive payment base period 
from which to calculate the estimated aggregated payment amounts.
    Using a complete calendar year of claims would allow for the most 
accurate representation of the covered professional services delivered 
by each eligible clinician, which we believe outweighs a modest 
potential delay in making the APM Incentive Payment. We solicited 
comment on our proposal to use the entire preceding calendar year as 
the incentive payment base period.
    The following is a summary of the comments we received in response 
to our proposal pertaining to the APM incentive payment base period.
    Comment: Several commenters supported our proposal to use the 
entire calendar year prior to the incentive payment year when 
calculating the amount of APM Incentive Payment.
    Response: We appreciate commenters' feedback and support of our 
proposal.
    Comment: One commenter suggested that we calculate the APM 
Incentive Payment based on the number of months an NPI was 
participating in an Advanced APM.
    Response: We appreciate this commenter's feedback. However, we 
disagree that the amount of APM Incentive Payment should only be based 
on the number of months of participation in an Advanced APM. Not

[[Page 77482]]

only would this potentially conflict with our policies setting the QP 
Performance Period and the incentive payment base period, but the 
statute provides that the APM Incentive Payment is based on estimated 
aggregate payment amounts for the entire ``preceding year.''
    After considering public comments, we are finalizing our proposal 
that the incentive payment base period is the full calendar year prior 
to the payment year.
(2) Timeframe of Claims
    Section 1833(z)(1)(A) of the Act directs us to make the APM 
Incentive Payment in a lump sum on an annual basis ``as soon as 
practicable.'' We believe that, in implementing this provision, it is 
important to balance the desire for accuracy in the data used to 
calculate the APM Incentive Payment with the desire to expedite the 
payments so that the APM Incentive Payments are made in an appropriate 
and timely manner.
    We proposed to calculate the APM Incentive Payment based on data 
available 3 months after the end of the incentive payment base period 
in order to allow time for claims to be processed. For example, for the 
2019 payment year, we would capture claims submitted with dates of 
service from January 1, 2018 through December 31, 2018 and processing 
dates of January 1, 2018 through March 31, 2019. We believe that 3 
months of claims run-out is sufficient to conduct the APM Incentive 
Payment calculations in an accurate and timely manner. This methodology 
is consistent with the claims run-out timeframes used for 
reconciliation payments in several current APMs, such as the Shared 
Savings Program, the Pioneer and Next Generation ACO Models, and the 
CEC model. We solicited comment on the potential use of a completion 
factor. We note that several current APMs apply the 3-month claims run-
out in conjunction with a completion factor. However, where a 
completion factor may be appropriate for payments based on claims 
submitted by groups of providers and suppliers that may be billing 
under multiple TINs, we believe that with payments based on individual 
eligible clinician claims, categorical variability in claims completion 
across types of eligible clinicians would cause inequitable results.
    In summary, for the incentive payment base period we proposed to 
use a complete calendar year of claims with 3 months of claims run-out 
from the end of the calendar year. We believe our proposed approach 
balances our goals of providing incentive payments in a reasonable 
timeframe while being able to account for the vast majority (on 
average, 99.3 percent of claims for) covered professional services. 
Given these parameters, we estimated that APM Incentive Payments could 
be made approximately 6 months after the end of the incentive payment 
base period, or roughly mid-way through the payment year. However, we 
proposed that the APM Incentive Payment would be made no later than 1 
year from end of the incentive payment base period. We did not propose 
to set a specific deadline mid-way during the payment year because we 
believe doing so could pose operational risks in the event that 6 
months is impracticable in a given year for reasons that CMS cannot 
predict. We solicited comment on our proposed timing for when we will 
make the APM Incentive Payment during a payment year.
    The following is a summary of the comments we received regarding 
our proposals for using 3 months of claims run-out when calculating the 
APM Incentive Payment and for the timing of making the APM Incentive 
Payment.
    Comment: Several commenters supported our proposal to use 3 months 
of claims run-out when calculating the APM Incentive Payment. Some 
commenters noted that additional run-out time is unlikely to yield more 
meaningful data and that further lag time may dilute the impact or 
incentive to eligible clinicians in receiving the APM Incentive 
Payment.
    Response: We agree that 3 months of claims run-out will allow us to 
make accurate APM Incentive Payment calculations without diluting the 
impact or incentives to QPs receiving APM Incentive Payments.
    Comment: Several commenters opposed our proposal to not specify a 
specific date during CY 2019 to make the APM Incentive Payment. Many of 
those commenters stated that CMS should be able to commit to making the 
APM Incentive Payment before the end of the payment year. The majority 
of commenters stated that CMS should identify a shorter and more 
defined period for eligible clinicians to receive their APM Incentive 
Payment and that a shorter, more defined period would encourage 
Advanced APM participation. Other commenters stated that too much lag 
time in making the APM Incentive Payment may negatively impact 
financial operations for, and subsequent-year quality performance of, 
entities that operate under risk-adjusted financial arrangements. One 
commenter suggested that we align the APM Incentive Payment with the 
shared savings payment from the Shared Savings Program.
    Response: We note that under section 1833(z)(1)(B) of the Act we 
are required to make the APM Incentive Payment ``as soon as 
practicable.'' We recognize the importance of the APM Incentive Payment 
and we believe that accuracy of the APM Incentive Payment is of the 
utmost importance under the Quality Payment Program. An accurate APM 
Incentive Payment will maintain and encourage participation in Advanced 
APMs. While we estimate that the APM Incentive Payment could be made 
approximately mid-way through the payment year, we reserve the right to 
take additional time to calculate the APM Incentive Payment if 
necessary.
    After considering public comments, we are finalizing our proposal 
to use 3 months of claims run-out when calculating the amount of APM 
Incentive Payment, and we are finalizing our proposal to make the APM 
Incentive Payment no later than 1 year from end of the incentive 
payment base period.
(3) Treatment of Payment Adjustments in Calculating the Amount of APM 
Incentive Payment
    Part B covered professional services under the Medicare PFS are 
currently subject to several statutory provisions that are geared 
towards improving quality and efficiency in service delivery. Eligible 
clinicians are subject to payment adjustments under the Medicare EHR 
Incentive Program for Eligible Professionals (MU), the PQRS, and the 
VM. Beginning in 2019, the MIPS adjustment, as described in section 
II.E.5. of the final rule, will replace payment adjustments under the 
MU, PQRS, and VM for all MIPS eligible clinicians. These special 
payment adjustments directly adjust the payment amount that eligible 
clinicians receive under the PFS. In contrast, we consider the APM 
Incentive Payment to be separate from, and, as indicated under section 
1833(z)(1)(A) of the Act, in addition to the amount of payments made 
for covered professional services under the Medicare PFS.
    We proposed to exclude the MIPS, VM, MU and PQRS payment 
adjustments when calculating the estimated aggregate payment amount for 
covered professional services upon which to base the APM Incentive 
Payment amount. For example, a QP who receives an upward fee adjustment 
during 2018 in VM would not see that adjustment reflected in the 
estimated aggregate payment amount for covered professional services 
used to calculate his or her APM Incentive Payment in

[[Page 77483]]

2019. Similarly, a QP who receives a downward fee adjustment during 
2018 in VM would not see that amount reflected in the aggregate payment 
amount for the APM Incentive Payment.
    We believed this proposed policy is most consistent with the 
specification in section 1833(z)(1)(A) of the Act that the APM 
Incentive Payment is based on the estimated aggregate payment amounts 
for ``such'' covered professional services for the preceding year, 
which refers to the Part B covered professional services furnished by 
the particular eligible clinician.
    While we considered the alternative of including these performance-
related payment adjustments in calculating the APM Incentive Payment, 
we were concerned that such a policy would create incentives that are 
not aligned with the intent of the APM Incentive Payment. As previously 
stated in our policy principles, we believe that the APM Incentive 
Payment is best viewed as a complementary reward for eligible 
clinicians that have a substantial degree of participation in the most 
advanced APMs, not an evaluation of their performance within the APM or 
in another statutorily required performance-based payment adjustment.
    We also proposed in section II.F.6.b.(1) of the proposed rule to 
account for payment adjustments in the QP determination process in the 
same manner as when calculating the amount of the APM Incentive 
Payment. If we were to include statutory payment adjustments when 
determining QP status, there could be situations where an eligible 
clinician could become a QP because of a positive payment adjustment 
amount, or conversely, there could be situations where an eligible 
clinician would not meet the QP threshold because of a negative payment 
adjustment. We believe that our proposal to not include payment 
adjustments when determining QP status for a year, or when calculating 
the amount of the APM Incentive Payment, allows us to assess all 
eligible clinicians on the same merits throughout the entire QP 
determination and when calculating the APM Incentive Payment. We do not 
believe the intent of the statute was to enhance or negate an eligible 
clinician's opportunity to become a QP in a given performance year, or 
to enhance or negate the amount of APM Incentive Payment a QP receives, 
based on factors that are extraneous to APM participation.
    We solicited comment on this proposed approach to coordinating the 
various PFS payment adjustments when calculating the amount of the APM 
Incentive Payment.
    The following is a summary of the comments we received regarding 
our proposals for how to treat PFS payment adjustments when calculating 
the amount of the APM Incentive Payment.
    Comment: Several commenters expressed support for our proposal to 
exclude the MIPS, VM, MU, and PQRS payment adjustments when calculating 
the estimated aggregate payment amount for covered professional 
services upon which to base the APM Incentive Payment amount. All 
commenters who responded to this proposal agreed with our belief that 
the intent of the APM Incentive Payment is not to further magnify 
existing and future payment adjustments.
    Response: We thank commenters for their feedback.
    After considering public comments, we are finalizing our proposal 
to exclude the MIPS, VM, MU and PQRS payment adjustments when 
calculating the estimated aggregate payment amount for covered 
professional services upon which to base the APM Incentive Payment 
amount.
(4) Treatment of Payments for Services Paid on a Basis Other Than Fee-
for-Service
    We recognize that many APMs use incentives and financial 
arrangements that differ from usual fee schedule payments. Section 
1833(z)(1)(A)(i) of the Act requires us to establish policies for 
payments that are made to an Advanced APM Entity rather than directly 
to the QP. Section 1833(z)(1)(A)(ii) of the Act requires us to 
establish policies for when payment is made on a basis other than FFS. 
For the purposes of this rule, we place such payments into three 
categories: Financial risk payments, supplemental service payments, and 
cash flow mechanisms. We also recognize that payment methods and 
financial arrangements may evolve over time and those would need to be 
addressed in future rulemaking. We solicited comment on the proposals 
for accounting for risk-based payments, supplemental service payments, 
and cash flow mechanisms when calculating the amount of APM Incentive 
Payment.
(a) Financial Risk Payments
    Financial risk payments are non-claims-based payments based on 
performance in an APM when an APM Entity assumes responsibility for the 
cost of a beneficiary's care, whether it be for an entire performance 
year, or for a shorter duration of time, such as over the course of a 
defined episode of care. We note that in the context of categorizing 
these types of payments as ``financial risk payments,'' we refer to 
payments that may be based on the cost of a beneficiary's care and do 
not necessarily limit these payments to financial arrangements that 
would require an APM Entity to accept downside risk. For instance, we 
would consider the shared savings payments made to ACOs in all tracks 
of the Shared Savings Program to be financial risk payments. We would 
also consider net payment reconciliation amounts from us to an Awardee 
(or vice versa) under the BPCI Initiative, and reconciliation payments 
from us to a participant hospital or repayment amounts from a 
participant hospital to us under the CJR model to be examples of 
financial risk payments.
    We proposed to exclude financial risk payments when calculating the 
estimated aggregate payment amount for covered professional services 
upon which to base the APM Incentive Payment amount. Financial risk 
payments are not for specific Medicare Part B covered professional 
services; rather they are for performance in an APM. Therefore, we 
believe their inclusion in the estimated aggregate payment amount would 
be inconsistent with the statutory language and our stated policy 
principles. In addition, the difficulty of disaggregating payments to 
individual QPs and the lagged timing of some financial risk payments 
creates significant policy and operational barriers that we do not 
believe are in line with our objective of making APM Incentive Payments 
in a timely manner.
    The following is a summary of the comments we received regarding 
our proposal to exclude financial risk payments when calculating the 
amount of the APM Incentive Payment.
    Comment: Some commenters expressed support for our proposal to 
exclude financial risk payments when calculating the estimated 
aggregate payment amount and encouraged CMS to finalize this proposal. 
Conversely, some commenters did not believe that CMS should exclude 
financial risk payments when calculating the amount of the APM 
Incentive Payments. These commenters noted that financial risk payments 
under CMS shared savings models are the only way that eligible 
clinicians can be compensated for services not directly paid under the 
fee schedule, and that these payments are actually compensation that 
are contingent on performance in an APM.
    Response: We note that while financial risk payments may be 
considered compensation for physician services, many financial risk 
payments are inclusive of services paid under Medicare Part A in 
addition to services paid under Medicare Part B. We are not

[[Page 77484]]

currently able to distinguish which portion of financial risk payments 
is from services paid under Part A from covered professional services 
paid under Medicare Part B. We also note that section 1833(z)(1)(A) of 
the Act stipulates that we are to calculate the amount of the APM 
Incentive Payment based on the amount that is equal to 5 percent of the 
estimated aggregate payment amounts for Medicare Part B covered 
professional services.
    Additionally, we note that many financial risk payments are 
calculated based on the performance of the APM Entity as a whole, not 
on the performance of individual eligible clinicians that participate 
in the APM Entity. We do not currently have a way in which we are able 
to attribute portions of a financial risk payment to an APM Entity to 
individual eligible clinicians.
    After considering public comments, we are finalizing our proposal 
to exclude financial risk payments when calculating the amount of APM 
Incentive Payment.
(b) Supplemental Service Payments
    Supplemental service payments are Medicare Part B payments for 
longitudinal management of a beneficiary's health or for services that 
are within the scope of medical and other health services under 
Medicare Part B that are not separately reimbursed through the PFS. 
Often these are per-beneficiary per-month (PBPM) payments that are made 
for care management services or separately billable services that share 
the goal of improving quality of care overall, enabling investments in 
care improvement, and reducing Medicare expenditures for services that 
could be avoided through care coordination. For example, OCM makes a 
per beneficiary Monthly Enhanced Oncology Services (MEOS) payment to 
practices for care management and coordination during episodes of care 
initiated by chemotherapy treatment.
    We proposed to determine whether certain supplemental service 
payments are in lieu of covered services that are reimbursed under the 
PFS. In cases where payments are for covered services that are in lieu 
of services reimbursed under the PFS, those payments would be 
considered covered professional services and would be included in the 
APM Incentive Payment amounts. We proposed to include a supplemental 
service payment in calculation of the APM Incentive Payment amount if 
it meets all of the following 4 criteria:
    (1) Payment is for services that constitute physicians' services 
authorized under section 1832(a) of the Act and defined under section 
1861(s) of the Act;
    (2) Payment is made for only Part B services under the first 
criterion above, that is, payment is not for a mix of Part A and Part B 
services;
    (3) Payment is directly attributable to services furnished to an 
individual beneficiary; and
    (4) Payment is directly attributable to an eligible clinician.
    We further proposed to establish a process by which we notify the 
public of the supplemental service payments in all APMs and identify 
the supplemental service payments that meet our proposed criteria and 
would be included in the APM Incentive Payment calculations. Similar to 
our proposal to announce Advanced APM determinations, we proposed to 
post an initial list of supplemental service payments that would be 
included in our APM Incentive Payment calculations on the CMS Web site. 
As new APMs are announced, we would include the determination of 
whether supplemental service payment related to that APM would be 
included in our APM Incentive Payment calculations, if applicable, in 
conjunction with the first public notice of the APM. We proposed to 
update the list of supplemental service payments that would be included 
in our APM Incentive Payment calculations on an ad hoc basis, but no 
less frequently than on an annual basis.
    We solicited comment on this proposed approach to include certain 
supplemental service payments when calculating the basis for the amount 
of the APM Incentive Payment. Specifically, we solicited comment on our 
proposed criteria to include supplemental service payments in the basis 
for the APM Incentive Payment amounts, and our proposed method for 
announcing which supplemental service payments would be included in the 
basis for the APM Incentive Payment amounts.
    The following is a summary of the comments we received regarding 
our proposals for how to consider certain supplemental service payments 
when calculating the amount of the APM Incentive Payment.
    Comment: One commenter supported our proposal to include 
supplemental service payments in the calculation of the APM Incentive 
Payment when the four proposed criteria are met.
    Other commenters stated that CMS should withdraw its proposal to 
make specific determinations on each supplemental services payment 
based on the proposed criteria. These commenters were concerned this 
proposal adds unnecessary complexity and uncertainty to the 
calculations and could provide a disincentive for physicians who want 
to transition away from a FFS approach.
    Response: Although we recognize that determining whether certain 
supplemental service payments are included in the APM Incentive Payment 
may add limited complexity to calculating the APM Incentive Payment, we 
intend to mitigate this complexity by clearly communicating the results 
of these determinations. Additionally, we believe that by recognizing 
that certain supplemental service payments are in lieu of services 
traditionally billed under the Medicare PFS, we are incentivizing 
clinicians to transition away from FFS payment approaches with no link 
to quality by including supplemental service payments when calculating 
the amount of the APM Incentive Payment.
    Comment: A few commenters stated that CMS should consider ACO 
shared savings payments as supplemental service payments, and that 
these payments should always be included when calculating the APM 
Incentive Payment.
    Response: We thank commenters for their input. For the reasons 
discussed in this section of this final rule with comment, we disagree 
that shared savings payments to ACOs should be considered supplemental 
service payments. As clearly indicated in the previous section, we 
consider shared savings payments to ACOs to be financial risk payments 
and are finalizing our proposal not to include financial risk payments 
when calculating the amount of the APM Incentive Payment.
    Comment: We received one comment supporting our proposals related 
to public notification of supplemental service payments, which would 
include an initial posting of supplemental service payments included in 
estimated aggregate payment amounts and updates to that list no less 
than annually.
    Response: We thank commenters for their feedback and their support 
of these proposals.
    After considering public comments, we are finalizing our proposal 
to determine whether certain supplemental service payments are in lieu 
of covered professional services that are paid under the PFS on the 
basis of the four proposed criteria:
    (1) Payment is for services that constitute physicians' services 
authorized under section 1832(a) of the Act and defined under section 
1861(s) of the Act;

[[Page 77485]]

    (2) Payment is made for only Part B services under the first 
criterion above, that is, payment is not for a mix of Part A and Part B 
services;
    (3) Payment is directly attributable to services furnished to an 
individual beneficiary; and
    (4) Payment is directly attributable to an eligible clinician.
    We are also finalizing our proposal to establish a process by which 
we notify the public of the supplemental service payments in all APMs 
and identify the supplemental service payments that will be included in 
the APM Incentive Payment calculations. This process includes posting 
an initial list of supplemental service payments that would be included 
in our APM Incentive Payment calculations on the CMS Web site. We are 
finalizing our proposal that we will update this list no less 
frequently than annually and that we will include determinations and 
updates to this list as new APMs with supplemental service payments are 
announced.
(c) Cash Flow Mechanisms
    Cash flow mechanisms involve changes in the method of payments for 
services furnished by providers and suppliers participating in an APM 
Entity. In themselves, cash flow mechanisms do not change the overall 
amount of payments. Rather, they change cash flow by providing a 
different method of payment for services. An example of a cash flow 
mechanism is the population-based payment (PBP) available in the 
Pioneer ACO Model and the Next Generation ACO Model. A PBP is a monthly 
lump sum payment in exchange for a percentage reduction in Medicare FFS 
payments to certain ACO providers and suppliers.
    For expenditures affected by cash flow mechanisms, we proposed to 
calculate the estimated aggregate payment amount using the payment 
amounts that would have been incurred for Part B covered professional 
services if the cash flow mechanism had not been in place. For example, 
for QPs in an ACO receiving a PBP that have agreed to a 50 percent 
reduction in FFS payments, we would use the amount that would have been 
paid for Part B covered professional services in the absence of the 50 
percent reduction. Cash flow mechanisms represent a potential 
reallocation of dollars between eligible clinicians and APM Entities 
for specific purposes related to care improvement. We do not believe 
that the presence of cash flow mechanisms should impact the APM 
Incentive Payment amount, and we do not intend for the APM Incentive 
Payment to influence the use or attractiveness of cash flow mechanisms 
in current and future APMs.
    The following is a summary of the comments we received regarding 
our proposal for how to account for payments affected by any cash flow 
mechanism when calculating the amount of the APM Incentive Payment.
    Comment: We received one comment supporting our proposal to 
calculate the estimated aggregate payment amount using the payment 
amount that would have been made for Part B covered professional 
services if the cash flow mechanism had not been in place.
    Response: We thank the commenter for supporting our proposal.
    After considering public comments, we are finalizing our proposal 
to calculate the estimated aggregate payment amount using the payment 
amount that would have been made for Part B covered professional 
services if the cash flow mechanism had not been in place.
(d) Payments Made to an APM Entity Instead of to an Eligible Clinician
    Section 1833(z)(1)(A)(i) of the Act requires us to establish 
policies for payments that are made to an Advanced APM Entity rather 
than directly to a QP. We recognize that new payment methods and 
financial arrangements may be developed as part of APMs that meet this 
criterion. For instance, in the recently announced CPC+ Model, the 
supplemental service payments (that is, the CMFs) would meet all of our 
proposed criteria to be included in the APM Incentive Payment 
calculations. The CMFs are for Medicare Part B covered professional 
services and only Medicare Part B covered professional services. The 
CMF payment amounts would be risk-adjusted based on each individual 
beneficiary's HCC risk scores; therefore, these payments will be 
attributable to individual beneficiaries. Additionally, the attribution 
method in the CPC+ Model uses a combination of the TIN/Individual NPI/
Practice Address when attributing an individual beneficiary to a CPC+ 
Practice site. However, the CMF payments for attributed beneficiaries 
are aggregate payments made to each CPC+ Practice Site. We recognize 
that throughout the course of a QP Performance Period more than one NPI 
may furnish covered professional services to an attributed beneficiary. 
If that occurs, more than one NPI could potentially receive the 
corresponding CMF for that eligible beneficiary. We do not believe it 
would be appropriate to count the same CMF for more than one NPI. 
Therefore, assuming that the CPC+ Model is determined to be an Advanced 
APM and the APM Entity group achieves the QP threshold for a year, we 
could split the CMF amounts equally between the multiple NPIs, or we 
could develop a method based on the plurality of visits with that 
beneficiary to ``assign'' the NPI to which the CMFs would be credited 
for purposes of the APM Incentive Payment calculation.
    We solicited comment on how to allocate payments made to an APM 
Entity rather than an eligible clinician.
    The following is a summary of the comments we received regarding 
our proposal.
    Comment: We received two comments with respect to allocating the 
supplemental service payments to individual NPIs in scenarios in which 
payment for a supplemental service payment is made in the aggregate to 
an APM Entity. One commenter stated that it would be ideal to attribute 
the payments to an individual NPI to whom the patient is attributed. If 
that were not possible, then the commenter favored splitting the CMF 
amounts equally between the multiple eligible clinicians within the APM 
Entity as long as those eligible clinicians are limited to the ones 
actually providing care management. Another commenter stated that any 
allocation method for CMFs under the APM Incentive Payment should 
reduce burden by using the same calculation as that of the CMFs 
themselves.
    Response: We appreciate this input. We note that when payments are 
paid to an APM Entity it may not be possible to identify which eligible 
clinicians are providing care management services, especially if a 
beneficiary is attributed to an APM Entity rather than a specific NPI. 
It is possible that this beneficiary could receive care management 
services from more than one eligible clinician within the APM Entity. 
We sought an approach that could provide the most equitable solution 
for how to identify NPIs to which payment is attributable without 
resulting in additional operational complexity.
    After considering public comments, we are finalizing our proposal 
that when payments are paid to an APM Entity instead of to an 
individual eligible clinician, and those payments are not attributable 
to an individual eligible clinician, we will divide the amount of such 
payments s equally across all eligible clinicians who are on the 
Participation List for that APM Entity, and each eligible clinician who 
is a QP will be considered to have been paid that portion of the 
payments for

[[Page 77486]]

purposes of the APM Incentive Payment amount calculations.
(5) Treatment of Other Incentive Payments in Calculating the Amount of 
APM Incentive Payments
    Section 1833(z)(1)(D) of the Act specifies that we shall not 
include certain existing Medicare incentive payments in the calculation 
of the APM Incentive Payment. This includes payments made under section 
1833 of the Act (sections (m), (x), and (y)).
    Section 1833(m) of the Act describes the HPSA Physician Bonus 
Program. The HPSA Physician Bonus Program provides bonus payments to 
physicians for physicians' services furnished in geographic areas that 
are designated as of December 31 of the prior year by HRSA as HPSAs 
under section 332(a)(1)(A) of the PHS Act. The HPSA bonus payment is 10 
percent of the Medicare Part B payment amount for the service; and this 
bonus is paid as a quarterly lump sum payment.
    Section 1833(x) of the Act describes the Primary Care Incentive 
Payment (PCIP) program. The PCIP payment amount was 10 percent of the 
payment amount for Medicare Part B primary care services furnished by 
primary care practitioners for whom primary care services accounted for 
at least 60 percent of their allowed FFS charges in a prior 
qualification period. For purposes of the PCIP program, primary care 
practitioners were defined as physicians with certain Medicare 
specialty codes and as certain types of non-physician practitioners. 
The PCIP payment was made on a quarterly basis. This bonus payment 
expired under the statute on December 31, 2015.
    Section 1833(y) of the Act describes the HPSA Surgical Incentive 
Payment (HSIP). For major surgical procedures furnished by physicians 
with a primary specialty designation of ``general surgeon'' in HPSAs 
(under section 332(a)(1)(A) of the PHS Act), physicians received an 
additional 10 percent bonus payment in addition to the amount of 
payment that would have otherwise been made. This additional payment 
was combined with any other HPSA payment outlined in section 1833(m) of 
the Act and was paid on a quarterly basis. This bonus payment expired 
under the statute on December 31, 2015.
    Section 1833(z)(1)(D) of the Act also directs us not to include APM 
Incentive Payments when calculating payments made under section 1833 
(sections (m), (x), and (y)) of the Act. We consider the APM Incentive 
Payment to be separate from the incentive payments as previously 
discussed in the proposed rule, and we have established procedures to 
ensure that the APM Incentive Payment would not be included when 
calculating the amount of incentive payments made under section 
1833(m), (x), and (y) of the Act.
    We received no comments in response to our proposal this section.
    As directed by the statute, we are finalizing our proposal not to 
include incentive payments made under section 1833(m), (x), and (y) of 
the Act when calculating the amount of the APM Incentive Payment, and 
not to include APM Incentive Payments when calculating payments made 
under section 1833(m), (x), and (y) of the Act.
(6) Treatment of the APM Incentive Payment in APM Calculations
    Section 1833(z)(1)(C) of the Act states that the amount of the APM 
Incentive Payment shall not be taken into account for purposes of 
determining actual expenditures under an APM and for purposes of 
determining or rebasing any benchmarks used under the APM. As a lump 
sum payment, the APM Incentive Payments will be made outside of the 
Medicare claims processing system. Current APMs, such as the Medicare 
ACO initiatives and the CJR model, have established procedures for 
ensuring that lump sum payments from other APMs are excluded when they 
do their APM reconciliations and rebasing calculations. We anticipate 
that each APM will have in place a procedure to avoid counting APM 
Incentive Payments toward determining actual expenditures or rebasing 
any benchmarks under the APM.
    The following is a summary of comments we received in response to 
our proposals for how to treat the APM Incentive Payment in APM-related 
calculations.
    Comment: We received several comments supporting exclusion of the 
APM Incentive Payment when calculating expenditures under an APM. Some 
commenters specifically requested that APM Incentive Payments not be 
taken into account when determining shared savings payments for ACOs 
and considered it reasonable that we would expect each APM to have a 
procedure in place to avoid counting APM Incentive Payments when 
determining actual expenditures or determining or rebasing any 
benchmarks under an APM.
    Another commenter requested further confirmation from CMS that the 
MIPS payment adjustments are not included in Medicare ACO expenditures 
for benchmark calculations. The commenter stated that if this were not 
the case, it would create a disincentive for participation in an ACO 
and nullify the incentive of an upward payment adjustment.
    Response: We note that decisions regarding whether or not to 
include fee schedule adjustments when calculating expenditures under an 
APM are typically made on an APM-by-APM basis, and we anticipate that 
each APM will have procedures in place to exclude the APM Incentive 
Payment and provide clarification on whether fee schedule adjustments 
are included when calculating expenditures under that APM.
b. Services Furnished Through CAHs, RHCs, and FQHCs
(1) Critical Access Hospitals (CAHs)
    Eligible clinicians who furnish services at CAHs that have elected 
to be paid for outpatient services under section 1834(g)(2)(B) of the 
Act (Method II) will be eligible to become QPs and receive the APM 
Incentive Payment if they are part of an Advanced APM Entity. As stated 
in section II.F.6.d.(1) of this final rule with comment, professional 
services furnished at a Method II CAH are considered ``covered 
professional services'' because they are furnished by an eligible 
clinician and payments are based on the Medicare PFS. Therefore, we 
proposed that the APM Incentive Payment would be based on the amounts 
paid for those services attributed to the eligible clinician in the 
same manner as all other covered professional services.
    For an eligible clinician who becomes a QP based on covered 
professional services furnished at a Method II CAH, we proposed that 
the APM Incentive Payment would be made to the CAH TIN that is 
affiliated with the Advanced APM Entity. This proposal was consistent 
with the way in which we proposed to make the APM Incentive Payment to 
eligible clinicians who practice at locations other than Method II 
CAHs. We solicited comment on this proposal.
    We did not receive any specific comments on this proposal, and we 
are finalizing our proposal to make the APM Incentive Payment for an 
eligible clinician who becomes a QP based on covered professional 
services furnished at a Method II CAH to the CAH TIN that is affiliated 
with the Advanced APM Entity.
(2) Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    As explained in section II.F.6.d.(2) of this final rule with 
comment, payment for services furnished by eligible clinicians in RHCs 
and FQHCs is not

[[Page 77487]]

reimbursed under or based on the PFS. Therefore, professional services 
furnished in those settings would not constitute covered professional 
services under section 1848(k)(3)(A) of the Act and would not be 
considered part of the estimated aggregate payment amount upon which 
the APM Incentive Payment is based. For eligible clinicians who 
practice in RHCs or FQHCs, this does not preclude the inclusion of 
payment amounts for covered professional services furnished by those 
eligible clinicians in other settings. This only excludes payments made 
for RHC and FQHC services furnished by the eligible clinicians. For 
example, an eligible clinician may practice at both an FQHC and with a 
separate physician group practice that receives payment under the PFS. 
If the eligible clinician becomes a QP under the methodologies 
described in II.F.6. of this final rule with comment, whether based on 
their participation in an Advanced APM Entity that includes the FQHC as 
outlined in section II.F.6.d.(2) of this final rule with comment or 
based on their participation in an Advanced APM Entity that includes 
the separate physician group practice, or both, only the eligible 
clinician's payments for covered professional services at the separate 
physician group practice setting would form the estimated aggregate 
payment amount for the APM Incentive Payment.
    We did not receive any specific comments on our proposal for 
eligible clinicians who become a QP who may also practice at an RHC or 
FQHC.
    We are finalizing our proposal that professional services furnished 
in RHCs and FQHCs would not constitute covered professional services 
under section 1848(k)(3)(A) of the Act and would not be considered part 
of the amount upon which the APM Incentive Payment is based.
c. Payment of the APM Incentive Payment
(1) Payment to the QP
    In the proposed rule, we proposed that the APM Incentive Payment 
would be made to QPs who are identified by their unique NPI. We 
proposed that we would make the APM Incentive Payment for a QP to the 
eligible clinician's TIN that is affiliated with the Advanced APM 
Entity through which the eligible clinician was determined to be a QP. 
For both individual eligible clinicians and group practices, we would 
use the TIN as the billing unit. We proposed that the APM Incentive 
Payment would be calculated across all billing TINs associated with an 
NPI. Medicare has the ability to track all unique TIN/NPI combinations 
associated with an individual NPI, including which TINs are affiliated 
with an Advanced APM Entity. We considered making separate payments for 
each TIN/NPI combination associated with the individual eligible 
clinician's APM Incentive Payment, similar to how the current PQRS 
incentive payment program operates. Under the current PQRS incentive 
payment program, incentive payments are paid to the holder of the TIN, 
aggregating individual incentive payments for groups that bill under 
one TIN. For eligible clinicians who submit claims under multiple TINs, 
we group claims by TIN for payment purposes, and any incentive payments 
earned are paid to that specific TIN. As a result, an eligible 
clinician with multiple TINs who qualifies for the PQRS incentive 
payment under more than one TIN would receive a separate PQRS incentive 
payment associated with each TIN.
    However, we believe that making the APM Incentive Payments to the 
TIN associated with the Advanced APM Entity during the QP Performance 
Period would be most consistent with the requirements of section 
1833(z) of the Act and would incentivize participation in Advanced 
APMs. Rewarding TINs that are not involved in an Advanced APM for their 
constituent NPI's activities through separate entities is antithetical 
to the objective of the Quality Payment Program. We also believe that 
making the APM Incentive Payments to the TIN associated with the 
Advanced APM Entity during the QP Performance Period is most consistent 
with section 1833(z) of the Act with regards to making the APM 
Incentive Payments to eligible clinicians who become QPs. We believe 
that making multiple separate payments would increase complexity for 
both CMS and eligible clinicians.
    Additionally, we finalized in section II.F.5. of this final rule 
with comment, that to be a QP, an eligible clinician must be identified 
on a CMS-maintained Participation List of an Advanced APM Entity. That 
will allow us to track the APM participant identifiers for each 
eligible clinician, and we believe that this information will allow us 
to determine which of the QPs' TINs should receive APM Incentive 
Payments.
    We recognize that there may be scenarios in which an eligible 
clinician may change his or her affiliation between the QP Performance 
Period and the payment year such that the eligible clinician no longer 
practices at the TIN affiliated with the Advanced APM Entity. In this 
instance, we proposed to make the APM Incentive Payment to the TIN 
provided on the eligible clinician's CMS-588 EFT Application. This 
proposal is consistent with the process that we have used to make 
incentive payments under other programs, such as the PCIP program.
    We solicited comment on our proposal to make the APM Incentive 
Payments to the TIN affiliated with the Advanced APM Entity through 
which an individual eligible clinician becomes a QP and our proposal to 
make the APM Incentive Payment to the TIN provided on the eligible 
clinician's CMS-588 EFT Application in the event that an eligible 
clinician no longer practices at the TIN affiliated with the Advanced 
APM Entity at the time of payment. We also solicited comment on 
alternative options that maintain the goals of equity and simplicity 
and encourage and reward participation in Advanced APMs.
    The following is a summary of the comments we received regarding 
our proposal to make the APM Incentive Payment to the TIN affiliated 
with the APM Entity through which an eligible clinician becomes a QP.
    Comment: We received a few comments in support of our proposal. One 
commenter stated that this proposal would allow for maximum flexibility 
in the development of APMs, their various organizational structures, 
and the ways in which revenues might flow through APM Entities. Another 
commenter supported the suggestion that the APM Incentive Payment is a 
coordinated effort among eligible clinicians and other aligned 
providers and suppliers.
    We received several comments suggesting alternatives to our 
proposal. Some commenters stated that they believe the APM Incentive 
Payment should be made directly to the QP, as identified by either the 
QP's NPI or by the QP's unique TIN/NPI combination. Some commenters 
also cited statutory language in section 1833(z) of the Act stating 
that APM Incentive Payments should be made to ``such professionals.'' 
Some of the commenters also stated that paying eligible clinicians 
directly will encourage them to become more engaged in an Advanced APM 
and its potential impact on patient care. One commenter stated that 
eligible clinicians have more control over their performance and can 
respond more quickly to incentives.
    Conversely, we received some comments stating that the APM 
Incentive Payment should be made to the Advanced APM Entity TIN, 
similar to how shared savings payments are

[[Page 77488]]

distributed to ACOs in the Shared Savings Program.
    Response: APM Incentive Payments will be calculated and made for 
each QP as identified by an NPI. We further clarify that when referring 
to the ``TIN associated with the Advanced APM Entity,'' our intent is 
that the APM Incentive Payment would be sent to the Medicare enrolled 
billing TIN that is affiliated with the Advanced APM Entity, and not 
the TIN of the Advanced APM Entity itself.
    Even in instances where an incentive payment has been calculated at 
an NPI level, CMS has traditionally used the TIN as the billing unit 
such that any incentive payments earned are paid to the TIN holder of 
record. This precedent has been followed in various other incentive 
payment programs, such as the Physician Quality Reporting Initiative 
(PQRI) incentive payment and the PQRS incentive payment program, and we 
intend to follow this established precedent of making incentive 
payments to billing TINs. However, under those incentive payment 
programs, CMS grouped eligible clinician' claims by TIN for payment 
purposes, and any incentive payments earned were paid to that TIN. As a 
result, an eligible clinician with multiple TINs who qualified for an 
incentive payments under more than one TIN would have received a 
separate incentive payment associated with each TIN.
    We believe that making the APM Incentive Payments to the TIN 
associated with the Advanced APM Entity through which an eligible 
clinician becomes a QP would be most consistent with the requirements 
of section 1833(z) of the Act and would incentivize participation in 
Advanced APMs. We also believe that making the APM Incentive Payments 
to the TIN associated with the Advanced APM Entity during the QP 
Performance Period is most consistent with section 1833(z) of the Act 
with regards to making the APM Incentive Payments to eligible 
clinicians who become QPs.
    Given the precedent of making incentive payments to the TIN holder 
of record, we will make APM Incentive Payments to the Medicare-enrolled 
billing TIN of a QP's NPI that is in the Advanced APM Entity. We do not 
prescribe whether or how APM Incentive Payments are to be distributed 
to QPs within the TIN.
    Comment: We received one comment suggesting that CMS allow QPs to 
share APM Incentive Payments with beneficiaries.
    Response: We thank this commenter for their feedback. The Quality 
Payment Program does not change any existing laws or regulations 
regarding provider or supplier payments or incentives to beneficiaries.
    Comment: Some commenters requested that CMS support fair and timely 
distribution of the APM Incentive Payment to QPs and encourage all 
Advanced APM Entities to issue notifications to participating eligible 
clinicians regarding the distribution of an APM Incentive Payment.
    Response: We appreciate the commenter's feedback, and we encourage 
clear and open communication between Advanced APM Entities, 
participating TINs, and eligible clinicians regarding the distribution 
of the APM Incentive Payment. We refer readers to section II.F.8.c.(3) 
of this final rule with comment period for further details on how we 
will notify APM Entities, Medicare enrolled billing TINs, and QPs of 
the amount of the APM Incentive Payment calculated for each QP, as 
identified by the QP's NPI, so that all involved parties are informed 
of the amount of the APM Incentive Payment associated with each QP.
    After considering public comments, we are finalizing our proposal 
to make the APM Incentive Payment to the TIN affiliated with the 
Advanced APM Entity through which an eligible clinician becomes a QP, 
and we further clarify that the APM Incentive Payment would be sent to 
the Medicare-enrolled billing TIN associated with the Advanced APM 
Entity. As discussed in our responses to comments, we note that all 
Medicare payments are made to a billing TIN, and the ultimate 
distribution of the APM Incentive Payment is a consideration of the 
Medicare-enrolled billing TIN and their associated QPs. We are also 
finalizing our proposal to make the APM Incentive Payment to the TIN 
provided on the eligible clinician's CMS-588 EFT Application in the 
event that an eligible clinician no longer practices at the TIN 
affiliated with the Advanced APM Entity at the time of payment. QP 
status is determined for, and attached to, an eligible clinician for 
the payment year based on Advanced APM participation during the QP 
Performance Period; therefore, changes in practice afterward should not 
affect a QP's ability to receive the APM Incentive Payment or to be 
excluded from MIPS reporting requirements and payment adjustments.
(2) Exception for Eligible Clinicians in Multiple Advanced APMs
    We recognize that there may be instances where none of the multiple 
Advanced APM Entities with which an individual eligible clinician 
participates meets the QP threshold. In this instance, we have proposed 
to assess the eligible clinician individually, using services furnished 
through all Advanced APM Entities during the QP Performance Period. 
When we make the QP determination at the individual eligible clinician 
level, we proposed to split the APM Incentive Payment amount 
proportionally across all of the QP's TINs associated with Advanced APM 
Entities. For example, if an eligible clinician is determined to be a 
QP at the individual level based on participation in two Advanced APM 
Entities (Advanced APM Entity 1 and Advanced APM Entity 2), and has 75 
percent of his or her payments used to make the QP determination are 
through Advanced APM Entity 1 and 25 percent of his or her payments 
used to make the QP determination are through Advanced APM Entity 2, we 
would make 75 percent of the APM Incentive Payment to the QP's billing 
TIN associated with Advanced APM Entity 1, and 25 percent of the APM 
Incentive Payment to the QP's billing TIN affiliated with Advanced APM 
Entity 2. We believe that splitting the APM Incentive Payment in this 
way is consistent with section 1833(z) of the Act as well as our goal 
to encourage participation in multiple Advanced APMs where applicable. 
We also believe that splitting the incentive payment in this way 
appropriately recognizes the several activities of the individual 
eligible clinician toward achieving the QP threshold.
    We solicited comment on the proposal to split the APM Incentive 
Payment among the QP's TINs associated with Advanced APM Entities in 
instances where the QP determination is made at the individual level 
based on participation in multiple Advanced APMs. We also welcomed 
comments regarding to which TIN(s) payments should be made in the cases 
where the QP changes TIN affiliations between the QP Performance Period 
and the payments of the APM Incentive Payment.
    We did not receive any comments with regards to our proposal to 
split the APM Incentive Payment among a QP's TINs associated with 
Advanced APM Entities in instances where the QP determination is made 
at the individual eligible clinician level.
    Comment: We received a few comments regarding our proposal to make 
the APM Incentive Payment to the TIN provided on the eligible 
clinician's CMS-588 Electronic Funds Transfer (EFT) Application in 
scenarios when the eligible clinician is no longer affiliated

[[Page 77489]]

with the TIN affiliated with the Advanced APM Entity. Some commenters 
disagreed with our proposal to make the APM Incentive Payment to the 
TIN provided on the eligible clinician's CMS-588 EFT Application and 
instead stated that CMS should make the APM Incentive Payment to the 
individual QP's NPI, not a TIN.
    Some commenters questioned why, in the event an eligible clinician 
is no longer associated with the TIN associated with the Advanced APM 
Entity, the APM Incentive Payment would be made to a new entity, and 
questioned why the APM Incentive Payment would not stay with the 
billing TIN participating in the Advanced APM Entity. In this instance, 
the commenter suggested we split the payment amount based on either the 
predominance of where that clinician provided services or based on an 
end date.
    Response: We thank commenters for their feedback, and note that for 
both individual eligible clinicians and group practices, we use the TIN 
as the billing unit, meaning that we must be able to track all Medicare 
payments to a TIN. We also note that not all individual eligible 
clinicians who are enrolled in Medicare have their own personal billing 
TIN. We also believe that the APM Incentive Payment is meant to reward 
eligible clinicians for their participation in an APM Entity. We do not 
believe that the individual QP's receipt of the APM Incentive Payment 
for a year should be affected by whether the QP maintains a 
relationship with the APM Entity between the performance and payment 
years, and proposed this policy in accordance with that belief.
    We are finalizing the proposal to split the APM Incentive Payment 
amount proportionally, based on the payment amounts used to make the QP 
determination across all of the QP's TINs associated with Advanced APM 
Entities when the QP determination is made at the individual level.
    We also further clarify that in the event that an eligible 
clinician participates in more than one Advanced APM Entity, and that 
eligible clinician meets the QP threshold through more than one 
Advanced APM Entity, as determined at the group level, we would split 
the total amount of the APM Incentive Payment in the same manner.
(3) Notification of APM Incentive Payment Amount
    We proposed to send notification to both Advanced APM Entities and 
QPs of the APM Incentive Payment amount as soon as we have calculated 
the amount of the APM Incentive Payment and performed all necessary 
validation of the results. Following our proposed method to notify 
eligible clinicians of their QP status, we proposed that the APM 
Incentive Payment amount notification would be made directly to QPs in 
combination with a general public notice that such calculations have 
been completed for the year. For the direct QP notification, we 
intended to include the amount of APM Incentive Payment and the TIN to 
which the incentive payments will be made. In the case that the APM 
Incentive Payment is split across multiple TINs, we proposed to 
identify which TINs would receive the payment and include the amount 
that would be paid to each TIN. For the notification to Advanced APM 
Entities, and other recipient TINs, we intend to include the total 
amount of APM Incentive Payments that will be made to each 
participating TIN within the Advanced APM Entity, as well as QP-
specific payment amounts. We believed that this would be the most 
efficient method to disseminate of this information to all QPs.
    We solicited comment on other methods for the notification of the 
APM Incentive Payment amount. We also solicited comment on the content 
of such notifications so that they may be as clear and useful as 
possible.
    The following is a summary of the comments we received regarding 
our proposal to notify Advanced APM Entities and QPs of the amount of 
the APM Incentive Payment.
    Comment: Several commenters supported our proposal to send a 
notification to both Advanced APM Entities and QPs of the APM Incentive 
Payment amount as soon as CMS has calculated the amount of the APM 
Incentive Payment and performed all necessary validation of the 
results. These commenters recommended that the notification include 
information that allows QP to verify that the payment is correct. Other 
commenters requested that we include a timeframe for making 
notifications regarding the APM Incentive Payment amount.
    Response: We appreciate the commenters' feedback and support of our 
proposals. We intend that the notifications of APM Incentive Payment 
Amounts will include contextual information that will allow QPs to 
verify the calculation of the APM Incentive Payment amount. We will 
provide more information on the format of the APM Incentive Payment 
notifications and the data included with such notifications before they 
are distributed. We further anticipate that the timing of the APM 
Incentive Payment amount notification will follow a similar timeline to 
that outlined in section II.F.8.a.(2) of this final rule with comment 
period, where we finalize our proposal for the incentive payment base 
period and timeframe of claims we will use to determine the estimated 
aggregate payment amounts used for the APM Incentive Payment Amount. We 
anticipate that the notification of the APM Incentive Payment amounts 
would occur once CMS has calculated the APM Incentive Payment Amounts 
but before the APM Incentive Payments are distributed to QPs.
    After considering public comments, we are finalizing our proposal 
to send a notification to both Advanced APM Entities and QPs of the APM 
Incentive Payment amount as soon as CMS has calculated the amount of 
the APM Incentive Payment and performed all necessary validation of the 
results as proposed.
9. Monitoring and Program Integrity
    In an effort to accurately award the APM Incentive Payment and 
preserve the integrity of the Medicare program, we will monitor APM 
Entities, Advanced APM Entities, and eligible clinicians on an ongoing 
basis for non-compliance with Medicare program requirements and for 
non-compliance with the law, regulation, or agreement governing the 
relevant Advanced APMs during the QP Performance Period. These efforts 
include vetting of the individuals and entities applying to participate 
in Advanced APMs and periodically assessing Advanced APM Entities and 
eligible clinicians by Advanced APMs in conjunction with the CMS Center 
for Program Integrity and other relevant federal departments and 
agencies. This vetting and monitoring already takes place for APMs and 
will continue.
    We proposed that if an Advanced APM terminates an Advanced APM 
Entity or eligible clinician during the QP Performance Period for 
program integrity reasons, or if the Advanced APM Entity or eligible 
clinician is out of compliance with program requirements, we may reduce 
or deny the APM Incentive Payment to such eligible clinicians. In 
addition, if the APM Incentive Payment is paid based on a QP 
Performance Period and the Advanced APM Entity or eligible clinician is 
later terminated due to a program integrity matter arising during that 
QP Performance Period, we may recoup all or a portion of the amount of 
the APM Incentive Payment from the individual or entity to which we 
made the payment.
    We also proposed that we would reopen and recoup any payments that

[[Page 77490]]

were made in error in accordance with procedures similar to those set 
forth at Sec. Sec.  405.980 and 405.370 et seq. or established under 
the relevant Advanced APM.
    As discussed in section II.F.7.b.(7) of this final rule with 
comment period, APM Entities or eligible clinicians who seek to be 
assessed under the All-Payer Combination Option must submit certain 
information for us to assess whether their other payer arrangements 
meet the Other Payer Advanced APM criteria and to calculate the 
Threshold Score for a QP determination under the All-Payer Combination 
Option.
    Relatedly, we proposed that Advanced APM Entities and eligible 
clinicians must maintain copies of all records related to assessment 
under the All-Payer Combination Option for at least 10 years from the 
time of submission and must provide the government with access to these 
records for auditing and inspection purposes. If an audit reveals that 
the information submitted is inaccurate, we may recoup the APM 
Incentive Payment.
    Nothing in this final rule imposes any limitations or restrictions 
on the authority of the Department of Health and Human Services Office 
of Inspector General.
    We solicited comment on our monitoring and program integrity 
proposals.
    The following is a summary of the comments we received regarding 
our proposals to continue CMS vetting of those applying to be and 
ongoing monitoring of those Advanced APM Entities and eligible 
clinicians.
    Comment: One commenter encouraged CMS to consider additional APM 
modifications and stringent monitoring mechanisms that will prevent 
stinting of care and encourage the delivery of high quality care while 
lowering overall costs.
    Response: We appreciate the commenter's input. We consider 
potential modifications to APM design to better promote program 
integrity and the delivery of high quality care on an ongoing basis and 
will continue to do so.
    We are finalizing our proposals to vet and monitor APM Entities, 
Advanced APM Entities, and eligible clinicians.
    The following is a summary of the comments we received regarding 
our proposals to deny, reduce, or recoup APM Incentive Payments made to 
eligible clinicians if an Advanced APM Entity or eligible clinician is 
either out of compliance with the Advanced APM's program requirements 
or if the Advanced APM Entity or eligible clinician is terminated from 
participating in the APM for program integrity reasons and to reopen 
and recoup any payments that were made in error in accordance with 
procedures similar to those set forth at Sec. Sec.  405.980 and 405.370 
et seq. or established under the relevant Advanced APM.
    Comment: Many commenters supported these proposals. One commenter 
stated that Advanced APM Entities behave more like insurers by taking 
on more than nominal risk; therefore, Advanced APMs should be subject 
to regulations traditionally imposed on risk-bearing entities, such as 
solvency standards or other equivalent program integrity rules. One 
commenter stated that physical therapists and other non-physician 
practitioners in APMs should not have conflicts of interest and 
improper financial motivations, and requested that CMS monitor any 
negative effect hospital and physician market dominance may have, 
especially on small non-physician providers in private practice. 
Alternatively, one commenter opposed penalizing non-compliant 
clinicians.
    Response: We appreciate commenters' suggestions of ways to preserve 
program integrity. We note that each APM and Advanced APM will be 
designed to include appropriate program integrity safeguards that will 
account for the risk-bearing nature of the APM and to protect public 
funds and the integrity of the Medicare program. We are not setting 
forth specific program integrity standards in this rule; rather, such 
standards are incorporated on an APM-specific basis as APMs and 
Advanced APMs are developed. Additionally, CMS does consider the 
effects that APMs and Advanced APMs may have in different marketplaces. 
For Advanced APM Entities and eligible clinicians who fail to comply 
with an Advanced APM's program requirements, the agreement, law, or 
regulation governing that Advanced APM defines the process for 
addressing these issues. Although we understand that some may oppose 
policies that protect public funds from those who fail to comply with 
the terms of an Advanced APM, CMS must have the ability to do so in 
order to preserve program integrity.
    Comment: Several commenters suggested that we consider beneficiary 
impacts of APMs, such as ensuring Advanced APMs have beneficiary 
protections in place, using patient-centered quality measures, 
collaborating with beneficiaries regarding APM design, and monitoring 
for access issues and risks to beneficiary freedom of choice.
    Response: We appreciate commenters' focus on protecting 
beneficiaries. Although largely outside the scope of this final rule, 
both APMs and Advanced APMs have requirements for beneficiary 
protections in their relevant agreements or regulations. We have taken 
outcome measures into account when finalizing the criteria for Advanced 
APMs, as discussed further in section II.F.4.b.(2) of this final rule 
with comment period. We also emphasize that if beneficiaries have 
concerns about their clinicians or the quality of care that they are 
receiving, they can seek assistance by filing a complaint. More 
information about filing complaints is available at https://www.medicare.gov/claims-and-appeals/file-a-complaint/complaint.html.
    Comment: A few commenters noted that there are barriers to APM 
Entity creation posed by the physician self-referral law, anti-kickback 
statute, and other fraud, waste, and abuse laws. The commenters 
requested exceptions, safe harbors, and clear guidelines on the 
application of these laws to APM participants in order to foster 
collaboration among clinicians that is beneficial to patients. One 
commenter requested that CMS ensure that APM Entities are prohibited 
from waiving copays, giving deep discounts, or offering other 
incentives to incentivize patients to receive services within the APM 
Entity. Another commenter requested that the federal government 
institute a system under which it continually assesses APM Entity 
compliance with physician self-referral laws, anti-kickback statutes, 
and gainsharing civil monetary penalty provisions.
    Response: Although addressing fraud and abuse laws is not within 
the scope of this final rule, we will send these comments to the 
appropriate subject matter experts.
    Comment: One commenter requested that we provide guidance to 
providers, suppliers, and other stakeholders on methods by which the 
health care community can disclose or report potential violations of 
fraud and abuse laws.
    Response: One way to report potential fraud is by contacting the 
HHS Office of Inspector General at 1-800-HHS-TIPS or by visiting 
https://forms.oig.hhs.gov/hotlineoperations/index.aspx. Potential fraud 
can also be reported by calling 1-800-MEDICARE. More information about 
what information to report is available at https://www.medicare.gov/forms-help-and-resources/report-fraud-and-abuse/report-fraud/reporting-fraud.html.

[[Page 77491]]

    Providers or suppliers who wish to voluntarily disclose self-
discovered evidence of potential fraud to CMS or the Office of 
Inspector General may do so under their respective self-disclosure 
protocols.
    We are finalizing our proposals with no changes. We will deny, 
reduce, or recoup APM Incentive Payments made to eligible clinicians if 
an Advanced APM Entity or eligible clinician is either out of 
compliance with the Advanced APM's program requirements or if the 
Advanced APM Entity or eligible clinician is terminated from 
participating in the APM for program integrity reasons and to reopen 
and recoup any payments that were made in error in accordance with 
procedures similar to those set forth at Sec. Sec.  405.980 and 405.370 
et seq. or established under the relevant Advanced APM.
    The following is a summary of the comments we received regarding 
our proposal to require that all Advanced APM Entities and eligible 
clinicians who submit information in order to obtain a QP determination 
under the All-Payer Combination Option retain all records, and provide 
the government with access to these records for auditing and inspection 
purposes, for at least 10 years.
    Comment: Several commenters expressed concern that this requirement 
is excessively burdensome and becomes more difficult when clinicians 
change practices. Some commenters suggested alternative retention 
timeframes such as 3 or 7 years. Some commenters requested that CMS 
clearly communicate the requirements so that new entrants into APMs can 
understand the expectations and not be unduly penalized in the future.
    Response: In the Medicare Option for QP determinations, we have the 
Medicare claims information necessary for us to make QP determinations, 
and there are pre-existing rules that govern record retention of that 
information. In the All-Payer Combination Option, CMS will make QP 
determinations based on information created by payers other than 
Medicare, and for this information to be used, it must be submitted to 
CMS. CMS must be able to verify this information, and the government 
must have access to all of these records. We appreciate commenters' 
concerns about the burdens this requirement may impose, but this 10-
year record retention requirement is consistent with other Medicare 
record retention rules, such as that in the Shared Savings Program, and 
it aligns with the statute of limitations for claims arising under the 
False Claims Act.
    In order to address the requests for more detail, we intend to 
issue further details regarding the All-Payer Combination Option before 
the 2019 QP Performance Period, which is when it first becomes 
available.
    We are finalizing that Advanced APM Entities and eligible 
clinicians must retain, maintain, and provide the government with 
access to copies of all records related to submitting data or 
information to CMS for purposes of QP determinations under the All-
Payer Combination Option for at least 10 years from the date that the 
record was created. We clarify that for any single record, the 
responsibilities finalized here may be carried out by either an 
Advanced APM Entity or an eligible clinician so that collectively, all 
necessary records are retained, maintained, and accessible to the 
government.
10. Physician-Focused Payment Models
a. Introduction and Overview
    Section 101(e)(1) of the MACRA statute entitled, ``Increasing the 
Transparency of Physician-Focused Payment Models,'' adds a new section 
1868(c) to the Act. In general, this subsection establishes an 
innovative process for individuals and stakeholder entities 
(stakeholders) to propose PFPMs to the Physician-Focused Payment Model 
Technical Advisory Committee (PTAC). A copy of the PTAC's charter, 
established by the Secretary on January 5, 2016, is available at 
https://aspe.hhs.gov/charter-physician-focused-payment-model-technical-advisory-committee.
(1) Overview of the Roles of the Secretary, the PTAC, and CMS
    Section 1868(c)(2)(A) of the Act requires the Secretary to 
establish, through notice and comment rulemaking following an RFI, 
criteria for PFPMs (PFPM criteria), including models for specialist 
physicians, that could be used by the PTAC in making comments and 
recommendations on PFPMs. We issued the MIPS and APMs RFI requesting 
stakeholder input on PFPMs on October 1, 2015, and we proposed PFPM 
criteria in section II.F.10.c. of the Quality Payment Program proposed 
rule.
    The PTAC, established under section 1868(c)(1)(A) of the Act, is a 
federal advisory committee comprised of 11 members that provides 
independent advice to the Secretary. As required under section 
1868(c)(1)(B) of the Act, the initial appointments to the PTAC were 
made by the Comptroller General of the United States (GAO) on October 
9, 2015.
    Section 1868(c)(2)(B) of the Act specifies that stakeholders may 
submit proposals to the PTAC on an ongoing basis for PFPMs that they 
believe meet the PFPM criteria established by the Secretary. We 
recognize this statutory directive, but did not propose to define 
``ongoing basis'' because we believe that the process for submitting 
proposals to the PTAC should be determined by the PTAC.
    Section 1868(c)(2)(C) of the Act requires the PTAC to review 
stakeholders' proposed PFPMs, prepare comments and recommendations 
regarding whether such proposed PFPMs meet the PFPM criteria 
established by the Secretary, and submit those comments and 
recommendations to the Secretary.
    Section 1868(c)(2)(D) of the Act requires the Secretary to review 
the PTAC's comments and recommendations on proposed PFPMs and to post 
``a detailed response'' to those comments and recommendations on the 
CMS Web site.
    Without being able to predict the volume, quality, or 
appropriateness of the proposed PFPMs that the PTAC will make comments 
and recommendations on, we are not in a position to propose a 
commitment to test all such models. Section 1868(c) of the Act does not 
require us to test models that are recommended by the PTAC. However, 
this does not imply that we would not give serious consideration to 
proposed PFPMs recommended by the PTAC.
    The PTAC serves an important advisory role in the implementation of 
PFPMs, but there are additional considerations that must be made by the 
Secretary beyond what is provided by the PTAC, such as competing 
priorities and available resources. We believe that this flexibility is 
important because the Secretary and CMS must retain the ability to make 
final decisions on which models to test and when, based on multiple 
factors including those that the Innovation Center currently uses to 
determine which payment models to test, available on the Innovation 
Center Web site: https://innovation.cms.gov/Files/x/rfi-Websitepreamble.pdf.
    While we would consider these factors separately from the PTAC's 
comments and recommendations, the decision to test a model recommended 
by the PTAC would not require submission of a second proposal to us; we 
would review the proposal submitted to the PTAC along with comments 
from the PTAC and the Secretary, and any other resources we believe 
would be useful. In order to test

[[Page 77492]]

a PFPM based on a recommendation from the PTAC, CMS may seek to obtain 
additional information based on the contents of the proposal. After a 
PFPM proposal has been recommended by the PTAC, if it is selected for 
implementation, we may work with the individual stakeholders who 
submitted their proposals to consider design elements for testing the 
PFPM and make changes as necessary. We note that if a PFPM we select 
for implementation requires those interested to apply in order to 
participate, a stakeholder who submitted the proposal would have to 
apply in order to participate.
    Proposed PFPMs that the PTAC recommends to the Secretary but that 
are not immediately tested by us may be considered for testing at a 
later time. We may continue to test PFPMs that are developed within CMS 
but believe that the PTAC process will be instrumental in our goal to 
develop more PFPMs.
(2) Deadlines for the Duties of the Secretary, the PTAC, and CMS
    We did not propose to set deadlines for these tasks through 
regulations. We believe that setting a deadline for the PTAC's comments 
and recommendations could potentially interfere with the PTAC's ability 
to develop its own process and timeline for reviewing proposed PFPMs. 
We wish to preserve the PTAC's ability to determine how and when it 
would review proposed PFPMs.
    We believe that setting a deadline through rulemaking for the 
Secretary's review of the PTAC's comments and recommendations, 
publication of a response to them, and our potential testing of a 
proposed PFPM submitted to the PTAC is inappropriate because these 
tasks would take varying amounts of time depending on factors that we 
cannot predict. Proposed PFPMs may be submitted to the PTAC on ``an 
ongoing basis'' in accordance with section 1868(c)(2)(B) of the Act, 
and given that there may be variation in the number and frequency of 
proposals, setting a deadline for the Secretary's response would be 
difficult. We do not believe we can effectively set deadlines through 
rulemaking because we do not know how many PFPM proposals the PTAC 
would receive or review. The Secretary would need varying lengths of 
time to review, comment on, and respond to PFPM proposals depending on 
the volume and nature of each proposal.
    We do not believe it would be reasonable to require that we adhere 
to a deadline in deciding whether to test a particular proposed PFPM. 
It is important for us to retain the flexibility to test APMs when we 
believe that it is the right time to do so, taking into account the 
other APMs we are currently testing, any potential design changes to 
the proposed PFPM, interactions with our other policies, and resource 
allocation. APMs generally take 18 months for us to develop, although 
the period of development may vary in length significantly, making a 
deadline difficult to establish.
    We believe that setting deadlines for testing proposed PFPMs would 
be inappropriate. Entities need time to complete applications for 
voluntary models and we need time to review applications and prepare 
participation agreements for entities to sign. Entities need time to 
review these participation agreements and to begin planning for 
implementation of the model. To maintain rigorous evaluation of model 
outcomes, we also need time to build the necessary model infrastructure 
for such functions as quality measurement, financial calculations, and 
payment disbursements, and to coordinate with other payers if they are 
included in the model's design.
    We believe that proposed PFPMs that meet all of the PFPM criteria 
and are recommended by the PTAC may need less time to go through the 
development process; however, we cannot guarantee that the development 
process would be shortened, or estimate by how much it would be 
shortened. These processes depend on the nature of the PFPM's design, 
and any attempt to impose a deadline on them would not benefit 
stakeholders because it would not allow us to tailor the review and 
development process to the needs of the proposed PFPM.
    The following is a summary of the comments we received regarding 
the roles of the Secretary, the PTAC, and CMS.
    Comment: Commenters encouraged CMS to be open to the PTAC's 
comments and recommendations and commit to testing PFPMs recommended by 
the PTAC. A few commenters stated they want CMS to test as many PFPMs 
as possible. Two commenters expressed concern that CMS would not test 
PFPMs because CMS has stated it would not commit to testing PFPMs 
recommended by the PTAC or specifically commit to testing all PFPMs 
recommended by the Secretary.
    Response: We are open to the PTAC's comments and recommendations 
and believe the PTAC review and recommendation process will be an 
essential resource for us to use in developing new APMs. While we 
cannot commit in advance to pursue any particular model before knowing 
its substance, we are committed to giving all models recommended by the 
PTAC a thorough and thoughtful review, and to testing high-quality 
PFPMs, within the limits of our resources and other constraints.
    Comment: We received many comments on our process for testing new 
PFPMs, with an emphasis on PFPMs that would be Advanced APMs if tested. 
Many commenters requested that we provide details regarding the process 
for HHS review of comments and recommendations from the PTAC, the 
Secretary's response to comments and recommendations from the PTAC, and 
our process for testing PFPMs; and that such details include deadlines. 
Many commenters requested a clear path to implementation of PFPMs. One 
commenter agreed that CMS need not establish a deadline in regulations 
for potential testing of a proposed PFPM. One commenter suggested that 
not setting deadlines effectively allows the agency to have no 
responsibility in evaluating PFPM proposals, and requested that we 
establish deadlines and public criteria for CMS to use in reviewing 
PFPM proposals. One commenter was concerned that the process for 
proposing PFPMs is overly complicated and the timeframe is 
unrealistically aggressive. One commenter disagreed that setting a 
deadline through rulemaking for the Secretary's review of the PTAC's 
comments and recommendations, publication of a response, and potential 
testing is inappropriate and stated that having a time frame should be 
standard practice.
    Response: We did not propose to establish a process or timeline for 
our review of proposed PFPMs or to provide additional information 
regarding such a process in this rule. To allow us flexibility in 
considering diverse models of varying scope and features, we do not 
believe it would be appropriate to establish through rulemaking a 
single process we would follow, with or without timelines. However, we 
appreciate that commenters seek additional information from us on our 
process. Section 1868(c)(2)(D) of the Act requires the Secretary to 
review the PTAC's comments and recommendations on proposed PFPMs and to 
post a ``detailed response'' to those comments and recommendations on 
the CMS Web site. Therefore, the Secretary has a responsibility to 
review comments and proposals from the PTAC on PFPM proposals and a 
responsibility to respond. We are mindful of stakeholders' interest in 
a timely process and are committed to reviewing (and where appropriate, 
implementing) model proposals as quickly as possible.

[[Page 77493]]

We intend to provide more information about this process outside of 
notice and comment rulemaking.
    Comment: A few commenters requested that CMS consider how to 
increase transparency and to incorporate public input into the 
development of APMs. One commenter expressed concern that the process 
for designing and updating APMs does not consistently include feedback 
from consumers and purchasers, which they believed is an essential 
piece that should always be included. One commenter stated that prior 
to the implementation of any PFPM or Advanced APM, CMS must be 
transparent concerning the model design and provide the public with the 
opportunity to review and provide comments on the model with ample time 
built in for preparation and implementation.
    Response: We aspire to foster transparency and cooperation with 
regard to testing PFPMs, including feedback from consumers and 
purchasers. We have made public the factors the Innovation Center uses 
in considering whether to test a model, which would also be relevant to 
its review of PFPMs, on the Innovation Center Web site: https://
innovation.cms.gov/Files/x/rfi-websitepreamble.pdf. Of note, the PTAC 
has made public information regarding its process for its review of 
PFPM proposals, and information about this process can be found on the 
PTAC Web site at https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee. We intend to provide more 
information about our process outside of notice and comment rulemaking.
    Comment: Multiple commenters requested that the PTAC, the 
Secretary, and CMS test new PFPMs as soon as possible. Commenters 
requested CMS facilitate a quick review and approval process for 
testing PFPMs, including expediting or altering its normal process. A 
few commenters requested CMS expedite the approval process for Advanced 
APM proposals, particularly those with specialty physician 
participants, or otherwise prioritize testing of PFPMs that would be 
Advanced APMs. Two commenters were concerned about the length of time 
CMS would need to develop, approve, and implement a PFPM after it is 
recommended for testing. A commenter stated that many specialty 
societies that have been working to develop PFPM proposals have been 
alarmed by comments from CMS officials indicating that even after these 
proposals have been recommended by the PTAC to the Secretary, they 
would still need to go through a separate, potentially years-long CMS 
process before they could be implemented and qualify as Advanced APMs 
under the Quality Payment Program. Commenters wanted to verify that 
there are PFPMs that are Advanced APMs available to eligible clinicians 
during the years the APM Incentive Payment is available. To this end, 
one commenter suggested making changes to the timing of when Advanced 
APM criteria need to be met so that PFPMs implemented in 2019 would 
apply to the 2017 QP performance period, and another commenter 
suggested we waive the application of section 1833(z)(2) of the Act, 
such that participants in APMs approved by the Innovation Center after 
2017 receive a transition period in which such participants' QP 
eligibility is determined under the eligibility criteria for CY 2017. 
One commenter requested that PFPMs be an opportunity for multiple APMs 
to be available to physicians to qualify for the APM Incentive Payment. 
One commenter suggested CMS interact with the submitter of a PFPM 
proposal to ensure determinations are made timely based on complete and 
accurate information with the benefit of full clinical and operational 
context received directly from the original source. One commenter 
suggested fast-tracking models that focus on expansion of existing APMs 
when adequate supporting data are available, and collaborating with 
specialty societies to provide sufficient feedback on drafts and 
upfront data to assist with impact modeling.
    Response: We appreciate that there is significant interest in 
creating new opportunities for APMs and Advanced APMs and that 
commenters would like these opportunities to be implemented quickly. We 
are mindful of stakeholders' interest in additional models and are 
committed to reviewing (and where appropriate, implementing) PFPM 
proposals as quickly as possible. We intend to provide additional 
information outside of the rulemaking process.
    Comment: A few commenters requested an appeals process or 
opportunity to resubmit if a PFPM proposal is (1) not recommended by 
the PTAC or (2) not selected for testing by the Secretary, or another 
form of feedback on proposals that are not commented on favorably by 
the Secretary. One commenter asked for templates and examples of APMs 
the PTAC would recommend to CMS. Commenters made requests related to 
the PTAC's review process, such as the frequency with which they will 
collect PFPM proposals and whether they will allow resubmissions.
    Response: The PTAC will decide whether it will include an appeals 
process for PFPM proposals it does not recommend and will set its own 
review process. CMS will not establish through rulemaking a formal 
reconsideration process for PFPM proposals that are recommended by the 
PTAC but not responded to favorably by the Secretary. However, we hope 
that stakeholders will be open to pursuing changes to the model so that 
it might be selected in future years for testing by the Secretary. We 
also appreciate that commenters seek additional information from us on 
our process. We are committed to transparency and encourage commenters 
to review the factors the Innovation Center uses in considering whether 
to test a model on the Innovation Center Web site: https://
innovation.cms.gov/Files/x/rfi-websitepreamble.pdf. We intend to 
provide additional information outside of rulemaking. With respect to 
the PTAC review process, we refer commenters to the PTAC Web site at 
https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee.
    Comment: We received comments about how PFPMs relate to specialty 
physicians and to primary care physicians. Commenters requested CMS 
prioritize PFPMs proposed by the specialty community and including 
specialist physicians, or just prioritize PFPMs in general. One 
commenter suggested that CMS prioritize PFPMs that use all members of 
the health care team. One commenter recommended that CMS invest in 
academic medical centers to support the testing of specialty Advanced 
APMs. A few commenters recommended CMS collaborate with the PTAC to 
expand opportunities for primary-care focused Advanced APMs and engage 
the PTAC to assist in the development, tracking, and reporting of 
primary care spending as a share of total health care spending.
    Response: We thank commenters for their feedback and appreciate the 
enthusiasm in the development of PFPMs. We are not finalizing a policy 
that establishes priorities for PFPMs beyond prioritizing those that 
meet the Secretary's criteria. We plan to pay close attention to PFPM 
proposals reviewed by the PTAC and look forward to reviewing the PTAC's 
comments and recommendations on PFPM proposals from stakeholders for 
both specialty models and primary care models.
    Comment: We received comments on the role and composition of the 
PTAC. Commenters stated they believe the

[[Page 77494]]

PTAC can play an important role in developing new APMs and support this 
opportunity for ideas for APMs to come from a variety of sources. Two 
commenters were in favor of the role of the PTAC and emphasized the 
value of input from clinicians and other stakeholders. A few commenters 
recommended that clinical experts be consulted as part of the PTAC 
review process, particularly for specialty models, and one commenter 
requested that the PTAC ensure all stakeholders be included in the PTAC 
review process. One commenter recommended that the PTAC focus on 
overarching strategic goals, including private sector initiatives, to 
lead to greater alignment. One commenter requested more care team 
diversity, including patients, on the PTAC, in order to further the 
goal of patient-centeredness. One commenter suggested that a particular 
specialty should be represented on the PTAC.
    Response: We appreciate the interest of commenters in the 
composition of the PTAC and the PTAC review process. We encourage 
commenters to engage with the PTAC and to follow its development of the 
processes it will use to review PFPM proposals. The statute requires 
that the PTAC be appointed by the GAO, and CMS does not have the 
authority to appoint members of the PTAC.
    Comment: A few commenters encouraged CMS and the PTAC to provide 
technical assistance for stakeholders in their work to develop and 
implement APMs. A few commenters requested technical assistance include 
support for a new team approach, data collection and analysis, access 
to financial resources, and overall ability to achieve APM status. One 
commenter noted that assistance and Medicare data need to be provided 
to organizations developing APM proposals to help them design APMs that 
will qualify as Advanced APMs.
    Response: We will explore opportunities for guidance and assistance 
that may be provided to stakeholders in drafting PFPM proposals outside 
of the rulemaking process.
b. Definition of PFPM
(1) Definition of PFPM
    Section 1868(c) of the Act does not define the term ``physician-
focused payment model'' (PFPM). In Sec.  414.1465 of the proposed 
regulatory text, we proposed to add the following definition of PFPM: 
An Alternative Payment Model wherein Medicare is a payer, which 
includes physician group practices (PGPs) or individual physicians as 
APM Entities and targets the quality and costs of physicians' services. 
We proposed to require that a PFPM target physicians' services to meet 
the definition of PFPM. To address physicians' services, we proposed 
PFPMs might address such elements as physician behavior or clinical 
decision-making. APM Entities may be individual eligible clinicians, 
physician group practices (PGPs), or other entities, depending on the 
payment model's design. We proposed a PFPM must focus on physicians' 
services and contain either individual physicians or PGPs as APM 
Entities, although it might also include facilities or other 
practitioner types.
    We proposed to require that PFPMs be designed to be tested as APMs 
with Medicare as a payer. Other Payer APMs would therefore not be 
PFPMs. We believe this is an appropriate standard for PFPMs because the 
Secretary is interested in reviewing comments and recommendations from 
the PTAC on models that may be tested with Medicare as a payer and 
because the statutory provisions regarding PFPMs and the PTAC are 
within section 1868 of the Act and title XVIII of the Act, which 
governs Medicare. A PFPM may include other payers in addition to 
Medicare under the proposed definition. We believe this definition is 
appropriate because it could include APMs with arms of their design 
that would include other payers beyond Medicare, but would not include 
models that involve only Other Payer APMs.
    We did not propose to limit a PFPM to exclusively targeting 
physicians and physicians' services because we believe that 
stakeholders should be able to propose payment models that include 
additional types of entities, as well as additional services. We did 
not propose to define PFPM as an APM that exclusively addresses 
Medicare FFS payments. A proposed PFPM may also include other payers in 
addition to Medicare, including Medicaid, Medicare Advantage, CHIP, and 
private payers, which may promote broader participation in PFPMs and 
greater potential for cost reduction. A PFPM that includes payers in 
addition to Medicare could potentially include an Other Payer Advanced 
APM as part of its design in addition to being an APM.
(2) Relationship Between PFPMs and Advanced APMs
    Section 1868(c) of the Act does not require PFPMs to meet the 
criteria to be an Advanced APM for purposes of the incentives for 
participation in Advanced APMs under section 1833(z) of the Act, and we 
did not propose to define PFPMs solely as Advanced APMs. Stakeholders 
may therefore propose as PFPMs either Advanced APMs or other APMs that 
might lead to better care for patients, better health for our 
communities, and lower health care spending.
    The following is a summary of the comments we received regarding 
our proposal to define Physician-Focused Payment Model as an APM 
wherein Medicare is a payer, which includes physician group practices 
(PGPs) or individual physicians as APM Entities and targets the quality 
and costs of physicians' services.
    Comment: Many commenters agreed with the proposed definition of a 
PFPM.
    Response: We thank commenters for their feedback.
    Comment: Commenters requested clarification or expressed confusion 
about the relationship between PFPMs, APMs, and Advanced APMs. A few 
commenters requested that proposed PFPMs, if implemented, should not 
have to meet the Advanced APM criteria to be Advanced APMs. One 
commenter requested the nominal risk standard for Advanced APMs 
specifically be changed for PFPMs, and one suggested that we consider 
payments through Advanced APMs in 2019, not 2017, for purposes of the 
QP determination for the APM Incentive Payment in 2019 to allow more 
time for new PFPMs to be included in this calculation. A few commenters 
stated that the clear Congressional intent was that PFPMs should be 
included in the Quality Payment Program as a way to support eligible 
clinician participation in APMs, even if CMS has determined that PFPMs 
are not necessarily, by definition, Advanced APMs. One commenter 
requested clarification that CMS is not limited to considering PFPMs 
only on the timeline and recommendation of the PTAC, and that CMS can 
develop its own specialty-related PFPMs.
    Response: The definition of PFPM specifies that a PFPM is an APM. 
APM is defined under section 1833(z)(3)(C) of the Act as any of the 
following: (1) A model under section 1115A (other than a health care 
innovation award) of the Act; (2) the Shared Savings Program under 
section 1899 of the Act; (3) a demonstration under section 1866C; or 
(4) a demonstration required by federal law. Therefore, if a model is a 
PFPM it is also an APM. A model that does not meet the definition of 
APM is not a PFPM. We anticipate PFPMs that are recommended by the PTAC 
and implemented by CMS will be tested under section 1115A authority. 
However, a model does not need to be

[[Page 77495]]

tested under section 1115A of the Act to be a PFPM.
    If a PFPM meets criteria for Advanced APMs under section 
1833(z)(3)(D) of the Act, as finalized in this rule, it is an Advanced 
APM. The criteria for Advanced APMs are specified by statute: The APM 
must require participants to use certified EHR technology; the APM must 
provide for payment for covered professional services based on quality 
measures comparable to those in the quality performance category under 
MIPS; and the APM must either require that participating APM Entities 
bear risk for monetary losses of a more than nominal amount under the 
APM, or be a Medical Home Model expanded under section 1115A(c) of the 
Act. For example, if a model is tested under section 1115A of the Act 
and it is not a health care innovation award, it is by definition an 
APM. If it is tested under section 1115A of the Act, is not a health 
care innovation award, and meets the criteria for Advanced APMs, it is 
an Advanced APM. We will not categorically waive the requirements for 
Advanced APMs for PFPMs we test. Section 1833(z)(3)(C) and (D) of the 
Act makes a clear distinction between APMs and Advanced APMs, and we do 
not believe the statutory requirements for Advanced APMs can or should 
be categorically waived for PFPMs. We retain the flexibility to 
consider and test PFPMs that are developed within CMS.
    For the QP determination timeline, we note that under the proposed 
and final policies in section II.F.5. of this final rule with comment 
period, participation in a PFPM that is determined to be an Advanced 
APM for 2017, which is the QP Performance Period for the 2019 APM 
Incentive Payment, offers the opportunity for participants to become 
QPs. Because eligible clinicians would have the opportunity to become 
QPs through participation in PFPMs that are Advanced APMs in the same 
way they would through participation in other Advanced APMs, we do not 
believe it would be appropriate to modify the QP determination process 
and APM Incentive Payment timeframe. Further, as stated in section 
II.F.5. of this final rule with comment period, the exclusion of QPs 
from MIPS reporting requirements and payment adjustments dictates an 
operational timeline that permits us to determine and communicate an 
eligible clinician's status for a payment year (whether QP, Partial QP, 
or MIPS eligible clinician) to facilitate timely decisions that impact 
payment and budget neutrality for the relevant payment year. We do not 
believe this operational timeline would allow us to retrospectively 
exclude eligible clinicians from MIPS adjustments already in effect 
based on later participation in a PFPM that is an Advanced APM.
    Comment: A few commenters requested that the definition of PFPM be 
expanded to include models that do not include physicians or PGPs but 
include other clinicians as participants. One commenter recommended 
that PFPM applicants should be required to document how they will 
include APRN services and how they will use APRNs to the fullest extent 
of their training.
    Response: We agree with commenters that non-physician practitioners 
are appropriate for inclusion in PFPMs, and we believe offering all 
eligible clinicians who have the potential to qualify as QPs the 
opportunity to propose PFPMs will benefit stakeholders and us in 
pursuing new opportunities for APMs. We believe it is appropriate to 
change the definition of PFPMs to include models that include any 
eligible clinicians that fall under the definition in section 
1848(k)(3)(B) of the Act. We appreciate that commenters are concerned 
that non-physician practitioners should be included in Advanced APMs. 
The list of eligible clinicians for purposes of the APM incentive is 
defined in section 1833(z)(3)(B) of the Act and includes: Physicians, 
physician assistants, nurse practitioners, clinical nurse specialists, 
certified registered nurse anesthetists, certified nurse-midwifes, 
clinical social workers, clinical psychologists, registered dietitians 
or nutrition professionals, physical or occupational therapists, 
qualified speech-language pathologists, and qualified audiologists. We 
are revising the definition of PFPM to include this group of clinicians 
because these are eligible clinicians under the APM track of the 
Quality Payment Program. Proposed PFPMs can include non-physician 
eligible clinicians as the participants or as vital to model design. We 
do not believe it is necessary to require as part of the definition of 
PFPMs or within the PFPM criteria that a particular specialty or 
category of clinician be addressed.
    Comment: We received comments on how the definition of PFPM relates 
to APMs and Advanced APMs. One commenter agreed with the proposal not 
to limit PFPMs to Advanced APMs and was pleased the definition of PFPMs 
would mean that any PFPM is an APM if tested by CMS. One commenter 
stated that CMS has gone too far in restricting the ability of APMs to 
become Advanced APMs and should ensure a more realistic and attainable 
pathway allowing physician-developed APMs to be recognized.
    Response: As stated above, to be a PFPM, a model must meet the 
definition of APM under section 1833(z)(3)(C) of the Act. If it meets 
the criteria for an Advanced APM under section 1833(z)(3)(D) of the 
Act, it will be an Advanced APM. We do not believe that our policy in 
defining Advanced APMs will impair the ability of PFPMs to be tested as 
Advanced APMs. We do not believe there is a reason that PFPMs, as a 
type of APM, should not be subject to the same criteria as other APMs 
in order to be considered Advanced APMs.
    Comment: A couple of commenters supported the decision to permit 
PFPMs to contain both Medicare and other payers, while prohibiting 
consideration of PFPMs that contain only third-party payers without 
also involving Medicare. A few commenters supported efforts to broaden 
the scope of PFPMs by not limiting the definition to only physicians' 
services and by permitting models to address payments other than 
Medicare FFS. One commenter suggested the PTAC focus on PFPMs based on 
models from private payers that are not currently APMs.
    Response: We are finalizing our policy to define a PFPM as 
requiring Medicare be a payer while not precluding the inclusion of 
other payers in addition to Medicare such as Medicaid or private payers 
in the PFPM's design.
    Comment: One commenter proposed changing the language of the 
definition that addresses physicians' services to instead target ``the 
quality and costs of physician services that the physicians 
participating in the payment model deliver, order, or can significantly 
influence.'' One commenter suggested that physicians should not be held 
accountable for being part of an APM in which they do not have a role 
to contribute. One commenter asked that CMS ensure that PFPMs place 
physicians at the nexus of control for managing a patient's care, rely 
on evidence-based guidelines (for example, to avoid reducing care 
without regard for quality), and incorporate sufficient safeguards to 
ensure that beneficiaries have access to the best care (for example, 
proper risk-adjustment and outlier payments). One commenter supported 
the PFPM definition and suggested that CMS implement stringent 
safeguards to ensure that the physician(s) remain in an indisputable 
position of leadership in these cases--reflecting the goal of this 
aspect of MACRA as being ``physician focused.'' Another commenter 
stated that APM Entities in PFPMs, if not explicitly

[[Page 77496]]

physician-owned, should provide a means for physicians to influence the 
policies and goals of the organization.
    Response: We thank commenters for their feedback and agree that 
PFPMs should meaningfully engage eligible clinicians. We are finalizing 
the definition of PFPM to specify that eligible clinicians in the PFPM 
must play a core role in implementing the APM's payment methodology, 
and the PFPM must target the quality and costs of services that these 
eligible clinicians provide, order, or can significantly influence. We 
believe this addresses the need for PFPMs to be driven by eligible 
clinicians without restricting APM Entities in PFPMs to a particular 
category.
    Comment: One commenter suggested that CMS allow stakeholders the 
opportunity to develop and test models that are simple to implement and 
flexible enough to allow clinicians to provide patient-centered care 
that yields improved patient outcomes. One commenter stated that the 
review criteria for the PFPM payment methodology should provide 
flexibility and encourage innovation.
    Response: We thank commenters for their feedback and agree that 
flexibility and innovation are important goals for PFPMs. We believe 
that the definition of PFPM and criteria for PFPMs in this rule provide 
stakeholders the flexibility to develop PFPM proposals that will fit 
their specialties and support patient-centered care.
    In response to the comments requesting that we include a broader 
category of clinicians than physicians in PFPMs and that PFPMs be 
flexible in their focus on the leadership and decision-making of such 
clinicians, we have changed the definition of PFPM to not require that 
PGPs or individual physicians be included as APM Entities. Instead, 
PFPMs must give eligible clinicians a core role in implementing the 
payment methodology. In response to the comments, we are changing the 
definition of PFPMs to include models that include any eligible 
clinicians that fall under the definition of EP in section 
1848(k)(3)(B) of the Act. We are also changing the definition to 
include models that address the services of all clinicians that fall 
under the definition of EP within section 1848(k)(3)(B) of the Act. We 
are finalizing our proposal not to limit PFPMs to Advanced APMs but 
instead to include models that, if tested, would be APMs and could 
potentially be Advanced APMs.
    We are finalizing the definition of PFPM to mean an APM: (1) In 
which Medicare is a payer; (2) in which eligible clinicians that are 
EPs as defined in section 1848(k)(3)(B) of the Act are participants and 
play a core role in implementing the APM's payment methodology, and (3) 
which targets the quality and costs of services that eligible 
clinicians participating in the Alternative Payment Model provide, 
order, or can significantly influence.
c. Finalized PFPM Criteria
    Section 1868(c)(2)(A) of the Act requires the Secretary to 
establish criteria for PFPMs, including models for specialist 
physicians, not later than November 1, 2016. The PFPM criteria would be 
used by the PTAC in discharging its duties under section 1868(c)(2)(C) 
of the Act to make comments and recommendations to the Secretary on 
proposed PFPMs. The proposed PFPM criteria were listed in section 
II.F.10.c.(1). of the proposed rule and at Sec.  414.1465(b) of the 
proposed regulatory text. We designed the proposed criteria to be broad 
enough to encompass all physician specialties and provide stakeholders 
with flexibility in designing PFPMs.
    We proposed PFPM criteria organized into three categories that are 
consistent with the Administration's strategic goals for achieving 
better care, smarter spending and healthier people: Payment incentives; 
care delivery; and information availability. First, we proposed a 
category of criteria that promote payment incentives for higher-value 
care, including paying for value over volume and providing resources 
and flexibility necessary for practitioners to deliver high-quality 
health care.
    To address paying for value over volume, we proposed a criterion 
that PFPMs should provide incentives to practitioners to deliver high-
quality health care, and that these incentives should be specifically 
expected to lead to high-quality health care. We believe that the 
correct incentives are necessary to drive change to improve quality of 
care. Similarly, we believe that it is important for a PFPM to provide 
sufficient flexibility for practitioners to deliver high-quality health 
care. Flexibility relates to operational feasibility, the PFPM's 
ability to adapt to accommodate clinical differences in patient 
subgroups, and the APM Entity's ability to respond to changes in health 
care.
    This category of criteria also aligns with the Innovation Center's 
statutory authority under section 1115A of the Act to test models aimed 
to improve care, reduce expenditures, or achieve both of these goals, 
by proposing a criterion that assesses to what extent a PFPM proposal 
is expected to achieve these goals. We believe estimates of any cost 
reduction under the PFPM to the most precise extent possible would also 
be useful in addressing this criterion.
    We proposed a criterion that the PFPM proposal must be designed to 
pay APM Entities under a payment methodology that furthers the PFPM 
Criteria. The payment methodology must address how it is different from 
current Medicare payment methodologies, and why the payment methodology 
cannot be tested under current payment methodologies. We believe it is 
necessary for PFPM proposals to contain such a payment methodology 
because the PTAC is tasked with reviewing payment models and therefore 
cannot evaluate a proposal without knowing the payment methodology.
    We also proposed to include in the first category a criterion that 
the PFPM must either aim to solve an issue in payment policy not 
addressed in the CMS APM portfolio at the time it is proposed or 
include in its design APM Entities who have had limited opportunities 
to participate in APMs. For a list of models in the CMS APM portfolio, 
please see https://innovation.cms.gov/initiatives/index.html#views=models. We proposed this criterion to promote 
participation in APMs by broadening and expanding our portfolio of APMs 
in areas such as geographic location, specialty, condition, and 
illness, without overly limiting proposed PFPMs. We proposed that 
because proposed PFPMs may satisfy this criterion by either addressing 
a new issue or including a new specialty, the criterion was 
sufficiently broad to allow stakeholders to submit many proposed PFPMs 
that could expand the CMS APM portfolio. Physicians and practitioners 
whose opportunities to participate in other PFPMs with us have been 
limited to date include, for example, those who have not been able to 
apply for any other PFPM because one has not been designed that would 
include physicians and practitioners of their specialty. We proposed 
that a proposed PFPM that includes multiple specialties might meet the 
PFPM criteria where a minimum of one of the specialties in the proposed 
PFPM is not currently being addressed by another APM. We made this 
proposal to reflect the intent of section 1868(c)(2)(A)(i) of the Act 
which specifically directs the Secretary to establish PFPM criteria, 
including models for specialist physicians.
    We also proposed a criterion that a PFPM proposal must have 
evaluable goals for the impact of cost and quality under the PFPM. To 
make the decision

[[Page 77497]]

to expand an APM under section 1115A(c) of the Act, the Secretary must 
evaluate its success. This standard informed our proposed criterion not 
only because it would be important for any APMs that are tested under 
section 1115A(c) of the Act, but also because it is necessary for 
measuring the success of any APM that it be evaluable. It is the 
evaluation of an APM that tells us whether the APM is successful in 
reducing cost and improving quality of health care.
    Second, we proposed a category of criteria that address care 
delivery improvements that promote better care. Here we proposed 
criteria to address integration and care coordination, patient choice, 
and patient safety.
    Third, we proposed a category of criteria that address information 
enhancements that improve the availability of information to guide 
decision-making. We believe that information enhancements, particularly 
through use of technology are important to improving Medicare payment 
policy and delivering better care. Here we proposed a criterion for 
encouraging use of health information technology.
    In carrying out its review of PFPM proposals, the PTAC shall assess 
whether the PFPM meets the following criteria for PFPMs sought by the 
Secretary as required by section 1868(c)(2)(C) of the Act. We proposed 
the following PFPM criteria. The Secretary seeks PFPMs that:
    (1) Incentives: Pay for higher-value care.
     Value over volume: Provide incentives to practitioners to 
deliver high-quality health care.
     Flexibility: Provide the flexibility needed for 
practitioners to deliver high-quality health care.
     Quality and Cost: Are anticipated to improve health care 
quality at no additional cost, maintain health care quality while 
decreasing cost, or both improve health care quality and decrease cost.
     Payment methodology: Pay APM Entities with a payment 
methodology designed to achieve the goals of the PFPM criteria. 
Addresses in detail through this methodology how Medicare and other 
payers, if applicable, pay APM Entities, how the payment methodology 
differs from current payment methodologies, and why the Physician-
Focused Payment Model cannot be tested under current payment 
methodologies.
     Scope: Aim to either directly address an issue in payment 
policy that broadens and expands the CMS APM portfolio or include APM 
Entities whose opportunities to participate in APMs have been limited.
     Ability to be evaluated: Have evaluable goals for quality 
of care, cost, and any other goals of the PFPM.
    (2) Care delivery improvements: Promote better care coordination, 
protect patient safety, and encourage patient engagement.
     Integration and Care Coordination: Encourage greater 
integration and care coordination among practitioners and across 
settings where multiple practitioners or settings are relevant to 
delivering care to the population treated under the PFPM.
     Patient Choice: Encourage greater attention to the health 
of the population served while also supporting the unique needs and 
preferences of individual patients.
     Patient Safety: Aim to maintain or improve standards of 
patient safety.
    (3) Information Enhancements: Improving the availability of 
information to guide decision-making.
     Health Information Technology: Encourage use of health 
information technology to inform care.
d. CMS Consideration of Models
    In the proposed rule, we described ``supplemental information 
elements'' that we find particularly useful in our review when we 
consider potential APMs. The ``supplemental information'' is meant to 
increase the transparency of our process and is not included within the 
PFPM criteria.
    The following is summary of the comments we received regarding the 
Secretary's proposed PFPM criteria and the supplemental information.
    Comment: Many commenters were generally in favor of the proposed 
criteria and enthusiastic about the opportunity for stakeholders to 
develop PFPMs. While one commenter was in favor of the proposed 
criteria because they do not limit PFPMs to a particular specialty, 
many commenters were concerned that the PFPM criteria narrow the field 
of potential PFPMs and gave recommendations for specific services, 
practitioners, specialties, and guidelines that should be incorporated 
into PFPMs. One commenter requested CMS allow flexibility for PFPMs to 
meet the criteria to promote parity in the availability of specialty-
focused models. One commenter requested we incorporate the preamble 
language regarding the supplemental information into the body of the 
criteria. One commenter was in favor of the proposed criteria because 
they did not require specific quality measures.
    Response: We appreciate the feedback from commenters regarding the 
proposed PFPM criteria. We are finalizing the quality and cost 
criterion that the PFPM be anticipated to improve health care quality 
at no additional cost, maintain health care quality while decreasing 
cost, or both improve health care quality and decrease cost. This 
criterion establishes the importance of quality measurement in PFPMs 
while allowing stakeholders flexibility in identifying the most 
appropriate way to measure quality in different PFPMs. In response to 
commenters that expressed concern about the role of non-physician 
clinicians and non-physician services, we are modifying the proposed 
definition of PFPMs to include models that include a broader group of 
clinicians and their services.
    Comment: One commenter was concerned that the proposed PFPM 
criteria are overly burdensome.
    Response: We designed the PFPM criteria to be broad enough to 
encompass all physician specialties and provide stakeholders with 
flexibility in designing proposed PFPMs, and to be consistent with the 
strategic goals for achieving better care, smarter spending, and 
healthier people. We believe these criteria will attract model 
proposals that are specifically aligned to achieve these goals.
    Comment: One commenter suggested each subcategory of the care 
delivery goal not be an absolute requirement, particularly where not 
applicable to a specialty PFPM.
    Response: We understand that the Integration and Care Coordination 
criterion within the care delivery improvements category may not apply 
to all specialty PFPMs, and as proposed, we accounted for this by 
stating within the criterion that this applies only ``where multiple 
practitioners or settings are relevant.''
    Comment: One commenter stated that providing information about how 
the PFPM could incorporate CEHRT would be problematic for a pathology 
PFPM. Another commenter suggested that criteria under the Information 
Enhancements category should be modified to explicitly address 
improving the availability of information to all members of the care 
team, including pharmacists, to guide decision-making in order to 
encourage communication and information sharing. One commenter 
supported the information we stated in the preamble would inform the 
criterion in the Information Enhancements category.
    Response: Information about use of CEHRT might inform this 
criterion, but it is not restricted only to CEHRT. We decline to add 
more specificity to this criterion to allow for more explicit

[[Page 77498]]

flexibility, but we believe information about how the PFPM would 
improve the availability of information to all members of the care team 
would inform this criterion as well as the Integration and Care 
Coordination criterion.
    Comment: One commenter stated that the PFPM criteria should include 
an evaluation of whether the entity to which payment will be directed 
is physician-led and if the majority of the governing board(s) is 
comprised of independent physicians, members of a participating 
Independent Practice Association, or physicians employed by physician 
organizations.
    Response: We have not added a criterion requiring that APM Entities 
in PFPMs be physician-led or requiring a specific composition of 
governing boards because we do not wish to limit the scope of potential 
PFPMs.
    Comment: One commenter stated that our direction regarding ``high 
value services'' runs counter to a push toward capitated payments.
    Response: We stated that payments for high-value services that we 
do not currently (or separately) pay for are changes that can be an 
important part of moving toward value-based delivery system reform, but 
that adding payment for specific services without any other change does 
not constitute a sufficient departure from current payment 
methodologies to meet our proposed PFPM criteria or to be considered an 
Advanced APM. This does not preclude PFPM proposals from including 
capitated payments.
    Comment: We received multiple comments emphasizing the importance 
of patients in the design of PFPMs. Commenters suggested that the PFPM 
design should strive to not further fragment care delivery and that 
PFPMs should be approved that support the move of Medicare to a program 
that is truly patient-centered and available on a constant basis, 
regardless of where the patient is located at a given time. One 
commenter suggested that CMS and the PTAC consider a proposal's impact 
on patient care, quality, and outcomes in addition to costs and 
believes that applicants may not be able to analyze the full impact a 
proposed PFPM may have on quality of care and cost. One commenter 
suggested adding criteria for patient access and experience. One 
commenter stated that CMS should require PFPMs to document policies and 
procedures to ensure that they do not employ discriminatory practices 
that result in the restriction of patient access to services and 
treatments furnished by any health care provider acting within the 
scope of their license. One commenter supported that the criteria had 
strong patient choice focus. One commenter supported CMS' proposed 
criteria to address integration and care coordination, patient choice, 
and patient safety, and suggested that PFPM adherence to these criteria 
should be assessed in the context of the model's proposed quality 
measures. One commenter recommended that CMS include patient and 
consumer advocacy in the development of new PFPMs and quality measures 
including establishing a separate, independent consumer advisory 
committee to help bring the consumer perspective for PFPM proposals 
coming from PTAC.
    Response: We appreciate feedback from commenters that underscores 
the importance of PFPMs emphasizing quality and patient-centered care. 
We believe that our criteria sufficiently require elements related to 
quality and in particular that the care delivery improvements category 
of criteria addresses patient experience.
    Comment: We received multiple comments on the incentive section of 
the PFPM criteria. A commenter supported CMS' proposed criteria 
promoting payment incentives for higher-value care. Another commenter 
asked that the PTAC and CMS be cautious in approaching procedural 
episode-based payments, as the commenter believed it is better to 
structure episodes involving hospice and palliative medicine as a 
separate bundle, commencing once the services are necessary, rather 
than including them in a more general condition-specific bundle. One 
commenter requested a specific payment methodology be included in the 
design of PFPMs. Another commenter encouraged CMS to add questions to 
the PFPM review criteria related to whether a model submitted to PTAC 
considers the inclusion of Hospice and Palliative Medicine providers 
or, at a minimum, how it will deliver care to patients with serious, 
life-limiting illness. One commenter stated that there was too much 
emphasis in the language for the PFPM section on ``incentives'' and not 
enough on paying adequately for needed care. This commenter stated that 
the PFPM incentives were set up to benefit PFPMs that pay adequately 
for lower volumes of services rather than those that try to incentivize 
higher quality and included suggested language changes to fix this part 
of Quality Payment Program.
    Response: We appreciate the comments on the incentive category of 
PFPM criteria. These criteria were designed to promote payment 
incentives for higher-value care, including paying for value over 
volume and providing resources and flexibility necessary for 
practitioners to deliver high-quality health care.
    Comment: One commenter suggested that PFPMs should be designed to 
mitigate the risk of excess spending, perhaps by limiting guaranteed 
additional payments, or ensuring a balance between guaranteed payment 
and performance-based payment.
    Response: We agree that these are sound ideas for the payment 
structure of PFPMs, but we are not requiring the payment methodology 
criterion be met through a specific payment structure.
    Comment: A commenter suggested that entities should be large enough 
to detect changes in spending and outcome measures. A commenter 
recommended that CMS provide more detail on evaluable goals, 
specifically on evaluation study design and the level of precision the 
evaluation may reach.
    Response: We agree that a means to assess the impact of a PFPM is 
an important part of its design and would inform the ``ability to be 
evaluated'' criterion. Because the diversity of potential proposed 
PFPMs will necessitate a variety of evaluation designs, we do not 
require that a specific evaluation design be utilized. As we do for 
other APMs, we will evaluate the scope of impact of potential PFPMs, 
and consider whether the potential outcomes merit the required 
investments and opportunity costs, and whether the impact of the 
payment model can be measured to determine if it should be expanded.
    Comment: Two commenters requested that CMS or the PTAC provide 
formal guidance and clarification on the definition of ``supplemental 
information'' and how it impacts a PFPM proposal. One commenter 
suggested that CMS specify that other items ``the PTAC may request or 
stakeholders may wish to provide'' are not essential and will not 
result in any negative consequences in the PTAC consideration process. 
One commenter asked CMS to clarify if the entity submitting a proposal 
will be able to recruit participants after submission of the proposal 
to the PTAC and/or CMS.
    Response: We thank commenters for their interest in the 
``supplemental information'' discussed in the proposed rule. The 
``supplemental information'' is meant to increase the transparency of 
our APM review process and is not included within the PFPM criteria. If 
a PFPM is tested it will not be necessary for the entity submitting a 
proposal to recruit applicants to participate in the PFPM.
    Comment: One commenter suggested that it may be particularly 
helpful to

[[Page 77499]]

ensure that there are sufficient models addressing vulnerable and 
underserved beneficiary populations. Another commenter believed that 
applicants should describe how they will monitor changes in disparities 
during the model implementation.
    Response: We appreciate the concerns from commenters that PFPMs 
should address vulnerable populations and monitor changes in 
disparities during implementation. While we do not have a criterion 
that requires considerations for any specific population, the scope 
criterion requires that PFPMs aim to solve an issue in payment policy 
that broadens and expands the APM portfolio at the time it is tested. 
We will consider how changes in disparities during model implementation 
would be monitored as part of our consideration of the scope criterion.
    Comment: We received numerous comments about the scope criterion. A 
few commenters supported requiring that proposed PFPMs expand the CMS 
portfolio of APMs. A few commenters recommended that PFPM proposals 
should focus on physicians who do not have the opportunity to 
participate in other APMs because they are not available to such 
physicians' specialties. One commenter stated that PFPMs should not 
duplicate existing efforts and should harmonize with one another to 
ensure appropriate care coordination and transitions of care for 
patients. Commenters expressed concern that the scope criterion as 
proposed is vague and could be interpreted to mean, for example, that 
the agency is uninterested in models that address cancer care, because 
there is already an APM specific to cancer care: The Oncology Care 
Model (OCM). A few commenters stated that multiple APMs should be 
available to physicians and recommends development of a policy that the 
current availability of APMs addressing a disease, condition, or 
episode should not preclude PFPM proposals on the same disease, 
condition, or episodes(s) within a different APM. A few commenters 
stated that different designs and approaches for the same disease, 
condition, or episode should be encouraged and that the approaches 
should identify decision points and treatment protocols. One commenter 
suggested physicians that have already participated in a PFPM with CMS 
be excluded from participation in the proposed PFPMs. One commenter 
requested that CMS not be overly restrictive in that the commenter 
believes innovation in PFPMs could generate ideas about how to better 
address those issues that are perhaps already somewhat incorporated 
into existing models. One commenter suggested that we specify that 
PFPMs should rely on evidence-based information to either directly 
address an issue in payment policy that broadens and expands the CMS 
APM portfolio or include APM entities whose opportunities to 
participate in APMs have been limited.
    Response: In response to comments we agree that the scope criterion 
should be broadened and clarified. Regarding who may be included in the 
PFPM's design, we recognize the opportunity the PTAC represents for 
clinicians who have not already participated in APMs, but at the same 
time we do not want to unduly limit the scope of proposals we receive 
through the PTAC by excluding PFPMs from consideration that include 
clinicians who have had other opportunities to participate in APMs. We 
understand the desire of clinicians who have not already participated 
in an APM with CMS to begin participating through a proposal submission 
to the PTAC. To ensure we do not obstruct proposals that may have 
significant positive outcomes for patients and CMS, however, we will 
not limit proposals to eligible clinicians based on their past 
participation in APMs. Additionally, we recognize that while CMS may 
already have an APM addressing a specific disease, condition, or 
episode, there may still be unique, valuable payment approaches to 
similar conditions. We are finalizing the scope criterion to require 
that PFPMs aim to broaden or expand the CMS APM portfolio by addressing 
an issue in payment policy in a new way or including APM Entities whose 
opportunities to participate in APMs have been limited. We believe that 
this criterion will further our goal to promote participation in APMs 
by broadening and expanding our portfolio of APMs in areas such as 
geographic location, specialty, condition, and illness, without overly 
limiting proposed PFPMs. This criterion can be met by either addressing 
an issue in payment policy in a new way or including APM Entities whose 
opportunities to participate in APMs have been limited, therefore it is 
broad to allow stakeholders to submit many proposed PFPMs that could 
expand the CMS APM portfolio.
    We are finalizing our proposed criteria with one modification. We 
are broadening the proposed scope criterion. The final scope criterion 
now requires that PFPMs aim to broaden or expand the CMS APM portfolio 
by addressing an issue in payment policy in a new way or including APM 
Entities whose opportunities to participate in APMs have been limited. 
We are finalizing the other PFPM criteria as proposed.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    In the proposed rule (81 FR 28350 through 28364), we solicited 
public comment on each of the section 3506(c)(2)(A)-required issues for 
the following information collection requirements. PRA-related comments 
were received as indicated below under the relevant information 
collection requirements (ICRs).
    In response to our request for public comment on our Information 
Collections, we received several general comments regarding the burden 
of data collection and the privacy of CMS information collection.
    Comment: Several commenters agreed with CMS's effort to streamline 
multiple reporting programs under one single program to save both time 
and cost for healthcare providers in tracking and reporting quality to 
CMS. Several commenters recommended further streamlining and 
simplifying data reporting to reduce the burden of reporting.
    Response: In response to public comments, we have further 
streamlined reporting in the quality, advancing care information, and 
improvement activities performance categories between the proposal and 
the final rule with comment period. In part because of this additional 
streamlining, the total burden estimate has been reduced between the 
proposal and the final rule with comment period. The gross burden 
estimate in the proposal was 12,493,654 burden hours and a burden cost 
of $1,327,177,693 (81 FR 28362). The finalized burden estimates are

[[Page 77500]]

10,947,453 burden hours and a burden cost of $1,311,245,806.
    Comment: Several commenters disagreed with the proposed rule and 
suggested that it be withdrawn. The commenters stated that the 
proposals were unethical and would jeopardize patient confidentiality 
through the sharing of patient data with the government.
    Response: Patient confidentiality is very important to us. Please 
note that we will collect and disclose personally identifiable 
information (PII) and/or individually identifiable health information 
only in accordance with applicable privacy and security laws, 
including, but not limited to, the Privacy Act of 1974 and the HIPAA 
Privacy Rule.
    In summary, we are finalizing policies that further streamline 
reporting and reduce burden and have provided additional information to 
commenters on privacy protections in response to public comments.
    The remainder of this section focuses on the estimated burden of 
clinicians and groups that submit data in response to information 
collections established by this final rule with comment period. This 
estimated burden is expressed in terms of time and labor costs. First, 
we discuss the wage estimates that are used to calculate the labor 
costs associated with data submission for all the information 
collection requirements established by this final rule with comment 
period. Second, we provide a framework summarizing how the information 
collection requirements vary by the type of data submitted and the type 
of respondent submitting the data (individual clinician, group, APM 
Entity, or APM billing TIN). Third, we provide burden estimate 
calculations for each of the information collection requirements 
established by this final rule with comment period. Finally, we 
calculate the total gross and net burden across all information 
collection requirements.

A. Wage Estimates

    To derive wage estimates, we used data from the U.S. Bureau of 
Labor Statistics' (BLS) May 2015 National Occupational Employment and 
Wage Estimates. Table 42 presents the mean hourly wage, the cost of 
fringe benefits and overhead, and the adjusted hourly wages for billing 
and posting clerks, computer systems analysts, physicians, practice 
administrators, and licensed practical nurses as derived from this 
data. We believe these are the primary positions that will be involved 
in the collection and reporting of information under this regulation. 
We have adjusted these employee hourly wage estimates by a factor of 
100 percent to reflect current HHS department-wide guidance on 
estimating the cost of fringe benefits and overhead. These are 
necessarily rough adjustments, both because fringe benefits and 
overhead costs vary significantly from employer to employer and because 
methods of estimating these costs vary widely from study to study. 
Nonetheless, there is no practical alternative and we believe that 
these are reasonable estimation methods. In addition, to calculate 
beneficiary time costs, we have used wage estimates for Civilian, all 
occupations, using the same BLS data discussed above. We have not 
adjusted these costs for fringe benefits and overhead because direct 
wage costs represent the ``opportunity cost'' to beneficiaries 
themselves for time spent in health care settings.

                            Table 42--Adjusted Hourly Wages Used in Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                                    Mean hourly    benefits and      Adjusted
           Occupation title                 Occupational code      wage  ($/hr.)   overhead  ($/  hourly wage ($/
                                                                                       hr.)            hr.)
----------------------------------------------------------------------------------------------------------------
Billing and Posting Clerks............  43-3021.................          $17.60          $17.60          $35.20
Computer Systems Analysts.............  15-1121.................           43.36           43.36           86.72
Physicians............................  29-060..................           97.33           97.33          194.66
Practice Administrator................  11-91111................           50.99           50.99          101.98
Licensed Practical Nurse (LPN)........  29-2061.................           21.17           21.17           42.34
Civilian, All Occupations.............  Not applicable..........           23.23             N/A           23.23
----------------------------------------------------------------------------------------------------------------
Source: ``Occupational Employment and Wage Estimates May 2015,'' U.S. Department of Labor, Bureau of Labor
  Statistics. http://www.bls.gov/oes/current/oes_nat.htm.

    We added additional occupational titles to the list of occupational 
titles used in the proposed rule as part of our burden estimates here 
in order to better reflect the skill mix of the staff that we believe 
will take part in reviewing measure specifications. Specifically, we 
are adding practice administrator and licensed practical nurse (LPN) to 
this list. These changes were in response to comments discussed below 
under section III.C. ICRs Related to Quality Performance Category and 
Previously Approved under PQRS.

B. A Framework for Understanding the Burden of MIPS Data Submission

    Because of the wide range of information collection requirements 
under MIPS, Table 43 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians varies across the types of data, and whether the clinician 
is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM 
participant. As shown in the first row of Table 43, MIPS eligible 
clinicians that are not in MIPS APMs and other clinicians voluntarily 
submitting data will submit data either as individuals or groups to the 
quality, advancing care information, and improvement activities 
performance categories.
    For MIPS APMs, the organizations submitting data on behalf of 
participating MIPS eligible clinicians will vary across categories of 
data, and in some instances across APMs. For the performance period in 
2017, the quality data submitted by Shared Savings Program Accountable 
Care Organizations (ACOs) and Next Generation ACOs on behalf of their 
participants will fulfill both MIPS submission requirements for the 
quality performance category. For the advancing care information 
performance category, billing TINs will submit data on behalf of 
participants who are MIPS eligible clinicians. For the improvement 
activities performance category, we will assume no reporting burden for 
MIPS APM participants because CMS will assign the improvement 
activities performance category score at the MIPS APM level and all APM 
Entity groups in the same MIPS APM will receive the same score. 
Advanced APM participants who are determined to be Partial QPs will be 
required to submit elections as to whether they will participate in 
MIPS, which is discussed in more detail in section III.I. of this final 
rule with comment period.

[[Page 77501]]



Table 43--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
                                                  of Clinician
----------------------------------------------------------------------------------------------------------------
                                                             Type of data submitted
                              ----------------------------------------------------------------------------------
    Category of clinician                               Advancing care          Improvement
                                Quality performance       information           activities          Partial QP
                                     category        performance category  performance category      election
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not  As groups or          As groups or          As groups or          Not applicable.
 in MIPS APMs).                 individuals.          individuals.          individuals.
And other clinicians
 voluntarily submitting data.
Eligible Clinicians            ACOs submit to the    Each TIN in the APM   CMS will assign the   Advanced APM
 participating in the Shared    CMS Web Interface     Entity group          same improvement      Entities will
 Savings Program.               on behalf of their    reports advancing     activities            make election
                                participating MIPS    care information to   performance           for
                                eligible clinicians.  MIPS \36\.            category score to     participating
                                                                            each APM Entity       MIPS eligible
                                                                            group based on the    clinicians.
                                                                            activities involved
                                                                            in participation in
                                                                            the Shared Savings
                                                                            Program.* [The
                                                                            burden estimates
                                                                            assume no
                                                                            improvement
                                                                            activity reporting
                                                                            burden for APM
                                                                            participants.]
Eligible Clinicians in the     ACOs submit to the    Each MIPS eligible    CMS will assign the   Advanced APM
 Next Generation ACO Model.     CMS Web Interface     clinician in the      same improvement      Entities will
                                on behalf of their    APM Entity group      activities            make election
                                participating MIPS    reports advancing     performance           for
                                eligible clinicians.  care information to   category score to     participating
                                                      MIPS through either   each APM Entity       eligible
                                                      group TIN or          group based on the    clinicians.
                                                      individual            activities involved
                                                      reporting. [The       in participation in
                                                      burden estimates      the Next Generation
                                                      assume TIN-level      ACO Model.* [The
                                                      reporting.]           burden estimates
                                                                            assume no
                                                                            improvement
                                                                            activities
                                                                            reporting burden
                                                                            for APM
                                                                            participants.]
Eligible Clinicians            The APM Entity group  Each MIPS eligible    CMS will assign the   Advanced APM
 participating in MIPS APMs     would not be          clinician in the      same improvement      Entities will
 other than the Shared          assessed on quality   APM Entity group      activities            make election
 Savings Program or Next        under MIPS in the     reports advancing     performance           for
 Generation ACO Model.          first performance     care information to   category score to     participating
                                period. The APM       MIPS through either   each APM Entity       eligible
                                Entity group would    group TIN or          group based on the    clinicians.
                                submit quality        individual            activities involved
                                measures to CMS       reporting. [The       in participation in
                                required by the       burden estimates      the MIPS APM.* [The
                                APM. [No burden for   assume TIN-level      burden estimates
                                submitting MIPS       reporting.]           assume no
                                quality data.]                              improvement
                                                                            activities
                                                                            performance
                                                                            category reporting
                                                                            burden for APM
                                                                            participants.]
----------------------------------------------------------------------------------------------------------------
* APM Entity groups participating in MIPS APMs do not need to report improvement activities data unless the CMS-
  assigned improvement activities scores is below the maximum improvement activities score.

    We did not receive comments on the framework for understanding the 
burden of MIPS data submission. However, we are updating the framework 
to reflect changes in reporting requirements for participants in MIPS 
APMs, as discussed in section II.E.h of this final rule with comment 
period.
---------------------------------------------------------------------------

    \36\ For MIPS APMs other than the Shared Savings Program, both 
group and individual clinician advancing care information data will 
be accepted. If both group and individual scores are submitted for 
the same MIPS APM Entity, CMS would take the higher score for each 
TIN/NPI. The TIN/NPI scores are then aggregated for the APM Entity 
score.
---------------------------------------------------------------------------

C. ICRs Regarding Quality Performance Category (Sec.  414.1330 and 
Sec.  414.1335) and Previously Approved Under PQRS

    We anticipate that two groups of clinicians will submit quality 
data under MIPS, those who submit as MIPS eligible clinicians and other 
clinicians who opt to submit data voluntarily in, but will not be 
subject to MIPS payment adjustments. Based on 2015 data from the PQRS 
and other CMS sources,\37\ we estimate that up to 611,876 (or 88 
percent of) MIPS eligible clinicians will submit quality performance 
category data including those participating as groups. Historically, 
the PQRS has never experienced 100 percent participation; the 
participation rate for 2014 was 63 percent. For purposes of these 
analyses, we assume that clinicians who participated in the 2015 PQRS 
will continue to submit quality data under MIPS as either MIPS eligible 
clinicians or voluntary reporters. We also assume that the number of 
MIPS eligible clinicians will be the same in the transition year as it 
was in our estimate based on 2015 data. Similarly, we assume that the 
population of clinicians excluded from MIPS will be the same size in 
2017 as it was in our 2015 data. We anticipate that the professionals 
submitting data voluntarily will include Medicare clinicians that are 
ineligible clinician types, clinicians that meet the low-volume 
threshold, and newly enrolled Medicare clinicians.\38\ Based on those 
assumptions, we estimate that an additional 296,776 clinicians, or 44 
percent of clinicians excluded from MIPS, will submit MIPS quality data 
voluntarily.
---------------------------------------------------------------------------

    \37\ The other data sources include 2014 VM data, 2015 PECOS 
data, and Medicare Part B claims data from 2014 and 2015.
    \38\ The category of 668,090 clinicians permitted to voluntarily 
submit data includes 199,308 ineligible clinician types, 85,268 
newly enrolled Medicare clinicians, and 383,514 low-volume 
clinicians. See Table 57 in section V.D of this final rule with 
comment period for additional details on the estimated counts of 
clinicians excluded from or ineligible for MIPS.
---------------------------------------------------------------------------

    Our burden estimates for quality data submission combine the burden 
for MIPS eligible clinicians and other clinicians submitting data 
voluntarily.

[[Page 77502]]

We assume clinicians will continue to submit quality data under the 
same submission mechanisms that they used under the 2015 PQRS. Using 
the 2015 PQRS counts of individuals and groups submitting through 
various mechanisms, we assume that 332,729 clinicians will submit as 
individuals through claims submission mechanisms; 258,993 clinicians 
will submit as individuals or groups through qualified registry or QCDR 
submission mechanisms; 105,987 clinicians will submit as individuals or 
groups through EHR submission mechanisms; and 107,884 clinicians will 
submit as groups through CMS Web Interface. We also assume that 
clinicians that submitted quality data as groups under the 2015 PQRS 
will continue to do so under the MIPS first performance year. 
Specifically, we assume that 2,678 groups will submit data via QCDR and 
registry submission mechanisms on behalf of 139,772 clinicians; 903 
groups will submit via EHR submission mechanisms on behalf of 54,460 
eligible clinicians; and 299 groups will submit data via the CMS Web 
Interface on behalf of 107,884 clinicians. For CMS Web Interface 
submission by Shared Savings Program ACOs and Next Generation ACOs, we 
assume that the 2017 counts of APM Entities and their participants will 
be the same as the 2016 counts. Specifically, we assume that 433 Shared 
Savings Program ACOs will submit on behalf of 140,341 participants and 
18 Next Generation ACOs will submit on behalf of 24,144 participants.
    For clinicians or groups, the burden associated with the 
requirements of the MIPS quality performance category is the time and 
effort associated with clinicians identifying applicable quality 
measures, and submission of the measures.
    The burden estimates were revised to reflect differences between 
the policies established in this final rule with comment period, and 
those proposed in the proposed rule. In addition, the burden estimates 
were revised in response to public comments about the underlying 
assumptions, which are discussed at the end of this section. As a 
result of these revisions, the gross burden estimate in the proposed 
rule was 12,493,654 burden hours with an associated burden cost of 
$1,327,177,693 (81 FR 28362). The finalized burden estimates are 
10,894,214 burden hours with an associated burden cost of 
$1,311,245,806.
    Several differences between the revised policies set forth in this 
final rule with comment period and the policies in the proposed rule 
are reflected in the burden estimates, including the reduction in the 
number of required advancing care information measures from 11 to five 
and the reduction in the number of recommended improvement activities 
from six to four. The burden estimates also reflect a simplification of 
the data submission requirements for MIPS APM participants. 
Specifically, this final rule with comment period does not generally 
require MIPS APM participants to submit improvement activities data, 
whereas the proposed rule did. For the advancing care information 
performance category, this final rule with comment period establishes 
the capability for participants in MIPS APMs other than the Shared 
Savings Program to submit data at the billing TIN level. In contrast, 
we had proposed that participants in Shared Savings Program ACOs submit 
advancing care information data at the billing TIN level and 
participants in other MIPS APMs submit advancing care information data 
at the individual clinician level.
    Finally, under the revised policy set forth in this final rule with 
comment period, Advanced APM participants will be notified about their 
QP or Partial QP status before the end of the performance period, 
whereas in the proposed rule, Advanced APM participants would not have 
been notified of their QP or Partial QP status until after the end of 
the submission period. Due to the timing of the QP and Partial QP 
status data, the proposed rule's burden estimates assumed that all 
Advanced APM Entities would be required to submit Partial QP election 
data. In the final rule with comment period, we assume the vast 
majority of Advanced APM participants will not be required to submit 
Partial QP election data.
    In addition to policy differences between the proposed rule and 
final rule with comment period, the burden estimates also reflect 
changes in methods. In response to public comments, we have changed our 
assumptions about the number of hours and skill mix of labor needed to 
review quality measure specifications. We have also changed our 
assumptions to more accurately reflect the efficiency gains from group 
reporting. In the proposed rule, we assumed that the burden per 
clinician was the same whether they submitted as an individual or as 
part of a group. In this final rule with comment period's burden 
estimates, we calculate the burden at the level of the respondent 
(group or individual clinician) submitting data, and assume the average 
burden per respondent is the same.
    These burden estimates have some limitations. We believe it is 
difficult to quantify the burden accurately because clinicians and 
groups may have different processes for integrating quality data 
submission into their practices' work flows. Moreover, the time needed 
for a clinician to review quality measures and other information, 
select measures applicable to their patients and the services they 
furnish, and incorporate the use of quality data codes into the office 
workflows is expected to vary along with the number of measures that 
are potentially applicable to a given clinician's practice. Further, 
the final burden estimates are based on historical rates of 
participation in the PQRS program, and the rate of participation in 
MIPS are expected to differ.
    We believe the burden associated with actually submitting the 
quality measures will vary depending on the submission method selected 
by the clinician or group. As such, we break down the burden estimates 
by clinicians and groups according to the submission method used.
    We anticipate that clinicians and groups using claims, QCDR and 
registry, and EHR submission mechanisms will have the same start-up 
costs related to reviewing measure specifications. As such, we estimate 
for clinicians and groups using any of these three submission 
mechanisms a total of 8 staff hours needed to review the quality 
measures list, review the various submission options, select the most 
appropriate submission option, identify the applicable measures or 
specialty measure sets for which they can report the necessary 
information, review the measure specifications for the selected 
measures or measures group, and incorporate submission of the selected 
measures or specialty measure sets into the office work flows. Building 
on data in a recent Health Affairs article (Casilano et al., 2016) 
http://content.healthaffairs.org/content/35/3/401.abstract we assume 
that a range of expertise is needed to review quality measures: 3 hours 
of an administrator's time, 2 hours of a clinician's time, 1 hour of a 
LPN/medical assistant's time, 1 hour of a computer systems analyst's 
time, and 1 hour of a billing clerk's time.\39\ We estimate that the 
start-up

[[Page 77503]]

cost for a MIPS eligible clinician's practice to review measure 
specifications is $730.40, including 3 hours of a practice 
administrator's time (3 hours x $101.98 = $305.94), 2 hours of a 
clinician's time (2 hours x $182.46/hour = $346.92), 1 hour of a LPN/
medical assistant's time (1 hour x $42.34), and 1 hour of a billing 
clerk's time (1 hour x $35.20/hour = $35.20). These start-up costs 
pertain to the specific quality submission methods below, and hence 
appear in the burden estimate tables.\40\
---------------------------------------------------------------------------

    \39\ Our burden estimates are based on prorated versions of the 
estimates for reviewing measure specifications in Lawrence P. 
Casalino et al., ``US Physician Practices Spend More than $15.4 
Billion Annually to Report Quality Measures,'' Health Affairs, 35, 
no. 3 (2016): 401-406. The estimates were annualized to 50 weeks per 
year, and then prorated to reflect that Medicare revenue is 30 
percent of all revenue paid by insurers, and then adjusted d to 
reflect that the decrease from 9 required quality measures under 
PQRS to 6 required measures under MIPS.
    \40\ The one exception is the start-up cost for a billing clerk 
to submit data is not listed in the CMS Web Interface Reporting 
Burden because the CMS Web Interface measures are very similar to 
the GPRO Web Interface measures used in the 2016 PQRS.
---------------------------------------------------------------------------

    For the purposes of our burden estimates for the claims, registry 
and QCDR, and EHR submission mechanisms, we also assume that, on 
average, each clinician or group will submit six quality measures. 
Given the lack of historical data on MIPS, it is difficult to estimate 
the number of physicians who will voluntary elect to test this system 
by submitting fewer than the six measures required for many clinicians. 
We believe that the number of clinicians and groups that submit fewer 
than six measures as they gain experience with the new system may be 
balanced out by the number of clinicians and groups that continue to 
submit more than six measures because they were required to submit nine 
measures under the PQRS.
    The revised quality performance requirements and burden estimates 
were submitted along with all other ICRs listed below under a new OMB 
control number (0938-NEW). Given that in the first year of 
implementation CAHPS for MIPS is replacing and using the same questions 
as CAHPS for the PQRS, the CAHPS for MIPS performance requirements and 
burden estimates were submitted as a request for continuation of OMB 
control number (0938-1222), CAHPS for PQRS.
    We received several general comments on the quality performance 
category burden estimates.
    Comment: Several commenters believed that the burden estimates in 
the Collection of Information section of the proposed rule were too low 
because MIPS eligible clinicians would require extensive time to become 
familiar with the program, including quality data reporting, in the 
transition year.
    Response: The estimated burden to become familiar with quality 
measure specifications has been increased from 1 hour in the proposed 
rule to 2 hours of clinician time for the transition year of the 
program. In future program years, we anticipate that the burden will be 
reduced as clinicians become more familiar with the quality measures 
and submission requirements.
    Comment: Several commenters disagreed with the assumption that a 
billing clerk could review proposed measures specifications due to 
their complexity.
    Response: We agree with the commenters, and believe that due the 
complexity of measure specifications, a broader range of occupational 
titles would need to be involved in reviewing measure specifications. 
In the proposed rule, we assumed that each practice would require 6 
hours of a billing clerk's time and 1 hour of a clinician's time to 
review measure specifications. As noted above, we have revised our 
burden estimates to include a mix of staff needed to review quality 
measure specifications using calculations informed by a recent Health 
Affairs article (http://content.healthaffairs.org/content/35/3/401.abstract). We assume that the skill mix to review measure 
specifications to include: 3 hours of practice administrator time, 2 
hours of clinician time, 1 hour of LPN/medical assistant time, 1 hour 
of computers systems analyst time, and 1 hour of billing clerk time.
    Comment: One commenter noted the reduction in the number of quality 
measures would reduce burden.
    Response: As noted above, the estimated burden to become familiar 
with quality measure specifications has been increased from 1 hour of 
clinician time to 2 hours of clinician time. After the transition year, 
we expect that the burden for quality measures submission will continue 
to decline in future years as MIPS eligible clinicians become more 
familiar with quality measures and submission requirements.
    Comment: One commenter requested that CMS provide time and cost 
estimates for determining which quality measures to report.
    Response: As noted above, our burden estimates factor in 8 hours of 
staff time to review quality measure specifications, which includes 
evaluating which quality measures to report. No further changes will be 
made in the burden estimates.
    In summary, CMS made several changes to the quality performance 
category data burden estimates in response to comments, including 
increasing our estimate of the time required to review measure 
specifications from 7 to 8 hours, and assuming that a broader and more 
skilled mix of occupational titles would be needed to review measure 
specifications. In addition, the burden estimates were revised to 
reflect updated 2015 wage and PQRS data, and to more accurately reflect 
the burden of group reporting.
1. Burden for Quality Data Submission by Clinicians: Claims-Based 
Submission
    As noted above, we assume that 332,729 individual clinicians will 
submit quality data via claims based on 2015 PQRS data. We anticipate 
the claims submission process for MIPS will be operationally similar to 
the way it functioned under the PQRS. Specifically, clinicians will 
need to gather the required information, select the appropriate quality 
data codes (QDCs), and include the appropriate QDCs on the claims they 
submit for payment. Clinicians will collect QDCs as additional 
(optional) line items on the CMS-1500 claim form or the electronic 
equivalent HIPAA transaction 837-P, approved by OMB under control 
number 0938-0999.
    The total estimated burden of claims-based submission will vary 
along with the volume of claims on which the submission is based. Based 
on our experience with the PQRS, we estimate that the burden for 
submission of quality data will range from 0.22 hours to 10.8 hours per 
clinician. The wide range of estimates for the time required for a 
clinician to submit quality measures via claims reflects the wide 
variation in complexity of submission across different clinician 
quality measures. As shown in Table 44, we also estimate that the cost 
of quality data submission using claims will range from $19.08 (0.22 
hours x $86.72) to $936.58 (10.8 hours x $86.72). The total estimated 
annual cost per clinician ranges from the minimum burden estimate of 
$878.60 to a maximum burden estimate of $1,796.10. The burden will 
involve becoming familiar with MIPS data submission requirements. We 
believe that the start-up cost for a clinician's practice to review 
measure specifications total 8, which includes 3 hours of a practice 
administrator's time (3 hours x $101.98 = $305.94), 2 hours of a 
clinician's time (2 hours x $194.66/hour = $389.32), 1 hour of a LPN/
medical assistant's time (1 hour x $42.34 = $42.34), 1 hour of a 
computer systems analyst's time (1 hour x $86.72 = $86.72), and 1 hour 
of a billing clerk's time (1 hour x $35.20/hour = $35.20). These start-
up costs pertain to the specific quality submission methods below, and 
hence appear in the burden estimate tables.

[[Page 77504]]

    Considering both data submission and start-up costs, the total 
estimated burden hours per clinician ranges from a minimum of 8.22 
hours (0.22 + 3 + 2 + 1 + 1 + 1) to a maximum of 18.8 hours (10.8 + 3 + 
2 + 1 + 1 + 1). The total estimated annual cost per clinician ranges 
from the minimum estimate of $878.60 ($19.08 + $305.94 + $389.32 + 
$42.34 + $86.72 + $35.20) to a maximum estimate of $1,796.10 ($936.58 + 
$305.94 + $389.32 + $42.34 + $86.72 + $35.20). Therefore, total annual 
burden cost is estimated to range from a minimum burden estimate of 
$292,335,167 (332,729 x $878.60) to a maximum burden estimate of 
$597,613,226 (332,729 x $1,796.10).
    Based on the assumptions discussed above, Table 44 summarizes the 
range of total annual burden associated with clinicians using the 
claims submission mechanism.
---------------------------------------------------------------------------

    \41\ In Tables 44-55, the numbers have been truncated to two 
decimals for readability.

 Table 44--Burden Estimate for Quality Performance Category: Clinicians Using the Claims Submission Mechanism 41
----------------------------------------------------------------------------------------------------------------
                                                                  Minimum burden   Median burden  Maximum burden
                                                                      estimate       estimate         estimate
----------------------------------------------------------------------------------------------------------------
Estimated # of Participating Clinicians (a).....................         332,729         332,729         332,729
Burden Hours Per Clinician to Submit Quality Data (b)...........            0.22            1.58            10.8
Estimated # of Hours Practice Administrator Review Measure                     3               3               3
 Specifications (c).............................................
Estimated # of Hours Computer Systems Analyst Review Measure                   1               1               1
 Specifications (d).............................................
Estimated # of Hours LPN Review Measure Specifications (e)......               1               1               1
Estimated # of Hours Billing Clerk Review Measure Specifications               1               1               1
 (f)............................................................
Estimated # of Hours Physician Review Measure Specifications (g)               2               2               2
Estimated Annual Burden hours per Clinician (h) = (b) + (c) +               8.22            9.58            18.8
 (d) + (e) + (f) + (g)..........................................
                                                                 -----------------------------------------------
Estimated Total Annual Burden Hours (i) = (a) * (h).............       2,735,032       3,187,544       6,255,305
Estimated Cost Per Clinician to Submit Quality Data (@computer            $19.08         $137.02         $936.58
 systems analyst's labor rate of $86.72/hr.) (j)................
Estimated Cost Practice Administrator Review Measure                     $305.94         $305.94         $305.94
 Specifications (@practice administrator's labor rate of $101.98/
 hr.) (k).......................................................
Estimated Cost Computer System's Analyst Review Measure                   $86.72          $86.72          $86.72
 Specifications (@computer systems analyst's labor rate of
 $86.72/hr.) (l)................................................
Estimated Cost LPN Review Measure Specifications (@LPN's labor            $42.34          $42.34          $42.34
 rate of $42.34/hr.) (m)........................................
Estimated Cost Billing Clerk Review Measure Specifications                $35.20          $35.20          $35.20
 (@clerk's labor rate of $35.2/hr.) (n).........................
Estimated Cost Physician Review Measure Specifications                   $389.32         $389.32         $389.32
 (@physician's labor rate of $194.66/hr.) (p)...................
                                                                 -----------------------------------------------
Estimated Total Annual Cost Per Eligible Clinician (q) = (j) +           $878.00         $996.54       $1,796.10
 (k) + (l) + (m) + (n) + (p)....................................
Estimated Total Annual Burden Cost (r) = (a) * (q)..............    $292,335,167    $331,576,959    $597,613,226
----------------------------------------------------------------------------------------------------------------

    We did not receive comments specific to the claims-based submission 
burden. We have updated the numbers to reflect updates based on 2015 
data and to reflect new assumptions on the staff time required to 
review measure specifications, but no other changes were made.
2. Burden for Quality Data Submission by Clinicians and Groups Using 
Qualified Registry and QCDR Submissions
    As noted above, we assume that 258,993 clinicians will submit 
quality data as individuals or groups via qualified registry or QCDR 
submissions based on 2015 PQRS data. Of these, we expect 119,201 
clinicians to submit as individuals and 2,678 groups are expected to 
submit on behalf of the remaining 139,792 clinicians. Given that the 
number of measures required is the same for clinicians and groups, we 
expect the burden to be the same for each respondent submitting data 
via qualified registry or QCDR, whether the clinician is participating 
in MIPS as an individual or group.
    We estimate that burdens associated with QCDR submissions are 
similar to the burdens associated with qualified registry submissions. 
Therefore, we discuss the burden for both data submissions together 
below. For qualified registry and QCDR submissions, we estimate an 
additional time burden for respondents (clinicians and groups) to 
become familiar with MIPS submission requirements and, in some cases, 
new specialty measure sets. Therefore, we believe that the start-up 
cost for an individual clinician or group to review measure 
specifications and report quality data to total $1,126.88. This total 
includes 3 hours per respondent to submit quality data (3 hours x 
$86.72/hour = $260.16), 3 hours of a practice administrator's time (3 
hours x $101.98/hour = $305.94), 2 hours of a clinician's time (2 hours 
x $194.66/hour = $389.32), 1 hour of a computer systems analyst's time 
(1 hour x $86.72/hour = $86.72), 1 hour of LPN/medical assistant's 
time, (1 hour x $42.34/hour = $42.34), and 1 hour of a billing clerk's 
time (1 hour x $35.20/hour = 35.20). Clinicians and groups will need to 
authorize or instruct the qualified registry or QCDR to submit quality 
measures' results and numerator and denominator data on quality 
measures to CMS on their behalf. We estimate that the time and effort 
associated with authorizing or instructing the quality registry or QCDR 
to submit this data will be approximately 5 minutes (0.083 hours) per 
clinician or group (respondent) for a total burden cost of $7.20, at a 
computer systems analyst's labor rate (.083 hours x $86.72/hour). 
Hence, we estimate 11.083 burden hours per respondent, with annual 
total burden hours of 1,350,785 (11.083 burden hours x 121,879 
respondents). The total estimated annual cost per respondent is 
estimated to be approximately $1,126.88. Therefore, total annual

[[Page 77505]]

burden cost is estimated to be $137,342,735 (121,879 x $1,126.88). 
Based on these burden requirements and the number of clinicians and 
groups historically using the Qualified Registry and QCDR submissions, 
we have calculated a burden estimate for these submissions:

 Table 45--Burden Estimate for Quality Performance Category: Clinicians
 (Participating Individually or as Part of a Group) Using the Qualified
                        Registry/QCDR Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Clinicians submitting via QCDR or registry (a).....         258,933
# of Clinicians submitting as individuals (b)...........         119,201
# of Groups submitting via QCDR or registry on behalf of           2,678
 individual clinicians (c)..............................
# of Respondents (groups plus clinicians submitting as           121,879
 individuals) (d) = (b) + (c)...........................
Estimated Burden Hours Per Respondent to Submit Quality                3
 Data (e)...............................................
Estimated # of Hours Practice Administrator Review                     3
 Measure Specifications (f).............................
Estimated # of Hours Computer Systems Analyst Review                   1
 Measure Specifications (g).............................
Estimated # of Hours LPN Review Measure Specifications                 1
 (h)....................................................
Estimated # of Hours Billing Clerk Review Measure                      1
 Specifications (i).....................................
Estimated # of Hours Physician Review Measure                          2
 Specifications (j).....................................
Estimated # of Hours Per Respondent to Authorize                   0.083
 Qualified Registry to Report on Respondent's Behalf)
 (k)....................................................
                                                         ---------------
Estimated Annual Burden Hours Per Respondent (l) = (e) +          11.083
 (f) + (g) + (h) + (i) + (j) + (k)......................
                                                         ---------------
Estimated Total Annual Burden Hours (m) = (d) * (l).....       1,350,785
Estimated Cost Per Respondent to Submit Quality Data             $260.16
 (@computer systems analyst's labor rate of $86.72/hr.)
 (n)....................................................
Estimated Cost Practice Administrator Review Measure             $305.94
 Specifications (@practice administrator's labor rate of
 $101.98/hr.) (p).......................................
Estimated Cost Computer System's Analyst Review Measure           $86.72
 Specifications (@computer systems analyst's labor rate
 of $86.72/hr.) (q).....................................
Estimated Cost LPN Review Measure Specifications (@LPN's          $42.34
 labor rate of $42.34/hr.) (r)..........................
Estimated Cost Billing Clerk Review Measure                       $35.20
 Specifications (@clerk's labor rate of $35.2/hr.) (s)..
Estimated Cost Physician Review Measure Specifications           $389.32
 (@physician's labor rate of $194.66/hr.) (t)...........
Estimated Burden for Submission Tool Registration etc.             $7.20
 (@computer systems analyst's labor rate of $86.72/hr.)
 (u)....................................................
                                                         ---------------
Estimated Total Annual Cost Per Respondent (v) = (n) +         $1,126.88
 (p) + (q) + (r) + (s) + (t) + (u)......................
                                                         ---------------
Estimated Total Annual Burden Cost (m) = (a) * (v)......    $137,342,735
------------------------------------------------------------------------

    The following is a summary of the comments we received regarding 
our burden estimate for the quality performance category using registry 
or QCDR.
    Comment: One commenter stated that the proposed rule underestimated 
data submission costs because it did not include the fees paid to 
registries.
    Response: The potential financial costs of fees paid to registries 
are discussed in the section V.C of this final rule with comment 
period. Because the burden estimates in this section addresses time 
costs, not direct financial costs, no changes were made to the burden 
estimate for data submission to registries and QCDRs as a result of 
this comment. In II.E.9.c(3), we are finalizing our proposal to post 
QCDR's self-reported costs for MIPS eligible clinicians or groups to 
use the QCDR on the CMS Web site alongside their organizational contact 
information and the services and measures offered.
    In summary, no changes were made to the registry or QCDR data 
submission burden estimate in response to comments specific to that 
section. We have updated the numbers to reflect updates based on 2015 
data and to reflect new assumptions on group submission and the staff 
time required to review measure specifications.
3. Burden for Quality Data Submission by Clinicians and Groups: EHR 
Submission
    As noted above, based on 2015 PQRS data, we assume that 105,987 
clinicians will submit quality data as individuals or groups via EHR 
submissions; 51,527 clinicians are expected to submit as individuals; 
and 903 groups are expected to submit on behalf of 54,460 clinicians. 
We expect the burden to be the same for each respondent submitting data 
via qualified registry or QCDR, whether the clinician is participating 
in MIPS as an individual or group.
    Under the EHR submission mechanism, the individual clinician or 
group may either submit the quality measures data directly to CMS from 
their EHR or utilize an EHR data submission vendor to submit the data 
to CMS on the clinician's or group's behalf.
    Based on our experience with the PQRS, we estimate that the time 
needed to perform all the steps necessary for clinicians or groups to 
submit quality performance measures includes the time to prepare for 
participating in quality performance category submissions for MIPS 
calculated at 8 hours of time to for reviewing specifications: (3 hours 
of a practice administrator's time, 2 hours of clinician's time, 1 hour 
of a LPN/medical assistant's time, plus 1 hour of a billing clerk's 
time). The time preparing for participating in EHR data submission also 
includes 1 hour for the respondent to obtain an account in the CMS 
identity management system plus 1 hour for submission of a test data 
file. This means the final step for quality data via an EHR submission 
mechanism is an additional 2 hours for data submission.
    To prepare for the EHR submission mechanism, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from EHRs, select the appropriate quality measures, 
extract the necessary clinical data from their EHR, and submit the 
necessary data to the CMS-designated clinical data warehouse or use a 
health IT vendor to submit the data on behalf of the clinician or 
group. We assume the burden for submission of quality measures data via 
EHR is similar for clinicians and groups who submit their data directly 
to CMS from their CERHT and clinicians and groups who use an

[[Page 77506]]

EHR data submission vendor to submit the data on their behalf. To 
submit data to CMS directly from their CEHRT, clinicians and groups 
must have access to a CMS-specified identity management system which we 
believe takes less than 1 hour to obtain. Once a clinician or group has 
an account for this CMS-specified identity management system, they will 
need to extract the necessary clinical data from their EHR, and submit 
the necessary data to the CMS-designated clinical data warehouse. We 
estimate that obtaining a CMS-specified identity management system will 
require 1 hour per respondent for a cost of $86.72 (1 hour x $86.72/
hour), and that submitting a test data file to CMS will also require 1 
hour per respondent for a cost of $86.72. With respect to submitting 
the actual data file, we believe that this will take clinicians or 
groups no more than 2 hours per respondent for a cost of submission of 
$173.44 (2 hours x $86.72/hour). The burden will involve becoming 
familiar with MIPS submission. We believe that the start-up cost for a 
clinician or group to review measure specifications total 8 hours, 
which includes 3 hours of a practice administrator's time (3 hours x 
$101.98/hour = $305.94), 2 hours of a clinician's time (2 hours x 
$194.66/hour = $389.32), 1 hour of a computer systems analyst's time (1 
hour x $86.72/hour = $86.72), 1 hour of a LPN/medical assistant's time 
(1 hour x $42.34/hour = $42.34), and 1 hour of a billing clerk's time 
(1 hour x $35.20/hour = $35.20). Hence, we estimated 12 total burden 
hours per respondent with annual total burden hours of 629,160 (12 
burden hours x 52,430 respondents). The total estimated annual cost per 
respondent is estimated to be $1,206.40. Therefore, total annual burden 
cost is estimated to be $63,251,552 (52,430 x $1,206.40).
    Based on these burden requirements and the number of clinicians and 
groups historically using the EHR submission mechanism, we have 
calculated a burden estimate for the quality data submission using EHR 
submission mechanism:

  Table 46--Burden Estimate for Quality Performance Category Clinicians
(Submitting Individually or as Part of a Group) Using the EHR Submission
                                Mechanism
------------------------------------------------------------------------
                                                        Burden estimate
------------------------------------------------------------------------
# of Clinicians submitting via EHR (a)...............            105,987
# of Clinicians submitting as individuals (b)........             51,527
# of Groups submitting via EHR on behalf of                          903
 individual clinicians (c)...........................
# of Respondents (groups plus clinicians submitting               52,430
 as individuals) (d) = (b) + (c).....................
Estimated Burden Hours Per Respondent to Obtain                        1
 Account in CMS-Specified Identity Management System
 (e).................................................
Estimated Burden Hours Per Respondents to Submit Test                  1
 Data File to CMS (f)................................
Estimated Burden Hours Per Respondent to Submit MIPS                   2
 Quality Data File to CMS (g)........................
Estimated # of Hours Practice Administrator Review                     3
 Measure Specifications (h)..........................
Estimated # of Hours Computer Systems Analyst Review                   1
 Measure Specifications (i)..........................
Estimated # of Hours LPN Review Measure                                1
 Specifications (j)..................................
Estimated # of Hours Billing Clerk Review Measure                      1
 Specifications (k)..................................
Estimated # of Hours Physician Review Measure                          2
 Specifications (l)..................................
Estimated Annual Burden Hours Per Respondent (m) =                    12
 (e) + (f) + (g) + (h) + (i) + (j) + (k) + (l).......
Estimated Total Annual Burden Hours (n) = (d) * (m)..            629,160
Estimated Cost Per Respondent to Obtain Account in                $86.72
 CMS-specified identity management system (@computer
 systems analyst's labor rate of $86.72/hr.) (p).....
Estimated Cost Per Respondent to Submit Test Data                 $86.72
 File to CMS (@computer systems analyst's labor rate
 of $86.72/hr.) (q)..................................
Estimated Cost Per Respondent to Submit Quality Data             $173.44
 (@computer systems analyst's labor rate of $86.72/
 hr.) (r)............................................
Estimated Cost Practice Administrator Review Measure             $305.94
 Specifications (@practice administrator's labor rate
 of $101.98/hr.) (s).................................
Estimated Cost Computer System's Analyst Review                   $86.72
 Measure Specifications (@computer systems analyst's
 labor rate of $86.72/hr.) (t).......................
Estimated Cost LPN Review Measure Specifications                  $42.34
 (@LPN's labor rate of $42.34/hr.) (u)...............
Estimated Cost Billing Clerk Review Measure                       $35.20
 Specifications (@clerk's labor rate of $35.2/hr.)
 (v).................................................
Estimated Cost Physician Review Measure                          $389.32
 Specifications (@physician's labor rate of $194.66/
 hr.) (w)............................................
Estimated Total Annual Cost Per Respondent (x) = (p)           $1,206.40
 + (q) + (r) + (s) + (t) + (u) + (v) + (w)...........
Estimated Total Annual Burden Cost (y) = (d) * (x)...        $63,251,552
------------------------------------------------------------------------

    We did not receive comments specific to the EHR submission burden. 
We have updated the numbers to reflect updates based on 2015 data and 
to reflect new assumptions on the staff time required to review measure 
specifications, but no other changes were made.
4. Burden for Quality Data Submission via CMS Web Interface
    Based on 2015 PQRS data and 2016 Shared Savings Program and Next 
Generation ACO participation data, we assume that 750 organizations 
will submit quality data via the CMS Web Interface in the 2017 
performance period (299 groups, 433 Shared Savings Program ACOs, and 18 
Next Generation ACOs). Approximately 272,369 clinicians will be 
represented (107,885 clinicians not participating in ACOs; 140,341 
Shared Savings Program participants, and 24,144 Next Generation ACO 
participants). Groups interested in participating in MIPS using the CMS 
Web Interface must complete a registration process, whereas Shared 
Savings Program ACOs and Next Generation ACOs do not need to complete a 
separate registration process. We estimate that the registration 
process for groups under MIPS involves approximately 1 hour of 
administrative staff time per group. The weighted average of the time 
required to register for the CMS Web Interface across all organizations 
is 0.40 hours (1 hour for each of the 299 groups and zero hours for 
each of the 433 Shared Savings Program ACOs or 18 Next Generation 
ACOs.) We assume that a billing clerk will be responsible for 
registering the group and that therefore, this process has an average 
labor cost of $35.20 per hour. Therefore, assuming the total burden 
hours per group associated with the group registration process is 1 
hour, we estimate the total cost to a group

[[Page 77507]]

associated with the group registration process to be approximately 
$14.08. ($35.20 per hour x 0.40 hours per group).
    The burden associated with the group submission requirements under 
the CMS Web Interface is the time and effort associated with submitting 
data on a sample of the organization's beneficiaries that is 
prepopulated in the CMS Web Interface. Based on experience with PQRS 
GPRO Web Interface submission mechanism, we estimate that, on average, 
it will take each group 79 hours of a computer system analyst's time to 
submit quality measures data via the CMS Web Interface at a cost of 
$86.72 per hour, for a total cost of $6,850.88 (79 hours x $86.72/
hour).
    Our estimate of 79 hours for submission includes the time needed 
for each group to populate data fields in the web interface with 
information on approximately 248 eligible assigned Medicare 
beneficiaries and then submit the data (CMS will partially pre-populate 
the CMS Web Interface with claims data from their Medicare Part A and B 
beneficiaries). The patient data can either be manually entered or 
uploaded into the CMS Web Interface via a standard file format, which 
can be populated by CEHRT. Because each group must provide data on 248 
eligible assigned Medicare beneficiaries (or all eligible assigned 
Medicare beneficiaries if the pool of eligible assigned beneficiaries 
is less than 248), we are assuming that entering or uploading data for 
one Medicare beneficiary requires 19 minutes of a computer systems 
analyst's time (79 hours /248 patients).
    We also estimate that for each organization (group or ACO) 
submitting data, a clinician will need to spend 1 hour per year to 
review quality measure specifications, for a total cost of $194.66. The 
estimated time for reviewing quality measure specifications is lower 
than under the quality submission mechanisms because the CMS Web 
Interface measures are very similar to the GPRO Web Interface measures 
used in the 2016 PQRS. As mentioned above, we estimate it will take an 
average of 0.40 hours for each organization to register to submit 
through the CMS Web Interface, for a total of cost of $14.03 (0.40 x 
$35.20). The cost of these 1.40 hours is included in the total 
estimated annual cost per organization of $7,059.57. The total annual 
burden hours are estimated to be 60,299 (750 organizations x 80.40 
annual hours), and the total annual burden cost is estimated to be 
$5,294,680 (750 organizations x $7.059.57).
    Based on the assumptions discussed above we have calculated the 
following burden estimate for groups, Shared Savings Program ACOs, and 
Next Generation ACOs submitting to MIPS with the CMS Web Interface.

    Table 47--Burden Estimate for Quality Performance Category Group
                  Submission via the CMS Web Interface
------------------------------------------------------------------------
                                                        Burden estimate
------------------------------------------------------------------------
Estimated # of Eligible Group Practices (a)..........                750
Estimated # of Burden Hours Per Group Practice to                   0.40
 Self-Nominate to Participate in MIPS Under the Group
 Reporting Option (b)................................
Estimated # of Burden Hours Per Group to Report (c)..                 79
Estimated # of Burden Hours for Physician                              1
 Familiarizing Self with MIPS Measures (d)...........
Estimated Total Annual Burden Hours Per Group (e) =                80.40
 (b) + (c) + (d).....................................
Estimated Total Annual Burden Hours (f) = (a) * (e)..             60,299
Estimated Cost Per Group Practice to Self-Nominate to             $14.08
 Participate in MIPS Under the Group Reporting Option
 (@clerk's labor rate of $35.2/hr.) (g)..............
Estimated Cost Per Group to Report (@computer systems          $6,850.88
 analyst's labor rate of $86.72/hr.) (h).............
Estimated Cost for Physician Familiarizing Self with             $194.66
 MIPS Measures (@physician's labor rate of $194.66/
 hr.) (i)............................................
Estimated Total Annual Cost Per Group (j) = (g) + (h)          $7,059.57
 + (i)...............................................
Estimated Total Annual Burden Cost (k) = (a) * (j)...         $5,294,680
                                                      ------------------
                                                             By Provider
                                                      ------------------
Estimated # of Participating Eligible Professionals              272,369
 (l).................................................
Average Burden Hours Per Eligible Professional (m) =                0.22
 (f) / (l)...........................................
Estimated Cost Per Eligible Professional to Submit                   $19
 Quality Data (n) = (k) / (l)........................
------------------------------------------------------------------------

    We did not receive comments specific to the Web Interface 
submission reporting burden. We have updated the numbers to reflect 
updates based on 2015 data, but no other edits were made.

D. ICRs Regarding Burden for Third Party Reporting and Data Validation 
(Sec.  414.1400 and Sec.  414.1390)

1. Burden for Qualified Registry and QCDR Self-Nomination 42
---------------------------------------------------------------------------

    \42\ We do not anticipate any changes in the CEHRT process for 
health IT vendors as we transition to MIPS. Hence, health IT vendors 
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

    For CY 2016, 114 qualified registries and 69 QCDRs were qualified 
to report quality measures data to CMS for purposes of the PQRS, an 
increase from 98 qualified registries and 49 QCDRs in CY2015.\43\ Under 
MIPS we believe that the number of QCDRs and qualified registries will 
continue to increase because (1) many MIPS eligible clinicians will be 
able to use the qualified registry and QCDR for all MIPS submission 
(not just for quality submission) and (2) QCDRs will be able to provide 
innovative measures that address practice needs. Qualified registries 
or QCDRs interested in submitting quality measures results and 
numerator and denominator data on quality measures to CMS on their 
participants' behalf will need to complete a self-nomination process in 
order to be considered qualified to submit on behalf of MIPS eligible 
clinicians or groups, unless the qualified registry or QCDR was 
qualified to submit on behalf of MIPS eligible

[[Page 77508]]

clinicians or groups for prior program years and did so successfully.
---------------------------------------------------------------------------

    \43\ The full list of qualified registries for 2016 is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2016QualifiedRegistries.pdf 
and the full list of QCDRs is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2016QCDRPosting.pdf.
---------------------------------------------------------------------------

    We estimate that the self-nomination process for qualifying 
additional qualified registries or QCDRs to submit on behalf of MIPS 
eligible clinicians or groups for MIPS will involve approximately 1 
hour per qualified registry or QCDR to complete the online self-
nomination process.\44\
---------------------------------------------------------------------------

    \44\ Appendix D of the MIPS Paperwork Reduction Act package is a 
screen shot of the online self-nomination form for qualified 
registries and QCDRs.
---------------------------------------------------------------------------

    Please note that the self-nomination statement will occur by 
submission of an email to CMS, or if technically feasible it will occur 
via an online form that organizations will use to provide information 
on their business. We estimate that either of these mechanisms will 
require the same amount of time for respondents.
    In addition to completing a self-nomination statement, qualified 
registries and QCDRs will need to perform various other functions, such 
as meet with CMS officials when additional information is needed. In 
addition, QCDRs must benchmark and calculate their measure results. The 
time it takes to perform these functions may vary depending on the 
sophistication of the entity, but we estimate that a qualified registry 
or QCDR will spend an additional 9 hours performing various other 
functions related to being a MIPS qualified registry or QCDR.
    We estimate that the staff involved in the qualified registry or 
QCDR self-nomination process will mainly be computer systems analysts 
or their equivalent, who have an average labor cost of $86.72/hour. 
Therefore, assuming the total burden hours per qualified registry or 
QCDR associated with the self-nomination process is 10 hours, the 
annual burden hours is 1,830 (183 QCDRs or qualified registries x 10 
hours). We estimate that the total cost to a qualified registry or QCDR 
associated with the self-nomination process will be approximately 
$867.20 ($86.72 per hour x 10 hours per qualified registry). We also 
estimate that 183 new qualified registries or QCDRs will go through the 
self-nomination process leading to a total burden of $158,697.60 
($867.20 x 183).
    The burden associated with the qualified registry and QCDR 
submission requirements in MIPS will be the time and effort associated 
with calculating quality measure results from the data submitted to the 
qualified registry or QCDR by its participants and submitting these 
results, the numerator and denominator data on quality measures, the 
advancing care information performance category, and improvement 
activities data to CMS on behalf of their participants. We expect that 
the time needed for a qualified registry to accomplish these tasks will 
vary along with the number of MIPS eligible clinicians submitting data 
to the qualified registry or QCDR and the number of applicable 
measures. However, we believe that qualified registries and QCDRs 
already perform many of these activities for their participants. We 
believe the estimate above represents the upper bound of QCDR burden, 
with the potential for less additional MIPS burden if the QCDR already 
provides similar data submission services.
    Based on the assumptions previously discussed, we provide an 
estimate of total annual burden hours and total annual cost burden 
associated with a qualified registry or QCDR self-nominating to be 
considered ``qualified'' for the purpose of submitting quality measures 
results and numerator and denominator data on MIPS eligible clinicians.

     Table 48--Burden Estimate for QCDR and Registry Self-Nomination
------------------------------------------------------------------------
                                                        Burden estimate
------------------------------------------------------------------------
Estimated # of Qualified registries or QCDRs Self-                   183
 Nominating for the PQRS (a).........................
Estimated Total Annual Burden Hours Per Qualified                     10
 registry or QCDR (b)................................
Estimated Total Annual Burden Hours for Qualified                  1,830
 registries or QCDRs (c) = (a) * (b).................
Estimated Cost Per Qualified registry or QCDR                    $867.20
 (@computer systems analyst's labor rate of $86.72/
 hr.) (d)............................................
Estimated Total Annual Burden Cost for Qualified                $158,698
 registries or QCDRs (e) = (a) * (d).................
------------------------------------------------------------------------

    With regard to the QCDR and registry self-nomination and data 
submission, we did not receive any public comments regarding the 
proposed requirements or burden and are adopting them without change.
2. Burden for MIPS Data Validation Survey
    Under MIPS, a CMS contractor will conduct the MIPS Data Validation 
Survey in order to identify and address problems with data handling, 
data accuracy, and incorrect payments. The survey will be part of a 
broader MIPS strategy to combine our past program integrity processes, 
including 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''.
    Because the data that will be submitted to CMS by, or on behalf of, 
MIPS eligible clinicians and will be used to calculate payment 
adjustments, it is critical that this data be accurate. Additionally, 
the data will be used to generate performance feedback for MIPS 
eligible clinicians and groups and, in some cases, will be posted 
publicly on the CMS Web site. This further supports the need for 
accurate and complete data. The CMS data validation contractor will 
conduct surveys of groups, registries, QCDRs, health IT vendors, and 
MIPS eligible clinicians in support of evaluating the data submitted 
for MIPS. It will be similar to the PQRS Data Validation Survey, which 
uses a series of approximately 30 questions, arranged by category, to 
gather information about data handling practices, training, quality 
assurance, and the challenges that stakeholders face as part of PQRS 
participation. Under MIPS, the survey's topics will be expanded beyond 
validation of quality measures to include improvement activities and 
potentially advancing care information performance category data.
    The MIPS Data Validation Survey for performance period 2017 will be 
conducted in late 2018 for data reported in early 2018. Because the 
MIPS verification process is still under development, the precise 
sample size for respondents has not yet been determined. We anticipate 
that at most 500 organizations would be contacted for MIPS data 
verification for

[[Page 77509]]

performance period 2017. Based on the most recent year of the PQRS Data 
Validation Survey, we will assume that the response rate will be 86 
percent. Hence, we estimated the total number of respondents for 
performance period 2017 will be 430 (500 organizations contacted x 86 
percent response rate).
    We estimate the total annual burden for the ongoing MIPS data 
validation survey will be up to 645 hours each performance period (430 
responses x 1.5 hours), and the data validation will be conducted at a 
billing clerk's labor rate of $35.20 per hour for a total burden cost 
of $22,704 ($35.20/hour x 1.5 hours x 430 responses).

                                            Table 49--Total Estimated Burden for MIPS Data Validation Survey
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Burden per
                            Respondents                                 Responses         response       Total annual     Hourly labor     Total burden
                                                                                          (hours)       burden (hours)      cost ($)         cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
430................................................................             430              1.5              645           $35.20          $22,704
--------------------------------------------------------------------------------------------------------------------------------------------------------

    With regard to the MIPS data validation survey, we did not receive 
any public comments regarding the proposed requirements or burden and 
are adopting them without change.

E. Burden for Quality Data Submission via CAHPS for MIPS Survey

    Under MIPS, groups of two or more clinicians can elect to contract 
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as 
one of their six required quality measures. Beneficiaries will 
experience burden under the CAHPS for MIPS Survey.
    The usual practice in estimating the burden on public respondents 
to surveys such as CAHPS is to assume that respondent time is valued, 
on average, at civilian wage rates. As previously explained, the BLS 
data show the average hourly wage for civilians in all occupations to 
be $23.23. Although most Medicare beneficiaries are retired, we believe 
that their time value is unlikely to depart significantly from prior 
earnings expense, and have used the average hourly wage to compute the 
dollar cost estimate for these burden hours.
    Under the first performance period of MIPS, we assume that 461 
groups will elect to report on the CAHPS for MIPS survey, which is 
equal to the number of groups reporting via CAHPS for the PQRS in 2014. 
Table 50 shows the estimated annualized burden for beneficiaries to 
participate in the CAHPS for MIPS Survey. Based on historical 
information on the numbers of CAHPS for PQRS survey respondents, we 
assume that an average of 287 beneficiaries will respond per group. 
Therefore, the CAHPS for MIPS survey will be administered to 
approximately 132,307 beneficiaries per year (461 groups x an average 
of 287 beneficiaries per group responding). The survey contains 81 
items and is estimated to require an average administration time of 
18.0 minutes in English (at a pace of 4.5 items per minute) and 21.6 
minutes in Spanish (assuming 20 percent more words in the Spanish 
translation), for an average response time of 19.8 minutes or 0.33 
hours. These burden and pace estimates are based on CMS's experience 
with surveys of similar length that were fielded with Medicare 
beneficiaries. Given that we expect approximately 132,307 respondents 
per year, the annual total burden hours are estimated to be 43,661 
hours (132,307 respondents x .33 burden hours per respondent). The 
estimated total burden annual burden cost is $1,014,252 (43,661 total 
burden hours x $23.23 per hour)

  Table 50--Burden Estimate for Beneficiary Participation in CAHPS for
                               MIPS Survey
------------------------------------------------------------------------
                                                        Burden estimate
------------------------------------------------------------------------
Estimated # of Eligible Group Practices Administering                461
 CAHPS for MIPS Survey (a)...........................
Estimated # of Beneficiaries Per Group Responding to                 287
 Survey (b)..........................................
Estimated # of Total Respondents Completing Survey...            132,307
Estimated # of Burden Hours Per Respondent to Report                0.33
 (d).................................................
Estimated Cost Per Beneficiary Reporting (@labor rate              $7.67
 of $23.23/hr.) (e)..................................
Estimated Total Annual Burden Hours (f) = (c) * (d)..             43,661
Estimated Total Annual Burden Cost for Beneficiaries          $1,014,252
 Responding to CAHPS PQRS (g) = (c) * (e)............
------------------------------------------------------------------------

    With regard to the CAHPS for MIPS Survey, we did not receive any 
public comments regarding the proposed requirements or burden. We are 
updating the CAHPS burden estimates to reflect 2015 data, but no 
further changes were made.

F. ICRs Regarding Burden Estimate for Advancing Care Information Data 
(Sec.  414.1375)

    During the transition year, clinicians and groups can submit 
advancing care information data through qualified registry, QCDR, EHR, 
CMS Web Interface, and attestation data submission methods. Also, we 
have streamlined the submission requirements for advancing care 
information under the MIPS. Compared to the reporting requirements in 
the 2015 Medicare EHR Incentive Program Final Rule, two objectives and 
their associated measures (Clinical Decision Support and Computerized 
Provider Order Entry) will no longer be required for submission 
purposes. We have also worked to align the advancing care information 
performance category with other MIPS performance categories, such as 
submitting eCQMs to the quality category, which will streamline 
submission requirements and reduce MIPS eligible clinician confusion. 
In addition, as part of our efforts to align and streamline submission 
requirements, we are providing a group reporting option (which did not 
exist under the Medicare EHR Incentive Program). Hence, a MIPS eligible 
clinician's estimated burden for the advancing care information 
performance category is lower than the estimated 7 hours per MIPS 
eligible clinician in the Medicare EHR Incentive Program --Stage 3 PRA 
(OMB control number 0938-1278) currently under review at OMB. We are 
requesting that effective

[[Page 77510]]

January 1, 2017, the MIPS Collection of Information Requirements 
replace those for eligible clinicians in the Medicare EHR Incentive 
Program Stage 3 PRA.\45\
---------------------------------------------------------------------------

    \45\ We do not anticipate any changes in the CERHT process for 
EHR vendors as we transition to MIPS. Hence, EHR vendors are not 
included in these burden estimates.
---------------------------------------------------------------------------

    As noted above in section B, billing TINs may report advancing care 
information performance category data on behalf of MIPS eligible 
clinicians in MIPS APMs, or, except for participants in the Shared 
Savings Program, MIPS eligible clinicians in MIPS APMs may report 
advancing care information performance category data individually. 
Because billing TINs in APM Entities will be report advancing care 
information performance category data to fulfill the requirements of 
submitting to MIPS, we have included MIPS APMs in our burden estimate 
for the advancing care information performance category. Consistent 
with the proposed list of APMs that are MIPS APMs in the proposed rule, 
we assume that three MIPS APMs that do not also qualify as Advanced 
APMs will operate in the first performance period: Track 1 of the 
Shared Savings Program, CEC (one-sided risk arrangement), and OCM (one-
sided risk arrangement).

 Table 51--Estimated Numbers of Organizations Submitting Advancing Care
 Information Performance Category Data on Behalf of Eligible Clinicians
------------------------------------------------------------------------
                                                     Estimated number of
    Category of clinician     Available mechanisms      organizations
                                 for submission        submitting data
------------------------------------------------------------------------
MIPS Eligible Clinicians      As groups or          503,457 clinicians
 (not in APMs).                individuals.          submitting as
                                                     individuals.
                                                    3,880 groups
                                                     submitting on
                                                     behalf of 194,192
                                                     clinicians.
 
MIPS Eligible Clinicians      Each TIN in the APM   14,384 billing TINs
 participating in the Shared   Entity group          representing
 Savings Program.              reports advancing     140,341
                               care information to   participants in 433
                               MIPS through group    Shared Savings
                               TIN reporting.        Program ACOs.
MIPS Eligible Clinicians      Each MIPS eligible    33 Billing TINs
 participating in MIPS APMs    clinician in the      representing 1 APM
 other than the Shared         APM Entity group      Entity in CEC (non-
 Savings Program.              reports advancing     LDO arrangement).
                               care information to  6,478 Billing TINS
                               MIPS through either   representing 195
                               group TIN or          APM Entities in OCM
                               individual            one-sided risk
                               reporting [The        arrangement.
                               burden estimates
                               assume TIN-level
                               reporting.].
Total Number of               ....................  528,231 respondents.
 Organizations and
 Individuals Submitting Data.
------------------------------------------------------------------------

    Because performance year 2017 will be the first year for clinicians 
to report the advancing care information performance category data as 
groups, there is considerable uncertainty about what number of 
clinicians will report as part of a groups. Given the limitations of 
historical 2015 EHR Incentive Program data, some of our burden 
estimate's assumptions are based on 2015 PQRS data. Specifically, we 
assume that the number of individual clinicians and groups submitting 
advancing care information data will be the same as the number of 
individual clinicians and groups submitting data under the 2015 PQRS. 
Hence, we assume 503,457 clinicians will submit as individuals and 
3,880 groups submitting data on behalf of 194,192 clinicians. Further 
we anticipate that the 433 Shared Savings Program ACOs will submit data 
at the ACO participant billing TIN level, for a total of 14,384 billing 
TINS representing 140,341 participants. We anticipate that the APM 
Entity in the CEC model one-sided risk arrangement (at the time of 
publication, there is only one APM Entity in this track) will submit 
data at the billing TIN level, for an estimated total of 33 billing 
TINs submitting data. Finally, we anticipate that the 195 APM Entities 
in the OCM one-sided risk arrangement will submit at the billing TIN 
level, for an estimated 6,478 billing TINs submitting data. Hence, as 
shown in Table 51, we estimate that up to approximately 528,231 
respondents will be submitting data under the advancing care 
information performance category (503,457 MIPS eligible clinicians + 
3,880 groups submitting on behalf of clinicians + 14,384 billing TINs 
within the Shared Savings Program ACOs + 33 billing TINs within the APM 
Entity participating in CEC one-sided risk arrangement and 6,578 
billing TINs within the OCM one-sided risk arrangement). The total 
burden hours for a clinician or group to report on the specified 
Advancing Care Information Objectives and Measures will be 3 hours. The 
total estimated burden hours are 1,584,694 (528,231 responses x 3 
hours). At a clinician's hourly rate, the total burden cost is 
$304,476,511 (1,584,694 hours x $194.66/hour).

                          Table 52--Total Estimated Burden for Advancing Care Information Performance Category Data Submission
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Burden per
                            Respondents                                 Responses         response       Total annual     Hourly labor     Total burden
                                                                                          (hours)       burden (hours)      cost ($)         cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
528,231............................................................         528,231                3        1,584,694           194.66      308,476,511
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The following is summary of the comments we received regarding our 
burden estimate for the advancing care information performance 
category.
    Comment: Two commenters noted that group reporting under advancing 
care information and other categories would reduce reporting burden.
    Response: As noted above, there is considerable uncertainty about 
the number of MIPS eligible clinicians who will report as part of a 
group, and no

[[Page 77511]]

historical data on group reporting for the EHR Incentive Program We 
have revised our burden to more appropriately reflect the reduction in 
burden due to group reporting by assuming that groups that submitted 
quality data to the 2015 PQRS would also do so under the advancing care 
information performance category. We assume that the burden of 
advancing care information data submission is the same for each 
respondent, whether that respondent is a group, individual clinician, 
or billing TIN in a MIPS APM. In the proposed rule, we assumed that all 
MIPS eligible clinicians not in MIPS APMs would report as individuals. 
Due to the change in our assumptions about group reporting, our 
estimated burden of advancing care information is lower than in the 
proposed rule.
    Comment: Two commenters noted that the removal of redundant eCQMs 
in the advancing care information category would reduce burden.
    Response: As noted above, our efforts to align the advancing care 
information performance category with other MIPS performance 
categories, such as submitting eCQMs to the quality category, will 
streamline submission requirements and reduce confusion for MIPS 
eligible clinicians. Consistent with the reduction in measures, we have 
reduced our burden estimates for the advancing care information 
performance category from the proposed 4 hours to 3 hours per 
respondent. Note that the estimated burden of 3 hours is lower than the 
estimated 7 hours per clinician in the Medicare EHR Incentive Program--
Stage 3 Paperwork Reduction Act Package.\46\ After the transition year, 
we anticipate a further reduction in the burden of submitting advancing 
care information measures as MIPS eligible clinicians and organizations 
submitting data on their behalf become more familiar with and have 
adapted to the measure specifications.
---------------------------------------------------------------------------

    \46\ The Medicare EHR Incentive Program--Stage 3 PRA package 
Paperwork Reduction Act Package is available at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
---------------------------------------------------------------------------

    Comment: Several commenters stated that the burden estimates in the 
Collection of Information section of the proposed rule were too low 
because MIPS eligible clinicians would require extensive time to become 
familiar with the program, including the advancing care information 
performance category, in the transition year.
    Response: In response to public comments on the advancing care 
information performance category, we have reduced the number of 
required measures from 11 to five. Accordingly, we have reduced our 
burden estimates for the advancing care information performance 
category from the proposed 4 hours to 3 hours per respondent. After the 
transition year, we anticipate a reduction in the burden of reporting 
advancing care information measures as MIPS eligible clinicians and 
organizations reporting on their behalf become more familiar with and 
have adapted to the measure specifications.
    In summary, we have modified our advancing care information data 
submission requirements in response to public comment, and reduced the 
corresponding burden estimates as compared to the proposal. In response 
to public comments, we have also adjusted our estimates to more 
accurately reflect the burden due to group reporting. Further, the 
burden estimates have been revised to reflect changes advancing care 
information data submission requirements for APM Entities under the APM 
scoring standard between the proposal and final rule, and changed to 
incorporate updated data on wages, PQRS, and counts of ACOs and their 
participants.

G. ICRs Regarding Burden for Improvement Activities Submission 
(Sec. Sec.  414.1355 and 414.1365)

    Requirements for submitting improvement activities are new, and we 
do not have historical data which is directly relevant. As noted in 
section II.E.F of this final rule with comment period, a variety of 
organizations and in some cases, individual clinicians, will report 
improvement activity performance category data. For clinicians who are 
not part of APMs, we assume that the number of clinicians submitting 
improvement activities as part of a group will be approximately the 
same as the number of clinicians submitting PQRS data as part of a 
group through the QCDR and registry, EHR, and GPRO Web Interface 
submission mechanisms in 2015. As noted above, MIPS eligible clinicians 
participating in MIPS APMs do not need to report improvement activities 
data unless the CMS-assigned improvement activities score is below the 
maximum improvement activities score. We estimate that that there could 
be as many as 503,547 clinicians submitting improvement activities 
performance category data as individuals, which is equal to the number 
of clinicians submitting as individuals using the claims, QCDR or 
qualified registry, or EHR submission mechanisms under the 2015 
PQRS.\47\ We estimate that approximately 194,192 clinicians comprising 
3,880 groups may submit at the group level. The burden estimates assume 
no improvement activities reporting burden for MIPS APM participants. 
CMS will assign the improvement activities performance category score 
at the APM level; each APM Entity within the same MIPS APM will be 
assigned the same score.
---------------------------------------------------------------------------

    \47\ Because of the lack of historical data on improvement 
activities submission, our estimate of 595,100 eligible clinicians 
submitting improvement activities data is based on 2014 PQRS 
historical data (595,100 eligible clinicians = 299,169 eligible 
clinicians submitting quality data through claims + 214,590 eligible 
clinicians submitting quality data through QCDR or qualified 
registry + 77,241 eligible clinicians submitting quality data 
through EHR).

   Table 53--Estimated Numbers of Organizations Submitting Improvement
  Activities Performance Category Data on Behalf of Eligible Clinicians
------------------------------------------------------------------------
                                    Available       Estimated number of
     Category of clinician        mechanisms for    entities submitting
                                    submission              data
------------------------------------------------------------------------
MIPS Eligible Clinicians (not   As groups or       3,880 groups
 in APMs).                       individuals.       representing 302,076
                                                    eligible clinicians.
                                                   503,337 eligible
                                                    clinicians
                                                    submitting
                                                    individually.
MIPS APM participants.........  No reporting       0
                                 burden.
------------------------------------------------------------------------

    During the transition year, clinicians and groups can submit data 
via qualified registry, QCDR, EHR, CMS Web Interface, or attestation 
data submission mechanisms. In addition to collecting necessary 
supporting documentation, each clinician and group, will provide a yes/
no attestation submitted during the data submission period for 
successfully completed improvement activities. We estimate that up to 
approximately 507,457 groups or individuals (3,880 groups and + 503,337 
individual clinicians) will be submitting data for improvement

[[Page 77512]]

activities. We estimate it will take no longer than 2 hours per group 
or individual to submit data for the improvement activities performance 
category. The total estimated burden is 1,014,674 hours (507,337 groups 
or individuals x 2 hours each). At a physician's hourly rate, the total 
estimated burden cost is $197,516,441 (1,014,674 hours x $194.66).

                                         Table 54--Total Estimated Burden for Improvement Activities Submission
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Burden per
                            Respondents                                 Responses         response       Total annual     Hourly labor     Total burden
                                                                                          (hours)      burden  (hours)     cost  ($)        cost  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
507,337............................................................         507,337                2        1,014,674           194.66      197,516,441
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We received comments regarding the improvement activities 
submission burden estimates.
    Comment: Several commenters believed that the burden estimates were 
too low because MIPS eligible clinicians would require extensive time 
to become familiar with the program in the transition year.
    Response: In response to public comments on the improvement 
activities performance category, we have reduced the number of 
recommended improvement activities from six to four. Consistent with 
the reduction in measures, we have reduced our estimate of the data 
submission in this final rule with comment to 2 hours from the 3 hours 
estimated in the proposed rule.
    We have also simplified the improvement activities data submission 
requirements for MIPS APM participants. The proposal was to require 
individual MIPS eligible clinicians participating in MIPS APMs to 
submit improvement activities data. Under the policies finalized in 
this final rule with comment period, MIPS APM participants will not be 
required to submit improvement activities data because CMS will assign 
the score at the MIPS APM level. As noted above, APM Entities in MIPS 
APMs may submit improvement activities data if the CMS-assigned 
improvement activities scores is below the maximum improvement 
activities score.
    In summary, we have simplified the improvement activities 
submission requirements in response to public comments. We have updated 
the improvement activities burden estimate to reflect the updated data 
submission requirement, to reflect 2015 data and to more accurately 
reflect the proportion of clinicians that will submit data as groups.

H. ICRs Regarding Burden for Cost (Sec.  414.1350)

    The cost performance category relies on administrative claims data. 
For claims-based submitting, the Medicare Parts A and B claims 
submission process is used to collect data on resource measures from 
MIPS eligible clinicians. MIPS eligible clinicians are not asked to 
provide any documentation by CD or hardcopy. Therefore, under the cost 
performance category, we do not anticipate any new or additional 
submission requirements for MIPS eligible clinicians.

I. ICR Regarding Partial QP Elections for Advanced APMs

    In the proposed rule, we discussed the MIPS-related submission 
requirements for participants in MIPS APMs. Advanced APM Entities may 
face an additional submission requirement under MIPS related to Partial 
QP elections. The final rule has changed the timing of when eligible 
clinicians in Advanced APMs receive notification about their Partial QP 
status, which reduced the burden estimates. Under the revised policy 
set forth in this final rule with comment period, Advanced APM 
participants will be notified about their QP or Partial QP status 
before the end of the performance period, whereas in the proposed rule, 
Advanced APM participants would not have been notified of their QP or 
Partial QP status until after the end of the submission period. If an 
Advanced APM Entity is notified its eligible clinicians are determined 
as a group to be Partial QPs, a representative from the Advanced APM 
Entity will log into the MIPS portal to indicate whether MIPS eligible 
clinicians determined to be Partial QPs wish to participate in 
MIPS.\48\ Our analyses of 2014 data indicate that nearly all Advanced 
APM participants would meet the QP threshold, and that no participants 
would be determined as a group to be Partial QPs. Hence, we assume that 
no Advanced APM Entities will face the data submission requirement in 
the 2017 performance period.
---------------------------------------------------------------------------

    \48\ If the Advanced APM Entity or CJR model participant chooses 
not to make the election, the default is for the clinicians meeting 
the partial QP threshold to opt out of MIPS.
---------------------------------------------------------------------------

    In addition, Affiliated Practitioners participating as gainsharers 
in the CJR model and assessed individually for purposes of the QP 
determination may face a data submission requirement for Partial QP 
elections. Under the proposed rule, we did not discuss the CJR model as 
potentially contributing to the burden for Partial QP elections. 
However, CMS has recently proposed changes to the CJR model in the 
proposed Advancing Care Coordination Through Episode Payment Models 
rule (81 FR 50794 through 28364) that, if finalized, would allow the 
CJR model to meet the Advanced APM criteria. Because CMS will assess 
Affiliated Practitioners in the CJR model individually, Affiliated 
Practitioners must make a Partial QP election at the individual 
eligible clinician level if they are determined to be Partial QPs. We 
also estimate that CJR participants are much more likely to be Partial 
QPs than participants in other Advanced APMs. We therefore estimate 
that up to 12,800 individual participants in the CJR model may submit 
partial QP election data.
    We estimate it will take each Advanced APM Entity representative or 
CJR model participant 15 minutes to make this election, and an 
additional 15 minutes to register for the MIPS Portal. As noted above, 
we assume that 12,800 participants in the CJR model and no Advanced APM 
Entities will make this election. Hence, we assume that 12,800 APM 
Entities' participants will make this election on the MIPS Portal, for 
a total burden estimate of 6,400 hours (12,800 participants x 0.5 
hours). At a computer systems analyst's hourly labor cost, the total 
burden cost of these elections is collectively estimated to be $555,008 
(6,400 x $86.72/hour).
    We did not receive any comments on the Partial QP election burden 
estimates. As noted above, we are adopting changes in the Partial QP 
burden estimates that reflect policy changes between the proposed rule 
and final rule with comment period, and the

[[Page 77513]]

Advancing Care Coordination Through Episode Payment Models that, if 
finalized, would create a new Advanced APM.

                                                Table 55--Total Estimated Burden for Partial QP Election
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Burden per
                            Respondents                                 Responses         response       Total annual     Hourly labor     Total burden
                                                                                          (hours)       burden (hours)      cost ($)        cost  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
12,800.............................................................          12,800              0.5            6,400            86.72          555,008
--------------------------------------------------------------------------------------------------------------------------------------------------------

J. Summary of Annual Burden Estimates

    The total gross burden estimate includes the total burden of 
recordkeeping and data submission under MIPS. Table 56 provides an 
estimate of the total annual burden of MIPS of 10,947,453 hours and a 
total labor cost of reporting of $1,311,245,806. Some of the 
information collection burden under MIPS does not represent an 
additional burden to the public, but replaces information collection 
burden that existed under two of its predecessor programs, the PQRS and 
the Medicare EHR Incentive Program. The estimated total existing burden 
approved for information collections related to PQRS and the Medicare 
EHR Incentive Program (for EPs) was 11,954,112 hours for a total labor 
cost of reporting of $1,318,689,857. The net burden estimate reflects 
only the incremental burden associated with this rule, and excludes the 
burden of existing recordkeeping and data submission under the PQRS, 
the Medicare EHR Incentive Program, CAHPS for PQRS, and PQRS Data 
Validation.\49\ Mindful of the combined data submission burden of MIPS, 
we have sought to avoid duplication of data submission efforts and 
simplified data submission structures within the unified program. The 
streamlining and simplification of data submission structures is 
reflected in our net burden estimates, which show a reduction in burden 
of -1,006,658 burden hours and -$7,444,051 labor cost of reporting 
compared to the existing information collections.
---------------------------------------------------------------------------

    \49\ The previously approved data collections OMB control 
numbers were as follows: PQRS (OCN 0938-1059), CAHPS for PQRS (OCN 
0938-1222), and PQRS Data Validation (OCN 0938-1255) and the 
Objectives/Measures (EP) ICR in the EHR Incentive Program Stage III 
PRA under review at OMB (OCN 0938-1278).

                                           Table 56--Proposed Annual Recordkeeping and Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Total
   Section(s) in title 42 of the CFR and                               Burden per     annual                                               Total annual
              section of rule               Respondents   Responses     response      burden          Labor cost of reporting  ($)          burden cost
                                                                        (hours)      (hours)                                                    ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   414.1330 and Sec.   414.1335             332,729      332,729         18.8    6,255,305  Varies (see Table 44)...................     597,613,226
 (Quality Performance Category) Claims
 Submission Mechanism.
Sec.   414.1330 and Sec.   414.1335             121,879      121,879         11.1    1,350,785  Varies (see Table 45)...................     137,342,735
 (Quality Performance Category) Qualified
 Registry or QCDR Submission Mechanisms.
Sec.   414.1330 and Sec.   414.1335              52,430       52,430         12.0      629,160  Varies (See Table 46)...................      63,251,552
 (Quality Performance Category) EHR--
 Submission Mechanism.
Sec.   414.1330 and Sec.   414.1335                 750          750         80.4       60,299  Varies (See Table 47)...................       5,294,680
 (Quality Performance Category) CMS Web
 Interface Submission Mechanism.
Sec.   414.1400 (QCDR and Registries) QCDR          183          183         10.0        1,830  86.72...................................         158,698
 and qualified registry self-nomination.
Sec.   414.1390 (Data Validation and                430          430          1.5          645  35.20...................................          22,704
 Auditing).
Sec.   414.1375 (Advancing Care                 528,231      528,231          3.0    1,584,694  194.66..................................     308,476,511
 Information Performance Category).
Sec.   414.1360 (Improvement Activities)..      507,337      507,337          2.0    1,014,674  194.66..................................     197,516,441
$414.1430 (Partial Qualifying APM                12,800       12,800          0.5        6,400  86.72...................................         555,008
 Participant (QP) election).
Sec.   414.1400 (Quality Performance            132,307      132,307          0.3       43,661  23.23...................................       1,014,252
 Category) CAHPS for MIPS.
                                           -------------------------------------------------------------------------------------------------------------
    Total Gross Burden....................  ...........    1,689,076  ...........   10,947,453  ........................................   1,311,245,806
                                           -------------------------------------------------------------------------------------------------------------
    Total Approved Burden Under Previous    ...........    1,338,865  ...........   11,954,112  ........................................   1,318,689,857
     Programs.
                                           -------------------------------------------------------------------------------------------------------------
    Total Net Burden......................  ...........      350,211  ...........   -1,006,658  ........................................      -7,444,051
                                           -------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We received one general comment regarding our calculations for the 
burden of the data submission requirements.
    Comment: One commenter requested that CMS provide time and cost 
estimates for reading educational materials and attending educational 
sessions, learning which of the new reporting requirements apply to 
each practice, and the costs for practices with CEHRT vs. those without 
CEHRT.
    Response: We agree that clinicians will need to review educational 
materials and attend outreach sessions to become familiar with the 
rule. We will use our extensive outreach efforts to improve clinician 
understanding to the greatest extent we can. The Regulatory Impact 
Analysis includes a general discussion of the potential costs to 
clinicians of meeting MIPS requirements. Because the Collection of 
Information section, by statute, discusses only the costs for 
submitting data, the costs of learning general information about the 
new requirements are not included. Hence, no changes were made to the 
burden estimate as a result of this comment.
    In summary, no changes were made to the rule as a result of general 
comments on the burden estimates.

K. Submission of PRA-Related Comments

    We have submitted a copy of this rule's information collection and

[[Page 77514]]

recordkeeping requirements to OMB for review and approval. The 
requirements are not effective until they have been approved by the 
OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed above, please visit CMS's Web 
site at www.cms.hhs.gov/PaperworkReductionActof1995, or call the 
Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please identify the rule (CMS-
5517-FC) and submit your comments to the OMB desk officer via one of 
the following transmissions: Mail: OMB, Office of Information and 
Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: 202-395-
5806 OR, Email: [email protected]. ICR-related comments must 
be received on/by November 18, 2016.

IV. Regulatory Impact Analysis

A. Statement of Need

    This final rule with comment period is necessary to make payment 
and policy changes under the PFS and to make statutorily-required 
changes under the MACRA. The MACRA's enactment consolidated certain 
aspects of physician quality data submission and performance programs 
into the new Merit-based Incentive Payment System (MIPS), including 
using certified EHR technology (section 1848(o) of the Act), the PQRS 
(sections 1848(k) and (m) of the Act), and the VM (section 1848(p) of 
the Act). These programs have been developed and most recently 
implemented by us as the Medicare EHR Incentive Program (80 FR 62761), 
the PQRS (80 FR 71135), and the VM (80 FR 71273). The MACRA's enactment 
altered the Medicare EHR Incentive Program such that the existing 
Medicare payment adjustment for EPs under section 1848(a)(7)(A) of the 
Act will end in CY 2018. Similarly, the MACRA ends the separate PQRS in 
CY 2018 and provides for the inclusion of various aspects of PQRS in 
MIPS, and sunsets the VM, ending it in CY 2018 and establishing certain 
aspects of the VM as a component of MIPS in CY 2019. Finally, the MACRA 
introduces incentive payment to eligible clinicians who become 
Qualifying APM Participants (QPs) through participation in Advanced 
APMs.
    This consolidated program for MIPS eligible clinicians represents a 
new approach to the delivery of health care in this care setting aimed 
at reducing burden on Medicare-enrolled eligible clinicians, improving 
population health, lowering growth in overall health care costs, and 
providing clear incentives for the provision of the best quality care 
for Medicare beneficiaries. MIPS provides payment adjustments for MIPS 
eligible clinicians for providing value-driven health care services to 
their patients, and APMs offer a variety of opportunities that 
substantially alter the methods of payment for health care and enable 
clinicians to make fundamental changes to their day-to-day operations 
to improve the quality and reduce the cost of health care.

B. Overall Impact

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the 
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 14-04), 
Executive Order 13132 on Federalism (August 4, 1999) and the 
Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate, as discussed below in this section, that the PFS 
provisions included in this final rule with comment period will 
redistribute more than $199 million in budget neutral payments in the 
initial performance year. In addition, this final rule with comment 
period will increase government outlays for the exceptional performance 
payments under MIPS ($500 million), and incentive payments to QPs 
(approximately $333-$571 million). Therefore, we estimate that this 
rulemaking is ``economically significant'' as measured by the $100 
million threshold, and hence also a major rule under the Congressional 
Review Act. Accordingly, we have prepared a RIA that, to the best of 
our ability, presents the costs and benefits of the rulemaking. The RFA 
requires agencies to analyze options for regulatory relief of small 
entities. For purposes of the RFA, small entities include small 
businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals, practitioners, and most other providers 
and suppliers are small entities, either by nonprofit status or by 
having annual revenues that qualify for small business status under the 
Small Business Administration (SBA) standards. (For details, see the 
SBA's Web site at http://www.sba.gov/content/table-smallbusiness-size-standards (refer to the 620000 series)). Individuals and States are not 
included in the definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a ``significant 
economic impact on a substantial number of small entities.'' The 
analysis must include a justification concerning the reason action is 
being taken, the kinds and number of small entities the rule affects, 
and an explanation of any meaningful options that achieve the 
objectives with less significant adverse economic impact on the small 
entities.
    There are over 1 million physicians, other practitioners, and 
medical suppliers that receive Medicare payment under the PFS. 
Approximately 95 percent of practitioners, other providers and 
suppliers are considered to be small entities, based upon the SBA 
standards. As shown later in this analysis, however, potential losses 
to MIPS eligible clinicians under the MIPS are a small percentage of 
their total Medicare Part B PFS revenue--4 percent in the initial 
payment year--though rising to as high as 9 percent in subsequent 
years. On average, clinicians' Medicare billings are only about 23 
percent of total revenue,\50\ so even those MIPS eligible clinicians 
adversely affected by MIPS would rarely face losses in excess of 3 
percent of revenues, the HHS standard for determining whether an 
economic effect is ``significant.'' (In order to determine whether a 
rule meets the RFA threshold of ``significant'' impact HHS has for many 
years used as a standard adverse effects that exceed 3 percent of 
either revenues or costs.) However, because there are so many affected 
MIPS eligible clinicians, even if only a small proportion is 
significantly adversely affected, the number could be ``substantial.'' 
Therefore, we are unable

[[Page 77515]]

to conclude that an Initial Regulatory Flexibility Analysis (IRFA) is 
not required. Accordingly, the analysis and discussion provided in this 
section, as well as elsewhere in this final rule with comment period, 
together meet the requirements for an IRFA. We note that whether or not 
a particular MIPS eligible clinician or other eligible clinician is 
adversely affected would depend in large part on the performance of 
that MIPS eligible clinician or other eligible clinician and that CMS 
will offer significant technical assistance to MIPS eligible clinicians 
and other eligible clinicians in meeting the new standards.
---------------------------------------------------------------------------

    \50\ Based on National Health Expenditure Data, Physicians and 
Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.
---------------------------------------------------------------------------

    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. We are not preparing 
an analysis for section 1102(b) of the Act because we have determined, 
and the Secretary certifies, that this final rule with comment period 
would not have a significant impact on the operations of a substantial 
number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2016, that 
threshold is approximately $146 million. This final rule with comment 
period would impose no mandates on state, local, or tribal governments 
or on the private sector because participation in Medicare is voluntary 
and because physicians and other clinicians have multiple options as to 
how they will participate under MIPS and discretion over their 
performance. Moreover, HHS interprets UMRA as applying only to 
``unfunded'' mandates. We do not interpret Medicare payment rules as 
being ``unfunded mandates,'' but simply as conditions for the receipt 
of payments from the federal government for providing services that 
meet federal standards. This interpretation applies whether the 
facilities or providers are private, state, local, or tribal.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    We have prepared the following analysis, which together with the 
information provided in the rest of this final rule with comment 
period, meets all assessment requirements. The analysis explains the 
rationale for and purposes of this final rule with comment period; 
details the costs and benefits of the rule; analyzes alternatives; and 
presents the measures we would use to minimize the burden on small 
entities. As indicated elsewhere in this final rule with comment 
period, we are implementing a variety of changes to our regulations, 
payments, or payment policies to implement statutory provisions. We 
provide information for each of the policy changes in the relevant 
sections of this final rule with comment period. We are unaware of any 
relevant federal rules that duplicate, overlap, or conflict with this 
final rule with comment period. The relevant sections of this final 
rule with comment period contain a description of significant 
alternatives if applicable.

C. Changes in Medicare Payments

    Section 101 of the MACRA, (1) repeals the SGR formula for physician 
payment updates in Medicare, and (2) requires that we establish MIPS 
for eligible clinicians under which the Secretary must use a MIPS 
eligible clinician's final score to determine and apply a MIPS payment 
adjustment factor to the clinician for a year.
    Repealing the SGR formula eliminated significant and immediate 
problems with Medicare's annual PFS payment updates, including 
implausible payment reductions (such as the 21.2 percent decrease that 
was scheduled for April 1, 2015). The Office of the Actuary estimated 
that avoiding those payment reductions results in a budgetary cost of 
$150.5 billion for fiscal years 2015 through 2025 compared to the prior 
law baseline. However, that cost is partially offset by other MACRA 
provisions that are estimated to have a net reduction in federal 
expenditures of $47.7 billion, bringing the net cost of the legislation 
to $102.8 billion.51 52 The largest component of the MACRA 
costs is its replacement of scheduled reductions in physician payments 
with payment rates first frozen at 2015 levels and then increasing at a 
rate of 0.5 percent a year during CYs 2016 through 2019. The estimates 
in this RIA take those legislated rates as the baseline for the 
estimates we make as to the costs, benefits, and transfer effects of 
the regulation, with some data collection provisions taking effect in 
2017 and substantial payment reforms first taking effect in 2019.
---------------------------------------------------------------------------

    \51\ Based on National Health Expenditure Data, Physicians and 
Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.
    \52\ Estimated Financial Effects of the Medicare Access and CHIP 
Reauthorization Act of 2015 (H.R. 2), CMS Office of the Actuary, 
https://www.cms.gov/research-statistics-data-and-systems/research/actuarialstudies/downloads/2015hr2a.pdf.
---------------------------------------------------------------------------

    As required by the MACRA, overall payment rates for services for 
which payment is made under the PFS would remain at the 2019 level 
through 2025, but starting in 2019, the amounts paid to individual MIPS 
eligible clinicians and other eligible clinicians would be subject to 
adjustment through one of two mechanisms, depending on whether the MIPS 
eligible clinician or other eligible clinician meets the threshold for 
participation in Advanced APMs to be considered a Qualifying APM 
Participant (QP) or Partial QP, or is instead evaluated under MIPS.
1. Estimated Incentive Payments to QPs in Advanced APMs
    For APMs, from 2019 through 2024, eligible clinicians receiving a 
substantial portion of their revenue through Advanced APMs and meeting 
other applicable requirements to become QPs would receive a lump-sum 
APM Incentive Payment equal to 5 percent of their estimated aggregate 
payment amounts for Medicare covered professional services in the 
preceding year. The APM Incentive Payment is separate from, and in 
addition to, the payment for services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs would 
not receive a MIPS payment adjustment under the PFS. Eligible 
clinicians who do not become QPs, but meet a slightly lower threshold, 
would be deemed Partial QPs for that year, and may elect to report to 
and be scored under MIPS but do not receive the APM Incentive Payment. 
In the 2017 QP Performance Period, we define Partial QPs to be eligible 
clinicians in Advanced APMs who have at least 20 percent, but less than 
25 percent, of their payments for Part B covered professional services 
through an

[[Page 77516]]

Advanced APM Entity, or furnish Part B covered professional services to 
at least 10 percent, but less than 20 percent, of their Medicare 
beneficiaries through an Advanced APM Entity. If the Partial QP elects 
to be scored under MIPS, they would be subject to all MIPS requirements 
and would receive a MIPS payment adjustment. This adjustment may be 
positive or negative. If an eligible clinician does not meet either of 
those QP standards, the eligible clinician would be subject to MIPS and 
would report to MIPS and receive the corresponding MIPS payment 
adjustment.
    Beginning in 2026, payment rates for clinicians who achieve QP 
status for a year would be increased each year by 0.75 percent, while 
payment rates for clinicians who do not achieve QP status would be 
increased each year by 0.25 percent. In addition, MIPS eligible 
clinicians would receive positive, neutral, or negative MIPS payment 
adjustments to their Part B payments in a payment year based on 
performance during a prior performance period. Although the legislation 
establishes overall payment rate and procedure parameters until 2026 
and beyond, this impact analysis covers only the initial payment year 
(2019) in detail. After 2019, while overall payment levels will be 
partially bounded, we have also acknowledged in the preamble that the 
Department will likely revise its quality and other payment measures 
and overall payment thresholds and other parameters as clinicians' 
behavior changes.
2. Estimated Numbers of Clinicians Eligible for MIPS
    As discussed further in this final rule with comment period, we are 
finalizing requirements for MIPS that may result in the exclusion of 
certain clinicians for various reasons. For example, the MACRA requires 
us to restrict eligibility for the 2019 and 2020 MIPS payment year to 
selected clinician types as described in section II.E.1 of this final 
rule with comment period. Additionally, we are excluding eligible 
clinicians that do not exceed the low volume threshold as defined in 
section II.E.3 of this rule: Those with $30,000 or less in Part B 
allowed charges or 100 or fewer Medicare patients as measured at the 
TIN/NPI level for individual reporting, the TIN level for group 
reporting, and the APM Entity level for reporting under the APM scoring 
standard. We also exclude those who are newly enrolled to Medicare and 
those eligible clinicians who are QPs.
    We projected the number of clinicians that would be excluded from 
MIPS due to their being QPs using several sources of information. 
First, the projections are anchored in the most recently available 
public information on Advanced APMs. The projections reflect APMs 
operating in 2017 that we indicated in the proposed rule would be 
Advanced APMs under proposed policies, including the Next Generation 
ACO Model, Comprehensive Primary Care (CPC) Plus, Comprehensive ESRD 
Care (CEC) Model, and the Shared Savings Program Tracks 2 and 3. We 
also factored in information about potential new Advanced APM 
opportunities including the Advanced APM criteria finalized in Sec.  
414.1415 of this final rule with comment period and the updates to the 
CJR model that were proposed in the Advancing Care Coordination Through 
Episode Payment Models proposed rule (81 FR 50794 through 28364). We 
also projected Advanced APM participation based on applicant counts and 
estimated acceptance rates to Advanced APMs that had open application 
periods as of September 2016. Finally, we used historical data to 
examine the extent to which Advanced APM participants would meet the QP 
thresholds of having at least 25 percent of their Part B covered 
professional services or at least 20 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the Advanced APM Entity. We followed the methodologies for group 
determination of QP status outlined in section II.F.5 of this final 
rule with comment period, and we determined that all participants in 
the Advanced APMs that were in operation in 2014 and 2015 would have 
met the QP thresholds. Based on that information, we assumed that 
during the first QP Performance Period, the vast majority of eligible 
clinicians participating in Advanced APM would be QPs.\53\
---------------------------------------------------------------------------

    \53\ To estimate the percent of Advanced APM participants that 
meet the QP threshold using historical data, we identified APM 
Entities that participated in APMs that have similar design 
characteristics to those finalized for Advanced APMs in Sec.  
414.1415. In 2014, those models included the Pioneer ACO Model 
(which will end in 2016), and Comprehensive Primary Care Initiative 
(CPC). We also included the CEC model, which began in 2015. Further, 
we assigned Shared Savings Program ACOs that existed in 2014 their 
2016 track assignments because several ACOs have since transitioned 
to higher risk tracks. Next, we analyzed 2014 claims data to 
identify the APM Entities within each of those APMs to determine 
which of those APM Entities met the criteria for having at least 25 
percent of their Part B covered professional services or 20 percent 
of their beneficiaries furnished Part B covered professional 
services through the APM Entity.
---------------------------------------------------------------------------

    Using those procedures, we estimated that between approximately 
70,000 and 120,000 clinicians would become QPs in the transition year 
with total Part B allowed charges of approximately $6,666 to $11,428 
million. We estimated that the total incentive payment of 5 percent of 
Part B allowed charges would be between approximately $333 and $571 
million. In this regard, it is longstanding HHS policy not to attempt 
to predict the effects of future rulemakings in order to maximize 
future Secretarial discretion over whether, and if so how, payment or 
other rules would be changed.
    To estimate the number of clinicians that are not in MIPS due to 
their clinician type not being eligible, or exclusions due to the low-
volume or newly-enrolled eligible clinicians, we began with a list of 
the clinicians participating in Medicare Part B in 2015.\54\ We would 
like to note that we have used the most recent data available (2015 
data) for these analyses where possible. In the instances where 2015 
data is unavailable, we have used data from 2014 from the VM and other 
sources. We refined the number of eligible clinicians by restricting 
the sample to doctors of medicine, doctors of osteopathy, 
chiropractors, dentists, optometrists, podiatrists, nurse 
practitioners, physician assistants, certified registered nurse 
anesthetists, and clinical nurse specialists since those are the 
practitioner types that can be MIPS eligible clinicians for CY 2017 in 
accordance with section 1848(q)(1)(C) of the Act.
---------------------------------------------------------------------------

    \54\ We identified the clinicians (at TIN-NPI level) that had 
positive Part B allowed charges, a positive number of beneficiaries 
and a reported specialty NPPES data. Exception: for CAH-II only 
providers we included providers with CAH-II PFS allowed charges >0 
and a specialty record; we did not have any beneficiary data or non-
PFS charges for CAH-II only providers.
---------------------------------------------------------------------------

    We estimated the number of excluded clinicians by identifying and 
counting the clinicians on this list who in 2015 (a) exceeded the low-
volume threshold; or (b) were assumed to be newly enrolled in Medicare 
by virtue of having PFS charges in 2015 but not 2014. We have estimated 
the effects of these various exclusions in Table 57. More than half 
(53-57 percent) of 1,380,209 Medicare clinicians billing to Part B will 
be ineligible for or excluded from MIPS. The excluded or ineligible 
clinicians represent approximately one-fourth (22-27 percent) of 
allowed Medicare Part B charges.
    According to National Health Expenditure data,\55\ in 2014, 
payments for physician and other clinician services totaled $603.7 
billion from all

[[Page 77517]]

sources. Medicare paid $138.4 billion of that amount. Based on the 
lower bound total in Table 57 of $23,314 million in allowed charges for 
clinicians excluded from MIPS, we estimate that less than 17 percent of 
clinicians' Medicare Part B spending for services covered under the PFS 
will be excluded from MIPS, and less than 4 percent of all clinicians' 
spending from all sources will be excluded.
---------------------------------------------------------------------------

    \55\ Physicians and Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.

                          Table 57--Projected Number of Clinicians Ineligible for or Excluded From MIPS in CY 2017, by Reason *
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Count of Medicare                               Part B allowed charges
                                               Medicare clinicians (TIN/NPIs)   clinicians (TIN/NPIs)    Part B allowed charges      remaining after
            Reason for exclusion                          excluded                 remaining after           excluded ($ in          exclusion ($ in
                                                                                      exclusion                millions)                millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ALL MEDICARE CLINICIANS BILLING PART B......  ...............................                1,380,209  .......................                 $104,674
Qualifying APM Participants (QPs) **........  70,000 lower bound.............      1,260,209-1,310,209           $6,666-$11,428          $93,246-$98,008
                                              120,000 upper bound............
Ineligible Clinician Types ***..............  199,308........................      1,060,901-1,110,901                  $10,614          $82,632-$87,394
Newly-enrolled clinicians ****..............  85,268.........................        975,633-1,025,633                   $1,283          $81,349-$86,111
Low-volume clinicians *****.................  383,514........................          592,119-642,119                   $4,751          $76,598-$81,360
    TOTAL EXCLUDED MEDICARE CLINICIANS......  738,090-788,090................  .......................          $23,314-$28,076  .......................
        PERCENT EXCLUDED....................  53-57%.........................  .......................                   22-27%  .......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Allowed charges for covered services of the clinician under Part B. 2015 data used to estimate 2017 performance. Payments estimated using 2015
  dollars.
** QPs have at least 25 percent of their Medicare Part B covered professional services or least 20 percent of their Medicare beneficiaries furnished
  part B covered professional services through an Advanced APM. The upper bound estimate for QPs also reflects that a small number of Advanced APM
  participants may be Partial Qualifying APM Participants (Partial QPs) that opt to be excluded from MIPS. For MIPS Year 1, Partial QPs are APM
  participants that have at least 20 percent, but less than 25 percent, of their Medicare Part B covered professional services through an Advanced APM
  Entity, or at least 10 percent, but less than 20 percent, of their Medicare beneficiaries furnished part B covered professional services through an
  Advanced APM Entity.
*** Section 1848(q)(1)(C) of the Act defines a MIPS eligible clinician for payment years 1 and 2 as a physician, physician's assistant, nurse
  practitioner, or clinical nurse anesthetist, or a group that includes such clinicians. (See section II.E.1 for further details) Our estimates of
  ineligible clinician types count clinician types who received part B payments but are not listed as eligible clinicians in the Act for payment year 1
  or 2.
**** Newly enrolled Medicare clinicians in our data had allowed PFS charges in CY 2015 but the NPI did not have allowed PFS charges in CY 2014.
***** Low-volume clinicians have less than or equal to $30,000 in allowed Medicare Part B charges or less than or equal to 100 Medicare patients.

    We have estimated the number of clinicians that we believe will be 
excluded from MIPS in CY 2017 by specialty. Our estimates follow in 
Table 58. The estimates in Table 58 are based on clinicians in eligible 
specialties that were excluded because they were newly enrolled, QPs, 
or met the proposed low-volume exclusion. However, due to data 
limitations, the estimates in Table 58 include only a portion of the 
70,000-120,000 QPs that are listed in Table 57.\56\
---------------------------------------------------------------------------

    \56\ The QP estimates in Table 58 are counts of eligible 
clinicians that participated in the three APMs that were in effect 
in 2015 and meet the criteria for Advanced APMs, that is, CPC 
initiative and Pioneer ACO Model. (In our 2015 data, the Pioneer ACO 
Model serves as a proxy for its successor, the Next Generation ACO 
Model; similarly, the CPC initiative serves as a proxy for its 
successor, CPC+). Due to data limitations, the QP estimates in Table 
58 do not count Shared Savings Program Tracks 2 and 3 participants 
in Advanced APMs that were implemented after 2015, including CEC, 
Comprehensive Primary Care Plus, and changes to the CJR model 
proposed in the Advancing Care Coordination Through Episode Payment 
Models proposed rule (81 FR 50794 through 28364). In contrast, the 
QP estimate in Table 57 includes publicly announced APMs that will 
be implemented in 2016 or 2017.
---------------------------------------------------------------------------

    Among eligible clinicians, Table 58 shows that the percent excluded 
from MIPS varies widely across specialties, ranging from a low of 16.8 
percent in gastroenterology to a high of 90.2 percent for 
chiropractors.
    We have also estimated the numbers of eligible clinicians that will 
be excluded from MIPS in CY 2017 by practice size as shown in Table 59. 
Eligible clinicians in small practices are much more likely to be 
excluded from MIPS than those in larger practices. For example, more 
than half (51.6 percent) of eligible clinicians in practices of 1-9 
clinicians will be excluded from MIPS, whereas about one-fourth (27.3 
percent) of eligible clinicians in practices of 100 or more clinicians 
will be excluded.
BILLING CODE 4120-01-P

[[Page 77518]]

[GRAPHIC] [TIFF OMITTED] TR04NO16.017


[[Page 77519]]


[GRAPHIC] [TIFF OMITTED] TR04NO16.018


[[Page 77520]]


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3. Estimated Impacts on Payments to MIPS Eligible Clinicians
    Based on the estimates of excluded clinicians in Table 57, we 
estimate that between approximately 592,119 and 642,119 eligible 
clinicians will be required to submit MIPS data to CMS in year 1.\57\ 
They are clinicians with eligible clinician types that (a) are not QPs 
participating in Advanced APMs (b) exceeded the low volume threshold 
and (c) have been enrolled as Medicare physicians for more than 1 year.
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    \57\ Because our model assigned final scores using data from the 
quality performance category, our model did not assign final scores 
to 21,764 eligible clinicians who are eligible for MIPS, but 
reported measures groups which is no longer continuing in MIPS. 
However, these eligible clinicians may be scored on advancing care 
information and improvement activities, and those two performance 
categories could not be modeled at this time given limited 
historical data.
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    Payment impacts in this final rule with comment period reflect 
averages by specialty and practice size based on Medicare utilization. 
The payment impact for a MIPS eligible clinician could vary from the 
average and would depend on the mix of services that the MIPS eligible 
clinician furnishes. The average percentage change in total revenues 
would be less than the impact displayed here because MIPS eligible 
clinicians generally furnish services to both Medicare and non-Medicare 
patients. In addition, MIPS eligible clinicians may receive substantial 
Medicare revenues for services under other Medicare payment systems 
that would not be affected by MIPS payment adjustment factors.
    In order to estimate the impact of MIPS on clinicians required to 
report, we used the most recently available data, including data from 
2015 PQRS, NPPES data and other available data to model the scoring 
provisions described in this regulation. First, we arithmetically 
calculated a hypothetical final score for each MIPS eligible clinician 
based on quality performance. Because the cost performance category has 
a zero percent weight for the initial payment year, we did not include 
any cost measures in the final score. Because of the lack of historical 
data for the advancing care information and improvement activities 
measures, the model does not estimate scores for the advancing care 
information and improvement activities performance categories either.
    Then, we implemented an exchange function based on the provisions 
of this final rule with comment period to translate the hypothetical 
final score into a negative MIPS payment adjustment or positive MIPS 
payment adjustment. This entailed modifying parameters of the exchange 
function iteratively in order to achieve distributions in MIPS payment 
adjustments that meet requirements related to budget neutrality and 
aggregate exceptional performance payment amounts using a 3 point 
performance threshold and a 70 point additional performance threshold.
    Given the wide diversity of clinical practices, the initial 
development period of the Quality Payment Program implementation was 
designed to allow physicians to pick their pace of participation for 
the first performance period that begins January 1, 2017. Eligible 
clinicians will have three flexible options to submit data to MIPS and 
a fourth option to join Advanced APMs in order to become QPs, all of 
which would ensure they do not receive a negative payment adjustment in 
2019. With the extensive changes to policy and flexibility, estimating 
impacts of this final rule with comment period using only historic 2015 
quality submission data significantly overestimates the impact on 
clinicians, particularly on clinicians in practices with 1-9 
clinicians, which have traditionally had lower participation rates. In 
order to assess the sensitivity of the impact to the participation 
rate, we have prepared two sets of analyses.
    The first analysis, which we label as ``standard participation 
assumptions,'' relies on the assumption that policy goals are designed 
to encourage a minimum 90 percent of MIPS eligible clinicians to 
participate, regardless of practice size. Therefore, we assumed that, 
on average, the categories of practices with 1-9 clinicians and 
practices with 10-24 clinicians would have 90 percent participation. 
This assumption is an increase from existing historical data. PQRS 
participation rates have increased steadily since the program began; 
the 2014 PQRS experience report showed an increase in the participation 
rate from 15 percent in 2007 to 62 percent in 2014.\58\ In 2015, among 
those eligible for MIPS, 87.2 percent participated in the PQRS. In 
2015, MIPS eligible practices of less than 10 clinicians participated 
in the PQRS at a rate of 58.2 percent, and MIPS eligible practices of 
10-24 clinicians participated in the PQRS at a rate of 83.7 percent. 
Because practices of 25-99 clinicians have a 92.6 percent participation 
rate based on historical data and practices of 100+ clinicians have a 
98.5 percent participation rate, we assumed the average participation 
rates of those categories of clinicians would be the same as under the 
2015 PQRS. Our assumption of 90 percent average participation for the 
categories of practices with 1-9 or 10-24 clinicians reflects our 
belief that small and solo practices will respond to this final rule 
with comment period's flexibility, reduced data submission burden, 
financial incentives, the support they will receive through technical 
assistance by participating at a rate close to that of other practice 
sizes, enhancing the existing upward trend in quality data submission 
rates. Therefore, we assume that the quality scores assigned to new 
participants reflect the distribution of MIPS quality scores.
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    \58\ 2014 PQRS Experience Report at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Experience_Rpt.pdf.
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    The second analysis, which we label as ``alternative participation 
assumptions,'' assumes a minimum participation rate of 80 percent. 
Because the 2015 PQRS participation rates for practices of more than 10 
clinicians are greater than 80 percent, this analysis assumes increased 
participation for practices of 1-9 clinicians. Practices of more than 
10 clinicians are included in the model at their historic participation 
rates.
    Table 60 summarizes the impact on Part B services of MIPS eligible 
clinicians by specialty for the standard participation assumptions. 
Table 61 summarizes the impact on Part B services of MIPS eligible 
clinicians by specialty under the alternative participation 
assumptions.
    Tables 62 and 63 summarize the impact on Part B services of MIPS 
eligible clinicians by practice size for the standard participation 
assumptions (Table 62) and the alternative participation assumptions 
(Table 63).
    Tables 60 and 62 show that under our standard participation 
assumptions, the vast majority (94.7percent) of MIPS eligible 
clinicians are anticipated to receive positive or neutral payment 
adjustments for the 2019 MIPS payment year, with only 5.3 percent 
receiving negative MIPS payment adjustments. Using the alternative 
participation assumptions, Table 63 shows that 91.9 percent of MIPS 
eligible clinicians are expected to receive positive or neutral payment 
adjustments. Due to limitations of modeling the new payment policies 
using historic data, it is not possible to differentiate between 
positive and neutral adjustment expectations. However, in both the 
standard and alternative assumptions, participating practices of all 
sizes are expected to experience a neutral or small net

[[Page 77523]]

positive impact in the 2019 MIPS payment year.
    The distribution of funds reflects this final rule with comment 
period's emphasis on increasing participation of MIPS eligible 
clinicians for the transition year of MIPS, which creates a ramp to 
more robust participation in future MIPS performance years.
    The following policy changes were made between the proposed and 
final rule with comment period to support that emphasis: modifying the 
low-volume threshold to exclude more clinicians, modifying the 
performance threshold to 3 for the initial payment year, and adding a 
performance floor on quality measure benchmarks.
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    We received several comments about the data used in the RIA.
    Comment: Several commenters noted that the 2014 data used in the 
RIA was

[[Page 77532]]

not representative of the 2019 MIPS payment year of MIPS. One commenter 
requested that CMS use 2015 data for its RIA estimates.
    Response: The RIA has been updated as requested, to the extent 
feasible, with 2015 data, which is the most recently available data. 
The claims-based readmission measures are still based on 2014 data. The 
identification of newly enrolled Medicare clinicians is based on both 
2014 and 2015 data, and the estimated number of QPs and their allowed 
charges is based on 2014, 2015, and more recent data.
    In summary, in response to comments, the RIA was updated with more 
recent data where feasible.
4. Potential Impact of Advancing Care Information Score
    As noted earlier, our impact does not include either the advancing 
care information or the improvement activities performance categories. 
The proposed rule discussed preliminary data on potential advancing 
care information scores (81 FR 28370). While we estimate the final 
score using only the quality performance category score, we recognize 
the final scores for the 2019 MIPS payment year would be estimated 
using advancing care information and improvement activities data.
    The costs for implementation and complying with the advancing care 
information performance category requirements could potentially lead to 
higher operational expenses for MIPS eligible clinicians. However, we 
believe that the combination of MIPS payment adjustments and long-term 
overall gains in efficiency will likely offset the initial 
expenditures. Because section II.E.5.g of this final rule with comment 
period establishes a policy to reweight the advancing care information 
performance category scores for MIPS eligible clinicians that were 
exempt from the Medicare EHR Incentive Program or received hardship 
exemptions (see 81 FR 28232), the final rule with comment period would 
not impose additional requirements for EHR adoption during the 
transition year. Health IT vendors may face additional costs in the 
transition year of MIPS if they choose to develop additional 
capabilities in their systems in order to submit advancing care 
information and improvement activities performance category data on 
behalf of MIPS eligible clinicians.
    Additionally, we believe a majority of MIPS eligible clinicians who 
are able to report the advancing care information performance category 
of MIPS have already adopted an EHR during Stage 1 and 2 of the prior 
Medicare EHR Incentive Program. As we have stated with respect to the 
Medicare EHR Incentive Program, we believe that future retrospective 
studies on the costs to implement an EHR and the return on investment 
(ROI) will demonstrate efficiency improvements that offset the actual 
costs incurred by MIPS eligible clinicians participating in MIPS and 
specifically in the advancing care information performance category, 
but we are unable to quantify those costs and benefits at this time.
    At present, evidence on EHR benefits in either improving quality of 
care or reducing health care costs is mixed. This is not surprising 
since the adoption of EHR as a fully functioning part of medical 
practice is progressing, with numerous areas of adoption, use, and 
sophistication demonstrating need for improvement. Even physicians and 
hospitals that can meet Medicare EHR Incentive Program standards have 
not necessarily fully implemented all the functionality of their 
systems or fully exploited the diagnostic, prescribing, and 
coordination of care capabilities that these systems promise. Moreover, 
many of the most important benefits of EHR depend on interoperability 
among systems and this functionality is still lacking in many EHR 
systems. A recent RAND report prepared for the ONC reviewed 236 recent 
studies that related the use of health IT to quality, safety, and 
efficacy in ambulatory and non-ambulatory care settings and found 
that--

    A majority of studies that evaluated the effects of health IT on 
healthcare quality, safety, and efficiency reported findings that 
were at least partially positive. These studies evaluated several 
forms of health IT: metrics of satisfaction, care process, and cost 
and health outcomes across many different care settings . . . Our 
findings agree with previous [research] suggesting that health IT, 
particularly those functionalities included in the Medicare EHR 
Incentive Program regulation, can improve healthcare quality and 
safety. The relationship between health IT and [health care] 
efficiency is complex and remains poorly documented or understood, 
particularly in terms of healthcare costs, which are highly 
dependent upon the care delivery and financial context in which the 
technology is implemented.\59\
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    \59\ Paul G. Shekelle, et al. Health Information Technology: An 
Updated Systematic Review with a Focus on Meaningful Use 
Functionalities. RAND Corporation. 2014.

    Other recent studies have not found definitive quantitative 
evidence of benefits.\60\ The proposed rule requested comments 
providing better evidence concerning EHR benefits in reducing the costs 
or increasing the value of EHR-supported health care. No commenters 
provided evidence concerning EHR benefits in reducing the costs or 
increasing the value of EHR-supported health care.
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    \60\ See, for example, Saurabh Rahurkar, et al, ``Despite the 
Spread of Health Information Exchange, There Is Little Information 
of Its Impact On Cost, Use, And Quality of Care,'' Health Affairs, 
March 2015; and Hemant K. Bharga and Abhay Nath Mishra, ``Electronic 
Medical Records and Physician Productivity: Evidence from Panel Data 
Analysis,'' Management Science, July 2014.
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    Similarly, the costs for implementation and complying with the 
improvement activities performance category requirements could 
potentially lead to higher expenses for MIPS eligible clinicians. Costs 
per full-time equivalent primary care clinician for improvement 
activities will vary across practices, including for some activities or 
certified patient-centered medical home practices, in incremental costs 
per encounter, and in estimated costs per member per month. Costs may 
vary based on panel size and location of practice among other 
variables. For example, Magill (2015), conducted a study of certified 
patient-centered medical home practices in two states.\61\ Magill 
(2015), found that costs associated with a full-time equivalent primary 
care clinician, who were associated with certified patient-centered 
medical home practices, varied across practices. Specifically, Magill 
(2015) found an average of $7,691 per month in Utah practices, and an 
average of $9,658 in Colorado practices. Consequently, certified 
patient-centered medical home practices incremental costs per encounter 
were $32.71 in Utah and $36.68 in Colorado (Magill, 2015). Magill 
(2015) also found that the average estimated cost per member, per 
month, for an assumed panel of 2,000 patients was $3.85 in Utah and 
$4.83 in Colorado. However, given the lack of comprehensive historical 
data for proposed improvement activities, we are unable to quantify 
those costs in detail at this time. The proposed rule requested public 
comments on the costs associated with improvement activities from 
practices that have implemented clinical practice improvements in the 
past. No commenters provided specific cost estimates of improvement 
activities.
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    \61\ Magill et al. ``The Cost of Sustaining a Patient-Centered 
Medical Home: Experience from 2 States.'' Annals of Family Medicine, 
2015; 13:429-435.
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D. Impact on Beneficiaries

    There are a number of changes in this final rule with comment 
period that would have an effect on beneficiaries. In general, we 
believe that the changes will have a positive impact and improve the

[[Page 77533]]

quality and value of care provided to Medicare beneficiaries.
    More broadly, we expect that over time clinician engagement in the 
Quality Payment Program will increasingly result in improved quality of 
care, resulting in lower morbidity and mortality, and in reduced 
spending, as physicians respond to the incentives offered by MIPS and 
APMs and adjust their clinical practices in order to maximize their 
performance on specified quality measures and activities. The various 
shared savings initiatives already operating have demonstrated that all 
three outcomes are possible. For example, in August of 2015, we issued 
2014 quality and financial performance results showing that Medicare 
ACOs continue to improve the quality of care for Medicare beneficiaries 
while generating net savings to the Medicare trust fund as well as 
shared savings to some model participants.\62\ In 2014, the 20 ACOs in 
the Pioneer ACO Model and 333 Shared Shavings Program ACOs generated 
more than $411 million in total savings, which includes all ACOs' 
savings and losses. Additionally, in their first years of 
implementation, both Pioneer and Shared Savings Program ACOs had higher 
quality care than Medicare FFS providers on measures for which 
comparable data were available. Shared Savings Program patients with 
multiple chronic conditions and with high predicted Medicare spending 
received better quality care than comparable FFS patients.\63\ Between 
the first and third performance periods, Pioneer ACOs improved their 
average quality score from 73 percent to 87 percent. The Shared Savings 
Program ACOs yielded $465 million in savings to the Medicare Trust 
Funds in 2014.\64\
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    \62\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-08-25.html.
    \63\ J.M. McWilliams et al., ``Changes in Patients' Experiences 
in Medicare Accountable Care Organizations.'' New England Journal of 
Medicine 2014; 371:1715-1724, DOI: 10.1056/NEJMsa1406552.
    \64\ The cost savings were for the second year of Shared Savings 
Program implementation and the third year of Pioneer ACO 
implementation. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-08-25.html.
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    Results from the first year of the CPC Initiative indicate that it 
has generated nearly enough savings in Medicare health care 
expenditures to offset care management fees paid by CMS. The primary 
sources of the savings were reduced rates of hospital admissions and ED 
visits. The bulk of the savings was generated by patients in the 
highest-risk quartile, but favorable results were also seen in other 
patients. Over 90 percent of practices successfully met all first-year 
transformation requirements. The expenditure impact estimates differ 
across the seven regions. Additional time and data are needed to assess 
impact on care quality. The results from the first year of the CPC 
Initiative should be interpreted cautiously as effects are emerging 
earlier than anticipated, and additional research is needed to assess 
how the initiative affects cost and quality of care beyond the first 
year. Because the effects of the CPC Initiative are likely to be larger 
in subsequent years, these early results suggest it is likely the model 
will eventually break even or generate savings.\65\
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    \65\ https://blog.cms.gov/2015/01/23/moving-forward-on-primary-care-transformation/. For more detail see https://innovation.cms.gov/files/reports/cpci-evalrpt1.pdf.
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    Basing payment in part on performance metrics is still an evolving 
art and, as discussed throughout this preamble, there are multiple 
variables and as yet no definitive answers as to what combinations of 
measures, benchmarks, and other variables will achieve the best results 
over time. Accordingly, we are unable at this time to provide specific 
dollar estimates of these benefits and cost reductions.

E. Impact on Other Health Care Programs and Providers

    The MIPS is aimed at Medicare FFS physicians and other clinicians 
paid under the PFS. These physicians and other clinicians are almost 
all engaged in serving patients covered by other payers as well. 
Because Medicare covers only about one in seven persons (though a 
considerably higher share of total healthcare spending, since older 
persons incur far higher expenses on average than younger persons), for 
most of those services that will be subject to MIPS payment 
adjustments, Medicare provides only a fraction of practice revenues. 
Moreover, it is unlikely that many insurance payers will adopt MIPS or 
MIPS-like payment models in the short run. Hence, MIPS incentives are 
necessarily attenuated. On the other hand, changing practices for one 
group of patients will possibly lead to changes for other patients (for 
example, EHR systems are almost always used for all patients served by 
a physician). Physicians and other clinicians may find it simpler and 
more efficient to adopt clinical practice improvements for all 
patients, regardless of payer, in response to the Quality Payment 
Program's incentives, through the use of both MIPS measures and 
activities and APMs. Furthermore, since the Quality Payment Program 
eventually rewards participation in APMs based on services furnished to 
patients beyond those in Medicare, other payers may start to develop 
more models in which clinicians and patients can participate. Hence, 
there are likely to be beneficial effects on a far broader range of 
patients in the health care system than simply Medicare patients, and 
we believe those effects would include improved health care quality and 
lower costs over time. However, we have no basis at this time for 
quantifying such effects.
    We note that large proportions of the Medicare and Medicaid 
programs are already delivered through capitated insurance payments to 
HMOs, PPOs, and related organizations. The Medicare Advantage Plans and 
related State programs therefore already have substantial incentives to 
improve quality and reduce costs. MIPS does not affect provider 
payments under those programs directly, which have their own 
reimbursement mechanisms for physicians and other clinicians. In many 
but not all cases, those insurance carriers do use incentive mechanisms 
that are similar in purpose and design to the kinds of APMs that we 
expect will arise under the new payment adjustments. We would not 
expect major near-term changes in HMO and PPO payment arrangements, or 
performance, from any MIPS or APM spillover effects. Regardless, we 
have no basis at this time for quantifying any such effects.
    There are other potentially affected provider entities, including 
hospitals, skilled nursing facilities, CAHs (largely small rural 
hospitals), and providers serving unique populations, such as providers 
of tribal health care services. In none of these cases do we believe 
that MIPS would have significant effects on substantial numbers of 
providers. But to the extent that MIPS and increasing participation in 
APMs over time succeed in improving quality and reducing costs, there 
may be some beneficial effects not only on patients but also on some 
providers.
    As noted previously in this section of the final rule with comment 
period, and as discussed in this subsection, we have concluded that 
financial effects on either directly or indirectly affected small 
entities, including rural hospitals, will be minimal. We welcomed 
comments on these conclusions.
    The following is summary of the comments we received regarding the 
financial effects on either directly or indirectly affected small 
entities, including rural hospitals.

[[Page 77534]]

    Comment: Many commenters expressed concerns that the proposed rule 
would have negative financial consequences on small or solo practices, 
practices in rural and medically underserved areas, small hospital 
systems, primary care practices, and practices treating medically 
complex patients. Several commenters recommended policies to address 
the disparate effect on small and solo practices.
    Response: As noted above, in response to many public comments, we 
implemented several policy changes that reduced the impact of this 
final rule with comment period on small and solo practices, including 
modifying the low-volume threshold to reduce the burden for small and 
solo practices. Further, this final rule with comment period's scoring 
provisions are designed to encourage participation, incentivize 
continuous improvement, and move participants on a glide path to 
improved health care delivery in the quality payment program. The RIA 
has been modified to reflect these policy changes, and shows that this 
final rule with comment period does not have disparate effects of small 
and solo practices that participate in reporting.
    Comment: Several commenters were concerned that the negative 
effects of small/solo practices would be discriminatory against racial/
ethnic minority physicians or racial/ethnic minority/patients. One 
commenter noted that Hispanic physicians were more likely to be in 
small and solo practices, and Hispanic and non-English speaking 
patients were more likely to be treated for small and solo practices, 
and recommended that small and solo practices be protected for their 
diversity value. Further, one commenter stated the rule would have a 
negative impact on inner city clinics and lower-income patients.
    Response: As noted above, we implemented several policy changes 
designed to address the commenters' concerns. The RIA has been modified 
to reflect these policy changes, and our modeling shows that the rule 
does not have disparate effects of small and solo practices that 
participate in reporting.
    Comment: Many commenters believed that the rule was 
administratively complex and confusing, and increased administrative 
burden for clinicians, especially small and solo practices, and rural 
practices, including hospitals.
    Response: We have taken numerous steps to simplify the Quality 
Payment Program, particularly for the transition. For example, as 
discussed in II.E.5.f.(3) and II.E.5.g.(6) of this final rule with 
comment period, the advancing care information and improvement 
activities performance category reporting requirements have been 
simplified between the proposed and final rule with comment period. We 
do not believe, however, that our general discussion of the potential 
costs of implementing the rule need further modification.
    Comment: Several commenters expressed concerns about the increased 
administrative costs and potential detrimental effects to IHS and 
Tribal providers. Several commenters requested clarification on the 
extent to which the proposed rule requirements would affect IHS and 
tribal providers. Two commenters requested clarification on the extent 
to which the RIA tables included IHS and tribal providers, and 
requested further analyses if they were not included. Several 
commenters recommended provisions to limit any detrimental impact to 
IHS and tribal providers including: Excluding them from MIPS, accepting 
the measures they report to other programs, technical assistance, 
separate benchmarks, and non-putative approaches to compliance.
    Response: As we stated in the proposed rule, we continue to believe 
that the Quality Payment Program will not have significant effects on 
substantial numbers of providers of tribal health care services. 
Because the data used for our scoring model does not identify tribal 
and IHS providers, we are unable to estimate the amount of MIPS 
payments for those providers. While tribal and IHS provided care is not 
covered under MACRA, physicians working in tribal or IHS health 
facilities may be eligible for MACRA if they treat Medicare 
beneficiaries. However, we believe the number of IHS and tribal 
providers that will be covered under MACRA will be small, especially 
because many of those clinicians will not exceed the low-volume 
threshold. We will consider whether we should adopt any policies aimed 
specifically at IHS and other tribal providers in the future.
    We will consider whether we should adopt any policies aimed 
specifically at IHS and other tribal providers in the future.
    Comment: Many commenters noted the high cost of implementing EHRs 
and Health IT, particularly for small, solo, or rural clinicians. 
Several commenters noted that Medicare does not reimburse physicians 
for the time required to implement or use EHRs and other Health IT. 
Several commenters noted their practices had spent large amounts of 
money to comply with the previous EHR Incentive Program requirements, 
and expressed frustration that they needed to spend additional funds to 
comply with the new requirements.
    Response: As we noted in the CY 2012 PFS final rule (76 FR 73464), 
we believe some eligible clinicians will incur costs associated with 
purchasing an EHR product if they have not purchased them already. 
However, we do not believe that the majority of eligible clinicians 
will purchase an EHR solely for the purpose of participating in MIPS.
    We understand commenters' concerns about the costs of purchasing 
and implementing EHR systems in order to participate in MIPS. In 
response to public comments, we have further simplified the advancing 
care information reporting requirement and modified the low-volume 
threshold to exclude more small and solo clinicians with few encounters 
and low Medicare allowed costs.
    In summary, we received many comments about the potential impacts 
of the rule on small, solo, or rural clinicians. In response to many 
comments, we modified the low-volume threshold to increase the number 
of small, solo, and rural clinicians exempt from MIPS requirements. 
Further, as a result of comments, we have decided to finalize policies 
throughout the rule, which will focus the Quality Payment Program in 
its transition year on encouraging participation and educating 
clinicians while minimizing the risks for negative MIPS payment 
adjustment. The transition year policies will create a ramp to more 
robust participation in future years. The policy changes are reflected 
in the RIA estimates, which show that the risk for negative MIPS 
payment adjustment is minimal for MIPS eligible clinicians, including 
small and solo practices that participate.

F. Alternatives Considered

    This final rule with comment period contains a range of policies, 
including many provisions related to specific statutory provisions. The 
preceding preamble provides descriptions of the statutory provisions 
that are addressed, identifies those policies where discretion has been 
exercised, presents our rationale for our finalized policies and, where 
relevant, analyzes alternatives that we considered. Although it is hard 
to single out any one alternative for public comment, the proposed rule 
particularly called attention to and requested comments on the 
performance threshold and the level at which it is set for scoring 
purposes under MIPS.
    As described previously, under section 1848(q)(6)(D)(i) of the Act, 
for each year of MIPS, the Secretary shall

[[Page 77535]]

compute a performance threshold with respect to which the final scores 
of MIPS eligible clinicians are compared for purposes of determining 
the MIPS payment adjustment factors under section 1848(q)(6)(A) of the 
Act for a year. The performance threshold for a year must be either the 
mean or median (as selected by the Secretary, which may be reassessed 
every 3 years) of the final scores for all MIPS eligible clinicians for 
a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) 
of the Act outlines a special rule for the initial 2 years of MIPS, 
which requires the Secretary, prior to the performance period for such 
years, to establish a performance threshold for purposes of determining 
the MIPS payment adjustment factors under paragraph (A) and an 
additional performance threshold for purposes of determining the 
additional MIPS payment 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.
    Depending on where the threshold is set within those parameters, 
the proportions and distributions of MIPS eligible clinicians receiving 
payment reductions versus positive payment adjustments can change 
dramatically from our estimates. For example, in Table 60, we estimated 
(based on available data) that 3.7 percent of Colon/Rectal Surgery 
specialists will receive a negative payment adjustment under MIPS. 
Setting the performance threshold at a lower level would enable more 
Colon/Rectal Surgery specialists to avoid negative MIPS payment 
adjustments and potentially qualify for more positive MIPS payment 
adjustments. Conversely, we estimated above that 96.7 percent of 
Interventional Radiology specialists would receive a positive MIPS 
payment adjustment under the current proposal. Setting the performance 
threshold at a higher level would result in fewer Interventional 
Radiology specialists qualifying for positive MIPS payment adjustments, 
and potentially more of them receiving negative MIPS payment 
adjustments. But any payment changes resulting from changes to the 
performance threshold policy will depend primarily on changes to 
practices and other responses from MIPS eligible clinicians.
    The proposed rule requested comment on these alternatives, on all 
previous estimates of effects, and on any other issues or options that 
might improve the substantive effects of the proposed rule, or our 
estimates of those effects. We were particularly interested in comments 
on any aspects of the proposed rule that might inadvertently or 
unintentionally create adverse effects on the delivery of high quality 
and high value health care, and on options that might reduce such 
effects.
    Comments on the alternatives to the proposed performance threshold 
are discussed in section II.E.7.c. of this final rule with comment 
period.

G. Assumptions and Limitations

    We would like to note several limitations to the analyses that 
estimated MIPS eligible clinicians' eligibility, negative MIPS payment 
adjustments, and positive payment adjustments based for the first MIPS 
performance period (2017) based primarily on 2015 data described above:
     The scoring model cannot fully reflect MIPS eligible 
clinicians' behavioral responses to MIPS. The scoring model assumes 
higher participation in MIPS quality reporting than under the PQRS. 
Other potential behavioral responses are not addressed in our scoring 
model. The scoring model assumes that quality measures submitted and 
the distribution of scores on those measures would be similar under the 
transition year as they were under the 2015 PQRS program.
     Limited historical data for two performance categories. 
Because we have limited historical data for the proposed advancing care 
information and improvement activities performance categories, the 
modeled scoring estimates were based solely on quality measures. Our 
scoring model estimates do not include advancing care information or 
improvement activities performance category scores.
     The scoring model does not reflect the growth in Advanced 
APM participation between 2015 and 2017. Due to data limitations, the 
scoring model could only identify clinicians that participated in APMs 
that may have been determined to be Advanced APM in 2015 were they 
operating in 2017. Several new APMs that we anticipate will be Advanced 
APM have been implemented or will be implemented between 2015 and 2017. 
Further, some eligible clinicians will join the successors of APMs 
already in existence in 2015. In contrast to the scoring model, the CMS 
Innovation Center's QP estimates use methods that do reflect projected 
growth in APM participation between 2015 and 2017.
    There are additional limitations to our estimates. To the extent 
that there are year-to-year changes in the data submission, volume and 
mix of services provided by MIPS eligible clinicians, the actual impact 
on total Medicare revenues will be different from those shown in Tables 
60-63. Due the limitations above, there is considerable uncertainty 
around our estimates that is difficult to quantify in detail.

H. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 64 (Accounting 
Statement), we have prepared an accounting statement.
    We have not attempted to quantify the benefits of this rule because 
of the many uncertainties as to both clinician behaviors and resulting 
effects on patient health and cost reductions. For example, the 
applicable percentage for MIPS incentives changes over time, increasing 
from 4 percent in 2019 to 9 percent in 2022 and subsequent years, and 
we are unable to estimate precisely how physicians will respond to the 
increasing incentives. As noted above, in CY 2019, we estimate that we 
will distribute approximately $199 million in payment adjustments on a 
budget-neutral basis, which represents the applicable percent for 2019 
required under section 1848(q)(6)(B)(i) of the Act and excludes $500 
million in exceptional performance payments. In 2020, section 
1848(q)(6)(B)(ii) of the Act specifies that the applicable percent will 
be 5 percent, which we estimate would mean that we will distribute 
approximately $249 million in payment adjustments on a budget-neutral 
basis, ignoring changes in clinical practice, volume growth, inflation, 
or other changes that may affect Medicare physician payments, effects 
of changes in data submission practices, advancing care information 
scores, and innovation activities scores, as well as the $500 million 
in exceptional performance payments. Finally, in 2021, section 
1848(q)(6)(B)(iii) of the Act specifies that the applicable percent 
will be 7 percent, which we estimate would mean that we will distribute 
approximately $435 million in payment adjustments on a budget-neutral 
basis, again ignoring changes in clinical practice, volume growth, 
inflation or other changes that may affect Medicare physician payments, 
as well as the $500 million in exceptional performance payments.
    Further, the addition of new Advanced APMs and growth in Advanced 
APM participation over time will affect the pool of MIPS eligible 
clinicians, and for those that are MIPS eligible clinicians, may change 
their relative performance. The $500 million

[[Page 77536]]

available for exceptional performance and the 5 percent APM Incentive 
Payment for QPs are only available from 2019 through 2024. Beginning in 
2026, payment for services furnished by QPs will receive a higher 
update than for services furnished by non-QPs. However, we are unable 
to estimate the number of QPs in those years, as we cannot project the 
number or types of Advanced APMs that will be made available in those 
years through future CMS initiatives proposed and implemented in those 
years, nor the number of QPs for those future Advanced APMs.
    The percentage of the final score attributable to each performance 
category will change over time, and we will incorporate improvement 
scoring in future years. The Improvement activities category represents 
an entirely new category for measuring MIPS eligible clinicians' 
performance. We may also propose policy changes in future years as we 
continue implementing MIPS and as MIPS eligible clinicians accumulate 
experience with the new system. Moreover, there are interactions 
between the MIPS and APM incentive programs and other shared savings 
and incentive programs that we cannot model or project. Nonetheless, 
even if ultimate savings and health benefits represent only low 
fractions of current experience, benefits are likely to be substantial 
in overall magnitude.
    Table 64 includes our estimate for MIPS payment adjustments ($199 
million), the exceptional performance payments under MIPS ($500 
million), and incentive payments to QPs (using the range described in 
the preceding analysis, approximately $333-$571 million). However, of 
these three elements, only the negative MIPS payment adjustments are 
shown as estimated decreases.
---------------------------------------------------------------------------

    \66\ A range of estimates is provided due to uncertainty about 
the number of Advanced APM participants that will meet the QP 
threshold in 2016.

                     Table 64--Accounting Statement
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers.  Estimated increase of between
                                          $1,032 and $1,270 million in
                                          payments for higher
                                          performance under MIPS and to
                                          QPs.\66\
From Whom to Whom?.....................  Increased Federal Government
                                          payments to physicians, other
                                          practitioners and suppliers
                                          who receive payment under the
                                          Medicare Physician Fee
                                          Schedule.
CY 2019 Annualized Monetized Transfers.  Estimated decrease of $199
                                          million for lower performance
                                          under MIPS.
From Whom to Whom?.....................  Reduced Federal Government
                                          payments to physicians, other
                                          practitioners and suppliers
                                          who receive payment under the
                                          Medicare Physician Fee
                                          Schedule.
------------------------------------------------------------------------
Note: These estimates are identical under both a 7 percent and 3 percent
  discount rate.

    We received three comments in response to the estimated federal 
costs of implementing the rule in Table 64.
    Based on National Health Expenditure data,\67\ total Medicare 
expenditures for physician and clinical services in 2014 reached $138.4 
billion. Expenditures for physician and clinical services from all 
sources reached $603.7 billion. Table 60 shows that the aggregate 
negative MIPS payment adjustment for all MIPS eligible clinicians under 
MIPS is estimated at $199 million, which represents less than 0.2 
percent of Medicare payments for physician and clinical services and 
less than 0.1 percent of payments for physician and clinician services 
from all sources. Table 60 also shows that the aggregate positive 
payment adjustment for MIPS eligible clinicians under MIPS is estimated 
at $699 million (including additional MIPS payment adjustments for 
exceptional performance), which represents less than 1 percent of 
Medicare expenditures for physician and clinician services and 0.2 
percent of expenditures from all sources for physician and clinical 
services.
---------------------------------------------------------------------------

    \67\ Physicians and Clinical Services Expenditures, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.
---------------------------------------------------------------------------

    Comment: One commenter requested that the government provide an 
estimate of its costs to implement the rule.
    Response: Supporting Statement A of this rule's Paperwork Reduction 
Act package has a discussion of the cost to the government of 
implementing the rule. Hence, no revisions were made to the accounting 
table as result of this comment.
    Comment: Two commenters noted the administrative complexity of 
meeting both federal Medicare and state Medicaid administrative 
requirements for dually eligible beneficiaries, those commenters 
requested that CMS factor dually eligible beneficiaries into its 
thinking about the timing of the MIPS and requested that CMS provide 
guidance to states on implementing the Quality Payment Program.
    Response: We intend to work with the states during the MIPS' 
implementation, and will consider commenters' suggestions about 
policies with respect to dually-eligible beneficiaries in the future. 
No revisions were made to the accounting table as result of this 
comment.
    In summary, after considering comments on government costs, no 
changes were made to the accounting table.

List of Subjects

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Kidney diseases, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Health professions, Health records, 
Medicaid, Medicare, Penalties, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
1. The authority citation for part 414 continues to read as follows:

    Authority:  Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

[[Page 77537]]

Sec.  414.90   [Amended]

0
2. In Sec.  414.90--
0
a. Amend paragraph (e) introductory text by removing the phrase ``and 
subsequent years'' and adding in its place the phrase ``through 2018''; 
and
0
b. Amend paragraph (e)(1)(ii) by removing the phrase ``and each 
subsequent year'' and adding in its place the phrase ``through 2018''.
0
3. Subpart O is added to part 414 to read as follows:
Subpart O--Merit-Based Incentive Payment System and Alternative Payment 
Model Incentive
Sec.
414.1300 Basis and scope.
414.1305 Definitions.
414.1310 Applicability.
414.1315 [Reserved]
414.1320 MIPS performance period.
414.1325 Data submission requirements.
414.1330 Quality performance category.
414.1335 Data submission criteria for the quality performance 
category.
414.1340 Data completeness criteria for the quality performance 
category.
414.1350 Cost performance category.
414.1355 Improvement activities performance category.
414.1360 Data submission criteria for the improvement activities 
performance category.
414.1365 Subcategories for the improvement activities performance 
category.
414.1370 APM scoring standard under MIPS.
414.1375 Advancing care information performance category.
414.1380 Scoring.
414.1385 Targeted review and review limitations.
414.1390 Data validation and auditing.
414.1395 Public reporting.
414.1400 Third party data submission.
414.1405 Payment.
414.1410 Advanced APM determination.
414.1415 Advanced APM criteria.
414.1420 Other payer advanced APMs.
414.1425 Qualifying APM participant determination: In general.
414.1430 Qualifying APM participant determination: QP and partial QP 
thresholds.
414.1435 Qualifying APM participant determination: Medicare option.
414.1440 Qualifying APM participant determination: All-payer 
combination option.
414.1445 Identification of other payer advanced APMs.
414.1450 APM incentive payment.
414.1455 Limitation on review.
414.1460 Monitoring and program integrity.
414.1465 Physician-focused payment models.

Subpart O--Merit-Based Incentive Payment System and Alternative 
Payment Model Incentive


Sec.  414.1300  Basis and scope.

    (a) Basis. This subpart implements the following provisions of the 
Act:
    (1) Section 1833(z)--Incentive Payments for Participation in 
Eligible Alternative Payment Models.
    (2) Section 1848(a)--Payment for Physicians' Services Based on Fee 
Schedule.
    (3) Section 1848(k)--Quality Reporting System.
    (4) Section 1848(q)--Merit-based Incentive Payment System.
    (b) Scope. This subpart part sets forth the following:
    (1) The circumstances under which eligible clinicians are not 
considered MIPS eligible clinicians with respect to a year.
    (2) How individual MIPS eligible clinicians can have their 
performance assessed as a group.
    (3) The data submission methods and data submission criteria for 
each of the MIPS performance categories.
    (4) Methods for calculating a performance category score for each 
of the MIPS performance categories.
    (5) Methods for calculating a MIPS final score and applying the 
MIPS payment adjustment to MIPS eligible clinicians.
    (6) Requirements for an APM to be designated an ``Advanced APM.''
    (7) Methods for eligible clinicians and entities participating in 
Advanced APMs to meet the participation thresholds to become Qualifying 
APM Participants (QPs) and Partial QPs.
    (8) Methods and processes for counting participation in Other Payer 
Advanced APMs in making QP and Partial QP determinations.
    (9) Methods for calculating and paying the APM Incentive Payment to 
QPs.
    (10) Criteria for Physician-Focused Payment Models (PFPMs).


Sec.  414.1305  Definitions.

    As used in this section, unless otherwise indicated--
    Additional performance threshold means the numerical threshold for 
a MIPS payment year against which the final scores of MIPS eligible 
clinicians are compared to determine the additional MIPS payment 
adjustment factors for exceptional performance.
    Advanced Alternative Payment Model (Advanced APM) means an APM that 
CMS determines meets the criteria set forth in Sec.  414.1415.
    Advanced APM Entity means an APM Entity that participates in an 
Advanced APM or Other Payer Advanced APM.
    Affiliated practitioner means an eligible clinician identified by a 
unique APM participant identifier on a CMS-maintained list who has a 
contractual relationship with the Advanced APM Entity for the purposes 
of supporting the Advanced APM Entity's quality or cost goals under the 
Advanced APM.
    Affiliated practitioner list means the list of Affiliated 
Practitioners of an APM Entity that is compiled from a CMS-maintained 
list.
    Alternative Payment Model (APM) means any of the following:
    (1) A model under section 1115A of the Act (other than a health 
care innovation award).
    (2) The shared savings program under section 1899 of the Act.
    (3) A demonstration under section 1866C of the Act.
    (4) A demonstration required by Federal law.
    APM Entity means an entity that participates in an APM or payment 
arrangement with a non-Medicare payer through a direct agreement or 
through Federal or State law or regulation.
    APM Entity group means the group of eligible clinicians 
participating in an APM Entity, as identified by a combination of the 
APM identifier, APM Entity identifier, Taxpayer Identification Number 
(TIN), and National Provider Identifier (NPI) for each participating 
eligible clinician.
    APM Incentive Payment means the lump sum incentive payment for a 
year paid to an eligible clinician who is a QP for the year from 2019 
through 2024.
    Attestation means a secure mechanism, specified by CMS, with 
respect to a particular performance period, whereby a MIPS eligible 
clinician or group may submit the required data for the advancing care 
information or the improvement activities performance categories of 
MIPS in a manner specified by CMS.
    Attributed beneficiary means a beneficiary attributed to the 
Advanced APM Entity under the terms of the Advanced APM or Other Payer 
Advanced APM and listed as an attributed beneficiary on the latest 
available list of attributed beneficiaries at the time of a QP 
determination.
    Attribution-eligible beneficiary means a beneficiary who during the 
QP Performance Period:
    (1) Is not enrolled in Medicare Advantage or a Medicare cost plan;
    (2) Does not have Medicare as a secondary payer;
    (3) Is enrolled in both Medicare Parts A and B;
    (4) Is at least 18 years of age;
    (5) Is a United States resident; and
    (6) Has a minimum of one claim for evaluation and management 
services

[[Page 77538]]

furnished by an eligible clinician who is in the APM Entity for any 
period during the QP Performance Period or, for an Advanced APM that 
does not base attribution on evaluation and management services and for 
which attributed beneficiaries are not a subset of the attribution-
eligible beneficiary population based on the requirement to have at 
least one claim for evaluation and management services furnished by an 
eligible clinician who is in the APM Entity for any period during the 
QP Performance Period, the attribution basis determined by CMS based 
upon the methodology the Advanced APM uses for attribution, which may 
include a combination of evaluation and management and/or other 
services.
    Certified Electronic Health Record Technology (CEHRT) means the 
following:
    (1) For any calendar year before 2018, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets one of the following:
    (i) The 2014 Edition Base EHR definition (as defined at 45 CFR 
170.102) and that has been certified to the certification criteria that 
are necessary to report on applicable objectives and measures specified 
for the MIPS advancing care information performance category, including 
the applicable measure calculation certification criterion at 45 CFR 
170.314(g)(1) or (2) for all certification criteria that support an 
objective with a percentage-based measure.
    (ii) Certification to--
    (A) The following certification criteria:
    (1) CPOE at--
    (i) 45 CFR 170.314(a)(1), (18), (19) or (20); or
    (ii) 45 CFR 170.315(a)(1), (2) or (3).
    (2)(i) Record demographics at 45 CFR 170.314(a)(3); or
    (ii) 45 CFR 170.315(a)(5).
    (3)(i) Problem list at 45 CFR 170.314(a)(5); or
    (ii) 45 CFR 170.315(a)(6).
    (4)(i) Medication list at 45 CFR 170.314(a)(6); or
    (ii) 45 CFR 170.315(a)(7).
    (5)(i) Medication allergy list 45 CFR 170.314(a)(7); or
    (ii) 45 CFR 170.315(a)(8).
    (6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or
    (ii) 45 CFR 170.315(a)(9).
    (7) Health information exchange at transitions of care at one of 
the following:
    (i) 45 CFR 170.314(b)(1) and (2).
    (ii) 45 CFR 170.314(b)(1), (b)(2), and (h)(1).
    (iii) 45 CFR 170.314(b)(1), (b)(2), and (b)(8).
    (iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and (h)(1).
    (v) 45 CFR 170.314(b)(8) and (h)(1).
    (vi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(h)(2).
    (vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(h)(2).
    (viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(h)(2).
    (ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(h)(2).
    (x) 45 CFR 170.314(b)(8), (h)(1), and 170.315(h)(2).
    (xi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(b)(1).
    (xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(b)(1).
    (xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(b)(1).
    (xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(b)(1).
    (xv) 45 CFR 170.314(b)(8), (h)(1), and 170.315(b)(1).
    (xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(1).
    (xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(2).
    (xviii) 45 CFR 170.314(h)(1) and 170.315(b)(1).
    (xix) 45 CFR 170.315(b)(1) and (h)(1).
    (xx) 45 CFR 170.315(b)(1) and (h)(2).
    (xxi) 45 CFR 170.315(b)(1), (h)(1), and (h)(2); and
    (B) Clinical quality measures at--
    (1) 45 CFR 170.314(c)(1) or 170.315(c)(1);
    (2) 45 CFR 170.314(c)(2) or 170.315(c)(2);
    (3) Clinical quality measure certification criteria that support 
the calculation and reporting of clinical quality measures at 45 CFR 
170.314(c)(2) and (3) and optionally (4); or 45 CFR 170.315(c)(3)(i) 
and (ii) and optionally (c)(4); and can be electronically accepted by 
CMS if the data is submitted electronically.
    (C) Privacy and security at--
    (1) 45 CFR 170.314(d)(1) or 170.315(d)(1);
    (2) 45 CFR 170.314(d)(2) or 170.315(d)(2);
    (3) 45 CFR 170.314(d)(3) or 170.315(d)(3);
    (4) 45 CFR 170.314(d)(4) or 170.315(d)(4);
    (5) 45 CFR 170.314(d)(5) or 170.315(d)(5);
    (6) 45 CFR 170.314(d)(6) or 170.315(d)(6);
    (7) 45 CFR 170.314(d)(7) or 170.315(d)(7);
    (8) 45 CFR 170.314(d)(8) or 170.315(d)(8); and
    (D) The certification criteria that are necessary to report on 
applicable objectives and measures specified for the MIPS advancing 
care information performance category, including the applicable measure 
calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 
45 CFR 170.315(g)(1) or (2) for all certification criteria that support 
an objective with a percentage-based measure.
    (iii) The definition for 2018 and subsequent years specified in 
paragraph (2) of this definition.
    (2) For 2018 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition 
(as defined at 45 CFR 170.102) and has been certified to the 2015 
Edition health IT certification criteria--
    (i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 
170.315(e)(3) (patient health information capture); and
    (ii) Necessary to report on applicable objectives and measures 
specified for the MIPS advancing care information performance category 
including the following:
    (A) The applicable measure calculation certification criterion at 
45 CFR 170.315(g)(1) or (2) for all certification criteria that support 
an objective with a percentage-based measure.
    (B) Clinical quality measure certification criteria that support 
the calculation and reporting of clinical quality measures at 45 CFR 
170.315(c)(2) and (c)(3)(i) and (ii) and optionally (c)(4), and can be 
electronically accepted by CMS.
    CMS-approved survey vendor means a survey vendor that is approved 
by CMS for a particular performance period to administer the CAHPS for 
MIPS survey and to transmit survey measures data to CMS.
    CMS Web Interface means a web product developed by CMS that is used 
by groups that have elected to utilize the CMS Web Interface to submit 
data on the MIPS measures and activities.
    Covered professional services has the meaning given by section 
1848(k)(3)(A) of the Act.
    Eligible clinician means ``eligible professional'' as defined in 
section 1848(k)(3) of the Act, as identified by a unique TIN and NPI 
combination and, includes any of the following:
    (1) A physician.
    (2) A practitioner described in section 1842(b)(18)(C) of the Act.
    (3) A physical or occupational therapist or a qualified speech-
language pathologist.
    (4) A qualified audiologist (as defined in section 1861(ll)(3)(B) 
of the Act).

[[Page 77539]]

    Episode payment model means an APM or other payer arrangement 
designed to improve the efficiency and quality of care for an episode 
of care by bundling payment for services furnished to an individual 
over a defined period of time for a specific clinical condition or 
conditions.
    Estimated aggregate payment amounts means the total payments to a 
QP for Medicare Part B covered professional services for the incentive 
payment base period, estimated by CMS as described in Sec.  
414.1450(b).
    Final score means a composite assessment (using a scoring scale of 
0 to 100) for each MIPS eligible clinician for a performance period 
determined using the methodology for assessing the total performance of 
a MIPS eligible clinician according to performance standards for 
applicable measures and activities for each performance category. The 
final score is the sum of each of the products of each performance 
category score and each performance category's assigned weight, 
multiplied by 100.
    Group means a single TIN with two or more eligible clinicians 
(including at least one MIPS eligible clinician), as identified by 
their individual NPI, who have reassigned their billing rights to the 
TIN.
    Health Professional Shortage Areas (HPSA) means areas as designated 
under section 332(a)(1)(A) of the Public Health Service Act.
    High priority measure means an outcome, appropriate use, patient 
safety, efficiency, patient experience, or care coordination quality 
measure.
    Hospital-based MIPS eligible clinician is a MIPS eligible clinician 
who furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the Place of Service codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital or emergency room setting based on claims 
for a period prior to the performance period as specified by CMS.
    Improvement activities means an activity that relevant MIPS 
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.
    Incentive payment base period means the calendar year prior to the 
year in which CMS disburses the APM Incentive Payment.
    Low-volume threshold means an individual MIPS eligible clinician or 
group who, during the low-volume threshold determination period, have 
Medicare Part B allowed charges less than or equal to $30,000 or 
provides care for 100 or fewer Part B-enrolled Medicare beneficiaries.
    Meaningful EHR user for MIPS means a MIPS eligible clinician who 
possesses CEHRT, uses the functionality of CEHRT, 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, supports information exchange and the 
prevention of health information blocking, and engages in activities 
related to supporting providers with the performance of CEHRT.
    Measure benchmark means the level of performance that the MIPS 
eligible clinician is assessed on for a specific performance period at 
the measures and activities level.
    Medicaid APM means a payment arrangement authorized by a State 
Medicaid program that meets the criteria for an Other Payer Advanced 
APM under Sec.  414.1420(a).
    Medical Home Model means an APM under section 1115A of the Act that 
is determined by CMS to have the following characteristics:
    (1) The APM has a primary care focus with participants that 
primarily include primary care practices or multispecialty practices 
that include primary care physicians and practitioners and offer 
primary care services. For the purposes of this provision, primary care 
focus means the inclusion of specific design elements related to 
eligible clinicians practicing under one or more of the following 
Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 
Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 
38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse 
Specialist; and 97 Physician Assistant;
    (2) Empanelment of each patient to a primary clinician; and
    (3) At least four of the following:
    (i) Planned coordination of chronic and preventive care.
    (ii) Patient access and continuity of care.
    (iii) Risk-stratified care management.
    (iv) Coordination of care across the medical neighborhood.
    (v) Patient and caregiver engagement.
    (vi) Shared decision-making.
    (vii) Payment arrangements in addition to, or substituting for, 
fee-for-service payments (for example, shared savings or population-
based payments).
    Medicaid Medical Home Model means a payment arrangement under title 
XIX that CMS determines to have the following characteristics:
    (1) The payment arrangement has a primary care focus with 
participants that primarily include primary care practices or 
multispecialty practices that include primary care physicians and 
practitioners and offer primary care services. For the purposes of this 
provision, primary care focus means the inclusion of specific design 
elements related to eligible clinicians practicing under one or more of 
the following Physician Specialty Codes: 01 General Practice; 08 Family 
Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 
Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 
Clinical Nurse Specialist; and 97 Physician Assistant;
    (2) Empanelment of each patient to a primary clinician; and
    (3) At least four of the following:
    (i) Planned coordination of chronic and preventive care.
    (ii) Patient access and continuity.
    (iii) Risk-stratified care management.
    (iv) Coordination of care across the medical neighborhood.
    (v) Patient and caregiver engagement.
    (vi) Shared decision-making.
    (vii) Payment arrangements in addition to, or substituting for, 
fee-for-service payments (for example, shared savings or population-
based payments).
    Merit-based Incentive Payment System (MIPS) means the program 
required by section 1848(q) of the Act.
    MIPS APM means an APM that meets the criteria specified under Sec.  
414.1370(b).
    MIPS eligible clinician as identified by a unique billing TIN and 
NPI combination used to assess performance, means any of the following 
(excluding those identified at Sec.  414.1310(b)):
    (1) A physician as defined in section 1861(r) of the Act.
    (2) A physician assistant, a nurse practitioner, and clinical nurse 
specialist as such terms are defined in section 1861(aa)(5) of the Act.
    (3) A certified registered nurse anesthetist as defined in section 
1861(bb)(2) of the Act.
    (4) A group that includes such clinicians.
    MIPS payment year means a calendar year in which the MIPS payment 
adjustment factor, and if applicable the additional MIPS payment 
adjustment factor, are applied to Medicare Part B payments.
    New Medicare-Enrolled MIPS eligible clinician means an eligible 
clinician who first becomes a Medicare-enrolled eligible clinician 
within the Provider Enrollment, Chain and Ownership System (PECOS) 
during the performance period for a year and had not previously

[[Page 77540]]

submitted claims under Medicare as an individual, an entity, or a part 
of a physician group or under a different billing number or tax 
identifier.
    Non-patient facing MIPS eligible clinician means an individual MIPS 
eligible clinician that bills 100 or fewer patient facing encounters 
(including Medicare telehealth services defined in section 1834(m) of 
the Act) during the non-patient facing determination period, and a 
group provided that more than 75 percent of the NPIs billing under the 
group's TIN meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period.
    Other Payer Advanced APM means a payment arrangement that meets the 
criteria set forth in Sec.  414.1420.
    Other payer arrangement means a payment arrangement with any payer 
that is not an APM.
    Partial Qualifying APM Participant (Partial QP) means an eligible 
clinician determined by CMS to have met the relevant Partial QP 
threshold under Sec.  414.1430(a)(2) and (4) and (b)(2) and (4) for a 
year.
    Partial QP patient count threshold means the minimum threshold 
score specified in Sec.  414.1430(a)(4) and (b)(4) that an eligible 
clinician must attain through a patient count methodology described in 
Sec. Sec.  414.1435(b) and 414.1440(c) to become a Partial QP for a 
year.
    Partial QP payment amount threshold means the minimum threshold 
score specified in Sec.  414.1430(a)(2) and (b)(2) that an eligible 
clinician must attain through a payment amount methodology described 
Sec. Sec.  414.1435(a) and 414.1440(b) to become a Partial QP for a 
year.
    Participation List means the list of participants in an APM Entity 
that is compiled from a CMS-maintained list.
    Performance category score means 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.
    Performance standards means 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.
    Performance threshold means the numerical threshold for a MIPS 
payment year against which the final scores of MIPS eligible clinicians 
are compared to determine the MIPS payment adjustment factors.
    QP patient count threshold means the minimum threshold score 
specified in Sec.  414.1430(a)(3) and (b)(3) that an eligible clinician 
must attain through a patient count methodology described in Sec. Sec.  
414.1435(b) and 414.1440(c) to become a QP for a year.
    QP payment amount threshold means the minimum threshold score 
specified in Sec.  414.1430(a)(1) and (b)(1) that an eligible clinician 
must attain through the payment amount methodology described in 
Sec. Sec.  414.1435(a) and 414.1440(b) to become a QP for a year.
    QP Performance Period means the time period that CMS will use to 
assess the level of participation by an eligible clinician in Advanced 
APMs and Other Payer Advanced APMs for purposes of making a QP 
determination for the eligible clinician for the year as specified in 
Sec.  414.1425. The QP Performance Period begins on January 1 and ends 
on August 31 of the calendar year that is 2 years prior to the payment 
year.
    Qualified Clinical Data Registry (QCDR) means a CMS-approved entity 
that has self-nominated and successfully completed a qualification 
process to determine whether the entity may collect medical or clinical 
data for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients.
    Qualified registry means a medical registry, a maintenance of 
certification program operated by a specialty body of the American 
Board of Medical Specialties or other data intermediary that, with 
respect to a particular performance period, has self-nominated and 
successfully completed a vetting process (as specified by CMS) to 
demonstrate its compliance with the MIPS qualification requirements 
specified by CMS for that performance period. The registry must have 
the requisite legal authority to submit MIPS data (as specified by CMS) 
on behalf of a MIPS eligible clinician or group to CMS.
    Qualifying APM Participant (QP) means an eligible clinician 
determined by CMS to have met or exceeded the relevant QP payment 
amount or QP patient count threshold under Sec.  414.1430(a)(1), 
(a)(3), (b)(1), or (b)(3) for a year based on participation in an 
Advanced APM Entity.
    Rural areas means clinicians in zip codes designated as rural, 
using the most recent HRSA Area Health Resource File data set 
available.
    Small practices means practices consisting of 15 or fewer 
clinicians and solo practitioners.
    Threshold Score means the percentage value that CMS determines for 
an eligible clinician based on the calculations described in Sec.  
414.1435 or Sec.  414.1440.
    Topped out non-process measure means a measure where the Truncated 
Coefficient of Variation is less than 0.10 and the 75th and 90th 
percentiles are within 2 standard errors.
    Topped out process measure means a measure with a median 
performance rate of 95 percent or higher.


Sec.  414.1310  Applicability.

    (a) Program Implementation. Except as specified in paragraph (b) of 
this section, MIPS applies to payments for items and services furnished 
by MIPS eligible clinicians on or after January 1, 2019.
    (b) Exclusions. (1) For a year, a MIPS eligible clinician does not 
include an eligible clinician who:
    (i) Is a Qualifying APM Participant (as defined at Sec.  414.1305);
    (ii) Is a Partial Qualifying APM Participant (as defined at Sec.  
414.1305) and does not report on applicable measures and activities 
that are required to be reported under MIPS for any given performance 
period in a year; or
    (iii) For the performance period with respect to a year, does not 
exceed the low-volume threshold as defined at Sec.  414.1305.
    (2) Eligible clinicians, as defined at Sec.  414.1305, who are not 
MIPS eligible clinicians, as defined at Sec.  414.1305, have the option 
to voluntarily report measures and activities for MIPS.
    (c) Treatment of new Medicare-enrolled eligible clinicians. New 
Medicare-enrolled eligible clinician, as defined at Sec.  414.1305, 
will not be treated as a MIPS eligible clinician until the subsequent 
year and the performance period for such subsequent year.
    (d) Clarification. In no case will a MIPS payment adjustment apply 
to the items and services furnished during a year by individual 
eligible clinicians, as described in paragraphs (b) and (c) of this 
section, who are not MIPS eligible clinicians, including eligible 
clinicians who voluntarily report on applicable measures and activities 
specified under MIPS.
    (e) Requirements for groups. (1) The following way is for 
individual eligible clinicians and individual MIPS eligible clinicians 
to have their performance assessed as a group:
    (i) As part of a single TIN associated with two or more eligible 
clinicians (including at least one MIPS eligible clinician), as 
identified by a NPI, that

[[Page 77541]]

have their Medicare billing rights reassigned to the TIN.
    (ii) [Reserved]
    (2) A group must meet the definition of a group at all times during 
the performance period for the MIPS payment year in order to have its 
performance assessed as a group.
    (3) Eligible clinicians and MIPS eligible clinicians within a group 
must aggregate their performance data across the TIN in order for their 
performance to be assessed as a group.
    (4) A group that elects to have its performance assessed as a group 
will be assessed as a group across all four MIPS performance 
categories.
    (5) A group must adhere to an election process established and 
required by CMS.


Sec.  414.1315   [Reserved]


Sec.  414.1320   MIPS performance period.

    (a) For purposes of the 2019 MIPS payment year, the performance 
period for all performance categories and submission mechanisms except 
for the cost performance category and data for the quality performance 
category reported through the CMS Web Interface, for the CAHPS for MIPS 
survey, and for the all-cause hospital readmission measure, is a 
minimum of a continuous 90-day period within CY 2017, up to and 
including the full CY 2017 (January 1, 2017 through December 31, 2017). 
For purposes of the 2019 MIPS payment year, for data reported through 
the CMS Web Interface or the CAHPS for MIPS survey and administrative 
claims-based cost and quality measures, the performance period under 
MIPS is CY 2017 (January 1, 2017 through December 31, 2017).
    (b) For purposes of the 2020 MIPS payment year, the performance 
period for:
    (1) The quality and cost performance categories is CY 2018 (January 
1, 2018 through December 31, 2018).
    (2) The advancing care information and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2018, up to and including the full CY 2018 (January 1, 2018 
through December 31, 2018).


Sec.  414.1325  Data submission requirements.

    (a) Data submission performance categories. MIPS eligible 
clinicians and groups must submit measures, objectives, and activities 
for the quality, improvement activities, and advancing care information 
performance categories.
    (b) Data submission mechanisms for individual eligible clinicians. 
An individual MIPS eligible clinician may elect to submit their MIPS 
data using:
    (1) A qualified registry for the quality, improvement activities, 
or advancing care information performance categories;
    (2) The EHR submission mechanism (which includes submission of data 
by health IT vendors or other authorized providers on behalf of MIPS 
eligible clinicians) for the quality, improvement activities, or 
advancing care information performance categories;
    (3) A QCDR for the quality, improvement activities, or advancing 
care information performance categories;
    (4) Medicare Part B claims for the quality performance category; or
    (5) Attestation for the improvement activities and advancing care 
information performance categories.
    (c) Data submission mechanisms for groups that are not reporting 
through an APM. Groups may submit their MIPS data using:
    (1) A qualified registry for the quality, improvement activities, 
or advancing care information performance categories;
    (2) The EHR submission mechanism (which includes the submission of 
data by health IT vendors on behalf of groups) for the quality, 
improvement activities, or advancing care information performance 
categories;
    (3) A QCDR for the quality, improvement activities, or advancing 
care information performance categories;
    (4) A CMS Web Interface (for groups comprised of at least 25 MIPS 
eligible clinicians) for the quality, improvement activities, and 
advancing care information performance categories;
    (5) Attestation for the improvement activities and advancing care 
information performance categories; or
    (6) A CMS-approved survey vendor for groups that elect to include 
the CAHPS for MIPS survey as a quality measure. Groups that elect to 
include the CAHPS for MIPS survey as a quality measure must select one 
of the above data submission mechanisms to submit their other quality 
information.
    (d) Requirement to use only one submission mechanism per 
performance category. Except as described in paragraph (c)(6) of this 
section, 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.
    (e) No data submission requirements for the cost performance 
category and certain quality measures. There are no data submission 
requirements for the cost performance category and for certain quality 
measures used to assess performance in the quality performance 
category. CMS will calculate performance on these measures using 
administrative claims data.
    (f) Data submission deadlines for all submission mechanisms for 
individual eligible clinicians and groups for all performance 
categories. The submission deadlines are:
    (1) For the qualified registry, QCDR, EHR, and attestation 
submission mechanisms are March 31 following the close of the 
performance period.
    (2) For Medicare Part B claims, data must be submitted on claims 
with dates of service during the performance period that must be 
processed no later than 60 days following the close of the performance 
period.
    (3) For the CMS Web Interface, data must be submitted during an 8-
week period following the close of the performance period. The period 
must begin no earlier than January 2 and end no later than March 31.


Sec.  414.1330  Quality performance category.

    (a) For purposes of assessing performance of MIPS eligible 
clinicians on the quality performance category, CMS will use:
    (1) Quality measures included in the MIPS final list of quality 
measures.
    (2) Quality measures used by QCDRs.
    (b) Subject to CMS's authority to reweight performance category 
weights under section 1848(q)(5)(F) of the Act, performance in the 
quality performance category will comprise:
    (1) 60 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2019.
    (2) 50 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 30 percent of a MIPS eligible clinician's final score for each 
MIPS payment year thereafter.


Sec.  414.1335  Data submission criteria for the quality performance 
category.

    (a) Criteria. A MIPS eligible clinician or group must submit data 
on MIPS quality measures in one of the following manners, as 
applicable:
    (1) Via claims, qualified registry, EHR or QCDR submission 
mechanism. For the performance period--
    (i) Submit data on at least six measures including at least one 
outcome measure. If an applicable outcome measure is not available, 
report one other high priority measure (appropriate use, patient 
safety, efficiency, patient experience, and care coordination 
measures). If fewer than six measures apply to the MIPS eligible 
clinician or

[[Page 77542]]

group, report on each measure that is applicable.
    (ii) Subject to paragraph (a)(1)(i) of this section, MIPS eligible 
clinicians and groups can either select their measures from the 
complete MIPS final measure list or a subset of that list, MIPS 
specialty-specific measure sets, as designated by CMS.
    (2) Via the CMS Web Interface--for groups only. For the 12-month 
performance period-
    (i) For a group of 25 or more MIPS eligible clinicians, report on 
all measures included in the CMS Web Interface. The group must report 
on the first 248 consecutively ranked beneficiaries in the sample for 
each measure or module.
    (ii) If the sample of eligible assigned beneficiaries is less than 
248, then the group must report on 100 percent of assigned 
beneficiaries. In some instances, the sampling methodology will not be 
able to assign at least 248 patients on which a group may report, 
particularly those groups on the smaller end of the range of 25-99 MIPS 
eligible clinicians.
    (iii) The group is required to report on at least one measure for 
which there is Medicare patient data.
    (iv) Groups reporting via the CMS Web Interface are required to 
report on all of the measures in the set.
    (3) Via CMS-approved survey vendor for CAHPS for MIPS survey- for 
groups only. (i) For the 12-month performance period, a group that 
wishes to voluntarily elect to participate in the CAHPS for MIPS survey 
measures must use a survey vendor that is approved by CMS for a 
particular performance period to transmit survey measures data to CMS.
    (A) The CAHPS for MIPS survey counts for one measure towards the 
MIPS quality performance category and, as a patient experience measure, 
also fulfills the requirement to report at least one high priority 
measure in the absence of an applicable outcome measure.
    (B) Groups that elect this data submission mechanism must select an 
additional group data submission mechanism in order to meet the data 
submission criteria for the MIPS quality performance category.
    (ii) [Reserved]
    (b) [Reserved]


Sec.  414.1340  Data completeness criteria for the quality performance 
category.

    (a) MIPS eligible clinicians and groups submitting quality measures 
data using the QCDR, qualified registry, or EHR submission mechanism 
must submit data on:
    (1) At least 50 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment year 2019.
    (2) At least 60 percent of the MIPS eligible clinician or group's 
patients that meet the measure's denominator criteria, regardless of 
payer for MIPS payment year 2020.
    (b) MIPS eligible clinicians submitting quality measures data using 
Medicare Part B claims, must submit data on:
    (1) At least 50 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment year 2019.
    (2) At least 60 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment year 2020.
    (c) Groups submitting quality measures data using the CMS Web 
Interface or a CMS-approved survey vendor to submit the CAHPS for MIPS 
survey must meet the data submission requirement on the sample of the 
Medicare Part B patients CMS provides.


Sec.  414.1350  Cost performance category.

    (a) For purposes of assessing performance of MIPS eligible 
clinicians on the cost performance category, CMS specifies cost 
measures for a performance period.
    (b) Subject to CMS's authority to reweight performance category 
weights under section 1848(q)(5)(F) of the Act, performance in the cost 
performance category comprises:
    (1) 0 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2019.
    (2) 10 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 30 percent of a MIPS eligible clinician's final score for each 
MIPS payment year thereafter.


Sec.  414.1355  Improvement activities performance category.

    (a) For purposes of assessing performance of MIPS eligible 
clinicians on the improvement activities performance category, CMS 
specifies an inventory of measures and activities for a performance 
period.
    (b) Subject to CMS's authority to reweight performance category 
weights under section 1848(q)(5)(F) of the Act, performance in the 
improvement activities performance category comprises:
    (1) 15 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2019 and for each MIPS payment year thereafter.
    (2) [Reserved].
    (c) For purposes of assessing performance of MIPS eligible 
clinicians on the improvement activities performance category, CMS uses 
activities included in the improvement activities inventory established 
by CMS through rulemaking.


Sec.  414.1360  Data submission criteria for the improvement activities 
performance category.

    (a) MIPS eligible clinicians must submit data on MIPS improvement 
activities in one of the following manners:
    (1) Via qualified registry, EHR submission mechanisms, QCDR, CMS 
Web Interface or Attestation. For activities that are performed for at 
least a continuous 90-days during the performance period, MIPS eligible 
clinicians must--
    (i) Submit a yes response for activities within the improvement 
activities inventory.
    (ii) [Reserved]
    (2) [Reserved]
    (b) [Reserved]


Sec.  414.1365  Subcategories for the improvement activities 
performance category.

    (a) The following are the list of subcategories, of which, with the 
exception of Participation in an APM, include activities for selection 
by a MIPS eligible clinician or group:
    (1) Expanded practice access, such as same day appointments for 
urgent needs and after-hours access to clinician advice.
    (2) Population management, such as monitoring health conditions of 
individuals to provide timely health care interventions or 
participation in a QCDR.
    (3) Care coordination, such as timely communication of test 
results, timely exchange of clinical information to patients or other 
clinicians, and use of remote monitoring or telehealth.
    (4) Beneficiary engagement, such as the establishment of care plans 
for individuals with complex care needs, beneficiary self-management 
assessment and training, and using shared decision-making mechanisms.
    (5) Patient safety and practice assessment, such as through the use 
of clinical or surgical checklists and practice assessments related to 
maintaining certification.
    (6) Participation in an APM.
    (7) Achieving health equity, such as for MIPS eligible clinicians 
that achieve high quality for underserved populations, including 
persons with behavioral health conditions, racial and

[[Page 77543]]

ethnic minorities, sexual and gender minorities, people with 
disabilities, people living in rural areas, and people in geographic 
HPSAs.
    (8) Emergency preparedness and response, such as measuring MIPS 
eligible clinician participation in the Medical Reserve Corps, 
measuring registration in the Emergency System for Advance Registration 
of Volunteer Health Professionals, measuring relevant reserve and 
active duty uniformed services MIPS eligible clinician activities, and 
measuring MIPS eligible clinician volunteer participation in domestic 
or international humanitarian medical relief work.
    (9) Integrated behavioral and mental health, such as measuring or 
evaluating such practices as: Co-location of behavioral health and 
primary care services; shared/integrated behavioral health and primary 
care records; cross-training of MIPS eligible clinicians, and 
integrating behavioral health with primary care to address substance 
use disorders or other behavioral health conditions, as well as 
integrating mental health with primary care.
    (b) [Reserved]


Sec.  414.1370  APM scoring standard under MIPS.

    (a) General. The APM scoring standard is the MIPS scoring 
methodology applicable for MIPS eligible clinicians identified on the 
Participation List for the performance period of an APM Entity 
participating in a MIPS APM.
    (b) Criteria for MIPS APMs. MIPS APMs are those in which:
    (1) APM Entities participate in the APM under an agreement with CMS 
or through a law or regulation;
    (2) The APM is designed such that APM Entities participating in the 
APM include at least one MIPS eligible clinician on a Participation 
List;
    (3) The APM bases payment on cost/utilization and quality measures; 
and
    (4) The APM is not either of the following:
    (i) New APMs. An APM for which the first performance year begins 
after the first day of the MIPS performance period for the year.
    (ii) APM in final year of operation for which the APM scoring 
standard is impracticable. An APM in the final year of operation for 
which CMS determines, within 60 days after the beginning of the MIPS 
performance period for the year, that it is impracticable for APM 
Entity groups to report to MIPS using the APM scoring standard.
    (c) APM scoring standard performance period. The MIPS performance 
period under Sec.  414.1320 applies for the APM scoring standard.
    (d) APM participant identifier. The APM participant identifier for 
an eligible clinician is the combination of four identifiers:
    (1) APM identifier (established for the APM by CMS);
    (2) APM Entity identifier (established for the APM Entity by CMS);
    (3) Medicare-enrolled billing TIN; and
    (4) Eligible clinician NPI.
    (e) APM Entity group determination. The APM Entity group is 
determined in the manner prescribed in Sec.  414.1425(b)(1).
    (f) APM Entity group scoring under the APM scoring standard. The 
MIPS final score calculated for the APM Entity group is applied to each 
MIPS eligible clinician in the APM Entity group. The MIPS payment 
adjustment is applied at the TIN/NPI level for each of the MIPS 
eligible clinicians in the APM Entity group. In the event that a Shared 
Savings Program ACO does not report quality measures as required by the 
Shared Savings Program, the ACO participant TINs will each be 
considered a unique APM Entity for purposes of the APM scoring 
standard.
    (g) MIPS performance category scoring under the APM scoring 
standard--(1) Quality--(i) MIPS APMs that require APM Entities to 
submit quality data using the CMS Web Interface. The MIPS performance 
category score for quality for a performance period will be calculated 
for the APM Entity group using the data submitted for the APM Entity 
through the CMS Web Interface according to the terms of the APM. In the 
event that a Shared Savings Program ACO does not report on quality 
measures as required by the Shared Savings Program, the ACO participant 
TINs must report data for the MIPS quality performance category 
according to the MIPS submission and reporting requirements.
    (ii) [Reserved]
    (2) Cost. The cost performance category weight is zero percent for 
APM Entity groups in MIPS APMs.
    (3) Improvement activities. (i) CMS assigns an improvement 
activities score for each MIPS APM for a performance period based on 
the requirements of the MIPS APM. The assigned improvement activities 
score applies to each APM Entity group in the MIPS APM for the 
performance year. In the event that the assigned score does not 
represent the maximum improvement activities score, APM Entities may 
report additional activities.
    (ii) [Reserved]
    (4) Advancing care information. (i) For APM Entity groups in the 
Shared Savings Program, each ACO participant TIN submits data on the 
advancing care information performance category as specified in Sec.  
414.1375(b) and performance on the advancing care information 
performance category is assessed for the APM Entity group by 
calculating the weighted mean of the TIN level scores, weighted based 
on the number of MIPS eligible clinicians in the TINs as compared to 
the total number of MIPS eligible clinicians in the APM Entity group.
    (ii) For APM Entity groups in MIPS APMs other than the Shared 
Savings Program, CMS uses one score for each MIPS eligible clinician in 
the APM Entity group to derive a single average APM Entity group score 
for advancing care information. The score for each MIPS eligible 
clinician is the higher of either:
    (A) A group score based on the measure data for the advancing care 
information performance category reported by a TIN for the MIPS 
eligible clinician according to the MIPS submission and reporting 
requirements for groups; or
    (B) An individual score based on the measure data for the advancing 
care information performance category reported by the MIPS eligible 
clinician according to the MIPS submission and reporting requirements 
for individuals.
    (h) APM scoring standard performance category weights. The 
performance category weights used to calculate the final score for an 
APM Entity group are:
    (1) Quality. (i) For the Shared Savings Program and other MIPS APMs 
that require APM Entities to submit quality data through the CMS Web 
Interface: 50 percent.
    (ii) For 2017, for MIPS APMs that do not require APM Entities to 
submit quality data through the CMS Web Interface: 0 percent.
    (2) Cost. 0 percent.
    (3) Improvement activities. (i) For the Shared Savings Program and 
other MIPS APMs that require APM Entities to submit quality data 
through the CMS Web Interface: 20 percent.
    (ii) For 2017, for MIPS APMs that do not require APM Entities to 
submit quality data through the CMS Web Interface: 25 percent.
    (4) Advancing care information. (i) For the Shared Savings Program 
and other MIPS APMs that require APM Entities to submit quality data 
through the CMS Web Interface: 30 percent.
    (ii) For 2017, for MIPS APMs that do not require APM Entities to 
submit quality data through the CMS Web Interface: 75 percent.

[[Page 77544]]

Sec.  414.1375  Advancing care information performance category.

    (a) Final score. Subject to CMS's authority to reweight performance 
category weights under section 1848(q)(5)(E)(ii) and (q)(5)(F) of the 
Act, performance in the advancing care information performance category 
will comprise 25 percent of a MIPS eligible clinician's final score for 
MIPS payment year 2019 and each MIPS payment year thereafter.
    (b) Reporting for the advancing care information performance 
category: To earn a performance category score for the advancing care 
information performance category for inclusion in the final score, a 
MIPS eligible clinician must:
    (1) CEHRT. Use CEHRT as defined at Sec.  414.1305 for the 
performance period;
    (2) Report MIPS--advancing care information objectives and 
measures. Report on the objectives and associated measures as specified 
by CMS for the advancing care information performance category for the 
performance period as follows:
    (i) Report the numerator (of at least one) and denominator, or yes/
no statement as applicable, for each required measure; or
    (ii) Report a null value for each required measure that includes a 
null value as an acceptable result in the measure specification.
    (3) Support information exchange and the prevention of health 
information blocking, and engage in activities related to supporting 
providers with the performance of CEHRT. (i) Supporting providers with 
the performance of CEHRT (SPPC). To engage in activities related to 
supporting providers with the performance of CEHRT, the MIPS eligible 
clinician--
    (A) Must attest that he or she:
    (1) Acknowledges the requirement to cooperate in good faith with 
ONC direct review of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC direct review is received; and
    (2) If requested, cooperated in good faith with ONC direct review 
of his or her health information technology 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, including by permitting timely access to 
such technology and demonstrating its capabilities as implemented and 
used by the MIPS eligible clinician in the field.
    (B) Optionally, may also attest that he or she:
    (1) Acknowledges the option to cooperate in good faith with ONC-ACB 
surveillance of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC-ACB surveillance is received; and
    (2) If requested, cooperated in good faith with ONC-ACB 
surveillance of his or her health information technology 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, including by permitting 
timely access to such technology and demonstrating its capabilities as 
implemented and used by the MIPS eligible clinician in the field.
    (ii) Support for health information exchange and the prevention of 
information blocking. The MIPS eligible clinician must attest to CMS 
that he or she--
    (A) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (B) 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--
    (1) Connected in accordance with applicable law;
    (2) Compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, 
and certification criteria adopted at 45 CFR part 170;
    (3) Implemented in a manner that allowed for timely access by 
patients to their electronic health information; and
    (4) 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 health IT vendors.
    (C) 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.


Sec.  414.1380  Scoring.

    (a) General. MIPS eligible clinicians are scored under MIPS based 
on their performance on measures and activities in four performance 
categories. MIPS eligible clinicians are scored against performance 
standards for each performance category and receive a final score, 
composed of their scores on individual measures and activities, and 
calculated according to the final score methodology.
    (1) Measures and activities in the four performance categories are 
scored against performance standards.
    (i) For the quality performance category, measures are scored 
between zero and 10 points. Performance is measured against benchmarks. 
Bonus points are available for both submitting specific types of 
measures and submitting measures using end-to-end electronic reporting.
    (ii) For the cost performance category, measures are scored between 
one and 10 points. Performance is measured against a benchmark.
    (iii) For the improvement activities performance category, each 
improvement activity is worth a certain number of points. The points 
for each reported activity are summed and scored against a total 
potential performance category score of 40 points.
    (iv) For the advancing care information performance category, the 
performance category score is the sum of a base score, performance 
score, and bonus score.
    (2) [Reserved]
    (b) Performance categories. MIPS eligible clinicians are scored 
under MIPS in four performance categories.
    (1) Quality performance category. For the 2017 performance period. 
MIPS eligible clinicians receive three to ten achievement points for 
each scored quality measure in the quality performance category based 
on the MIPS eligible clinician's performance compared to measure 
benchmarks. A MIPS quality measure must have a measure benchmark to be 
scored based on performance. MIPS quality measures that do not have a 
benchmark will not be scored based on performance. Instead, these 
measures will receive 3 points for the 2017 performance period.
    (i) Measure benchmarks are based on historical performance for the 
measure based on a baseline period. Each benchmark must have a minimum 
of 20 individual clinicians or groups who reported the measure meeting 
the data completeness requirement and minimum case size criteria and 
performance greater than zero. We will restrict the benchmarks to data 
from MIPS eligible clinicians and comparable APM data, including data 
from QPs and Partial QPs.

[[Page 77545]]

    (ii) As an exception, if there is no comparable data from the 
baseline period, CMS would use information from the performance period 
to create measure benchmarks, which would not be published until after 
the performance period. For the 2017 performance period, CMS would use 
information from CY 2017 during which MIPS eligible clinicians may 
report for a minimum of any continuous 90-day period.
    (A) CMS Web Interface submission uses benchmarks from the 
corresponding reporting year of the Shared Savings Program.
    (B) [Reserved]
    (iii) Separate benchmarks are used for the following submission 
mechanisms:
    (A) EHR submission options;
    (B) QCDR and qualified registry submission options;
    (C) Claims submission options;
    (D) CMS Web Interface submission options;
    (E) CMS-approved survey vendor for CAHPS for MIPS submission 
options; and
    (F) Administrative claims submission options.
    (iv) Minimum case requirements for quality measures are 20 cases, 
unless a measure is subject to an exception.
    (v) As an exception, the minimum case requirements for the all-
cause hospital readmission measure is 200 cases.
    (vi) MIPS eligible clinicians failing to report a measure required 
under this category receive zero points for that measure.
    (vii) MIPS eligible clinicians do not receive zero points if the 
expected measure is submitted but is unable to be scored because it 
does not meet the required case minimum or if the measure does not have 
a measure benchmark for MIPS payment year 2019. Instead, these measures 
as well as measures that are below the data completeness requirement 
receive a score of 3 points in MIPS payment year 2019.
    (viii) As an exception, the administrative claims-based measures 
and CMS Web Interface measures will not be scored if these measures do 
not meet the required case minimum. For CMS Web Interface measures, we 
will recognize the measure was submitted but exclude the measure from 
being scored. For CMS Web Interface measures: measures that do not have 
a measure benchmark will also not be scored, although we will recognize 
that the measure was submitted, and measures that are below the data 
completeness requirement receive 0 points.
    (ix) Measures submitted by MIPS eligible clinicians are scored 
using a percentile distribution, separated by decile categories.
    (x) For each set of benchmarks, CMS calculates the decile breaks 
for measure performance and assigns points based on which benchmark 
decile range the MIPS eligible clinician's measure rate is between.
    (xi) CMS assigns partial points based on the percentile 
distribution.
    (xii) MIPS eligible clinicians are required to submit measures 
consistent with Sec.  414.1335.
    (xiii) Bonus points are available for measures determined to be 
high priority measures when two or more high priority measures are 
reported.
    (A) Bonus points are not available for the first reported high 
priority measure which is required to be reported. To qualify for bonus 
points, each measure must be reported with sufficient case volume to 
the meet the required case minimum and the required data completeness 
criteria and does not have a zero percent performance rate, regardless 
of whether it is included in the calculation of the quality performance 
category score.
    (B) Outcome and patient experience measures receive two bonus 
points.
    (C) Other high priority measures receive one bonus point.
    (D) Bonus points for high priority measures cannot exceed 10 
percent of the total possible points for MIPS payment year 2019 and 
2020.
    (xiv) One bonus point is also available for each measure submitted 
with end-to-end electronic reporting for a quality measure under 
certain criteria determined by the Secretary. Bonus points cannot 
exceed 10 percent of the total possible points for MIPS payment year 
2019 and 2020.
    (xv) A MIPS eligible clinician's quality performance category score 
is the sum of all the points assigned for the measures required for the 
quality performance category criteria plus the bonus points in 
paragraph (b)(1)(xiii) of this section and bonus points in paragraph 
(b)(1)(xiv) of this section. The sum is divided by the sum of total 
possible points. The quality performance category score cannot exceed 
the total possible points for the quality performance category.
    (2) Cost performance category. A MIPS eligible clinician receives 
one to ten achievement points for each cost measure attributed to the 
MIPS eligible clinician based on the MIPS eligible clinician's 
performance compared to the measure benchmark.
    (i) Cost measure benchmarks are based on the performance period. 
Cost measures must have a benchmark to be scored.
    (ii) A MIPS eligible clinician must meet the minimum case volume 
specified by CMS to be scored on a cost measure.
    (iii) A MIPS eligible clinician's cost performance category score 
is the equally-weighted average of all scored cost measures.
    (3) Improvement activities performance category. MIPS eligible 
clinicians and groups receive points for improvement activities based 
on patient-centered medical home or comparable specialty practice 
participation, APM participation, and improvement activities reported 
by the MIPS eligible clinician in comparison to the highest potential 
score (40 points) for a given MIPS year.
    (i) CMS assigns credit for the total possible category score for 
each reported improvement activity based on two weights: Medium-
weighted; and high-weighted activities.
    (ii) Improvement activities with a high weighting receive credit 
for 20 points, toward the total possible category score.
    (iii) Improvement activities with a medium weighting receive credit 
for
    10 points toward the total possible category score.
    (iv) A MIPS eligible clinician or group in a practice that is 
certified as a patient-centered medical home or comparable specialty 
practice, as determined by the Secretary, receives full credit for 
performance on the improvement activities performance category. For 
purposes of this paragraph (b)(3)(iv), ``full credit'' means that the 
MIPS eligible clinician or group has met the highest potential score of 
40 points. A practice is certified as a patient-centered medical home 
if it meets any of the following criteria:
    (A) The practice has received accreditation from one of four 
accreditation organizations that are nationally recognized;
    (1) The Accreditation Association for Ambulatory Health Care;
    (2) The National Committee for Quality Assurance (NCQA);
    (3) The Joint Commission; or
    (4) The Utilization Review Accreditation Commission (URAC).
    (B) The practice is participating in a Medicaid Medical Home Model 
or Medical Home Model.
    (C) The practice is a comparable specialty practice that has 
received the NCQA Patient-Centered Specialty Recognition.
    (D) The practice has received accreditation from other certifying 
bodies that have certified a large

[[Page 77546]]

number of medical organizations and meet national guidelines, as 
determined by the Secretary. The Secretary must determine that these 
certifying bodies must have 500 or more certified member practices, and 
require practices to include the following:
    (1) Have a personal physician/clinician in a team-based practice.
    (2) Have a whole-person orientation.
    (3) Provide coordination or integrated care.
    (4) Focus on quality and safety.
    (5) Provide enhanced access.
    (v) CMS compares the points associated with the reported activities 
against the highest potential category score of 40 points.
    (vi) A MIPS eligible clinician or group's improvement activities 
category score is the sum of points for all of their reported 
activities, which is capped at 40 points, divided by the highest 
potential category score of 40 points.
    (vii) Non-patient facing MIPS eligible clinicians and groups, small 
practices, and practices located in rural areas and geographic HPSAs 
receive full credit for improvement activities by selecting one high-
weighted improvement activity or two medium-weighted improvement 
activities. Non-patient facing MIPS eligible clinicians and groups, 
small practices, and practices located in rural areas and geographic 
HPSAs receive half credit for improvement activities by selecting one 
medium-weighted improvement activity.
    (viii) To receive full credit as a certified patient-centered 
medical home or comparable specialty practice requires that a TIN that 
is reporting includes at least one practice which is a certified 
patient-centered medical home or comparable specialty practice.
    (ix) 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 the 
improvement activities performance category.
    (4) Advancing care information performance category. (i) A MIPS 
eligible clinician's advancing care information performance category 
score equals the sum of the base score, performance score, Public 
Health and Clinical Data Registry bonus score and completing 
improvement activities using CEHRT bonus score. The advancing care 
information performance category score will not exceed 100 percentage 
points.
    (A) A MIPS eligible clinician earns a base score by reporting the 
numerator (of at least one) and denominator or yes/no statement or null 
value as applicable, for each required measure
    (B) A MIPS eligible clinician earns a performance score by 
reporting on certain measures specified by CMS. MIPS eligible 
clinicians may earn up to 10 or 20 percentage points as specified by 
CMS for each measure reported for the performance score.
    (C) A MIPS eligible clinician earn a bonus of five percentage 
points for reporting any measures beyond than the Immunization Registry 
Reporting measure for the Public Health and Clinical Data Registry 
objective.
    (D) A MIPS eligible clinician earns a bonus of 10 percentage points 
for attesting to completing one or more improvement activities 
specified by CMS using CEHRT.
    (ii) [Reserved]
    (c) Final score calculation. Each MIPS eligible clinician receives 
a final score of 0 to 100 points equal to the sum of each of the 
products of each performance category score and each performance 
category's assigned weight, multiplied by 100.
    (1) Performance category weights. Subject to CMS's authority to 
reweight, performance category weights under section 1848(q)(5)(F) of 
the Act:
    (i) Quality performance category weight is defined under Sec.  
414.1330(b).
    (ii) Cost performance category weight is defined under Sec.  
414.1350(b).
    (iii) Improvement activities performance category weight is defined 
under Sec.  414.1355(b).
    (iv) Advancing care information performance category weight is 
defined under Sec.  414.1375(a).
    (2) Reweighting the performance categories. If CMS determines there 
are not sufficient measures and activities applicable and available to 
MIPS eligible clinicians, CMS will assign weights to the performance 
categories that are different from the weights specified in Sec.  
414.1380(c)(1).
    (d) Scoring for APM entities. MIPS eligible clinicians in APM 
Entities that are subject to the APM scoring standard are scored using 
the methodology under Sec.  414.1370.


Sec.  414.1385  Targeted review and review limitations.

    (a) Targeted review. MIPS eligible clinicians or groups may request 
a targeted review of the calculation of the MIPS payment adjustment 
factor under section 1848(q)(6)(A) of the Act and, as applicable, the 
calculation of the additional MIPS payment adjustment factor under 
section 1848(q)(6)(C) of the Act applicable to such MIPS eligible 
clinician or group for a year. The process for targeted reviews is:
    (1) MIPS eligible clinicians and groups have a 60-day period to 
submit a request for targeted review, which begins on the day CMS makes 
available the MIPS payment adjustment factor, and if applicable the 
additional MIPS payment adjustment factor, for the MIPS payment year 
and ends on September 30 of the year prior to the MIPS payment year or 
a later date specified by CMS.
    (2) CMS will respond to each request for targeted review timely 
submitted and determine whether a targeted review is warranted.
    (3) The MIPS eligible clinician or group may include additional 
information in support of their request for targeted review at the time 
the request is submitted. If CMS requests additional information from 
the MIPS eligible clinician or group, it must be provided and received 
by CMS within 30 days of the request. Non-responsiveness to the request 
for additional information may result in the closure of the targeted 
review request, although the MIPS eligible clinician or group may 
submit another request for targeted review before the deadline.
    (4) Decisions based on the targeted review are final, and there is 
no further review or appeal.
    (b) Limitations on review. Except as specified in paragraph (a)(4) 
of this section, there is no administrative or judicial review under 
section 1869 or 1879 of the Act, or otherwise of--
    (1) The methodology used to determine the amount of the MIPS 
payment adjustment factor and the amount of the additional MIPS payment 
adjustment factor and the determination of such amounts;
    (2) The establishment of the performance standards and the 
performance period;
    (3) The identification of measures and activities specified for a 
MIPS performance category and information made public or posted on the 
Physician Compare Internet Web site of the CMS; and
    (4) 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.


Sec.  414.1390  Data validation and auditing.

    (a) General. CMS will selectively audit MIPS eligible clinicians 
and groups on a yearly basis. If a MIPS eligible clinician or group is 
selected for audit, the MIPS eligible clinician or group will be 
required to do the following in accordance with applicable law and 
timelines CMS establishes:
    (1) Comply with data sharing requests, providing all data as 
requested

[[Page 77547]]

by CMS or our designated entity. All data must be shared with CMS or 
our designated entity within 45 days of the data sharing request, or an 
alternate timeframe that is agreed to by CMS and the MIPS eligible 
clinician or group. Data will be submitted via email, facsimile, or an 
electronic method via a secure Web site maintained by CMS.
    (2) 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 
non-Medicare beneficiaries where applicable.
    (b) [Reserved]


Sec.  414.1395  Public reporting.

    (a) Public reporting of a MIPS eligible clinician's MIPS data. For 
each program year, CMS will post on a public Web site, in an easily 
understandable format, information regarding the performance of MIPS 
eligible clinicians or groups under the MIPS.
    (b) [Reserved]


Sec.  414.1400  Third party data submission.

    (a) General. (1) MIPS data may be submitted by third party 
intermediaries on behalf of a MIPS eligible clinician or group by:
    (i) A qualified registry;
    (ii) A QCDR;
    (iii) A health IT vendor or other authorized third party that 
obtains data from a MIPS eligible clinician's CEHRT; or
    (iv) A CMS-approved survey vendor.
    (2) Qualified registries, QCDRs, and health IT vendors or other 
authorized third parties may submit data on measures, activities, or 
objectives for any of the following MIPS performance categories:
    (i) Quality;
    (ii) Improvement activities; or
    (iii) Advancing care information, if the MIPS eligible clinician or 
group is using CEHRT.
    (3) CMS-approved survey vendors may submit data for the CAHPS for 
MIPS survey under the MIPS quality performance category.
    (4) Third party intermediaries must meet all the criteria specified 
by CMS to qualify and be approved as a third party intermediary for 
purposes of MIPS, including, but not limited to, the following 
criteria:
    (i) For measures, activities, and objectives under the quality, 
advancing care information, and improvement activities performance 
categories, if the data is derived from CEHRT, the QCDR, qualified 
registry, or health IT vendor must be able to indicate its data source.
    (ii) All submitted data must be submitted in the form and manner 
specified by CMS.
    (b) QCDR self-nomination criteria. QCDRs must self-nominate, for 
the 2017 performance period, from November 15, 2016 until January 15, 
2017. For future years of the program, starting with the 2018 
performance period, QCDRs must self-nominate 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 will need to self-nominate for that performance period and 
provide all information requested by CMS at the time of self-
nomination. Having qualified as a QCDR does not automatically qualify 
the entity to participate in subsequent MIPS performance periods.
    (c) Establishment of a QCDR entity. For an entity to become 
qualified for a given performance period as a QCDR, the entity must:
    (1) Be in existence as of January 1 of the performance period for 
which the entity seeks to become a QCDR.
    (2) Have at least 25 participants by January 1 of the performance 
period.
    (d) Collaboration of entities to become a QCDR. In situations where 
an entity may not meet the criteria of a QCDR solely on its own but can 
do so in conjunction with another entity, the entity must also comply 
with the following:
    (1) An entity that uses an external organization for purposes of 
data collection, calculation, or transmission may meet the definition 
of a QCDR as long as the entity has a signed, written agreement that 
specifically details the relationship and responsibilities of the 
entity with the external organization effective as of September 1 the 
year prior to the year for which the entity seeks to become a QCDR.
    (2) [Reserved]
    (e) Identifying non-MIPS quality measures. For purposes of QCDRs 
submitting data for the MIPS quality performance category, CMS 
considers the following types of quality measures to be non-MIPS 
quality measures:
    (1) A measure that is not contained in the annual list of MIPS 
quality measures for the applicable performance period.
    (2) A measure that may be in the annual list of MIPS quality 
measures but has substantive differences, as determined by the 
Secretary, in the manner it is reported by the QCDR.
    (3) CAHPS for MIPS survey. Although the CAHPS for MIPS survey 
included in the MIPS measure set, we consider the changes that need to 
be made for reporting by individual MIPS eligible clinicians (and not 
as a part of a group) significant enough as to treat the CAHPS for MIPS 
survey as a non-MIPS quality measure for purposes of individual MIPS 
eligible clinicians reporting the CAHPS for MIPS survey via a QCDR.
    (f) QCDR measure specifications criteria. A QCDR must provide 
specifications for each measure, activity, or objective the QCDR 
intends to submit to CMS. The QCDR must provide CMS descriptions and 
narrative specifications for each measure, activity, or objective no 
later than January 15 of the applicable performance period for which 
the QCDR wishes to submit quality measures or other performance 
category (improvement activities and advancing care information) data. 
In future years, starting with the 2018 performance period, those 
specifications must be provided to CMS by no later than November 1 
prior to the applicable performance period for which the QCDR wishes to 
submit quality measures or other performance category (improvement 
activities and advancing care information) data.
    (1) For non-MIPS quality measures, the quality measure 
specifications must include the following for each measure: Name/title 
of measures, NQF number (if NQF-endorsed), descriptions of the 
denominator, numerator, and when applicable, denominator exceptions, 
denominator exclusions, risk adjustment variables, and risk adjustment 
algorithms. The narrative specifications provided must be similar to 
the narrative specifications we provide in our measures list. CMS will 
consider all non-MIPS quality measures submitted by the QCDR but the 
measures must address a gap in care and outcome or other high priority 
measures are preferred. Documentation or ``check box'' measures are 
discouraged. Measures that have very high performance rates already or 
address extremely rare gaps in care (thereby allowing for little or no 
quality distinction between eligible clinicians) are also unlikely to 
be approved for inclusion.
    (2) For MIPS quality measures, the QCDR only needs to submit the 
MIPS measure numbers or specialty-specific measure sets (if 
applicable).
    (3) The QCDR must publicly post the measure specifications (no 
later than 15 days following CMS approval of the measure 
specifications) for each non-MIPS quality measure it intends to submit 
for MIPS. The QCDR may use any public format it prefers. Immediately 
following posting of the measures specification, the QCDR must

[[Page 77548]]

provide CMS with the link to where this information is posted.
    (g) Qualified registry self-nomination criteria. Qualified 
registries must self-nominate, for the 2017 performance period from 
November 15, 2016 until January 15, 2017. For future years of the 
program, starting with the 2018 performance period, the qualified 
registry must self-nominate from September 1 of the prior year until 
November 1 of the prior year. Entities that desire to qualify as a 
qualified registry for a given performance period must self-nominate 
and provide all information requested by CMS at the time of self-
nomination. Having qualified as a qualified registry does not 
automatically qualify the entity to participate in subsequent MIPS 
performance periods.
    (h) Establishment of a qualified registry entity. For an entity to 
become qualified for a given performance period as a qualified 
registry, the entity must:
    (1) Be in existence as of January 1 of the performance period for 
which the entity seeks to become a qualified registry.
    (2) Have at least 25 participants by January 1 of the performance 
period.
    (i) CMS-approved survey vendor application criteria. Vendors are 
required to undergo the CMS approval process for each year in which the 
survey vendor seeks to transmit survey measures data to CMS. All CMS-
approved survey vendor applications and materials will be due by April 
30 of the performance period.
    (j) Auditing of entities submitting MIPS data. Any third party 
intermediary (that is, a QCDR, health IT vendor, qualified registry, or 
CMS-approved survey vendor) must comply with the following procedures 
as a condition of their qualification and approval to participate in 
MIPS as a third party intermediary.
    (1) The entity must make available to CMS the contact information 
of each MIPS eligible clinician or group on behalf of whom it submits 
data. The contact information will include, at a minimum, the MIPS 
eligible clinician or group's practice phone number, address, and, if 
available, email.
    (2) The entity must retain all data submitted to CMS for MIPS for a 
minimum of 10 years.
    (3) For the purposes of auditing, CMS may request any records or 
data retained for the purposes of MIPS for up to 6 years and 3 months.
    (k) Probation and disqualification of a third party intermediary. 
(1) If at any time we determine that a third party intermediary (that 
is, a QCDR, health IT vendor, qualified registry, or CMS-approved 
survey vendor) has not met all of the applicable criteria for 
qualification and approval, CMS may place the third party intermediary 
on probation for the current performance period or the following 
performance period, as applicable.
    (2) For purposes of this section, probation means that, for the 
applicable performance period, the third party intermediary must meet 
all applicable criteria for qualification and approval and must submit 
a corrective action plan for remediation or correction of any 
deficiencies identified by CMS that resulted in the probation.
    (3) CMS requires a corrective action plan from the third party 
intermediary to address any deficiencies or issues and prevent them 
from recurring. The corrective action plan must be received and 
accepted by CMS within 14 days of the CMS notification to the third 
party intermediary of the deficiency or probation. If the corrective 
action plan is not received and accepted by CMS within the specified 
time, CMS may disqualify the third party intermediary from the MIPS 
program for the subsequent performance period.
    (4) If the third party intermediary has data inaccuracies including 
(but not limited to) TIN/NPI mismatches, formatting issues, calculation 
errors, data audit discrepancies affecting in excess of 3 percent (but 
less than 5 percent) of the total number of MIPS eligible clinicians or 
groups submitted by the third party intermediary, such inaccuracies 
will trigger paragraph (k)(3) of this section and may result in this 
information being posted on the CMS Web site.
    (5) If the third party intermediary does not reduce their data 
error rate below 3 percent for the subsequent performance period, the 
third party intermediary will 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 for one additional year. After 2 
years on probation, the third party intermediary will be disqualified 
for the subsequent performance period.
    (6) Before placing the third party intermediary on probation; CMS 
would notify the third party intermediary of the identified issues, at 
the time of discovery of such issues.
    (7) If the third party intermediary does not submit an acceptable 
corrective action plan within 14 days of notification of deficiencies, 
and correct the deficiencies within 30 days or before the submission 
deadline--whichever is sooner, CMS may disqualify the third party 
intermediary from participating in MIPS for the current performance 
period or the following performance period, as applicable.


Sec.  414.1405  Payment.

    (a) General. Each MIPS eligible clinician receives a MIPS payment 
adjustment factor, and if applicable an additional MIPS payment 
adjustment factor for exceptional performance, for a MIPS payment year 
determined by comparing their final score to the performance threshold 
and additional performance threshold for the year.
    (b) Performance threshold. A performance threshold will be 
specified for each MIPS payment year.
    (1) MIPS eligible clinicians with a final score at or above the 
performance threshold receive a zero or positive MIPS payment 
adjustment factor on a linear sliding scale such that an adjustment 
factor of 0 percent is assigned for a final score at the performance 
threshold and an adjustment factor of the applicable percent is 
assigned for a final score of 100.
    (2) MIPS eligible clinicians with a final score below the 
performance threshold receive a negative MIPS payment adjustment factor 
on a linear sliding scale such that an adjustment factor of 0 percent 
is assigned for a final score at the performance threshold and an 
adjustment factor of the negative of the applicable percent is assigned 
for a final score of 0; further, MIPS eligible clinicians with final 
scores that are equal to or greater than zero, but not greater than 
one-fourth of the performance threshold, receive a negative MIPS 
payment adjustment factor that is equal to the negative of the 
applicable percent.
    (3) A scaling factor not to exceed 3.0 may be applied to positive 
MIPS payment adjustment factors to ensure budget neutrality such that 
the estimated increase in aggregate allowed charges resulting from the 
application of the positive MIPS payment adjustment factors for the 
MIPS payment year equals the estimated decrease in aggregate allowed 
charges resulting from the application of negative MIPS payment 
adjustment factors for the MIPS payment year.
    (c) Applicable percent. For MIPS payment year 2019, 4 percent. For 
MIPS payment year 2020, 5 percent. For MIPS payment year 2021, 7 
percent. For MIPS payment year 2022 and each subsequent MIPS payment 
year, 9 percent.
    (d) Additional performance threshold. An additional performance 
threshold will be specified for each of the MIPS payment years 2019 
through 2024.
    (1) In addition to the MIPS payment adjustment factor, MIPS 
eligible

[[Page 77549]]

clinicians with a final score at or above the additional performance 
threshold receive an additional MIPS payment adjustment factor for 
exceptional performance on a linear sliding scale such that an 
additional adjustment factor of 0.5 percent is assigned for a final 
score at the additional performance threshold and an additional 
adjustment factor of 10 percent is assigned for a final score of 100, 
subject to the application of a scaling factor as determined by CMS, 
such that the estimated aggregate increase in payments resulting from 
the application of the additional MIPS payment adjustment factors for 
the MIPS payment year shall not exceed $500,000,000 for each of the 
MIPS payment years 2019 through 2024.
    (2) [Reserved]
    (e) Application of adjustments to payments. For each MIPS payment 
year, the MIPS payment adjustment factor, and if applicable the 
additional MIPS payment adjustment factor, are applied to Medicare Part 
B payments for items and services furnished by the MIPS eligible 
clinician during the year.


Sec.  414.1410  Advanced APM determination.

    (a) General. An APM is an Advanced APM for a payment year if CMS 
determines that it meets the criteria in Sec.  414.1415 during the QP 
Performance Period.
    (b) Advanced APM and Other Payer Advanced APM determination 
process. CMS identifies Advanced APMs and Other Payer Advanced APMs in 
the following manner:
    (1) Advanced APM determination. (i) No later than January 1, 2017, 
CMS will post on its Web site a list of all Advanced APMs for the first 
QP Performance Period.
    (ii) CMS updates the Advanced APM list on its Web site at intervals 
no less than annually.
    (iii) CMS will include notice of whether a new APM is an Advanced 
APM in the first public notice of the new APM.
    (2) Other Payer Advanced APM determination. (i) CMS identifies 
Other Payer Advanced APMs following conclusion of the QP Performance 
Period using information submitted to CMS according to Sec.  414.1445. 
CMS will not make determinations for other payer arrangements for which 
insufficient information is submitted.
    (ii) CMS makes Other Payer Advanced APM determinations prior to QP 
determinations under Sec.  414.1440.
    (iii) CMS makes final Other Payer Advanced APM determinations and 
notifies Advanced APM Entities and eligible clinicians of such 
determinations as soon as practicable.


Sec.  414.1415  Advanced APM criteria.

    (a) Use of certified electronic health record technology (CEHRT)--
(1) Required use of CEHRT. To be an Advanced APM, an APM must:
    (i) Require at least 50 percent of eligible clinicians in each 
participating APM Entity group, or, for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or other health care providers; or
    (ii) For the Shared Savings Program, apply a penalty or reward to 
an APM Entity based on the degree of the use of CEHRT of the eligible 
clinicians in the APM Entity.
    (b) Payment based on quality measures. (1) To be an Advanced APM, 
an APM must include quality measure results as a factor when 
determining payment to participants under the terms of the APM.
    (2) At least one of the quality measures upon which an Advanced APM 
bases the payment in paragraph (b)(1) of this section must have an 
evidence-based focus, be reliable and valid, and meet at least one of 
the following criteria:
    (i) Used in the MIPS quality performance category as described in 
Sec.  414.1330;
    (ii) Endorsed by a consensus-based entity;
    (iii) Developed under section 1848(s) of the Act;
    (iv) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (v) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid.
    (3) In addition to the quality measure requirements under paragraph 
(b)(2) of this section, the quality measures upon which an Advanced APM 
bases the payment in paragraph (b)(1) of this section must include at 
least one outcome measure. This requirement does not apply if CMS 
determines that there are no available or applicable outcome measures 
included in the MIPS quality measures list for the Advanced APM's first 
QP Performance Period.
    (c) Financial risk. To be an Advanced APM, an APM must either meet 
the financial risk standard under paragraph (d)(1) or (2) of this 
section and the nominal amount standard under paragraph (d)(3) or (4) 
of this section or be an expanded Medical Home Model under section 
1115A(c) of the Act.
    (1) Generally applicable financial risk standard. Except for 
paragraph (c)(2) of this section, to be an Advanced APM, an APM must, 
based on whether an APM Entity's actual expenditures for which the APM 
Entity is responsible under the APM exceed expected expenditures during 
a specified QP Performance Period, do one or more of the following:
    (i) Withhold payment for services to the APM Entity or the APM 
Entity's eligible clinicians;
    (ii) Reduce payment rates to the APM Entity or the APM Entity's 
eligible clinicians; or
    (iii) Require the APM Entity to owe payment(s) to CMS.
    (2) Medical Home Model financial risk standard. The following 
standard applies only for APM Entities that are participating in 
Medical Home Models, and, starting in the 2018 QP Performance Period, 
such APM Entities must be owned and operated by an organization with 
fewer than 50 eligible clinicians whose Medicare billing rights have 
been reassigned to the TIN(s) of the organization(s) or any of the 
organization's subsidiary entities. The APM Entity participates in a 
Medical Home Model that, based on the APM Entity's failure to meet or 
exceed one or more specified performance standards, which may include 
expected expenditures, does one or more of the following:
    (i) Withholds payment for services to the APM Entity or the APM 
Entity's eligible clinicians;
    (ii) Reduces payment rates to the APM Entity or the APM Entity's 
eligible clinicians;
    (iii) Requires the APM Entity to owe payment(s) to CMS; or
    (iv) Causes the APM Entity to lose the right to all or part of an 
otherwise guaranteed payment or payments.
    (3) Generally applicable nominal amount standard. (i) Except as 
provided in paragraph (c)(4) of this section, the total amount an APM 
Entity potentially owes CMS or foregoes under an APM must be at least 
equal to either:
    (A) For QP Performance Periods 2017 and 2018, 8 percent of the 
estimated average total Medicare Parts A and B revenues of 
participating APM Entities; or
    (B) 3 percent of the expected expenditures for which an APM Entity 
is responsible under the APM.
    (ii) [Reserved]
    (4) Medical Home Model nominal amount standard. (i) For a Medical 
Home Model to be an Advanced APM, the total annual amount that an 
Advanced APM Entity potentially owes CMS or foregoes must be at least 
the following amounts:
    (A) For QP Performance Period 2017, 2.5 percent of the estimated 
average

[[Page 77550]]

total Medicare Parts A and B revenues of participating APM Entities.
    (B) For QP Performance Period 2018, 3 percent of the estimated 
average total Medicare Parts A and B revenues of participating APM 
Entities;
    (C) For QP Performance Period 2019, 4 percent of the estimated 
average total Medicare Parts A and B revenues of participating APM 
Entities.
    (D) For QP Performance Period 2020 and later, 5 percent of the 
estimated average total Medicare Parts A and B revenues of 
participating APM Entities.
    (5) Expected expenditures. For the purposes of this section, 
expected expenditures is defined as the beneficiary expenditures for 
which an APM Entity is responsible under an APM. For episode payment 
models, expected expenditures mean the episode target price.
    (6) Capitation. A full capitation arrangement meets this Advanced 
APM criterion. For purposes of this part, a capitation arrangement 
means a payment arrangement in which a per capita or otherwise 
predetermined payment is made under the APM for all items and services 
for which payment is made through the APM furnished to a population of 
beneficiaries, and no settlement is performed to reconcile or share 
losses incurred or savings earned by the APM Entity. Arrangements 
between CMS and Medicare Advantage Organizations under the Medicare 
Advantage program (42 U.S.C. 422) are not considered capitation 
arrangements for purposes of this paragraph.


Sec.  414.1420  Other payer advanced APMs.

    (a) Other Payer Advanced APM criteria. A payment arrangement with a 
payer other than Medicare is an Other Payer Advanced APM for a QP 
Performance Period if CMS determines that the arrangement meets the 
following criteria during the QP Performance Period:
    (1) Use of CEHRT, as described in paragraph (b) of this section;
    (2) Quality measures comparable to measures under the MIPS quality 
performance category apply, as described in paragraph (c) of this 
section; and
    (3) Either:
    (i) Requires APM Entities to bears more than nominal financial risk 
if actual aggregate expenditures exceed expected aggregate 
expenditures, as described in paragraph (d) of this section; or
    (ii) Is a Medicaid Medical Home Model that meets criteria 
comparable to Medical Home Models expanded under section 1115A(c) of 
the Act, as described in paragraph (d)(3) of this section.
    (b) Use of CEHRT. To be an Other Payer Advanced APM, an other payer 
arrangement must require participants to use CEHRT as defined in Sec.  
414.1305. The other payer arrangement must require at least 50 percent 
of eligible clinicians in each participating APM Entity group, or each 
hospital if hospitals are the APM Entities, to use CEHRT to document 
and communicate clinical care.
    (c) Quality measure use. (1) To be an Other Payer Advanced APM, a 
payment arrangement must apply quality measures comparable to measures 
under the MIPS quality performance category, as described in paragraph 
(c)(2) of this section.
    (2) At least one of the quality measures used in the payment 
arrangement with an APM Entity must have an evidence-based focus, be 
reliable and valid, and meet at least one of the following criteria:
    (i) Used in the MIPS quality performance category, as described in 
Sec.  414.1330;
    (ii) Endorsed by a consensus-based entity;
    (iii) Developed under section 1848(s) of the Act;
    (iv) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (v) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid.
    (3) To meet the quality measure use criterion, an other payment 
arrangement must use an outcome measure if there is an applicable 
outcome measure on the MIPS quality measure list. If an Other Payer 
Advanced APM has no outcome measure, the Advanced APM Entity must 
attest that there is no applicable outcome measure on the MIPS list.
    (d) Other Payer Advanced APM financial risk. To be an Other Payer 
Advanced APM, an other payer arrangement must meet either the financial 
risk standard under paragraph (d)(1) or (2) of this section and the 
nominal risk standard under paragraph (d)(3) or (4) of this section, 
make payment using a full capitation arrangement under paragraph (d)(6) 
of this section, or be a Medicaid Medical Home Model that meets 
criteria comparable to an expanded Medical Home Model under section 
1115A(c) of the Act.
    (1) Other Payer Advanced APM financial risk standard. Except for 
APM Entities to which paragraph (d)(2) of this section applies, to be 
an Other Payer Advanced APM, an APM Entity must, based on whether an 
APM Entity's actual expenditures for which the APM Entity is 
responsible under the APM exceed expected expenditures during a 
specified performance period do one or more of the following:
    (i) Withhold payment for services to the APM Entity or the APM 
Entity's eligible clinicians;
    (ii) Reduce payment rates to the APM Entity or the APM Entity's 
eligible clinicians; or
    (iii) Require direct payment by the APM Entity to the payer.
    (2) Medicaid Medical Home Model financial risk standard. For an APM 
Entity owned and operated by an organization with fewer than 50 
eligible clinicians whose Medicare billing rights have been reassigned 
to the TIN(s) of the organization(s) or any of the organization's 
subsidiary entities, the following standard applies. The APM Entity 
participates in a Medicaid Medical Home Model that, based on the APM 
Entity's failure to meet or exceed one or more specified performance 
standards, does one or more of the following:
    (i) Withhold payment for services to the APM Entity or the APM 
Entity's eligible clinicians;
    (ii) Require direct payment by the APM Entity to the Medicaid 
program;
    (iii) Reduce payment rates to the APM Entity or the APM Entity's 
eligible clinicians; or
    (iv) Require the APM Entity to lose the right to all or part of an 
otherwise guaranteed payment or payments.
    (3) Other Payer Advanced APM nominal amount standard. (i) Except 
for risk arrangements described under paragraph (d)(2) of this section, 
the total amount an APM Entity potentially owes us or foregoes under an 
Other Payer Advanced APM is at least be equal to 3 percent of the 
expected expenditures for which an APM Entity is responsible under the 
payment arrangement.
    (ii) Except for risk arrangements described under paragraph (d)(2) 
of this section, the risk arrangement must have:
    (A) A marginal risk rate of at least 30 percent; and
    (B) Total potential risk of at least 4 percent of expected 
expenditures.
    (4) Medicaid Medical Home Model nominal amount standard. For an APM 
Entity owned and operated by an organization with fewer than 50 
eligible clinicians whose Medicare billing rights have been reassigned 
to the TIN(s) of the organization(s) or any of the organization's 
subsidiary entities, the following standard applies. For a Medicaid 
Medical Home Model to be an Other Payer Advanced APM, the total annual 
amount that an Advanced APM

[[Page 77551]]

Entity potentially owes CMS or foregoes must be at least the following 
amounts:
    (i) For QP Performance Period 2019, 4 percent of the estimated 
average total revenue of participating APM Entities from the payer.
    (ii) For QP Performance Period 2020 and later, 5 percent of the 
estimated average total revenue of participating APM Entities for the 
payer.
    (5) Marginal risk rate. For purposes of this section, the marginal 
risk rate is defined as the percentage of actual expenditures that 
exceed expected expenditures for which an APM Entity is responsible 
under an APM.
    (i) In the event that the marginal risk rate varies depending on 
the amount by which actual expenditures exceed expected expenditures, 
the lowest marginal risk rate across all possible levels of actual 
expenditures would be used for comparison to the marginal risk rate 
specified in paragraph (d)(3)(ii)(A) of this section, with exceptions 
for large losses as described in paragraph (d)(5)(ii) of this section 
and small losses as described in paragraph (d)(5)(iii) of this section.
    (ii) Allowance for large losses. The determination in paragraph 
(d)(3)(ii)(A) of this section may disregard the marginal risk rates 
that apply in cases when actual expenditures exceed expected 
expenditures by an amount sufficient to require the APM Entity to make 
financial risk payments under the Other Payer Advanced APM greater than 
or equal to the total risk requirement under paragraph (d)(3)(i) of 
this section.
    (iii) Allowance for minimum loss rate. The determination in 
paragraph (d)(3)(ii)(A) of this section may disregard the marginal risk 
rates that apply in cases when actual expenditures exceed expected 
expenditures by less than 4 percent of expected expenditures.
    (6) Expected expenditures. For the purposes of this section, 
expected expenditures is defined as the Other Payer Advanced APM 
benchmark, except for episode payment models, for which it is defined 
as the episode target price.
    (7) Capitation. A capitation arrangement meets this Other Payer 
Advanced APM criterion. For purposes of paragraph (d)(3) of this 
section, a capitation arrangement means a payment arrangement in which 
a per capita or otherwise predetermined payment is made under the APM 
for all items and services for which payment is made through the APM 
furnished to a population of beneficiaries, and no settlement is 
performed for the purpose of reconciling or sharing losses incurred or 
savings earned by the APM Entity. Arrangements made directly between 
CMS and Medicare Advantage Organizations under the Medicare Advantage 
program (42 U.S.C. 422) are not considered capitation arrangements for 
purposes of this paragraph.


Sec.  414.1425  Qualifying APM participant determination: In general.

    (a) List used for QP determination. (1) For Advanced APMs with 
Advanced APM Entities that include eligible clinicians on a 
Participation List, the Participation List defines the APM Entity 
group, regardless of whether the Advanced APM Entity also has eligible 
clinicians on an Affiliated Practitioner List.
    (2) For Advanced APMs with Advanced APM Entities that do not 
include eligible clinicians on a Participation List but do include 
eligible clinicians on an Affiliated Practitioner List, the Affiliated 
Practitioner List defines the eligible clinicians who will be assessed 
to become QPs.
    (3) For Advanced APMs with some Advanced APM Entities that include 
eligible clinicians on a Participation List and other Advanced APM 
Entities that only include eligible clinicians on an Affiliated 
Practitioner List, paragraph (a)(1) applies to APM Entities that 
include eligible clinicians on a Participation List, and paragraph 
(a)(2) applies to APM Entities that only include eligible clinicians on 
an Affiliated Practitioner List.
    (b) Group or individual determination--(1) APM Entity group 
determination. Except for Sec.  414.1445 and paragraph (b)(2) of this 
section, for purposes of the QP determinations for a year, eligible 
clinicians are grouped and assessed through their collective 
participation in an APM Entity group that is in an Advanced APM. To be 
included in the APM Entity group for purposes of the QP determination, 
an eligible clinician's APM participant identifier must be present on a 
Participation List of an APM Entity group on one of the dates: March 
31, June 30, or August 31 of the QP Performance Period. An eligible 
clinician included on a Participation List on any one of these dates is 
included the APM Entity group even if that eligible clinician is not 
included on that Participation List at one of the prior or later listed 
dates. CMS performs QP determinations for the eligible clinicians in 
APM Entity group three times during the QP Performance Period using 
claims data for services furnished from January 1 through each of the 
respective QP determination dates: March 31, June 30, and August 31. An 
eligible clinician can only be determined to be a QP if the eligible 
clinician appears on the Participation List on a date (March 31, June 
30, or August 31) CMS uses to determine the APM Entity group and to 
make QP determinations collectively for the APM Entity group based on 
participation in the Advanced APM.
    (2) Affiliated practitioner individual determination. When the 
Affiliated Practitioner List defines the eligible clinicians to be 
assessed, for purposes of the QP determinations for a year, those 
eligible clinicians are assessed individually. To be assessed as an 
Affiliated Practitioner, an eligible clinician must be identified on an 
Affiliated Practitioner List on one of the dates: March 31, June 30, or 
August 31 of the QP Performance Period. An eligible clinician included 
on an Affiliated Practitioner List on any one of these dates is 
assessed as an Affiliated Practitioner even if that eligible clinician 
is not included on that Affiliated Practitioner List at one of the 
prior or later listed dates. For such eligible clinicians, CMS performs 
QP determinations during the QP Performance Period using claims data 
for services furnished from January 1 through each of the respective QP 
determination dates that the eligible clinician is on the Affiliated 
Practitioner List: March 31, June 30, and August 31.
    (c) QP determination. (1) CMS makes QP determinations as set forth 
in Sec. Sec.  414.1435 and 414.1440.
    (2) An eligible clinician cannot be both a QP and a Partial QP for 
a year. A determination that an eligible clinician is a QP means that 
the eligible clinician is not a Partial QP.
    (3) An eligible clinician is a QP for a year if the eligible 
clinician is in an APM Entity group that achieves a Threshold Score 
that meets or exceeds the corresponding QP payment amount threshold or 
QP patient count threshold for that QP Performance Period, as described 
in Sec.  414.1430(a)(1) and (3) and (b)(1) and (3).
    (4) Notwithstanding paragraph (c)(3) of this section, an eligible 
clinician is a QP for a year if:
    (i) The eligible clinician is included in more than one Advanced 
APM Entity group and none of the Advanced APM Entity groups in which 
the eligible clinician is included meets the QP payment amount 
threshold or the QP patient count threshold, or the eligible clinician 
is an Affiliated Practitioner; and
    (ii) CMS determines that the eligible clinician individually 
achieves a Threshold Score that meets or exceeds the QP payment amount 
threshold or the QP patient count threshold.

[[Page 77552]]

    (5) Notwithstanding paragraph (c)(3) of this section, an eligible 
clinician is not a QP for a year if the APM Entity group voluntarily or 
involuntarily terminates from an Advanced APM before the end of the QP 
Performance Period.
    (6) Notwithstanding paragraph (c)(4) of this section, an eligible 
clinician is not a QP for a year if any of the Advanced APM Entities in 
which the eligible clinician participates voluntarily or involuntarily 
terminates from the Advanced APM before the end of the QP Performance 
Period.
    (d) Partial QP determination. (1) An eligible clinician is a 
Partial QP for a year if the APM Entity group collectively achieves a 
Threshold Score that meets or exceeds the corresponding Partial QP 
threshold for that year, as described in Sec.  414.1430(a)(2) and (4) 
and (b)(2) and (4).
    (2) Notwithstanding paragraph (d)(1) of this section, an eligible 
clinician is a Partial QP for a year if:
    (i) The eligible clinician is included in more than one APM Entity 
group and none of the APM Entity groups in which the eligible clinician 
is included meets the corresponding QP or Partial QP threshold, or the 
eligible clinician is an Affiliated Practitioner; and
    (ii) CMS determines that the eligible clinician individually 
achieves a Threshold Score that meets or exceeds the corresponding 
Partial QP Threshold.
    (3) Notwithstanding paragraph (d)(1) of this section, an eligible 
clinician is not a Partial QP for a year if the APM Entity group 
voluntarily or involuntarily terminates from an Advanced APM before the 
end of the QP Performance Period.
    (4) Notwithstanding paragraph (d)(2) of this section, an eligible 
clinician is not a Partial QP for a year if any of the Advanced APM 
Entities in which the eligible clinician participates voluntarily or 
involuntarily terminates from the Advanced APM before the end of the QP 
Performance Period.
    (e) Notification of QP determination. CMS notifies eligible 
clinicians determined to be QPs or Partial QPs for a year as soon as 
practicable following each QP determination date in the QP Performance 
Period.
    (f) Order of threshold options. (1) For payment years 2019 and 
2020, CMS performs QP determinations for an eligible clinicians only 
under the Medicare Option described in Sec.  414.1435.
    (2) For payment years 2021 and later, CMS performs QP 
determinations for eligible clinicians under the Medicare Option, as 
described in Sec.  414.1435 and, except as specified in paragraphs 
(d)(2)(i) and (ii) of this section, the All-Payer Combination Option, 
described in Sec.  414.1440.
    (i) If CMS determines the eligible clinician to be a QP under the 
Medicare Option, then CMS does not calculate a Threshold Score for such 
eligible clinician under the All-Payer Combination Option.
    (ii) If the Threshold Score for an eligible clinician under the 
Medicare Option is less than the amount specified in Sec.  
414.1430(b)(2)(ii) and (b)(3)(iii), then CMS does not perform a QP 
determination for such eligible clinician(s) under the All-Payer 
Combination Option.


Sec.  414.1430  Qualifying APM participant determination: QP and 
partial QP thresholds.

    (a) Medicare Option--(1) QP payment amount threshold. The QP 
payment amount thresholds are the following values for the indicated 
payment years:
    (i) 2019 and 2020: 25 percent.
    (ii) 2021 and 2022: 50 percent.
    (iii) 2023 and later: 75 percent.
    (2) Partial QP payment amount threshold. The Partial QP payment 
amount thresholds are the following values for the indicated payment 
years:
    (i) 2019 and 2020: 20 percent.
    (ii) 2021 and 2022: 40 percent.
    (ii) 2023 and later: 50 percent.
    (3) QP patient count threshold. The QP patient count thresholds are 
the following values for the indicated payment years:
    (i) 2019 and 2020: 20 percent
    (ii) 2021 and 2022: 35 percent
    (ii) 2023 and later: 50 percent
    (4) Partial QP patient count threshold. The Partial QP patient 
count thresholds are the following values for the indicated payment 
years:
    (i) 2019 and 2020: 10 percent
    (ii) 2021 and 2022: 25 percent
    (iii) 2023 and later: 35 percent
    (b) All-Payer Combination Option--(1) QP payment amount threshold.
    (i) The QP payment amount thresholds are the following values for 
the indicated payment years:
    (A) 2021 and 2022: 50 percent.
    (B) 2023 and later: 75 percent.
    (ii) To meet the QP payment amount threshold under this option, the 
eligible clinician must also meet a 25 percent QP payment amount 
threshold under the Medicare Option.
    (2) Partial QP payment amount threshold. (i) The Partial QP payment 
amount thresholds are the following values for the indicated payment 
years:
    (A) 2021 and 2022: 40 percent.
    (B) 2023 and later: 50 percent.
    (ii) To meet the QP payment amount threshold under this option, the 
eligible clinician must also meet a 20 percent Partial QP payment 
amount threshold under the Medicare Option.
    (3) QP patient count threshold. (i) The QP patient count thresholds 
are the following values for the indicated payment years:
    (A) 2021 and 2022: 35 percent.
    (B) 2023 and later: 50 percent.
    (ii) To meet the QP patient count threshold under this option, the 
eligible clinician must also meet a 20 percent QP patient count 
threshold under the Medicare Option.
    (4) Partial QP patient count threshold. (i) The Partial QP patient 
count thresholds are the following values for the indicated payment 
years:
    (A) 2021 and 2022: 25 percent.
    (B) 2023 and later: 35 percent.
    (ii) To meet the Partial QP patient count threshold under this 
option, the eligible clinician group or eligible clinician must also 
meet a 10 percent QP patient count threshold under the Medicare Option.


Sec.  414.1435  Qualifying APM participant determination: Medicare 
option.

    (a) Payment amount method. The Threshold Score for an Advanced APM 
Entity group or eligible clinician is calculated as a percent by 
dividing the value described under paragraph (a)(1) of this section by 
the value described under paragraph (a)(2) of this section.
    (1) Numerator. The aggregate of payments for Medicare Part B 
covered professional services furnished by the Advanced APM Entity 
group to attributed beneficiaries during the QP Performance Period.
    (2) Denominator. The aggregate of payments for Medicare Part B 
covered professional services furnished by the APM Entity group to all 
attribution-eligible beneficiaries during the QP Performance Period.
    (3) Claims and adjustments. In the calculations under paragraphs 
(a)(1) and (2) of this section, CMS compiles claims and treats claims 
adjustments, supplemental service payments, and alternative payment 
methods in the same manner as described in Sec.  414.1450.
    (b) Patient count method. The Threshold Score for each eligible 
clinician in an APM Entity group is calculated as a percent under the 
patient count method by dividing the value described under paragraph 
(b)(1) of this section by the value described under paragraph (b)(2) of 
this section.
    (1) Numerator. The number of attributed beneficiaries to whom the 
Advanced APM Entity group furnishes Medicare Part B covered 
professional services or services by a Rural Health

[[Page 77553]]

Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP 
Performance Period.
    (2) Denominator. The number of attribution-eligible beneficiaries 
to whom the APM Entity group or eligible clinician furnish Medicare 
Part B covered professional services or services by a Rural Health 
Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP 
Performance Period.
    (3) Unique beneficiaries. For each Advanced APM Entity group, a 
unique Medicare beneficiary is counted no more than one time for the 
numerator and no more than one time for the denominator.
    (4) Beneficiaries count multiple times. Based on attribution under 
the terms of an Advanced APM, a single Medicare beneficiary may be 
counted in the numerator or denominator for multiple different Advanced 
APM Entity groups.
    (c) Attribution. (1) Attributed beneficiaries are determined from 
Advanced APM attributed beneficiary lists generated by each Advanced 
APM's specific attribution methodology.
    (2) When operationally feasible, this attributed beneficiary list 
will be the final beneficiary list used for reconciliation purposes in 
the Advanced APM.
    (3) When it is not operationally feasible to use the final 
attributed beneficiary list, the attributed beneficiary list will be 
taken from the Advanced APM's most recently available attributed 
beneficiary list at the end of the QP Performance Period.
    (d) Use of methods. CMS calculates Threshold Scores for an Advanced 
APM Entity under both the payment amount and patient count methods for 
each QP Performance Period. CMS then assigns the score to the eligible 
clinicians included in the Advanced APM Entity that results in the 
greater QP status. QP status is greater than a Partial QP status, which 
is greater than no QP status.


Sec.  414.1440  Qualifying APM participant determination: All-payer 
combination option.

    (a) Payments excluded from calculations. (1) These calculations 
include a combination of both Medicare payments for Part B covered 
professional services and all other payments for all other payers, 
except for payments made by:
    (i) The Secretary of Defense for the costs of Department of Defense 
health care programs;
    (ii) The Secretary of Veterans Affairs for the cost of Department 
of Veterans Affairs health care programs; and
    (iii) Under Title XIX in a State in which no Medicaid Medical Home 
Model or APM is available.
    (2) Title XIX payments will only be included in the numerator and 
denominator as specified in paragraphs (b)(2) and (3) of this section 
for an Advanced APM Entity if:
    (i) A State has at least one Medicaid Medical Home Model or 
Medicaid APM in operation that is determined to be an Other Payer 
Advanced APM; and
    (ii) The Advanced APM Entity is eligible to participate in at least 
one of such Other Payer Advanced APMs during the QP Performance Period, 
regardless of whether the Advanced APM Entity actually participates in 
such Other Payer Advanced APMs. This will apply to both the payment 
amount and patient count methods.
    (b) Payment amount method--(1) In general. The Threshold Score for 
an Advanced APM Entity group or eligible clinician will be calculated 
by dividing the value described under the numerator by the value 
described under the denominator as specified in paragraphs (b)(2) and 
(3) of this section.
    (2) Numerator. The aggregate amount of all payments from all 
payers, except those excluded under paragraph (a) of this section, to 
the Advanced APM Entity group or eligible clinician under the terms of 
Other Payer Advanced APMs during the QP Performance Period. CMS 
calculates Medicare Part B covered professional services under the All-
Payer Combination Option in the same manner as it is calculated under 
the Medicare Option.
    (3) Denominator. The aggregate amount of all payments from all 
payers, except those excluded under paragraph (a) of this section, to 
the Advanced APM Entity group during the QP Performance Period. The 
portion of this amount that relates to Medicare Part B covered 
professional services is calculated under the All-Payer Combination 
Option in the same manner as it is calculated under the Medicare 
Option.
    (c) Patient count method--(1) In general. The Threshold Score for 
an Advanced APM Entity group or eligible clinician is calculated by 
dividing the value described under the numerator by the value described 
under the denominator as specified in paragraphs (c)(2) and (3) of this 
section).
    (2) Numerator. The number of unique patients to whom the Advanced 
APM Entity group or eligible clinician furnishes services that are 
included in the measures of aggregate expenditures used under the terms 
of all of their Other Payer Advanced APMs during the QP Performance 
Period, plus the patient count numerator specified in paragraph (a)(1) 
of this section.
    (3) Denominator. The number of unique patients to whom eligible 
clinicians in the Advanced APM Entity group furnish services under all 
non-excluded payers during the QP Performance Period.
    (d) Participation in multiple Other Payer Advanced APMs. (1) For 
each APM Entity group or eligible clinician, a unique patient is 
counted no more than one time for the numerator and no more than one 
time for the denominator for each payer.
    (2) CMS may count a single patient in the numerator and/or 
denominator for multiple different Advanced APM Entities or eligible 
clinicians.
    (3) For purposes of this section, Advanced APM Entities are 
considered the same entity across Other Payer Advanced APMs if CMS 
determines that the Participation Lists are substantially similar or if 
one entity is a subset of the other.


Sec.  414.1445  Identification of other payer advanced APMs.

    (a) Identification of Medicaid APMs. CMS will make an annual 
determination prior to the QP Performance Period to identify Medicaid 
Medical Home Models and Medicaid APMs.
    (b) Data used to calculate the Threshold Score under the All-Payer 
Combination Option. To be assessed under the All-Payer Combination 
Option, APM Entities or eligible clinicians must submit the following 
information for each other payment arrangement in a manner and by a 
date specified by CMS:
    (1) Payment arrangement information necessary to assess the other 
payer arrangement on all Other Payer Advanced APM criteria under Sec.  
414.1420;
    (2) For each other payment arrangement, the amount of revenues for 
services furnished through the arrangement, the total revenues from the 
payer, the numbers of patients furnished any service through the 
arrangement, and the total numbers of patients furnished any service 
through the payer.
    (3) An attestation from the payer that the submitted information is 
accurate.
    (c) Requirement to submit adequate information. (1) CMS makes a QP 
determination with respect to the individual eligible clinician under 
the All-Payer Combination Option if:
    (i) The eligible clinician's Advanced APM Entity submits the 
information required under this section for CMS to assess the APM 
Entity group under the All-Payer Combination Option; or
    (ii) The eligible clinician submits adequate information under this 
section.

[[Page 77554]]

    (2) If neither the Advanced APM Entity nor the eligible clinician 
submits all of the information required under this section, then CMS 
does not make a QP assessment for such eligible clinician under the 
All-Payer Combination Option.
    (d) Outcome measure. An Other Payer Advanced APM must base payment 
on at least one outcome measure.
    (1) Exception. If an Other Payer Advanced APM has no outcome 
measure, the Advanced APM Entity must submit an attestation in a manner 
and by a date determined by CMS that there is no available or 
applicable outcome measure on the MIPS list of quality measures.
    (2) [Reserved]


Sec.  414.1450  APM incentive payment.

    (a) In general. (1) CMS makes a lump sum payment to QPs in the 
amount described in paragraph (b) of this section in the manner 
described in paragraphs (d) and (e) of this section.
    (2) CMS provides notice of the amount of the APM Incentive Payment 
to QPs as soon as practicable following the calculation and validation 
of the APM Incentive Payment amount, but in any event no later than 1 
year after the incentive payment base period.
    (b) APM Incentive Payment amount. (1) The amount of the APM 
Incentive Payment is equal to 5 percent of the estimated aggregate 
payments for covered professional services as defined in section 
1848(k)(3)(A) of the Act furnished during the calendar year immediately 
preceding the payment year.
    (2) The estimated aggregate payment amount for covered professional 
services includes all such payments to any and all of the TIN/NPI 
combinations associated with the NPI of the QP.
    (3) In calculating the estimated aggregate payment amount for a QP, 
CMS uses claims submitted with dates of service from January 1 through 
December 31 of the incentive payment base period, and processing dates 
of January 1 of the base period through March 31 of the subsequent 
payment year.
    (4) The payment adjustment amounts, negative or positive, as 
described in sections 1848(m), (o), (p), and (q) of the Act are not 
included in calculating the APM Incentive Payment amount.
    (5) Incentive payments made to eligible clinicians under sections 
1833(m), (x), and (y) of the Act are not included in calculating the 
APM Incentive Payment amount.
    (6) Financial risk payments such as shared savings payments or net 
reconciliation payments are excluded from the amount of covered 
professional services in calculating the APM Incentive Payment amount.
    (7) Supplemental service payments in the amount of covered 
professional services are included in calculating the APM Incentive 
Payment amount according to this paragraph (b). Supplemental service 
payments are included in the amount of covered professional services 
when calculating the APM Incentive Payment amount when the supplemental 
service payment meets the following four criteria:
    (i) Is payment for services that constitute physicians services 
authorized under section 1832(a) and defined under section 1861(s) of 
the Act.
    (ii) Is made for only Part B services under the criterion in 
paragraph (b)(9)(i) of this section.
    (iii) Is directly attributable to services furnished to an 
individual beneficiary.
    (iv) Is directly attributable to an eligible clinician, including 
an eligible clinician that is a group of individual eligible 
clinicians.
    (8) For payment amounts that are affected by a cash flow mechanism, 
the payment amounts that would have occurred if the cash flow mechanism 
were not in place are used in calculating the APM Incentive Payment 
amount.
    (c) APM Incentive Payment recipient. (1) CMS pays the entire APM 
Incentive Payment amount to the TIN associated with the QP's 
participation in the Advanced APM entity that met the applicable QP 
threshold during the QP Performance Period.
    (2) In the event that an eligible clinician is no longer affiliated 
with the TIN associated with the QP's participation in the Advanced APM 
Entity that met the applicable QP threshold during the QP Performance 
Period at the time of the APM Incentive Payment distribution, CMS makes 
the APM Incentive Payment to the TIN listed on the eligible clinician's 
CMS-588 EFT Application form on the date that the APM Incentive Payment 
is distributed.
    (3) In the event that an eligible clinician becomes a QP through 
participation in multiple Advanced APMs, CMS divides the APM Incentive 
Payment amount between the TINs associated with the QP's participation 
in each Advanced APM during the QP Performance Period. Such payments 
will be divided in proportion to the amount of payments associated with 
each TIN that the eligible clinician received for covered professional 
services during the QP Performance Period.
    (d) Timing of the APM Incentive Payment. APM Incentive Payments 
made under this section are made as soon as practicable following the 
calculation and validation of the APM Incentive Payment amount, but in 
any event no later than 1 year after the incentive payment base period.
    (e) Treatment of APM Incentive Payment amount in APMs. (1) APM 
Incentive Payments made under this section are not included in 
determining actual expenditures under an APM.
    (2) APM Incentive Payments made under this section are not included 
in calculations for the purposes of rebasing benchmarks in an APM.
    (f) Treatment of APM Incentive Payment for other Medicare incentive 
payments and payment adjustments. APM Incentive Payments made under 
this section will not be included in determining the amount of 
incentive payment made to eligible clinicians under section 1833(m), 
(x), and (y) of the Act.


Sec.  414.1455  Limitation on review.

    There is no administrative or judicial review under sections 1869, 
1878, or otherwise, of the Act of the following:
    (a) The determination that an eligible clinician is a QP or Partial 
QP under Sec.  414.1425 and the determination that an APM Entity is an 
Advanced APM Entity under Sec.  414.1410.
    (b) The determination of the amount of the APM Incentive Payment 
under Sec.  414.1450, including any estimation as part of such 
determination.


Sec.  414.1460  Monitoring and program integrity.

    (a) Vetting eligible clinicians prior to payment of the APM 
Incentive Payment. Prior to payment of the APM Incentive Payment, CMS 
determines if eligible clinicians were in compliance with all Medicare 
conditions of participation and the terms of the relevant Advanced APMs 
in which they participate during the QP Performance Period. For QPs not 
meeting these standards there may be a reduction or denial of the APM 
Incentive Payment. A determination under this provision is not binding 
for other purposes.
    (b) Termination by Advanced APMs. CMS may reduce or deny an APM 
Incentive Payment to eligible clinicians who are terminated by APMs or 
whose Advanced APM Entities are terminated by APMs for non-compliance 
with all Medicare conditions of participation or the terms of the 
relevant Advanced APMS in which they participate during the QP 
Performance Periods.
    (c) Information submitted for All-Payer Combination Option. 
Information

[[Page 77555]]

submitted by eligible clinicians or Advanced APM Entities to meet the 
requirements of the All-Payer Combination Option may be subject to 
audit by CMS. Eligible clinicians and Advanced APM Entities must 
maintain copies of any supporting documentation related to All-Payer 
Combination Option for at least 10 years and must attest to the 
accuracy and completeness of the data submitted.
    (d) Recoupment of APM Incentive Payment. For any QPs who are 
terminated from an Advanced APM or found to be in violation of any 
Federal, State, or tribal statute, regulation, or other binding 
guidance during the QP Performance Period or Incentive Payment Base 
Period or terminated after these periods as a result of a violation 
occurring during either period, CMS may rescind such eligible 
clinicians' QP determinations and, if necessary, recoup part or all of 
any such eligible clinicians' APM Incentive Payment or deduct such 
amount from future payments to such individuals. CMS may reopen and 
recoup any payments that were made in error in accordance with 
procedures similar to those set forth at 42 CFR 405.980 and 42 CFR 
405.370 through 405.379 or established under the relevant APM. The APM 
Incentive Payment will be recouped if an audit reveals a lack of 
support for attested statements provided by eligible clinicians and 
Advanced APM Entities.
    (e) Maintenance of records. An Advanced APM Entity or eligible 
clinician that submits information to CMS under Sec.  414.1445 for 
assessment under the All-Payer Combination Option must maintain such 
books contracts, records, documents, and other evidence for a period of 
10 years from the final date of the QP Performance Period or from the 
date of completion of any audit, evaluation, or inspection, whichever 
is later, unless:
    (1) CMS determines there is a special need to retain a particular 
record or group of records for a longer period and notifies the 
Advanced APM Entity of eligible clinician at least 30 days before the 
formal disposition date; or
    (2) There has been a termination, dispute, or allegation of fraud 
or similar fault against the Advanced APM Entity or eligible clinician, 
in which case the Advanced APM Entity or eligible clinician must retain 
records for an additional 6 years from the date of any resulting final 
resolution of the termination, dispute, or allegation of fraud or 
similar fault.
    (f) OIG authority. None of the provisions of this part limit or 
restrict OIG's authority to audit, evaluate, investigate, or inspect 
the Advanced APM Entity, its eligible clinicians, and other individuals 
or entities performing functions or services related to its APM 
activities.


Sec.  414.1465  Physician-focused payment models.

    (a) Definition. A physician-focused payment model (PFPM) is an 
Alternative Payment Model:
    (1) In which Medicare is a payer;
    (2) In which eligible clinicians that are eligible professionals as 
defined in section 1848(k)(3)(B) of the Act are participants and play a 
core role in implementing the APM's payment methodology; and
    (3) Which targets the quality and costs of services that eligible 
professionals participating in the Alternative Payment Model provide, 
order, or can significantly influence.
    (b) Criteria. In carrying out its review of physician-focused 
payment model proposals, the PTAC must assess whether the physician-
focused payment model meets the following criteria for PFPMs sought by 
the Secretary. The Secretary seeks PFPMs that:
    (1) Incentives: Pay for higher-value care. (i) Value over volume: 
provide incentives to practitioners to deliver high-quality health 
care.
    (ii) Flexibility: provide the flexibility needed for practitioners 
to deliver high-quality health care.
    (iii) Quality and Cost: are anticipated to improve health care 
quality at no additional cost, maintain health care quality while 
decreasing cost, or both improve health care quality and decrease cost.
    (iv) Payment methodology: pay APM Entities with a payment 
methodology designed to achieve the goals of the PFPM Criteria. 
Addresses in detail through this methodology how Medicare, and other 
payers if applicable, pay APM Entities, how the payment methodology 
differs from current payment methodologies, and why the PFPM cannot be 
tested under current payment methodologies.
    (v) Scope: aim to broaden or expand the CMS APM portfolio by 
addressing an issue in payment policy in a new way or including APM 
Entities whose opportunities to participate in APMs have been limited.
    (vi) Ability to be evaluated: have evaluable goals for quality of 
care, cost, and any other goals of the PFPM.
    (2) Care delivery improvements: Promote better care coordination, 
protect patient safety, and encourage patient engagement. (i) 
Integration and Care Coordination: encourage greater integration and 
care coordination among practitioners and across settings where 
multiple practitioners or settings are relevant to delivering care to 
the population treated under the PFPM.
    (ii) Patient Choice: encourage greater attention to the health of 
the population served while also supporting the unique needs and 
preferences of individual patients.
    (iii) Patient Safety: aim to maintain or improve standards of 
patient safety.
    (3) Information Enhancements: Improving the availability of 
information to guide decision-making. (i) Health Information 
Technology: encourage use of health information technology to inform 
care.
    (ii) [Reserved]

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
4. The authority citation for part 495 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
5. Section 495.4 is amended by revising the definition of ``Meaningful 
EHR user'' to read as follows:


Sec.  495.4  Definitions.

* * * * *
    Meaningful EHR user means--
    (1) Subject to paragraph (3) of this definition, an EP, eligible 
hospital or CAH that, for an EHR reporting period for a payment year or 
payment adjustment year, demonstrates in accordance with Sec.  495.40 
meaningful use of certified EHR technology by meeting the applicable 
objectives and associated measures under Sec. Sec.  495.20, 495.22, and 
495.24, supporting information exchange and the prevention of health 
information blocking and engaging in activities related to supporting 
providers with the performance of CEHRT, and successfully reporting the 
clinical quality measures selected by CMS to CMS or the States, as 
applicable, in the form and manner specified by CMS or the States, as 
applicable; and
    (2)(i) Except as specified in paragraph (2)(ii) of this definition, 
a Medicaid EP or Medicaid eligible hospital, that meets the 
requirements of paragraph (1) of this definition and any additional 
criteria for meaningful use imposed by the State and approved by CMS 
under Sec. Sec.  495.316 and 495.332.
    (ii) An eligible hospital or CAH is deemed to be a meaningful EHR 
user for purposes of receiving an incentive payment under subpart D of 
this part, if the hospital participates in both the Medicare and 
Medicaid EHR incentive programs, and the hospital meets the

[[Page 77556]]

requirements of paragraph (1) of this definition.
    (3) To be considered a meaningful EHR user, at least 50 percent of 
an EP's patient encounters during an EHR reporting period for a payment 
year (or, in the case of a payment adjustment year, during an 
applicable EHR reporting period for such payment adjustment year) must 
occur at a practice/location or practices/locations equipped with 
certified EHR technology.
* * * * *

0
6. Section 495.40 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Revising paragraphs (a)(2)(i)(E) and (F);
0
c. Adding paragraphs (a)(2)(i)(G), (H), and (I);
0
d. Revising paragraph (b) introductory text; and
0
e. Adding paragraphs (b)(2)(i)(H) and (I).
    The revisions and additions read as follows:


Sec.  495.40  Demonstration of meaningful use criteria.

    (a) Demonstration by EPs. An EP must demonstrate that he or she 
satisfies each of the applicable objectives and associated measures 
under Sec.  495.20 or Sec.  495.24, supports information exchange and 
the prevention of health information blocking, and engages in 
activities related to supporting providers with the performance of 
CEHRT:
* * * * *
    (2) * * *
    (i) * * *
    (E) For CY 2015 and 2016, satisfied the required objectives and 
associated measures under Sec.  495.22(e) for meaningful use.
    (F) For CY 2017, the EP may satisfy either the objectives and 
measures specified in Sec.  495.22(e), or the objectives and measures 
specified in Sec.  495.24(d).
    (G) For CY 2018 and subsequent years, satisfied the required 
objectives and associated measures under Sec.  495.24(d) for meaningful 
use.
    (H) Supporting providers with the performance of CEHRT (SPPC). To 
engage in activities related to supporting providers with the 
performance of CEHRT, the EP--
    (1) Must attest that he or she:
    (i) Acknowledges the requirement to cooperate in good faith with 
ONC direct review of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC direct review is received; and
    (ii) If requested, cooperated in good faith with ONC direct review 
of his or her health information technology 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, including by permitting timely access to 
such technology and demonstrating its capabilities as implemented and 
used by the EP in the field.
    (2) Optionally, may also attest that he or she:
    (i) Acknowledges the option to cooperate in good faith with ONC-ACB 
surveillance of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC-ACB surveillance is received; and
    (ii) If requested, cooperated in good faith with ONC-ACB 
surveillance of his or her health information technology 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, including by permitting 
timely access to such technology and demonstrating capabilities as 
implemented and used by the EP in the field.
    (I) Support for health information exchange and the prevention of 
information blocking. For an EHR reporting period in CY 2017 and 
subsequent years, the EP must attest that he or she--
    (1) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (2) 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--
    (i) Connected in accordance with applicable law;
    (ii) Compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, 
and certification criteria adopted at 45 CFR part 170;
    (iii) Implemented in a manner that allowed for timely access by 
patients to their electronic health information; and
    (iv) 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.
    (3) 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.
* * * * *
    (b) Demonstration by Eligible Hospitals and CAHs. An eligible 
hospital or CAH must demonstrate that it satisfies each of the 
applicable objectives and associated measures under Sec.  495.20 or 
Sec.  495.24, supports information exchange and the prevention of 
health information blocking, and engages in activities related to 
supporting providers with the performance of CEHRT, as follows:
* * * * *
    (2) * * *
    (i) * * *
    (H) Supporting providers with the performance of CEHRT (SPPC). To 
engage in activities related to supporting providers with the 
performance of CEHRT, the eligible hospital or CAH--
    (1) Must attest that it:
    (i) Acknowledges the requirement to cooperate in good faith with 
ONC direct review of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC direct review is received; and
    (ii) If requested, cooperated in good faith with ONC direct review 
of its health information technology 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, including by permitting timely access to such 
technology and demonstrating its capabilities as implemented and used 
by the eligible hospital or CAH in the field.
    (2) Optionally, may attest that it:
    (i) Acknowledges the option to cooperate in good faith with ONC-ACB 
surveillance of his or her health information technology certified 
under the ONC Health IT Certification Program if a request to assist in 
ONC-ACB surveillance is received; and
    (ii) If requested, cooperated in good faith with ONC-ACB 
surveillance of his or her health information technology 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, including by permitting 
timely access to

[[Page 77557]]

such technology and demonstrating its capabilities as implemented and 
used by the eligible hospital or CAH in the field.
    (I) Support for health information exchange and the prevention of 
information blocking. For an EHR reporting period in CY 2017 and 
subsequent years, the eligible hospital or CAH must attest that it--
    (1) Did not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of certified EHR technology.
    (2) 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--
    (i) Connected in accordance with applicable law;
    (ii) Compliant with all standards applicable to the exchange of 
information, including the standards, implementation specifications, 
and certification criteria adopted at 45 CFR part 170;
    (iii) Implemented in a manner that allowed for timely access by 
patients to their electronic health information; and
    (iv) 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.
    (3) 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.
* * * * *

0
7. Section 495.102 is amended by revising paragraph (d)(1), (d)(2)(iv) 
and (d)(3) to read as follows:


Sec.  495.102  Incentive payments to EPs.

* * * * *
    (d) * * *
    (1) Subject to paragraphs (d)(3) and (4) of this section, for CY 
2015 through the end of CY 2018, for covered professional services 
furnished by an EP who is not hospital-based, and who is not a 
qualifying EP by virtue of not being a meaningful EHR user (for the EHR 
reporting period applicable to the payment adjustment year), the 
payment amount for such services is equal to the product of the 
applicable percent specified in paragraph (d)(2) of this section and 
the Medicare physician fee schedule amount for such services.
    (2) * * *
    (iv) For 2018, 97 percent, except as provided in paragraph (d)(3) 
of this section.
    (3) Decrease in applicable percent in certain circumstances. In CY 
2018, if the Secretary finds that the proportion of EPs who are 
meaningful EHR users is less than 75 percent, the applicable percent 
must be decreased by 1 percentage point for EPs from the applicable 
percent in the preceding year.
* * * * *

0
8. Section 495.316 is amended by revising paragraph (g)(2) and adding 
paragraph (g)(3) to read as follows:


Sec.  495.316  State monitoring and reporting regarding activities 
required to receive an incentive payment.

* * * * *
    (g) * * *
    (2) Subject to paragraph (h)(2) of this section, provider-level 
attestation data for each eligible hospital that attests to 
demonstrating meaningful use for each payment year beginning with 2013.
    (3) Subject to paragraph (h)(2) of this section, provider-level 
attestation data for each eligible EP that attests to demonstrating 
meaningful use for each payment year beginning with 2013 and ending 
after 2016.
* * * * *

    Dated: October 5, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 13, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.

    Note: The following Appendix will not appear in the Code of 
Federal Regulations.

Appendix

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    NOTE: ``TABLE C: Individual Quality Cross-Cutting Measures for 
the MIPS to Be Available to Meet the Reporting Criteria Via Claims, 
Registry, and EHR Beginning in 2017'' has been removed per policy 
change--See (add reference) for Rationale]

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[FR Doc. 2016-25240 Filed 10-19-16; 4:15 pm]
BILLING CODE 4120-01-P