[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 
mea